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You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 35 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................
6 D. Resource Management (2.4) ......................................................................................................
....7 E. Internal Communication (2.5) ...................................................................................................
...7 F. Management Review (2.6) .......................................................................................................
.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................
7 H. Management of Change in Product Ownership (2.8) .................................................................
8 IV. CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (3) ............................................................................................... 8 A. Lifecycle Stage Goals (3.1) ............................................................................................................
8 B. Pharmaceutical Quality Syst em Elements (3.2) ..........................................................................
9 V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (4) ....................................................................................................................
13 A. Management Review of the Pharmac eutical Quality System (4.1) ..........................................
13 B. Monitoring of Internal and External Fa ctors That Can Have an Impacton the Pharmaceutical Quality System (4.2) .........................................................................................
13 C. Outcomes of Management Review and Monitoring (4.3) ......................................................... 14 VI.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Management Review of the Pharmac eutical Quality S...'?",
"reference": "Management Review of the Pharmac eutical Quality System (4.1) ..........................................\n13 B.",
"options": {
"D": "Management Review of the Pharmac",
"A": "6 D. Resource Management",
"B": "E. Internal Communication",
"C": "13 A. Management Review"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Management Review of the Pharmac eutical Quality System (____) ..........................................\n13 B.",
"reference": "Management Review of the Pharmac eutical Quality System (4.1) ..........................................\n13 B.",
"options": {
"C": "4.1",
"A": "2.2",
"B": "2.3",
"D": "13 A. Management Review"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Management Review of the Pharmac eutical Quality System (4.1) ..........................................\n____ B.",
"reference": "Management Review of the Pharmac eutical Quality System (4.1) ..........................................\n13 B.",
"options": {
"D": "13",
"A": "2.2",
"B": "2.3",
"C": "8 B. Pharmaceutical Quality Syst em Elements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Pharmaceutical Quality Syst em Elements (____) ..........................................................................\n9 V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (4) ....................................................................................................................\n13 A.",
"reference": "Pharmaceutical Quality Syst em Elements (3.2) ..........................................................................\n9 V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (4) ....................................................................................................................\n13 A.",
"options": {
"D": "3.2",
"A": "2.2",
"B": "2.3",
"C": "13 A. Management Review"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Pharmaceutical Quality Syst em Elements (3.2) ..........................................................................\n____ V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (4) ....................................................................................................................\n13 A.",
"reference": "Pharmaceutical Quality Syst em Elements (3.2) ..........................................................................\n9 V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (4) ....................................................................................................................\n13 A.",
"options": {
"B": "9",
"A": "2.2",
"C": "2.3",
"D": "13 A. Management Review"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Pharmaceutical Quality Syst em Elements (3.2) ..........................................................................\n9 V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (____) ....................................................................................................................\n13 A.",
"reference": "Pharmaceutical Quality Syst em Elements (3.2) ..........................................................................\n9 V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (4) ....................................................................................................................\n13 A.",
"options": {
"A": "4",
"B": "2.2",
"C": "2.3",
"D": "13 A. Management Review"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Pharmaceutical Quality Syst em Elements (3.2) ..........................................................................\n9 V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (4) ....................................................................................................................\n____ A.",
"reference": "Pharmaceutical Quality Syst em Elements (3.2) ..........................................................................\n9 V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (4) ....................................................................................................................\n13 A.",
"options": {
"C": "13",
"A": "2.2",
"B": "2.3",
"D": "8 B. Pharmaceutical Quality Syst em Elements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND P...'?",
"reference": "CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (3) ............................................................................................... 8 A. Lifecycle Stage Goals (3.1) ............................................................................................................\n8 B.",
"options": {
"C": "CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE",
"A": "6 D. Resource Management",
"B": "E. Internal Communication",
"D": "13 A. Management Review"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND P...'?",
"reference": "CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (3) ............................................................................................... 8 A. Lifecycle Stage Goals (3.1) ............................................................................................................\n8 B.",
"options": {
"D": "8 B.",
"A": "13 A. Management Review",
"B": "7 F. Management Review",
"C": "CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (____) ............................................................................................... 8 A. Lifecycle Stage Goals (3.1) ............................................................................................................\n8 B.",
"reference": "CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (3) ............................................................................................... 8 A. Lifecycle Stage Goals (3.1) ............................................................................................................\n8 B.",
"options": {
"B": "3",
"A": "2.2",
"C": "2.3",
"D": "8 B. Pharmaceutical Quality Syst em Elements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (3) ............................................................................................... ____ A. Lifecycle Stage Goals (3.1) ............................................................................................................\n8 B.",
"reference": "CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (3) ............................................................................................... 8 A. Lifecycle Stage Goals (3.1) ............................................................................................................\n8 B.",
"options": {
"B": "8",
"A": "2.2",
"C": "2.3",
"D": "13 A. Management Review"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (3) ............................................................................................... 8 A. Lifecycle Stage Goals (____) ............................................................................................................\n8 B.",
"reference": "CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (3) ............................................................................................... 8 A. Lifecycle Stage Goals (3.1) ............................................................................................................\n8 B.",
"options": {
"D": "3.1",
"A": "2.2",
"B": "2.3",
"C": "13 A. Management Review"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Quality Policy (2.2) ................................'?",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"D": "6 D. Resource Management",
"A": "2.2",
"B": "2.3",
"C": "13 A. Management Review"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Quality Policy (2.2) ................................'?",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"C": "E. Internal Communication",
"A": "6 D. Resource Management",
"B": "7 F. Management Review",
"D": "13 A. Management Review"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Quality Policy (2.2) ................................'?",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"A": "7 F. Management Review",
"B": "6 D. Resource Management",
"C": "E. Internal Communication",
"D": "13 A. Management Review"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Quality Policy (2.2) ................................'?",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"C": "7 H. Management of Change",
"A": "6 D. Resource Management",
"B": "E. Internal Communication",
"D": "13 A. Management Review"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality Policy (____) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"D": "2.2",
"A": "2.3",
"B": "2.4",
"C": "13 A. Management Review"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality Policy (2.2) ......................................................................................................................... ____ C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"C": "6",
"A": "2.2",
"B": "2.3",
"D": "13 A. Management Review"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (____)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"B": "2.3",
"A": "2.2",
"C": "2.4",
"D": "13 A. Management Review"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality Policy (2.2) ......................................................................................................................... ____ C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"B": "6",
"A": "2.2",
"C": "2.3",
"D": "13 A. Management Review"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (____) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"A": "2.4",
"B": "2.2",
"C": "2.3",
"D": "13 A. Management Review"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....____ E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"D": "7",
"A": "2.2",
"B": "2.3",
"C": "13 A. Management Review"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (____) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"B": "2.5",
"A": "2.2",
"C": "2.3",
"D": "13 A. Management Review"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Pharmaceutical Quality Syst em Elements (____) ..........................................................................\n9 V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (4) ....................................................................................................................\n13 A.",
"reference": "Pharmaceutical Quality Syst em Elements (3.2) ..........................................................................\n9 V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (4) ....................................................................................................................\n13 A.",
"options": {
"B": "3.2",
"A": "2.2",
"C": "2.3",
"D": "13 A. Management Review"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Pharmaceutical Quality Syst em Elements (3.2) ..........................................................................\n____ V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (4) ....................................................................................................................\n13 A.",
"reference": "Pharmaceutical Quality Syst em Elements (3.2) ..........................................................................\n9 V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (4) ....................................................................................................................\n13 A.",
"options": {
"C": "9",
"A": "2.2",
"B": "2.3",
"D": "13 A. Management Review"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Pharmaceutical Quality Syst em Elements (3.2) ..........................................................................\n9 V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (____) ....................................................................................................................\n13 A.",
"reference": "Pharmaceutical Quality Syst em Elements (3.2) ..........................................................................\n9 V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (4) ....................................................................................................................\n13 A.",
"options": {
"A": "4",
"B": "2.2",
"C": "2.3",
"D": "13 A. Management Review"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Pharmaceutical Quality Syst em Elements (3.2) ..........................................................................\n9 V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (4) ....................................................................................................................\n____ A.",
"reference": "Pharmaceutical Quality Syst em Elements (3.2) ..........................................................................\n9 V. CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM (4) ....................................................................................................................\n13 A.",
"options": {
"B": "13",
"A": "2.2",
"C": "2.3",
"D": "8 B. Pharmaceutical Quality Syst em Elements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Management Review of the Pharmac eutical Quality S...'?",
"reference": "Management Review of the Pharmac eutical Quality System (4.1) ..........................................\n13 B.",
"options": {
"D": "Management Review of the Pharmac",
"A": "6 D. Resource Management",
"B": "E. Internal Communication",
"C": "13 A. Management Review"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Management Review of the Pharmac eutical Quality System (____) ..........................................\n13 B.",
"reference": "Management Review of the Pharmac eutical Quality System (4.1) ..........................................\n13 B.",
"options": {
"B": "4.1",
"A": "2.2",
"C": "2.3",
"D": "13 A. Management Review"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Management Review of the Pharmac eutical Quality System (4.1) ..........................................\n____ B.",
"reference": "Management Review of the Pharmac eutical Quality System (4.1) ..........................................\n13 B.",
"options": {
"D": "13",
"A": "2.2",
"B": "2.3",
"C": "8 B. Pharmaceutical Quality Syst em Elements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Quality Policy (2.2) ................................'?",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"D": "6 D. Resource Management",
"A": "2.2",
"B": "2.3",
"C": "13 A. Management Review"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Quality Policy (2.2) ................................'?",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"C": "E. Internal Communication",
"A": "6 D. Resource Management",
"B": "7 F. Management Review",
"D": "13 A. Management Review"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Quality Policy (2.2) ................................'?",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"D": "7 F. Management Review",
"A": "6 D. Resource Management",
"B": "E. Internal Communication",
"C": "13 A. Management Review"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Quality Policy (2.2) ................................'?",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"B": "7 H. Management of Change",
"A": "6 D. Resource Management",
"C": "E. Internal Communication",
"D": "13 A. Management Review"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality Policy (____) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"reference": "Quality Policy (2.2) ......................................................................................................................... 6 C. Quality Planning (2.3)....................................................................................................................\n6 D. Resource Management (2.4) ......................................................................................................\n....7 E. Internal Communication (2.5) ...................................................................................................\n...7 F. Management Review (2.6) .......................................................................................................\n.....7 G. Management of Outsourced Activities and Purchased Materials (2.7)....................................\n7 H. Management of Change in Product Ownership (2.8) .................................................................\n8 IV.",
"options": {
"D": "2.2",
"A": "2.3",
"B": "2.4",
"C": "13 A. Management Review"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 40 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
When generated to satisfy a CGMP requirement , all data become a CGMP record.14 You must document, or save, the data at the time of performance to create a record in compliance with CGMP requirements , including, but not limited to, 211.100(b) and 211.160(a) . FDA expects processes to be designed so that data required to be created and maintained cannot be modified witho ut a record of the modification . For example, chromatographic data should be saved to durable media upon completion of each step or injection (e.g., peak integration or processing steps; finished, incomplete , or aborted injections) instead of at the end of an injection set, and changes to the chromatographic data or injection sequence should be documented in an audit trail. Aborted or incomplete injections should be captured in audit trails and should be investigated and justified . It is not acceptable to record data on pieces of paper that will be discarded after the data are transcribed to a permanent laboratory notebook ( see 211.100(b), 211.160(a), and 211.180(d)). Similarly, it is not acceptable to store electronic records in a manner that allows for manipulation without creating a permanent record . You may employ a combination of technical and procedural controls to meet CGMP documentation practices for electronic systems. For example, a computer system, such as a Laboratory Information Management System (LIMS) or an Electronic Batch Record (EBR) system , can be designed to automatically save after each entry. This would be similar to indelibly recording each entry contemporaneously on a paper batch record to satisfy CGMP requirements . The computer system describ ed above could be combined with a procedure requiring data be keyed in or otherwise entered immediately when generated . For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'For PET drugs, see the Laboratory Controls section...'?",
"reference": "For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"D": "PET",
"A": "CGMP",
"B": "chromatographic data",
"C": "the chromatographic data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For PET drugs, see the Laboratory Controls section...'?",
"reference": "For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"B": "Laboratory Controls",
"A": "chromatographic data",
"C": "the chromatographic data",
"D": "PET"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For PET drugs, see the Laboratory Controls section...'?",
"reference": "For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"A": "PET Drugs ",
"B": "CGMP",
"C": "chromatographic data",
"D": "the chromatographic data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For PET drugs, see the Laboratory Controls section...'?",
"reference": "For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "Laboratory Information Management System",
"C": "chromatographic data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA expects processes to be designed so that data ...'?",
"reference": "FDA expects processes to be designed so that data required to be created and maintained cannot be modified witho ut a record of the modification .",
"options": {
"C": "FDA",
"A": "CGMP",
"B": "chromatographic data",
"D": "the chromatographic data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This would be similar to indelibly recording each ...'?",
"reference": "This would be similar to indelibly recording each entry contemporaneously on a paper batch record to satisfy CGMP requirements .",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "Laboratory Information Management System",
"D": "chromatographic data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For example, a computer system, such as a Laborato...'?",
"reference": "For example, a computer system, such as a Laboratory Information Management System (LIMS) or an Electronic Batch Record (EBR) system , can be designed to automatically save after each entry.",
"options": {
"D": "Laboratory Information Management System",
"A": "CGMP",
"B": "chromatographic data",
"C": "the chromatographic data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'For example, a computer system, such as a Laborato...'?",
"reference": "For example, a computer system, such as a Laboratory Information Management System (LIMS) or an Electronic Batch Record (EBR) system , can be designed to automatically save after each entry.",
"options": {
"A": "an Electronic Batch Record",
"B": "chromatographic data",
"C": "the chromatographic data",
"D": "Laboratory Information Management System"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For PET drugs, see the Laboratory Controls section...'?",
"reference": "For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"A": "PET",
"B": "CGMP",
"C": "chromatographic data",
"D": "the chromatographic data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For PET drugs, see the Laboratory Controls section...'?",
"reference": "For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"B": "Laboratory Controls",
"A": "chromatographic data",
"C": "the chromatographic data",
"D": "PET"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'It is not acceptable to record data on pieces of p...'?",
"reference": "It is not acceptable to record data on pieces of paper that will be discarded after the data are transcribed to a permanent laboratory notebook ( see 211.100(b), 211.160(a), and 211.180(d)).",
"options": {
"C": "211.160(a",
"A": "211.100(b",
"B": "chromatographic data",
"D": "the chromatographic data"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This would be similar to indelibly recording each ...'?",
"reference": "This would be similar to indelibly recording each entry contemporaneously on a paper batch record to satisfy CGMP requirements .",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "Laboratory Information Management System",
"C": "chromatographic data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA expects processes to be designed so that data ...'?",
"reference": "FDA expects processes to be designed so that data required to be created and maintained cannot be modified witho ut a record of the modification .",
"options": {
"A": "FDA",
"B": "CGMP",
"C": "chromatographic data",
"D": "the chromatographic data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This would be similar to indelibly recording each ...'?",
"reference": "This would be similar to indelibly recording each entry contemporaneously on a paper batch record to satisfy CGMP requirements .",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "Laboratory Information Management System",
"D": "chromatographic data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For PET drugs, see the Laboratory Controls section...'?",
"reference": "For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"D": "PET",
"A": "CGMP",
"B": "chromatographic data",
"C": "the chromatographic data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For PET drugs, see the Laboratory Controls section...'?",
"reference": "For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"D": "Laboratory Controls",
"A": "chromatographic data",
"B": "the chromatographic data",
"C": "PET"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For PET drugs, see the Laboratory Controls section...'?",
"reference": "For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"A": "PET Drugs ",
"B": "CGMP",
"C": "chromatographic data",
"D": "the chromatographic data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For PET drugs, see the Laboratory Controls section...'?",
"reference": "For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "Laboratory Information Management System",
"D": "chromatographic data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA expects processes to be designed so that data ...'?",
"reference": "FDA expects processes to be designed so that data required to be created and maintained cannot be modified witho ut a record of the modification .",
"options": {
"C": "FDA",
"A": "CGMP",
"B": "chromatographic data",
"D": "the chromatographic data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'You may employ a combination of technical and proc...'?",
"reference": "You may employ a combination of technical and procedural controls to meet CGMP documentation practices for electronic systems.",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "Laboratory Information Management System",
"D": "chromatographic data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA expects processes to be designed so that data ...'?",
"reference": "FDA expects processes to be designed so that data required to be created and maintained cannot be modified witho ut a record of the modification .",
"options": {
"A": "FDA",
"B": "CGMP",
"C": "chromatographic data",
"D": "the chromatographic data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA expects processes to be designed so that data ...'?",
"reference": "FDA expects processes to be designed so that data required to be created and maintained cannot be modified witho ut a record of the modification .",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "chromatographic data",
"C": "the chromatographic data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This would be similar to indelibly recording each ...'?",
"reference": "This would be similar to indelibly recording each entry contemporaneously on a paper batch record to satisfy CGMP requirements .",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "Laboratory Information Management System",
"C": "chromatographic data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For PET drugs, see the Laboratory Controls section...'?",
"reference": "For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"B": "PET",
"A": "CGMP",
"C": "chromatographic data",
"D": "the chromatographic data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For PET drugs, see the Laboratory Controls section...'?",
"reference": "For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"C": "Laboratory Controls",
"A": "chromatographic data",
"B": "the chromatographic data",
"D": "PET"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For PET drugs, see the Laboratory Controls section...'?",
"reference": "For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"C": "PET Drugs ",
"A": "CGMP",
"B": "chromatographic data",
"D": "the chromatographic data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For PET drugs, see the Laboratory Controls section...'?",
"reference": "For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "Laboratory Information Management System",
"C": "chromatographic data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'It is not acceptable to record data on pieces of p...'?",
"reference": "It is not acceptable to record data on pieces of paper that will be discarded after the data are transcribed to a permanent laboratory notebook ( see 211.100(b), 211.160(a), and 211.180(d)).",
"options": {
"B": "211.160(a",
"A": "211.100(b",
"C": "chromatographic data",
"D": "the chromatographic data"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When generated to satisfy a CGMP requirement , all...'?",
"reference": "When generated to satisfy a CGMP requirement , all data become a CGMP record.14 You must document, or save, the data at the time of performance to create a record in compliance with CGMP requirements , including, but not limited to, 211.100(b) and 211.160(a) .",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "Laboratory Information Management System",
"D": "chromatographic data"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When generated to satisfy a CGMP requirement , all...'?",
"reference": "When generated to satisfy a CGMP requirement , all data become a CGMP record.14 You must document, or save, the data at the time of performance to create a record in compliance with CGMP requirements , including, but not limited to, 211.100(b) and 211.160(a) .",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "Laboratory Information Management System",
"C": "chromatographic data"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA expects processes to be designed so that data ...'?",
"reference": "FDA expects processes to be designed so that data required to be created and maintained cannot be modified witho ut a record of the modification .",
"options": {
"A": "FDA",
"B": "CGMP",
"C": "chromatographic data",
"D": "the chromatographic data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This would be similar to indelibly recording each ...'?",
"reference": "This would be similar to indelibly recording each entry contemporaneously on a paper batch record to satisfy CGMP requirements .",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "Laboratory Information Management System",
"D": "chromatographic data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA expects processes to be designed so that data ...'?",
"reference": "FDA expects processes to be designed so that data required to be created and maintained cannot be modified witho ut a record of the modification .",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "chromatographic data",
"C": "the chromatographic data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For example, a computer system, such as a Laborato...'?",
"reference": "For example, a computer system, such as a Laboratory Information Management System (LIMS) or an Electronic Batch Record (EBR) system , can be designed to automatically save after each entry.",
"options": {
"B": "Laboratory Information Management System",
"A": "CGMP",
"C": "chromatographic data",
"D": "the chromatographic data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'For example, a computer system, such as a Laborato...'?",
"reference": "For example, a computer system, such as a Laboratory Information Management System (LIMS) or an Electronic Batch Record (EBR) system , can be designed to automatically save after each entry.",
"options": {
"D": "an Electronic Batch Record",
"A": "chromatographic data",
"B": "the chromatographic data",
"C": "Laboratory Information Management System"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'It is not acceptable to record data on pieces of p...'?",
"reference": "It is not acceptable to record data on pieces of paper that will be discarded after the data are transcribed to a permanent laboratory notebook ( see 211.100(b), 211.160(a), and 211.180(d)).",
"options": {
"D": "211.160(a",
"A": "211.100(b",
"B": "chromatographic data",
"C": "the chromatographic data"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For example, a computer system, such as a Laborato...'?",
"reference": "For example, a computer system, such as a Laboratory Information Management System (LIMS) or an Electronic Batch Record (EBR) system , can be designed to automatically save after each entry.",
"options": {
"B": "Laboratory Information Management System",
"A": "CGMP",
"C": "chromatographic data",
"D": "the chromatographic data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'For example, a computer system, such as a Laborato...'?",
"reference": "For example, a computer system, such as a Laboratory Information Management System (LIMS) or an Electronic Batch Record (EBR) system , can be designed to automatically save after each entry.",
"options": {
"A": "an Electronic Batch Record",
"B": "chromatographic data",
"C": "the chromatographic data",
"D": "Laboratory Information Management System"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When generated to satisfy a CGMP requirement , all...'?",
"reference": "When generated to satisfy a CGMP requirement , all data become a CGMP record.14 You must document, or save, the data at the time of performance to create a record in compliance with CGMP requirements , including, but not limited to, 211.100(b) and 211.160(a) .",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "Laboratory Information Management System",
"C": "chromatographic data"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When generated to satisfy a CGMP requirement , all...'?",
"reference": "When generated to satisfy a CGMP requirement , all data become a CGMP record.14 You must document, or save, the data at the time of performance to create a record in compliance with CGMP requirements , including, but not limited to, 211.100(b) and 211.160(a) .",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "Laboratory Information Management System",
"D": "chromatographic data"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 4 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Alan Kusinitz, Software Validation , Current Issues in Medical Device Quality Systems, Association for the Advancement of Medical Instrumentation, 1997. ISBN 1-57020-075-0. Nancy G. Leveson, Safeware, System Safety and Computers , Addison-Wesley Publishing Company, 1995. ISBN 0-201-11972-2. Michael R. Lyu, Editor, Handbook of Software Reliability Engineering , IEEE Computer Society Press, McGraw-Hill, 1996. ISBN 0-07-039400-8. Steven R. Mallory, Software Development and Quality Assurance for the Healthcare Manufacturing Industries , Interpharm Press,Inc., 1994. ISBN 0-935184-58-9. Brian Marick, The Craft of Software Testing , Prentice Hall PTR, 1995. ISBN 0-13-177411-5. Steve McConnell, Rapid Development , Microsoft Press, 1996. ISBN 1-55615-900-5. Glenford J. Myers, The Art of Software Testing , John Wiley Sons, 1979. ISBN 0-471-04328-1. Peter G. Neumann, Computer Related Risks , ACM Press/Addison-Wesley Publishing Co., 1995. ISBN 0-201-55805-X. Daniel Olivier, Conducting Software Audits, Auditing Software for Conformance to FDA Requirements , Computer Application Specialists, San Diego, CA, 1994. William Perry, Effective Methods for Software Testing , John Wiley Sons, Inc. 1995. ISBN 0- 471-06097-6. William E. Perry, Randall W. Rice, Surviving the Top Ten Challenges of Software Testing , Dorset Page 42General Principles of Software Validation Guidance for Industry and FDA Staff House Publishing, 1997. ISBN 0-932633-38-2. Roger S. Pressman, Software Engineering, A Practitioner's Approach , Third Edition, McGraw-Hill Inc., 1992. ISBN 0-07-050814-3. Roger S. Pressman, A Managers Guide to Software Engineering , McGraw-Hill Inc., 1993 ISBN 0-07-050820-8. A. P. Sage, J. D. Palmer , Software Systems Engineering , John Wiley Sons, 1990. Joc Sanders, Eugene Curran, Software Quality , Addison-Wesley Publishing Co., 1994. ISBN 0- 201-63198-9.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Who is mentioned in the context: 'Glenford J. Myers, The Art of Software Testing , J...'?",
"reference": "Glenford J. Myers, The Art of Software Testing , John Wiley Sons, 1979.",
"options": {
"C": "Glenford J. Myers",
"A": "Alan Kusinitz",
"B": "Nancy G. Leveson",
"D": "Software Systems Engineering"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Glenford J. Myers, The Art of Software Testing , J...'?",
"reference": "Glenford J. Myers, The Art of Software Testing , John Wiley Sons, 1979.",
"options": {
"B": "The Art of Software Testing",
"A": "Software Systems Engineering",
"C": "Software Reliability Engineering",
"D": "Glenford J. Myers"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Glenford J. Myers, The Art of Software Testing , J...'?",
"reference": "Glenford J. Myers, The Art of Software Testing , John Wiley Sons, 1979.",
"options": {
"D": "John Wiley Sons",
"A": "Alan Kusinitz",
"B": "Nancy G. Leveson",
"C": "Software Systems Engineering"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Glenford J. Myers, The Art of Software Testing , J...'?",
"reference": "Glenford J. Myers, The Art of Software Testing , John Wiley Sons, 1979.",
"options": {
"D": "1979",
"A": "1997",
"B": "1995",
"C": "Software Systems Engineering"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 4 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Is it acceptable to retain paper printouts or static records instead of original 260 electronic records from stand -alone computerized laboratory instruments, 261 such as an FT -IR instrum ent? 262 263 A paper printout or static record may satisfy retention requirements if it is a complete 264 copy of the original record ( see 211.68(b) , 211.188, 211.194, and 212.60). For 265 example, pH meters and balances may create a paper printout or static image du ring data 266 acquisition as the original record. In this case , the paper printout or static image created 267 during acquisition, or a true copy , should be retained ( 211.180). 268 269 However, electronic records from certain types of laboratory instruments are dynamic 270 records, and a printout or a static record does not preserve the dynamic format which is 271 part of the complete original record. For example, the spectral file created by FT -IR 272 (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or 273 printout is fixed, which would not satisfy CGMP requirements to retain original records 274 or true copies ( 211.180(d)) . Also, if the full spectrum is not displayed, contaminants 275 may be excluded. 276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported. 280 281 For PET drugs, see the guidance for industry PET Drugs Current Good Manufacturing 282 Practice (CGMP) for discussion of e quipment and l aboratory c ontrols, including 283 regulatory r equirements for records . 284 285 Contains Nonbinding Recommendations Draft Not for Implementation 8 11. Can electronic signatures be used instead of handwritten signatures for 286 master production and control records?
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: ____ 263 A paper printout or static record may satisfy retention requirements if it is a complete 264 copy of the original record ( see 211.68(b) , 211.188, 211.194, and 212.60).",
"reference": "262 263 A paper printout or static record may satisfy retention requirements if it is a complete 264 copy of the original record ( see 211.68(b) , 211.188, 211.194, and 212.60).",
"options": {
"C": "262",
"A": "260",
"B": "261",
"D": "a paper printout or static image du ring data 266 acquisition"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 262 ____ A paper printout or static record may satisfy retention requirements if it is a complete 264 copy of the original record ( see 211.68(b) , 211.188, 211.194, and 212.60).",
"reference": "262 263 A paper printout or static record may satisfy retention requirements if it is a complete 264 copy of the original record ( see 211.68(b) , 211.188, 211.194, and 212.60).",
"options": {
"D": "263",
"A": "260",
"B": "261",
"C": "a paper printout or static image du ring data 266 acquisition"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 262 263 A paper printout or static record may satisfy retention requirements if it is a complete ____ copy of the original record ( see 211.68(b) , 211.188, 211.194, and 212.60).",
"reference": "262 263 A paper printout or static record may satisfy retention requirements if it is a complete 264 copy of the original record ( see 211.68(b) , 211.188, 211.194, and 212.60).",
"options": {
"B": "264",
"A": "260",
"C": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 262 263 A paper printout or static record may satisfy retention requirements if it is a complete 264 copy of the original record ( see 211.68(b) , ____, 211.194, and 212.60).",
"reference": "262 263 A paper printout or static record may satisfy retention requirements if it is a complete 264 copy of the original record ( see 211.68(b) , 211.188, 211.194, and 212.60).",
"options": {
"C": "211.188",
"A": "260",
"B": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
The software design specification is a description of what the software should do and how it should do it. Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information. The completed software design specification constrains the programmer/coder to stay within the intent of the agreed upon requirements and design. A complete software design specification will relieve the programmer from the need to make ad hoc design decisions. The software design needs to address human factors. Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is one of the most persistent and critical problems encountered by FDA. Frequently, the design of the software is a factor in such use errors. Human factors engineering should be woven into the entire design and development process, including the device design requirements, analyses, and tests. Device safety and usability issues should be considered when developing flowcharts, state diagrams, prototyping tools, and test plans. Also, task and function analyses, risk analyses, prototype tests and reviews, and full usability tests should be performed. Participants from the user population should be included when applying these methodologies.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Use error caused by designs that are either overly...'?",
"reference": "Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is one of the most persistent and critical problems encountered by FDA.",
"options": {
"B": "FDA",
"A": "the design and detailed design information",
"C": "The completed software design specification",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is ____ of the most persistent and critical problems encountered by FDA.",
"reference": "Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is one of the most persistent and critical problems encountered by FDA.",
"options": {
"C": "one",
"A": "the design and detailed design information",
"B": "The completed software design specification",
"D": "ace"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Use error caused by designs that are either overly...'?",
"reference": "Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is one of the most persistent and critical problems encountered by FDA.",
"options": {
"A": "FDA",
"B": "the design and detailed design information",
"C": "The completed software design specification",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is ____ of the most persistent and critical problems encountered by FDA.",
"reference": "Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is one of the most persistent and critical problems encountered by FDA.",
"options": {
"D": "one",
"A": "the design and detailed design information",
"B": "The completed software design specification",
"C": "ace"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Due to complexity of the project or to enable Page...'?",
"reference": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information.",
"options": {
"C": "Page",
"A": "the design and detailed design information",
"B": "The completed software design specification",
"D": "Sir Frederick Handley Page"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Due to complexity of the project or to enable Page...'?",
"reference": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information.",
"options": {
"C": "FDA",
"A": "the design and detailed design information",
"B": "The completed software design specification",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Due to complexity of the project or to enable Page 18General...'?",
"reference": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information.",
"options": {
"A": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guida...",
"B": "Page",
"C": "the design and detailed design information",
"D": "The completed software design specification"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Due to complexity of the project or to enable Page...'?",
"reference": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information.",
"options": {
"C": "Page",
"A": "the design and detailed design information",
"B": "The completed software design specification",
"D": "Sir Frederick Handley Page"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Due to complexity of the project or to enable Page...'?",
"reference": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information.",
"options": {
"D": "FDA",
"A": "the design and detailed design information",
"B": "The completed software design specification",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Due to complexity of the project or to enable Page 18General...'?",
"reference": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information.",
"options": {
"C": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guida...",
"A": "Page",
"B": "the design and detailed design information",
"D": "The completed software design specification"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Due to complexity of the project or to enable Page...'?",
"reference": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information.",
"options": {
"D": "Page",
"A": "the design and detailed design information",
"B": "The completed software design specification",
"C": "Sir Frederick Handley Page"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Due to complexity of the project or to enable Page...'?",
"reference": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information.",
"options": {
"B": "FDA",
"A": "the design and detailed design information",
"C": "The completed software design specification",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Due to complexity of the project or to enable Page...'?",
"reference": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information.",
"options": {
"D": "Page",
"A": "the design and detailed design information",
"B": "The completed software design specification",
"C": "Sir Frederick Handley Page"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Due to complexity of the project or to enable Page...'?",
"reference": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information.",
"options": {
"D": "FDA",
"A": "the design and detailed design information",
"B": "The completed software design specification",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Due to complexity of the project or to enable Page 18General...'?",
"reference": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information.",
"options": {
"A": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guida...",
"B": "Page",
"C": "the design and detailed design information",
"D": "The completed software design specification"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Due to complexity of the project or to enable Page...'?",
"reference": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information.",
"options": {
"B": "Page",
"A": "the design and detailed design information",
"C": "The completed software design specification",
"D": "Sir Frederick Handley Page"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Due to complexity of the project or to enable Page...'?",
"reference": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information.",
"options": {
"A": "FDA",
"B": "the design and detailed design information",
"C": "The completed software design specification",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Due to complexity of the project or to enable Page 18General...'?",
"reference": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information.",
"options": {
"D": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guida...",
"A": "Page",
"B": "the design and detailed design information",
"C": "The completed software design specification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Use error caused by designs that are either overly...'?",
"reference": "Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is one of the most persistent and critical problems encountered by FDA.",
"options": {
"D": "FDA",
"A": "the design and detailed design information",
"B": "The completed software design specification",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is ____ of the most persistent and critical problems encountered by FDA.",
"reference": "Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is one of the most persistent and critical problems encountered by FDA.",
"options": {
"A": "one",
"B": "the design and detailed design information",
"C": "The completed software design specification",
"D": "ace"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Use error caused by designs that are either overly...'?",
"reference": "Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is one of the most persistent and critical problems encountered by FDA.",
"options": {
"C": "FDA",
"A": "the design and detailed design information",
"B": "The completed software design specification",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is ____ of the most persistent and critical problems encountered by FDA.",
"reference": "Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is one of the most persistent and critical problems encountered by FDA.",
"options": {
"A": "one",
"B": "the design and detailed design information",
"C": "The completed software design specification",
"D": "ace"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Use error caused by designs that are either overly...'?",
"reference": "Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is one of the most persistent and critical problems encountered by FDA.",
"options": {
"B": "FDA",
"A": "the design and detailed design information",
"C": "The completed software design specification",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is ____ of the most persistent and critical problems encountered by FDA.",
"reference": "Use error caused by designs that are either overly complex or contrary to users' intuitive expectations for operation is one of the most persistent and critical problems encountered by FDA.",
"options": {
"D": "one",
"A": "the design and detailed design information",
"B": "The completed software design specification",
"C": "ace"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Due to complexity of the project or to enable Page...'?",
"reference": "Due to complexity of the project or to enable Page 18General Principles of Software Validation Guidance for Industry and FDA Staff persons with varying levels of technical responsibilities to clearly understand design information, the design specification may contain both a high level summary of the design and detailed design information.",
"options": {
"D": "Page",
"A": "the design and detailed design information",
"B": "The completed software design specification",
"C": "Sir Frederick Handley Page"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 15 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination
Summary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:
Error guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "Digital",
"A": "Identify",
"C": "Independent",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "Identify",
"A": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "key"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Independent",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"C": "freelance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"D": "go along"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "go along"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "526",
"B": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate ____ 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "525",
"B": "529",
"C": "530",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 ____ 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "526",
"A": "525",
"B": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 ____ 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "527",
"B": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 ____ Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "528",
"A": "525",
"B": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has ____ developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "529",
"A": "525",
"B": "530",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data ____ stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "530",
"A": "525",
"B": "529",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "Digital",
"B": "Identify",
"C": "Independent",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Identify",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"C": "key"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "Independent",
"A": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "freelance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 3 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
It should be noted that im plementing an effective quality system in a manufacturing organization will require a significant investment of time and resources. However, we believe the long-term benefits of implementing a quality system will outweigh the costs.10
This section describes a robust quality systems model that, if properly implemented, can provide the controls to consistently produce a product of acceptable quality. Wh ere applicable, the relationship between elements of this model and CG MP regulations is noted. At the end of each section, a table shows how the specific CGMP regulat ions correlate to the elements in the quality systems model. As already explained, many of the quality systems elements correlate closely with the CGMP regulations. It is important to emphasize that this gui dance is not recommending new regulatory requirements. The guidance is intended to provide recommendations to manufacturers who are implementing, or plan to implement, a quality systems model to help them comply with CGMP regulations. FDA re gulatory and inspectional coverage will remain focused on the specific CGMP regulations. The model is described according to four major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described. When elements of the qual ity systems model correlate with specific CGMP regulations, this corre lation is noted. A. Management Responsibilities Modern robust quality systems models call for manageme nt to play a key role in the design, implementation, and management of the quality system. For example, management is responsible for establishing the qua lity system structure appropri ate for the specific organization. Management has ultimate responsibility to provide the leadership needed for the successful functioning of a quality system.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'The model is described according to four major fac...'?",
"reference": "The model is described according to four major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"options": {
"A": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"B": "CGMP",
"C": "a robust quality systems model",
"D": "the quality systems model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The model is described according to ____ major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"reference": "The model is described according to four major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"options": {
"C": "four",
"A": "a robust quality systems model",
"B": "the quality systems model",
"D": "quaternity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The model is described according to four major fac...'?",
"reference": "The model is described according to four major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"options": {
"C": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"A": "CGMP",
"B": "a robust quality systems model",
"D": "the quality systems model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 8 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Similarly, it is not acceptable to store dat a electronically in temporary 316 memory, in a manner that allows for manipulation, before creating a permanent record. 317 Electronic data that are automatic ally saved into temporary memory do not meet CGMP 318 documentation or retention requirements. 319 320 You may employ a combination of technical and procedural controls to meet CGMP 321 documentation practices for electronic systems. For example, a computer system, such as 322 a Laboratory Information Management System (LIMS) or an Electronic Batch Record 323 (EBR) system , can be de signed to automatically save after each separate entry. This 324 would be similar to recording each entry contemporaneously on a paper batch record to 325 satisfy CGMP requirements . The computer system could be combined with a procedure 326 requiring data be entered i mmediately when generated. 327 328 For PET drugs, see the Laboratory Controls section of the guidance for industry PET 329 Drugs Current Good Manufacturing Practice (CGMP) . 330 331 Contains Nonbinding Recommendations Draft Not for Implementation 9 13. Why has the FDA cited use of actual samples during s ystem s uitability or 332 test, prep, or equilibration runs in warning letters? 333 334 FDA prohibits sampling and testing with the goal of achieving a specific result or to 335 overcome an unacceptable result ( e.g., testing different samples until the desired passing 336 result is obtained ). This practice, also referred to as testing into compliance , is not 337 consistent with CGMP (see the guidance for i ndustry Investigating Out -of-Specification 338 (OOS) Test Results for Pharmaceutical Production) . In some situations, use of actual 339 samples to perform system suitability testing has been used as a means of testing into 340 compliance. We would consider it a violative practice to use an actual sample in test, 341 prep, or equilibration runs as a means of disguising testing into compliance.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: Similarly, it is not acceptable to store dat a electronically in temporary ____ memory, in a manner that allows for manipulation, before creating a permanent record.",
"reference": "Similarly, it is not acceptable to store dat a electronically in temporary 316 memory, in a manner that allows for manipulation, before creating a permanent record.",
"options": {
"C": "316",
"A": "317",
"B": "319 320",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Electronic data that are automatic ally saved into temporary memory do not meet CGMP 318 documentation or retention requirements.",
"reference": "317 Electronic data that are automatic ally saved into temporary memory do not meet CGMP 318 documentation or retention requirements.",
"options": {
"C": "317",
"A": "316",
"B": "319 320",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 317 Electronic data that are automatic ally saved into temporary memory do not meet CGMP ____ documentation or retention requirements.",
"reference": "317 Electronic data that are automatic ally saved into temporary memory do not meet CGMP 318 documentation or retention requirements.",
"options": {
"C": "318",
"A": "316",
"B": "317",
"D": "industry PET 329 Drugs Current Good Manufacturing Practice"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '333 334 FDA prohibits sampling and testing with th...'?",
"reference": "333 334 FDA prohibits sampling and testing with the goal of achieving a specific result or to 335 overcome an unacceptable result ( e.g., testing different samples until the desired passing 336 result is obtained ).",
"options": {
"C": "FDA",
"A": "Laboratory Information Management System",
"B": "CGMP",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 334 FDA prohibits sampling and testing with the goal of achieving a specific result or to 335 overcome an unacceptable result ( e.g., testing different samples until the desired passing 336 result is obtained ).",
"reference": "333 334 FDA prohibits sampling and testing with the goal of achieving a specific result or to 335 overcome an unacceptable result ( e.g., testing different samples until the desired passing 336 result is obtained ).",
"options": {
"C": "333",
"A": "316",
"B": "317",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 333 ____ FDA prohibits sampling and testing with the goal of achieving a specific result or to 335 overcome an unacceptable result ( e.g., testing different samples until the desired passing 336 result is obtained ).",
"reference": "333 334 FDA prohibits sampling and testing with the goal of achieving a specific result or to 335 overcome an unacceptable result ( e.g., testing different samples until the desired passing 336 result is obtained ).",
"options": {
"B": "334",
"A": "316",
"C": "317",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 333 334 FDA prohibits sampling and testing with the goal of achieving a specific result or to ____ overcome an unacceptable result ( e.g., testing different samples until the desired passing 336 result is obtained ).",
"reference": "333 334 FDA prohibits sampling and testing with the goal of achieving a specific result or to 335 overcome an unacceptable result ( e.g., testing different samples until the desired passing 336 result is obtained ).",
"options": {
"B": "335",
"A": "316",
"C": "317",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 333 334 FDA prohibits sampling and testing with the goal of achieving a specific result or to 335 overcome an unacceptable result ( e.g., testing different samples until the desired passing ____ result is obtained ).",
"reference": "333 334 FDA prohibits sampling and testing with the goal of achieving a specific result or to 335 overcome an unacceptable result ( e.g., testing different samples until the desired passing 336 result is obtained ).",
"options": {
"C": "336",
"A": "316",
"B": "317",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;
Supporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements. The first four of the elements noted above usually are separate pre-existing documents that are included by reference in the software design specification. Software requirements specification was discussed in the preceding section, as was software risk analysis. Written development procedures serve as a guide to the organization, and written programming procedures serve as a guide to individual programmers. As software cannot be validated without knowledge of the context in which it is intended to function, systems documentation is referenced.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Software requirements specification was discussed ...'?",
"reference": "Software requirements specification was discussed in the preceding section, as was software risk analysis.",
"options": {
"D": "Software",
"A": "Hardware",
"B": "Logical",
"C": "Written development procedures"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The ____ four of the elements noted above usually are separate pre-existing documents that are included by reference in the software design specification.",
"reference": "The first four of the elements noted above usually are separate pre-existing documents that are included by reference in the software design specification.",
"options": {
"D": "first",
"A": "The software design specification",
"B": "Software requirements specification",
"C": "firstly"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The first ____ of the elements noted above usually are separate pre-existing documents that are included by reference in the software design specification.",
"reference": "The first four of the elements noted above usually are separate pre-existing documents that are included by reference in the software design specification.",
"options": {
"D": "four",
"A": "The software design specification",
"B": "Software requirements specification",
"C": "quaternity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software requirements specification was discussed ...'?",
"reference": "Software requirements specification was discussed in the preceding section, as was software risk analysis.",
"options": {
"A": "Software",
"B": "Hardware",
"C": "Logical",
"D": "Written development procedures"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software requirements specification was discussed ...'?",
"reference": "Software requirements specification was discussed in the preceding section, as was software risk analysis.",
"options": {
"D": "Software",
"A": "Hardware",
"B": "Logical",
"C": "Written development procedures"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"C": "Software",
"A": "Hardware",
"B": "Logical",
"D": "Written development procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"D": "Software",
"A": "Hardware",
"B": "Logical",
"C": "Written development procedures"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"C": "Hardware",
"A": "The software design specification",
"B": "Software requirements specification",
"D": "computer hardware"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"B": "Logical",
"A": "The software design specification",
"C": "Software requirements specification",
"D": "consistent"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"C": "Data",
"A": "The software design specification",
"B": "Software requirements specification",
"D": "datum"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"B": "Software",
"A": "Hardware",
"C": "Logical",
"D": "Written development procedures"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"C": "Software",
"A": "Hardware",
"B": "Logical",
"D": "Written development procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"A": "Hardware",
"B": "The software design specification",
"C": "Software requirements specification",
"D": "computer hardware"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"B": "Logical",
"A": "The software design specification",
"C": "Software requirements specification",
"D": "consistent"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"D": "Data",
"A": "The software design specification",
"B": "Software requirements specification",
"C": "datum"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"A": "Error",
"B": "The software design specification",
"C": "Software requirements specification",
"D": "erroneousness"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"C": "Communication",
"A": "The software design specification",
"B": "Software requirements specification",
"D": "communicating"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The ____ four of the elements noted above usually are separate pre-existing documents that are included by reference in the software design specification.",
"reference": "The first four of the elements noted above usually are separate pre-existing documents that are included by reference in the software design specification.",
"options": {
"C": "first",
"A": "The software design specification",
"B": "Software requirements specification",
"D": "firstly"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The first ____ of the elements noted above usually are separate pre-existing documents that are included by reference in the software design specification.",
"reference": "The first four of the elements noted above usually are separate pre-existing documents that are included by reference in the software design specification.",
"options": {
"D": "four",
"A": "The software design specification",
"B": "Software requirements specification",
"C": "quaternity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software requirements specification was discussed ...'?",
"reference": "Software requirements specification was discussed in the preceding section, as was software risk analysis.",
"options": {
"D": "Software",
"A": "Hardware",
"B": "Logical",
"C": "Written development procedures"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"B": "Software",
"A": "Hardware",
"C": "Logical",
"D": "Written development procedures"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"D": "Software",
"A": "Hardware",
"B": "Logical",
"C": "Written development procedures"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"B": "Hardware",
"A": "The software design specification",
"C": "Software requirements specification",
"D": "computer hardware"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"D": "Logical",
"A": "The software design specification",
"B": "Software requirements specification",
"C": "consistent"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"D": "Data",
"A": "The software design specification",
"B": "Software requirements specification",
"C": "datum"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"A": "Error",
"B": "The software design specification",
"C": "Software requirements specification",
"D": "erroneousness"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software design specification should include: ...'?",
"reference": "The software design specification should include: Software requirements specification, including predetermined criteria for acceptance of the software; Software risk analysis; Development procedures and coding guidelines (or other programming procedures); Systems documentation (e.g., a narrative or a context diagram) that describes the systems context in which the program is intended to function, including the relationship of hardware, software, and the physical environment; Hardware to be used; Parameters to be measured or recorded; Logical structure (including control logic) and logical processing steps (e.g., algorithms); Data structures and data flow diagrams; Definitions of variables (control and data) and description of where they are used; Error, alarm, and warning messages;\nSupporting software (e.g., operating systems, drivers, other application software); Communication links (links among internal modules of the software, links with the supporting software, links with the hardware, and links with the user); Security measures (both physical and logical security); and Any additional constraints not identified in the above elements.",
"options": {
"B": "Communication",
"A": "The software design specification",
"C": "Software requirements specification",
"D": "communicating"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software requirements specification was discussed ...'?",
"reference": "Software requirements specification was discussed in the preceding section, as was software risk analysis.",
"options": {
"D": "Software",
"A": "Hardware",
"B": "Logical",
"C": "Written development procedures"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software requirements specification was discussed ...'?",
"reference": "Software requirements specification was discussed in the preceding section, as was software risk analysis.",
"options": {
"D": "Software",
"A": "Hardware",
"B": "Logical",
"C": "Written development procedures"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The ____ four of the elements noted above usually are separate pre-existing documents that are included by reference in the software design specification.",
"reference": "The first four of the elements noted above usually are separate pre-existing documents that are included by reference in the software design specification.",
"options": {
"C": "first",
"A": "The software design specification",
"B": "Software requirements specification",
"D": "firstly"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 3 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
It facilitates continual improve ment of process performance and product quality throughout the product lifecycle. IC H Q9 provides principles and ex amples of tools for quality risk management that can be applied to di fferent aspects of pharmaceutical quality. F. Design and Content Considerations (1.7) (a) The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to f acilitate common understanding and consistent application. (b) The elements of ICH Q10 should be applie d in a manner that is appropriate and proportionate to each of the product lifecycl e stages, recognizing the different goals 4 and knowledge available for each stage. (c) The size and complexity of the companys ac tivities should be taken into consideration when developing a new pharmaceutical quality system or modifying an existing one. The design of the pharmaceutical quality system should incorporate appropriate risk management principles. While some aspect s of the pharmaceutical quality system can be company wide and others site specific , the effectiveness of the pharmaceutical quality system is normally demonstrated at the site level. The pharmaceutical quality system should in clude appropriate processes, resources, and responsibilities to provide assurance of the quality of outsourced activities and purchased materials as described in section III.G (2.7). (e) Management responsibilities, as described in section III (2), should be identified within the pharmaceutical quality system. (f) The pharmaceutical quality system should include the following elements, as described in section IV (3): process performance and product quality monitoring, corrective and preventive action , change management, and management review. (g) Performance indicators , as described in section V (4), should be identified and used to monitor the effectiveness of processes w ithin the pharmaceutical quality system.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: The pharmaceutical quality system should in clude appropriate processes, resources, and responsibilities to provide assurance of the quality of outsourced activities and purchased materials as described in section III.G (____).",
"reference": "The pharmaceutical quality system should in clude appropriate processes, resources, and responsibilities to provide assurance of the quality of outsourced activities and purchased materials as described in section III.G (2.7).",
"options": {
"C": "2.7",
"A": "1.7",
"B": "a new pharmaceutical quality system",
"D": "pharmaceutical quality"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'F. Design and Content Considerations (1.7) (a) The...'?",
"reference": "F. Design and Content Considerations (1.7) (a) The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to f acilitate common understanding and consistent application.",
"options": {
"B": "Content Considerations",
"A": "ICH Q10",
"C": "a new pharmaceutical quality system",
"D": "pharmaceutical quality"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: F. Design and Content Considerations (____) (a) The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to f acilitate common understanding and consistent application.",
"reference": "F. Design and Content Considerations (1.7) (a) The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to f acilitate common understanding and consistent application.",
"options": {
"C": "1.7",
"A": "2.7",
"B": "a new pharmaceutical quality system",
"D": "pharmaceutical quality"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 6 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
......................................
12 Contains Nonbinding Recommendations 1 Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry1
This guidance represent s the current thinking of the Food and Drug Administration (FDA or Agency ) on this topic. It does not establish any rights for any person and is not bind ing on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for t his guidance as listed on the title page. The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212. Unless otherwise noted, the term CGMP in this guidance refers to CGMPs for drugs (including biologics) . FDAs authority for CGMP comes from section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FDC Act). Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General ; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals ; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography (PET) Drugs. All citations to part s 211 and 212 in this document pertain to finished pharmaceuticals and PET drugs , but these requirements are also consistent with Agency guidance on CGMP for active pharmaceutical ingredients with respect to data integrity . This guidance pr ovides the Agencys current thinking on the creation and handling of data in accordance with CGMP requirements. FDA expects that all data be reliable and accurate ( see the Background section ). CGMP regulations and guidance allow for flexible and risk- based strategies to prevent and detect data integrity issues.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Unless otherwise noted, the term CGMP in this guid...'?",
"reference": "Unless otherwise noted, the term CGMP in this guidance refers to CGMPs for drugs (including biologics) .",
"options": {
"A": "CGMP",
"B": "the Food and Drug Administration",
"C": "FDA",
"D": "current good manufacturing practice"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDAs authority for CGMP comes from section 501(a)(...'?",
"reference": "FDAs authority for CGMP comes from section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FDC Act).",
"options": {
"A": "CGMP",
"B": "the Food and Drug Administration",
"C": "FDA",
"D": "current good manufacturing practice"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDAs authority for CGMP comes from section 501(a)(...'?",
"reference": "FDAs authority for CGMP comes from section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FDC Act).",
"options": {
"C": "the Federal Food, Drug",
"A": "the Food and Drug Administration",
"B": "FDA",
"D": "current good manufacturing practice"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CGMP regulations and guidance allow for flexible a...'?",
"reference": "CGMP regulations and guidance allow for flexible and risk- based strategies to prevent and detect data integrity issues.",
"options": {
"B": "CGMP",
"A": "the Food and Drug Administration",
"C": "FDA",
"D": "current good manufacturing practice"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To discuss an alternative approach, contact the FD...'?",
"reference": "To discuss an alternative approach, contact the FDA office responsible for t his guidance as listed on the title page.",
"options": {
"B": "FDA",
"A": "the Food and Drug Administration",
"C": "Agency",
"D": "current good manufacturing practice"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDAs authority for CGMP comes from section 501(a)(...'?",
"reference": "FDAs authority for CGMP comes from section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FDC Act).",
"options": {
"B": "CGMP",
"A": "the Food and Drug Administration",
"C": "FDA",
"D": "current good manufacturing practice"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 1 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Documentation includes: Resources and facilities used Resources and facilities used Procedures to carry out the process Identification of the process owner who will maintain and update the process as needed Identification and control of important variables Quality control measures, necessary data collection, monitoring, and appropriate controls for the product and process Any validation activities, including operating ranges and acceptance criteria Effects on related process, functions, or personnel As discussed under section IV.A., above, the mode l calls for managers to ensure that product specifications and process parameters are determ ined by the appropriate technical experts (e.g., engineers, development scientists). In the pharmaceutical environment, experts would have an understanding of pharmaceutical science, equipmen t, facilities, and proc ess types and of how variations in materials and processes can ultimately aff ect the finished product. Packaging and labeling controls, critical stages in the pharmaceu tical manufacturing process, are not specifically addressed in quality systems models. However, the Agency recommends that manufacturers always refer to th e packaging and labeling control re gulations at 211 Subpart G.
In addition and this is consistent with modern quality systems FDA recommends that, as 15 Contains Nonbinding Recommendations part of the design process, before commercial production, the controls fo r all processes within the packaging and labeling system be planned and documented in written procedures. The procedures should outline quality control activities and the responsible positions. Specifications and controls for the packaging and labeling ma terials should also be determined before commercial production. Distinct labe ls with discriminating features for different products, such as a product marketed with different strengths, should be included to prevent mislabeling and resulting recalls. 2.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'However, the Agency recommends that manufacturers ...'?",
"reference": "However, the Agency recommends that manufacturers always refer to th e packaging and labeling control re gulations at 211 Subpart G.\nIn addition and this is consistent with modern quality systems FDA recommends that, as 15 Contains Nonbinding Recommendations part of the design process, before commercial production, the controls fo r all processes within the packaging and labeling system be planned and documented in written procedures.",
"options": {
"D": "Agency",
"A": "product specifications and process parameters",
"B": "Packaging and labeling controls",
"C": "government agency"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ). When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and 212. FDA requires that systems controls, 206 including documentation control s, be designed to follow CGMP to assure product quality 207 (for example, 211.100 and 212.50). How should blank forms be controlled ? 210 211 There must be document controls in place to as sure product quality (see 211.100, 212 211.160(a) , 211.186, 212.20(d) , and 212.60(g) ). FDA recommends that, if used, blank 213 forms (including, but not limited to, worksheets, laboratory notebooks, and MPCRs ) be 214 controlled by the quality unit or by another document control method. For example, 215 numbered sets of blank forms may be issued as appropriate and should be reconciled 216 upon completion of all issued forms. Incomplete or erroneous forms should be kept as 217 part of the permanent record along with written justification for their re placement ( for 218 example, see 211.192, 211.194, 212.50(a) , and 212.70(f)(1)(vi)). 219 220 Similarly, bound paginated notebooks, stamped for official use by a document control 221 group, allow detection of unofficial notebooks as well as of any gaps in notebook pages. How often should audit trails be reviewed ? 224 225 FDA recommends that audit trails that capture change s to critical data be reviewed with 226 each record and before final approval of the record .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'When login credentials are shared, a unique 204 in...'?",
"reference": "When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and 212.",
"options": {
"C": "CGMP",
"A": "laborat ory data",
"B": "FDA",
"D": "a document control 221 group"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When login credentials are shared, a unique ____ individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and 212.",
"reference": "When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and 212.",
"options": {
"C": "204",
"A": "198 199",
"B": "200",
"D": "a document control 221 group"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform ____ to the CGMP requirements in parts 211 and 212.",
"reference": "When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and 212.",
"options": {
"C": "205",
"A": "198 199",
"B": "200",
"D": "a document control 221 group"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts ____ and 212.",
"reference": "When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and 212.",
"options": {
"B": "211",
"A": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and ____.",
"reference": "When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and 212.",
"options": {
"B": "212",
"A": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, ____ numbered sets of blank forms may be issued as appropriate and should be reconciled 216 upon completion of all issued forms.",
"reference": "For example, 215 numbered sets of blank forms may be issued as appropriate and should be reconciled 216 upon completion of all issued forms.",
"options": {
"B": "215",
"A": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, 215 numbered sets of blank forms may be issued as appropriate and should be reconciled ____ upon completion of all issued forms.",
"reference": "For example, 215 numbered sets of blank forms may be issued as appropriate and should be reconciled 216 upon completion of all issued forms.",
"options": {
"C": "216",
"A": "198 199",
"B": "200",
"D": "a document control 221 group"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 220 Similarly, bound paginated notebooks, stamped for official use by a document control 221 group, allow detection of unofficial notebooks as well as of any gaps in notebook pages.",
"reference": "219 220 Similarly, bound paginated notebooks, stamped for official use by a document control 221 group, allow detection of unofficial notebooks as well as of any gaps in notebook pages.",
"options": {
"B": "219",
"A": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 219 ____ Similarly, bound paginated notebooks, stamped for official use by a document control 221 group, allow detection of unofficial notebooks as well as of any gaps in notebook pages.",
"reference": "219 220 Similarly, bound paginated notebooks, stamped for official use by a document control 221 group, allow detection of unofficial notebooks as well as of any gaps in notebook pages.",
"options": {
"D": "220",
"A": "198 199",
"B": "200",
"C": "a document control 221 group"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 219 220 Similarly, bound paginated notebooks, stamped for official use by a document control ____ group, allow detection of unofficial notebooks as well as of any gaps in notebook pages.",
"reference": "219 220 Similarly, bound paginated notebooks, stamped for official use by a document control 221 group, allow detection of unofficial notebooks as well as of any gaps in notebook pages.",
"options": {
"C": "221",
"A": "198 199",
"B": "200",
"D": "should blank forms"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '198 199 You must exercise appropriate controls to ...'?",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"C": "laborat ory data",
"A": "CGMP",
"B": "FDA",
"D": "a document control 221 group"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"B": "198",
"A": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 198 ____ You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"D": "199",
"A": "198 199",
"B": "200",
"C": "a document control 221 group"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 198 199 You must exercise appropriate controls to as sure that only authorized personnel make ____ changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"D": "200",
"A": "198 199",
"B": "201",
"C": "a document control 221 group"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into ____ computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"D": "201",
"A": "198 199",
"B": "200",
"C": "a document control 221 group"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure ____ actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"C": "202",
"A": "198 199",
"B": "200",
"D": "a document control 221 group"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), ____ 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"A": "203",
"B": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, ____ numbered sets of blank forms may be issued as appropriate and should be reconciled 216 upon completion of all issued forms.",
"reference": "For example, 215 numbered sets of blank forms may be issued as appropriate and should be reconciled 216 upon completion of all issued forms.",
"options": {
"A": "215",
"B": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, 215 numbered sets of blank forms may be issued as appropriate and should be reconciled ____ upon completion of all issued forms.",
"reference": "For example, 215 numbered sets of blank forms may be issued as appropriate and should be reconciled 216 upon completion of all issued forms.",
"options": {
"D": "216",
"A": "198 199",
"B": "200",
"C": "a document control 221 group"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 220 Similarly, bound paginated notebooks, stamped for official use by a document control 221 group, allow detection of unofficial notebooks as well as of any gaps in notebook pages.",
"reference": "219 220 Similarly, bound paginated notebooks, stamped for official use by a document control 221 group, allow detection of unofficial notebooks as well as of any gaps in notebook pages.",
"options": {
"A": "219",
"B": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 3 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
..................................................................
4 f. What are the systems in computer or related systems in 211.68? ........................................ When is it permissible to exclude CGMP data from decision making? .................................... Does each wo rkflow on our computer system need to be validated? ........................................
How should access to CGMP computer systems be restricted? ................................................
Why is FDA concerned with the use of shared login accounts for computer syst ems? ...........
How should blank forms be controlled? ......................................................................................
How often should audit trails be reviewed? .................................................................................
Who should review audit trails? ...................................................................................................
Can electronic copies be used as accurate reproductions of paper or electronic records? Is it acceptable to retain paper printouts or static records instead of original electronic records from stand -alone computerized laboratory instruments, such as an FT -IR instrument? . Can electronic signatures be used instead of handwritten signatures for master production and control records? ............................................................................................................................... 8 12. When does electronic data become a CGMP record? ................................................................
Why has the FDA cited use of actual samples during system suitability or test, prep, or equilibration runs in warning letters? .................................................................................................. 9 14. Is it acceptable to only sa ve the final results from reprocessed laboratory chromatography?
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'When is it permissible to exclude CGMP data from d...'?",
"reference": "When is it permissible to exclude CGMP data from decision making?",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "original electronic records",
"D": "computer or related systems"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '.....................................................'?",
"reference": "................................................................\nWhy has the FDA cited use of actual samples during system suitability or test, prep, or equilibration runs in warning letters?",
"options": {
"C": "FDA",
"A": "CGMP",
"B": "CGMP computer systems",
"D": "original electronic records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '.....................................................'?",
"reference": "................................................................\nWhy has the FDA cited use of actual samples during system suitability or test, prep, or equilibration runs in warning letters?",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "CGMP computer systems",
"C": "original electronic records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
System s uitability tests should be performed according to the firms established written procedures which should include the identity of the preparation to be injected and the rationale for its selection and the approved application or applicable compendial monograph ( 211.160 and 212.60). If an actual sample is to be used for system suitability testing, it should be a properly characterized secondary standard , written procedures should be es tablished and followed, and the sample should be from a different batch than the sample (s) being tested ( 211.160, 211.165, and 212.60). CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)). Transparency is necessary. A ll data including obvious errors and failing, passing, and suspect datamust be in the CGMP records that are retained and subject to review and oversight. An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) . For more information , see the ICH guidance for industry Q2(R1)
Validation of Analytical Procedure s: Text and Methodology and VICH guidances for industry GL1
Validation of Analytical Procedures: Definition and Terminology and GL2 Validation of Analytical Procedures: Methodology . Is it acceptable to only save the final results from reprocess ed laboratory chromatography? Analytical methods should be accurate and precise.16
For most lab analys es, reprocessing data should not be regularly needed. If chromatography is reprocessed, writ ten procedures
must be established and followed and each result retained for review (s ee 211.160, 211.165(c) , 211.194(a)(4) , and 212.60(a) ). FDA requires complete data in laboratory records, which includes 15 VICHVeteri nary International Conference on Harmonisation.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: System s uitability tests should be performed according to the firms established written procedures which should include the identity of the preparation to be injected and the rationale for its selection and the approved application or applicable compendial monograph ( ____ and 212.60).",
"reference": "System s uitability tests should be performed according to the firms established written procedures which should include the identity of the preparation to be injected and the rationale for its selection and the approved application or applicable compendial monograph ( 211.160 and 212.60).",
"options": {
"A": "211.160",
"B": "212.60",
"C": "211.165",
"D": "Analytical Procedures"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: System s uitability tests should be performed according to the firms established written procedures which should include the identity of the preparation to be injected and the rationale for its selection and the approved application or applicable compendial monograph ( 211.160 and ____).",
"reference": "System s uitability tests should be performed according to the firms established written procedures which should include the identity of the preparation to be injected and the rationale for its selection and the approved application or applicable compendial monograph ( 211.160 and 212.60).",
"options": {
"B": "212.60",
"A": "211.160",
"C": "Analytical Procedures",
"D": "This information is not provided in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA requires complete data in laboratory records, ...'?",
"reference": "FDA requires complete data in laboratory records, which includes 15 VICHVeteri nary International Conference on Harmonisation.",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "Analytical Procedures",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA requires complete data in laboratory records, ...'?",
"reference": "FDA requires complete data in laboratory records, which includes 15 VICHVeteri nary International Conference on Harmonisation.",
"options": {
"C": "VICHVeteri",
"A": "CGMP",
"B": "Analytical Procedures",
"D": "FDA"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA requires complete data in laboratory records, ...'?",
"reference": "FDA requires complete data in laboratory records, which includes 15 VICHVeteri nary International Conference on Harmonisation.",
"options": {
"A": "International Conference on Harmonisation",
"B": "Analytical Procedures",
"C": "FDA",
"D": "VICHVeteri"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA requires complete data in laboratory records, which includes ____ VICHVeteri nary International Conference on Harmonisation.",
"reference": "FDA requires complete data in laboratory records, which includes 15 VICHVeteri nary International Conference on Harmonisation.",
"options": {
"D": "15",
"A": "211.160",
"B": "212.60",
"C": "Analytical Procedures"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CGMP original records must be complete (e.g., 211...'?",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"C": "CGMP",
"A": "Terminology",
"B": "FDA",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP original records must be complete (e.g., 211.68(b), ____, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"C": "211.188",
"A": "211.160",
"B": "212.60",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP original records must be complete (e.g., 211.68(b), 211.188, ____) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"B": "211.194",
"A": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), ____, and 211.194(a)(8)).",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"A": "211.192",
"B": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Is it acceptable to only save the final results fr...'?",
"reference": "Is it acceptable to only save the final results from reprocess ed laboratory chromatography?",
"options": {
"B": "reprocess ed laboratory chromatography",
"A": "Q2(R1",
"C": "Analytical Procedures",
"D": "This information is not provided in the context"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'A ll data including obvious errors and failing, pa...'?",
"reference": "A ll data including obvious errors and failing, passing, and suspect datamust be in the CGMP records that are retained and subject to review and oversight.",
"options": {
"A": "CGMP",
"B": "Terminology",
"C": "FDA",
"D": "Analytical Procedures"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'A ll data including obvious errors and failing, pa...'?",
"reference": "A ll data including obvious errors and failing, passing, and suspect datamust be in the CGMP records that are retained and subject to review and oversight.",
"options": {
"C": "CGMP",
"A": "Terminology",
"B": "FDA",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see ____, 211.165, 211.188, and 211.192) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"B": "211.160",
"A": "212.60",
"C": "211.165",
"D": "Analytical Procedures"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, ____, 211.188, and 211.192) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"A": "211.165",
"B": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, ____, and 211.192) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"A": "211.188",
"B": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and ____) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"C": "211.192",
"A": "211.160",
"B": "212.60",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see ____, 211.165, 211.188, and 211.192) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"C": "211.160",
"A": "212.60",
"B": "211.165",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, ____, 211.188, and 211.192) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"B": "211.165",
"A": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, ____, and 211.192) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"C": "211.188",
"A": "211.160",
"B": "212.60",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CGMP original records must be complete (e.g., 211...'?",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"B": "CGMP",
"A": "Terminology",
"C": "FDA",
"D": "Analytical Procedures"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP original records must be complete (e.g., 211.68(b), ____, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"B": "211.188",
"A": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP original records must be complete (e.g., 211.68(b), 211.188, ____) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"B": "211.194",
"A": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), ____, and 211.194(a)(8)).",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"C": "211.192",
"A": "211.160",
"B": "212.60",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'A ll data including obvious errors and failing, pa...'?",
"reference": "A ll data including obvious errors and failing, passing, and suspect datamust be in the CGMP records that are retained and subject to review and oversight.",
"options": {
"D": "CGMP",
"A": "Terminology",
"B": "FDA",
"C": "Analytical Procedures"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'For more information , see the ICH guidance for in...'?",
"reference": "For more information , see the ICH guidance for industry Q2(R1)\nValidation of Analytical Procedure s: Text and Methodology and VICH guidances for industry GL1\nValidation of Analytical Procedures: Definition and Terminology and GL2 Validation of Analytical Procedures: Methodology .",
"options": {
"B": "Q2(R1",
"A": "reprocess ed laboratory chromatography",
"C": "Analytical Procedures",
"D": "Terminology"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For more information , see the ICH guidance for in...'?",
"reference": "For more information , see the ICH guidance for industry Q2(R1)\nValidation of Analytical Procedure s: Text and Methodology and VICH guidances for industry GL1\nValidation of Analytical Procedures: Definition and Terminology and GL2 Validation of Analytical Procedures: Methodology .",
"options": {
"A": "Terminology",
"B": "Analytical Procedures",
"C": "language",
"D": "nomenclature"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'A ll data including obvious errors and failing, pa...'?",
"reference": "A ll data including obvious errors and failing, passing, and suspect datamust be in the CGMP records that are retained and subject to review and oversight.",
"options": {
"B": "CGMP",
"A": "Terminology",
"C": "FDA",
"D": "Analytical Procedures"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'For more information , see the ICH guidance for in...'?",
"reference": "For more information , see the ICH guidance for industry Q2(R1)\nValidation of Analytical Procedure s: Text and Methodology and VICH guidances for industry GL1\nValidation of Analytical Procedures: Definition and Terminology and GL2 Validation of Analytical Procedures: Methodology .",
"options": {
"B": "Q2(R1",
"A": "reprocess ed laboratory chromatography",
"C": "Analytical Procedures",
"D": "Terminology"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For more information , see the ICH guidance for in...'?",
"reference": "For more information , see the ICH guidance for industry Q2(R1)\nValidation of Analytical Procedure s: Text and Methodology and VICH guidances for industry GL1\nValidation of Analytical Procedures: Definition and Terminology and GL2 Validation of Analytical Procedures: Methodology .",
"options": {
"B": "Terminology",
"A": "Analytical Procedures",
"C": "language",
"D": "nomenclature"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Review outcomes typically include: Improvements to the quality system and related quality processes Improvements to manufacturing processes and products Realignment of resources Under a quality system, the results o f a management review would typically be recorded. Planned actions should be implemented using effective corrective a nd preventive action and change control procedures. The following table shows how the CGMP regulati ons correlate to specific elements in the quality systems model for this section. Manufacturers should always refer to the specific regulations to make sure they are in compliance. Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Management Responsibilities Quality System Element Regulatory Citations 1. Structure Establish quality function: 211.22 (a) (see definition 210.3(b)(15))
Notification: 211.180(f) 3. Build QS QU procedures: 211.22(d)
reinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4. Establish Policies, Objectives and Plans Procedures: 211.22(c-d), 211.100(a) 5. System Review Record review: 211.100, 211.180(e), 211.192, 211.198(b)(2)
B. Resources Appropriate allocation of resources is key to cr eating a robust quality syst em and complying with the CGMP regulations. This sec tion discusses the role of resources in developing, implementing, and managing a robust quality system that complies with the CGMP regulations. General Arrangements Under a robust quality system, sufficient resour ces should be allocated for quality system and operational activities.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations 21 CFR CGMP Re...'?",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Management Responsibilities Quality System Element Regulatory Citations 1.",
"options": {
"A": "Management Responsibilities Quality System Element Regulatory Citations",
"B": "CGMP",
"C": "Establish Policies",
"D": "a robust quality syst em"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ CFR CGMP Regulations Related to Management Responsibilities Quality System Element Regulatory Citations 1.",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Management Responsibilities Quality System Element Regulatory Citations 1.",
"options": {
"B": "21",
"A": "211.22",
"C": "211.180(f",
"D": "a robust quality syst em"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations 2____ CFR CGMP Regulations Related to Management Responsibilities Quality System Element Regulatory Citations 1.",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Management Responsibilities Quality System Element Regulatory Citations 1.",
"options": {
"D": "1",
"A": "211.22",
"B": "211.180(f",
"C": "a robust quality syst em"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Resources Appropriate allocation of resources is k...'?",
"reference": "Resources Appropriate allocation of resources is key to cr eating a robust quality syst em and complying with the CGMP regulations.",
"options": {
"D": "Resources Appropriate",
"A": "a robust quality syst em",
"B": "Management Responsibilities Quality System Element Regulatory Citations",
"C": "CGMP"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Resources Appropriate allocation of resources is k...'?",
"reference": "Resources Appropriate allocation of resources is key to cr eating a robust quality syst em and complying with the CGMP regulations.",
"options": {
"D": "CGMP",
"A": "Management Responsibilities Quality System Element Regulatory Citations",
"B": "Establish Policies",
"C": "a robust quality syst em"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations 21 CFR CGMP Re...'?",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Management Responsibilities Quality System Element Regulatory Citations 1.",
"options": {
"C": "Management Responsibilities Quality System Element Regulatory Citations",
"A": "CGMP",
"B": "Establish Policies",
"D": "a robust quality syst em"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ CFR CGMP Regulations Related to Management Responsibilities Quality System Element Regulatory Citations 1.",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Management Responsibilities Quality System Element Regulatory Citations 1.",
"options": {
"A": "21",
"B": "211.22",
"C": "211.180(f",
"D": "a robust quality syst em"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations 2____ CFR CGMP Regulations Related to Management Responsibilities Quality System Element Regulatory Citations 1.",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Management Responsibilities Quality System Element Regulatory Citations 1.",
"options": {
"B": "1",
"A": "211.22",
"C": "211.180(f",
"D": "a robust quality syst em"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The following table shows how the CGMP regulati on...'?",
"reference": "The following table shows how the CGMP regulati ons correlate to specific elements in the quality systems model for this section.",
"options": {
"C": "CGMP",
"A": "Management Responsibilities Quality System Element Regulatory Citations",
"B": "Establish Policies",
"D": "a robust quality syst em"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: System Review Record review: ____, 211.180(e), 211.192, 211.198(b)(2)\nB.",
"reference": "System Review Record review: 211.100, 211.180(e), 211.192, 211.198(b)(2)\nB.",
"options": {
"D": "211.100",
"A": "211.22",
"B": "211.180(f",
"C": "a robust quality syst em"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Build QS QU procedures: 211.22(d)\nreinforcement i...'?",
"reference": "Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"options": {
"D": "211.180(a-d",
"A": "211.22",
"B": "211.180(f",
"C": "a robust quality syst em"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Build QS QU procedures: 211.22(d)\nreinforcement i...'?",
"reference": "Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"options": {
"B": "211.180(c",
"A": "211.22",
"C": "211.180(f",
"D": "a robust quality syst em"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), ____, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"reference": "Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"options": {
"B": "211.87",
"A": "211.22",
"C": "211.180(f",
"D": "a robust quality syst em"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), ____, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"reference": "Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"options": {
"B": "211.142",
"A": "211.22",
"C": "211.180(f",
"D": "a robust quality syst em"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), ____ QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"reference": "Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"options": {
"D": "211.192",
"A": "211.22",
"B": "211.180(f",
"C": "a robust quality syst em"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), ____ QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"reference": "Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"options": {
"A": "211.192",
"B": "211.22",
"C": "211.180(f",
"D": "a robust quality syst em"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), ____, 211.192, 211.194, 211.198(b) 4.",
"reference": "Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"options": {
"B": "211.186",
"A": "211.22",
"C": "211.180(f",
"D": "a robust quality syst em"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), ____ QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"reference": "Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"options": {
"B": "211.192",
"A": "211.22",
"C": "211.180(f",
"D": "a robust quality syst em"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, ____, 211.198(b) 4.",
"reference": "Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"options": {
"B": "211.194",
"A": "211.22",
"C": "211.180(f",
"D": "a robust quality syst em"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.____2(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"reference": "Build QS QU procedures: 211.22(d)\nreinforcement in: 211.100(a), 211.160(a) QU procedures, specifications: 211.22(c), with QU control steps: 211.22(a), with reinforcement in 211.42(c), 211.84(a), 211.87, 211.101(c)(1), 211.110(c), 211.115(b), 211.142, 211.165(d), 211.192 QU quality assurance; review/investigate: 211.22(a), 211.100(a-b) 211.180(f), 211.192, 211.198(a) Record control: 211.180(a-d), 211.180(c), 211.180(d), 211.180(e), 211.186, 211.192, 211.194, 211.198(b) 4.",
"options": {
"B": "4",
"A": "211.22",
"C": "211.180(f",
"D": "a robust quality syst em"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 8 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
(c) Monitoring and review of the performance of the contract acceptor or the quality of the material from the provider, and the identification and implementation of any essential improvements. (d) Monitoring incoming ingredients and materials to ensure they are from approved sources using the agre ed supply chain. H. Management of Change in Product Ownership (2.8) When product ownership changes (e.g., through acqui sitions), management should consider the complexity of this and ensure: (a)
The ongoing responsibilities are defined for each company involved (b) The essential information is transferred IV. CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (3)
This section describes the lifecycle stage goals and the four specific pharmaceutical quality system elements that augment regional requirements to achieve the ICH Q10 objectives, as defined in section II.D (1.5). It does not restate all regional GMP requirements. A. Lifecycle Stage Goals (3.1)
The goals of each product lifecycle stage are described below. 1. Pharmaceutical Development (3.1.1)
The goal of pharmaceutical development activitie s is to design a product and its manufacturing process to consistently deliver the intended pe rformance and meet the needs of patients and healthcare professionals, and regulatory authori ties and internal customers requirements. Approaches to pharmaceutical development are desc ribed in ICH Q8. The re sults of exploratory and clinical development studies, while outside the scope of this guidance, are inputs to pharmaceutical development. 2. Technology Transfer (3.1.2)
The goal of technology transfer ac tivities is to transfer produc t and process knowledge between development and manufacturing, and within or between manufacturing s ites to achieve product 8 realization. This knowledge forms the ba sis for the manufacturing process, control strategy , process validation approach, and ongoing continual improvement. 3.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND P...'?",
"reference": "CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (3)\nThis section describes the lifecycle stage goals and the four specific pharmaceutical quality system elements that augment regional requirements to achieve the ICH Q10 objectives, as defined in section II.D (1.5).",
"options": {
"A": "CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE",
"B": "H. Management of Change in Product Ownership",
"C": "GMP",
"D": "each product lifecycle stage"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (____)\nThis section describes the lifecycle stage goals and the four specific pharmaceutical quality system elements that augment regional requirements to achieve the ICH Q10 objectives, as defined in section II.D (1.5).",
"reference": "CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (3)\nThis section describes the lifecycle stage goals and the four specific pharmaceutical quality system elements that augment regional requirements to achieve the ICH Q10 objectives, as defined in section II.D (1.5).",
"options": {
"B": "3",
"A": "2.8",
"C": "four",
"D": "each product lifecycle stage"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (3)\nThis section describes the lifecycle stage goals and the ____ specific pharmaceutical quality system elements that augment regional requirements to achieve the ICH Q10 objectives, as defined in section II.D (1.5).",
"reference": "CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (3)\nThis section describes the lifecycle stage goals and the four specific pharmaceutical quality system elements that augment regional requirements to achieve the ICH Q10 objectives, as defined in section II.D (1.5).",
"options": {
"B": "four",
"A": "2.8",
"C": "1.5",
"D": "each product lifecycle stage"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (3)\nThis section describes the lifecycle stage goals and the four specific pharmaceutical quality system elements that augment regional requirements to achieve the ICH Q10 objectives, as defined in section II.D (____).",
"reference": "CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND PRODUCT QUALITY (3)\nThis section describes the lifecycle stage goals and the four specific pharmaceutical quality system elements that augment regional requirements to achieve the ICH Q10 objectives, as defined in section II.D (1.5).",
"options": {
"C": "1.5",
"A": "2.8",
"B": "four",
"D": "each product lifecycle stage"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Pharmaceutical Development (3.1.1)\nThe goal of pha...'?",
"reference": "Pharmaceutical Development (3.1.1)\nThe goal of pharmaceutical development activitie s is to design a product and its manufacturing process to consistently deliver the intended pe rformance and meet the needs of patients and healthcare professionals, and regulatory authori ties and internal customers requirements.",
"options": {
"C": "Pharmaceutical Development",
"A": "H. Management of Change in Product Ownership",
"B": "GMP",
"D": "each product lifecycle stage"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Pharmaceutical Development (____)\nThe goal of pharmaceutical development activitie s is to design a product and its manufacturing process to consistently deliver the intended pe rformance and meet the needs of patients and healthcare professionals, and regulatory authori ties and internal customers requirements.",
"reference": "Pharmaceutical Development (3.1.1)\nThe goal of pharmaceutical development activitie s is to design a product and its manufacturing process to consistently deliver the intended pe rformance and meet the needs of patients and healthcare professionals, and regulatory authori ties and internal customers requirements.",
"options": {
"C": "3.1.1",
"A": "2.8",
"B": "four",
"D": "each product lifecycle stage"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Pharmaceutical Development (3.1.1)\nThe goal of pha...'?",
"reference": "Pharmaceutical Development (3.1.1)\nThe goal of pharmaceutical development activitie s is to design a product and its manufacturing process to consistently deliver the intended pe rformance and meet the needs of patients and healthcare professionals, and regulatory authori ties and internal customers requirements.",
"options": {
"D": "Pharmaceutical Development",
"A": "H. Management of Change in Product Ownership",
"B": "GMP",
"C": "each product lifecycle stage"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Pharmaceutical Development (____)\nThe goal of pharmaceutical development activitie s is to design a product and its manufacturing process to consistently deliver the intended pe rformance and meet the needs of patients and healthcare professionals, and regulatory authori ties and internal customers requirements.",
"reference": "Pharmaceutical Development (3.1.1)\nThe goal of pharmaceutical development activitie s is to design a product and its manufacturing process to consistently deliver the intended pe rformance and meet the needs of patients and healthcare professionals, and regulatory authori ties and internal customers requirements.",
"options": {
"C": "3.1.1",
"A": "2.8",
"B": "four",
"D": "each product lifecycle stage"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 10 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
The source of the definition is identified in parentheses after the definition. Where no appropria te ICH or ISO definition was available, an ICH Q10 definition was developed. Capability of a Process: Ability of a process to real ize a product that will fulfill the requirements of that product. The concept of pro cess capability can also be defined in statistical terms. Change Management: A systematic approach to proposing, evaluating, approving, implementing, and reviewing changes. Continual Improvement: Recurring activity to increase the ab ility to fulfill requirements. (ISO 9000:2005) Control Strategy:
A planned set of controls, deri ved from current product and process understanding, that assures proc ess performance and product quali ty. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, fi nished product specifications, and the associated methods and frequency of monitoring and control. (ICH Q10) Corrective Action: Action to eliminate the cause of a detected nonconformity or other undesirable situation. Corrective action is taken to prevent recurrence whereas preventive action is taken to preven t occurrence. (ISO 9000:2005) Design Space: The multidimensional combination and interaction of input variables (e.g., material attributes) and process pa rameters that have been demons trated to provide assurance of quality. (ICH Q8) Enabler: A tool or process that provides the means to achieve an objective. (ICH Q10) Feedback/Feedforward: Feedback: The modification or control of a process or system by its results or effects. Feedforward: The modification or control of a pro cess using its anticipated results or effects. (Oxford Dictionary of Eng lish by Oxford University Press, 2003)
Feedback/feedforward can be applied technically in process control strate gies and conceptually in quality management.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: '(ICH Q10) Feedback/Feedforward: Feedback: The modi...'?",
"reference": "(ICH Q10) Feedback/Feedforward: Feedback: The modification or control of a process or system by its results or effects.",
"options": {
"B": "Feedback/Feedforward",
"A": "ISO",
"C": "ISO 9000:2005",
"D": "process control strate gies"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Where no appropria te ICH or ISO definition was av...'?",
"reference": "Where no appropria te ICH or ISO definition was available, an ICH Q10 definition was developed.",
"options": {
"B": "ISO",
"A": "ISO 9000:2005",
"C": "process control strate gies",
"D": "process pa rameters"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q8) Enabler: A tool or process that provides ...'?",
"reference": "(ICH Q8) Enabler: A tool or process that provides the means to achieve an objective.",
"options": {
"C": "ICH Q8) Enabler",
"A": "ISO",
"B": "ISO 9000:2005",
"D": "process control strate gies"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ISO 9000:2005) Design Space: The multidimensional...'?",
"reference": "(ISO 9000:2005) Design Space: The multidimensional combination and interaction of input variables (e.g., material attributes) and process pa rameters that have been demons trated to provide assurance of quality.",
"options": {
"B": "ISO 9000:2005",
"A": "ISO",
"C": "ICH Q8) Enabler",
"D": "process control strate gies"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Where no appropria te ICH or ISO definition was av...'?",
"reference": "Where no appropria te ICH or ISO definition was available, an ICH Q10 definition was developed.",
"options": {
"A": "ISO",
"B": "ISO 9000:2005",
"C": "process control strate gies",
"D": "process pa rameters"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ISO 9000:2005) Control Strategy:\nA planned set of...'?",
"reference": "(ISO 9000:2005) Control Strategy:\nA planned set of controls, deri ved from current product and process understanding, that assures proc ess performance and product quali ty.",
"options": {
"D": "ISO 9000:2005",
"A": "ISO",
"B": "ICH Q8) Enabler",
"C": "process control strate gies"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: '(ISO 9000:2005) Control Strategy:\nA planned set of...'?",
"reference": "(ISO 9000:2005) Control Strategy:\nA planned set of controls, deri ved from current product and process understanding, that assures proc ess performance and product quali ty.",
"options": {
"D": "deri",
"A": "process control strate gies",
"B": "process pa rameters",
"C": "ISO 9000:2005"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Where no appropria te ICH or ISO definition was av...'?",
"reference": "Where no appropria te ICH or ISO definition was available, an ICH Q10 definition was developed.",
"options": {
"D": "ISO",
"A": "ISO 9000:2005",
"B": "process control strate gies",
"C": "process pa rameters"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Where no appropria te ICH or ISO definition was av...'?",
"reference": "Where no appropria te ICH or ISO definition was available, an ICH Q10 definition was developed.",
"options": {
"B": "ISO",
"A": "ISO 9000:2005",
"C": "process control strate gies",
"D": "process pa rameters"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q10) Feedback/Feedforward: Feedback: The modi...'?",
"reference": "(ICH Q10) Feedback/Feedforward: Feedback: The modification or control of a process or system by its results or effects.",
"options": {
"C": "Feedback/Feedforward",
"A": "ISO",
"B": "ISO 9000:2005",
"D": "process control strate gies"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 45 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1. Analyze Data for Trends ............................................................................................................... 21 2. Conduct Internal Audits ................................................................................................................. 21 3. Quality Risk Management ..............................................................................................................
Corrective Action ...........................................................................................................................
22 Contains Nonbinding Recommendations 5. Preventive Actions ......................................................................................................................... 23 6. Promote Improvement ....................................................................................................................
23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................
25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any pe rson and does not operate to bind FDA or the public.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Preventive Actions ..................................'?",
"reference": "Preventive Actions ......................................................................................................................... 23 6.",
"options": {
"B": "Preventive Actions",
"A": "Analyze Data",
"C": "Conduct Internal Audits",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Preventive Actions ..................................'?",
"reference": "Preventive Actions ......................................................................................................................... 23 6.",
"options": {
"B": "23 6",
"A": "21 2",
"C": "Nonbinding Recommendations Guidance",
"D": "Pharmaceutical Current Good Manufacturing Practice Regulations"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Preventive Actions ......................................................................................................................... ____ 6.",
"reference": "Preventive Actions ......................................................................................................................... 23 6.",
"options": {
"D": "23",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Preventive Actions ......................................................................................................................... 23 ____.",
"reference": "Preventive Actions ......................................................................................................................... 23 6.",
"options": {
"A": "6",
"B": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Conduct Internal Audits .............................'?",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"B": "21 3",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Conduct Internal Audits ................................................................................................................. ____ 3.",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"B": "21",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Conduct Internal Audits ................................................................................................................. 21 ____.",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"C": "3",
"A": "21 2",
"B": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Address Nonconformities .............................'?",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"C": "21 1",
"A": "21 3",
"B": "Nonbinding Recommendations Guidance",
"D": "Pharmaceutical Current Good Manufacturing Practice Regulations"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... ____ D. Evaluation Activities .................................................................................................................... 21 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"B": "19",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... ____ 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"D": "21",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... ____9 D. Evaluation Activities .................................................................................................................... 21 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"C": "1",
"A": "21 2",
"B": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Quality Risk Management .............................'?",
"reference": "Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n22 Contains Nonbinding Recommendations 5.",
"options": {
"C": "Quality Risk Management",
"A": "Analyze Data",
"B": "Conduct Internal Audits",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n____ Contains Nonbinding Recommendations 5.",
"reference": "Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n22 Contains Nonbinding Recommendations 5.",
"options": {
"A": "22",
"B": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n22 Contains Nonbinding Recommendations ____.",
"reference": "Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n22 Contains Nonbinding Recommendations 5.",
"options": {
"A": "5",
"B": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Address Nonconformities .............................'?",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"A": "21 1",
"B": "21 3",
"C": "Nonbinding Recommendations Guidance",
"D": "Pharmaceutical Current Good Manufacturing Practice Regulations"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... ____ D. Evaluation Activities .................................................................................................................... 21 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"B": "19",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... ____ 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"B": "21",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... ____9 D. Evaluation Activities .................................................................................................................... 21 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"D": "1",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Address Nonconformities .............................'?",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"A": "21 1",
"B": "21 3",
"C": "Nonbinding Recommendations Guidance",
"D": "Pharmaceutical Current Good Manufacturing Practice Regulations"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... ____ D. Evaluation Activities .................................................................................................................... 21 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"B": "19",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... ____ 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"D": "21",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... ____9 D. Evaluation Activities .................................................................................................................... 21 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"A": "1",
"B": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Quality Risk Management .............................'?",
"reference": "Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n22 Contains Nonbinding Recommendations 5.",
"options": {
"C": "Quality Risk Management",
"A": "Analyze Data",
"B": "Conduct Internal Audits",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n____ Contains Nonbinding Recommendations 5.",
"reference": "Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n22 Contains Nonbinding Recommendations 5.",
"options": {
"C": "22",
"A": "21 2",
"B": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n22 Contains Nonbinding Recommendations ____.",
"reference": "Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n22 Contains Nonbinding Recommendations 5.",
"options": {
"B": "5",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Conduct Internal Audits .............................'?",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"C": "21 3",
"A": "21 2",
"B": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Conduct Internal Audits ................................................................................................................. ____ 3.",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"B": "21",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Conduct Internal Audits ................................................................................................................. 21 ____.",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"B": "3",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Conduct Internal Audits .............................'?",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"C": "21 3",
"A": "21 2",
"B": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Conduct Internal Audits ................................................................................................................. ____ 3.",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"A": "21",
"B": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Conduct Internal Audits ................................................................................................................. 21 ____.",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"D": "3",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It does not create or confer any rights for or on ...'?",
"reference": "It does not create or confer any rights for or on any pe rson and does not operate to bind FDA or the public.",
"options": {
"C": "FDA",
"A": "Analyze Data",
"B": "Conduct Internal Audits",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Address Nonconformities .............................'?",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"B": "21 1",
"A": "21 3",
"C": "Nonbinding Recommendations Guidance",
"D": "Pharmaceutical Current Good Manufacturing Practice Regulations"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... ____ D. Evaluation Activities .................................................................................................................... 21 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"A": "19",
"B": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Promote Improvement .................................'?",
"reference": "Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"options": {
"B": "Quality Systems Approach",
"A": "Analyze Data",
"C": "Conduct Internal Audits",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Promote Improvement .................................'?",
"reference": "Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"options": {
"C": "the Food and Drug Administrati",
"A": "Analyze Data",
"B": "Conduct Internal Audits",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Promote Improvement .................................'?",
"reference": "Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"options": {
"D": "FDA",
"A": "Analyze Data",
"B": "Conduct Internal Audits",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Promote Improvement ....................................................................................................................\n____ V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"reference": "Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"options": {
"B": "23",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... ____ USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"reference": "Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"options": {
"D": "24",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n____ GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"reference": "Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"options": {
"D": "25",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. ____ Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"reference": "Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"options": {
"D": "27",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It does not create or confer any rights for or on ...'?",
"reference": "It does not create or confer any rights for or on any pe rson and does not operate to bind FDA or the public.",
"options": {
"C": "FDA",
"A": "Analyze Data",
"B": "Conduct Internal Audits",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Address Nonconformities .............................'?",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"D": "21 1",
"A": "21 3",
"B": "Nonbinding Recommendations Guidance",
"C": "Pharmaceutical Current Good Manufacturing Practice Regulations"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... ____ D. Evaluation Activities .................................................................................................................... 21 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"B": "19",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... ____ 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"D": "21",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 5 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
453 454 12 Ibid., Section 4.16 . 13
Ibid., Section 4.37 . Ibid., Section 4.35. Contains Nonbinding Recommendations Draft Not for Implementation 15Established purchasing control processes for selecting and monitoring software 455 developers . For exa mple, the manufacturer could incorporate the practices, validation 456 work, and electronic information already performed by developers of the software as the 457 starting point and determine what additional activitie s may be needed. For some lower - 458 risk software features, functions, and operations, this may be all the assurance that is 459 needed by the manufacturer . 460 461 Additional process controls that have been incorporated throughout production. For 462 example, if a process is fully understood, all critical proc ess parameters are monitored, 463 and/or all outputs of a process undergo verification testing, these controls can serve as 464 additional mechanisms to detect and correct the occurrence of quality problems that may 465 occur if a software feature, function, or operat ion were to fail to perform as intended. In 466 this example, the presence of these controls can be leveraged to reduce the effort of 467 assurance activities appropriate for the software. The data and information periodically or continuously collected by the so ftware for the 470 purposes of monitoring or detecting issues and anomalies in the software after 471 implementation of the software. Th e capability to monitor and detect performance issues 472 or deviations and system errors may reduce the risk associated with a fail ure of the 473 software to perform as intended and may be considered when deciding on assurance 474 activities. 475 476 The use of Computer System Validation tools (e.g., bug tracker, automated testing) for 477 the assurance of software used in production or as part of th e quality system whenever 478 possible.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: For some lower - ____ risk software features, functions, and operations, this may be all the assurance that is 459 needed by the manufacturer .",
"reference": "For some lower - 458 risk software features, functions, and operations, this may be all the assurance that is 459 needed by the manufacturer .",
"options": {
"D": "458",
"A": "453",
"B": "455",
"C": "a software feature"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For some lower - 458 risk software features, functions, and operations, this may be all the assurance that is ____ needed by the manufacturer .",
"reference": "For some lower - 458 risk software features, functions, and operations, this may be all the assurance that is 459 needed by the manufacturer .",
"options": {
"C": "459",
"A": "453",
"B": "455",
"D": "some lower - 458 risk software features"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 454 12 Ibid., Section 4.16 .",
"reference": "453 454 12 Ibid., Section 4.16 .",
"options": {
"C": "453",
"A": "455",
"B": "456",
"D": "some lower - 458 risk software features"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 453 ____ 12 Ibid., Section 4.16 .",
"reference": "453 454 12 Ibid., Section 4.16 .",
"options": {
"C": "454",
"A": "453",
"B": "455",
"D": "some lower - 458 risk software features"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 453 454 ____ Ibid., Section 4.16 .",
"reference": "453 454 12 Ibid., Section 4.16 .",
"options": {
"C": "12",
"A": "453",
"B": "455",
"D": "some lower - 458 risk software features"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 40 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
76 77 Metadata is the contextual information required to understand data. A data value 78 is by itself meaningless without additional information about the data. Metadata is 79 often described as data about data. Metadata is structured information that 80 describes, exp lains, or otherwise makes it easier to retrieve, use, or manage data. For example, the number 23 is meaningless without metadata, such as an 82 indication of the unit mg. Among other things, metadata for a particular piece 83 of data could include a date /time
stamp for when the data w ere acquired, a user ID 84 of the person who conducted the test or analysis that generated the data, the 85 instrument ID used to acquire the data, audit trails, etc. 86 87 Data should be maintained throughout the record s retention period with all 88 associated metadata required to reconstruct the CGMP activity (e.g. , 211.188 89 and 211.194) . The relationships between data and their metadata should be 90 preserved in a secure and traceable manner. What is an audit trail ? For purposes of t his guidance, audit t rail means a secure, computer -generated, 95 time-stamped electronic record that allows for reconstruction of the course of 96 events relating to the creation, modification, or deletion of an electronic record. An audit trail is a chronology of the who, what, when, and why of a record. For 98 example, the audit trail for a high performance l iquid c hromatography (HPLC ) 99 run could include the user name, date/time of the run, the integration parameters 100 used, and details of a reprocessing , if any, i ncluding change justification for the 101 reprocessing . 102 103 Electronic audit trails include those that track creation, modification, or deletion 104 of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or 106 delete a file).
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: ____ 103 Electronic audit trails include those that track creation, modification, or deletion 104 of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or 106 delete a file).",
"reference": "102 103 Electronic audit trails include those that track creation, modification, or deletion 104 of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or 106 delete a file).",
"options": {
"D": "102",
"A": "211.194",
"B": "100",
"C": "86 87 Data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 102 ____ Electronic audit trails include those that track creation, modification, or deletion 104 of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or 106 delete a file).",
"reference": "102 103 Electronic audit trails include those that track creation, modification, or deletion 104 of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or 106 delete a file).",
"options": {
"A": "103",
"B": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 102 103 Electronic audit trails include those that track creation, modification, or deletion ____ of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or 106 delete a file).",
"reference": "102 103 Electronic audit trails include those that track creation, modification, or deletion 104 of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or 106 delete a file).",
"options": {
"D": "104",
"A": "211.194",
"B": "100",
"C": "86 87 Data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 102 103 Electronic audit trails include those that track creation, modification, or deletion 104 of data (such as processing parameters and results) and those that track actions at ____ the record or system level (such as attempts to access the system or rename or 106 delete a file).",
"reference": "102 103 Electronic audit trails include those that track creation, modification, or deletion 104 of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or 106 delete a file).",
"options": {
"A": "105",
"B": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 102 103 Electronic audit trails include those that track creation, modification, or deletion 104 of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or ____ delete a file).",
"reference": "102 103 Electronic audit trails include those that track creation, modification, or deletion 104 of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or 106 delete a file).",
"options": {
"C": "106",
"A": "211.194",
"B": "100",
"D": "86 87 Data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the number ____ is meaningless without metadata, such as an 82 indication of the unit mg.",
"reference": "For example, the number 23 is meaningless without metadata, such as an 82 indication of the unit mg.",
"options": {
"B": "23",
"A": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the number 23 is meaningless without metadata, such as an ____ indication of the unit mg.",
"reference": "For example, the number 23 is meaningless without metadata, such as an 82 indication of the unit mg.",
"options": {
"C": "82",
"A": "211.194",
"B": "100",
"D": "86 87 Data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: '76 77 Metadata is the contextual information requi...'?",
"reference": "76 77 Metadata is the contextual information required to understand data.",
"options": {
"C": "Metadata",
"A": "86 87 Data",
"B": "A data value",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 77 Metadata is the contextual information required to understand data.",
"reference": "76 77 Metadata is the contextual information required to understand data.",
"options": {
"D": "76",
"A": "211.194",
"B": "100",
"C": "86 87 Data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 76 ____ Metadata is the contextual information required to understand data.",
"reference": "76 77 Metadata is the contextual information required to understand data.",
"options": {
"C": "77",
"A": "211.194",
"B": "100",
"D": "86 87 Data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Among other things, metadata for a particular piece ____ of data could include a date /time\nstamp for when the data w ere acquired, a user ID 84 of the person who conducted the test or analysis that generated the data, the 85 instrument ID used to acquire the data, audit trails, etc.",
"reference": "Among other things, metadata for a particular piece 83 of data could include a date /time\nstamp for when the data w ere acquired, a user ID 84 of the person who conducted the test or analysis that generated the data, the 85 instrument ID used to acquire the data, audit trails, etc.",
"options": {
"C": "83",
"A": "211.194",
"B": "100",
"D": "86 87 Data"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Among other things, metadata for a particular piece 83 of data could include a date /time\nstamp for when the data w ere acquired, a user ID ____ of the person who conducted the test or analysis that generated the data, the 85 instrument ID used to acquire the data, audit trails, etc.",
"reference": "Among other things, metadata for a particular piece 83 of data could include a date /time\nstamp for when the data w ere acquired, a user ID 84 of the person who conducted the test or analysis that generated the data, the 85 instrument ID used to acquire the data, audit trails, etc.",
"options": {
"C": "84",
"A": "211.194",
"B": "100",
"D": "86 87 Data"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Among other things, metadata for a particular piece 83 of data could include a date /time\nstamp for when the data w ere acquired, a user ID 84 of the person who conducted the test or analysis that generated the data, the ____ instrument ID used to acquire the data, audit trails, etc.",
"reference": "Among other things, metadata for a particular piece 83 of data could include a date /time\nstamp for when the data w ere acquired, a user ID 84 of the person who conducted the test or analysis that generated the data, the 85 instrument ID used to acquire the data, audit trails, etc.",
"options": {
"A": "85",
"B": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the number ____ is meaningless without metadata, such as an 82 indication of the unit mg.",
"reference": "For example, the number 23 is meaningless without metadata, such as an 82 indication of the unit mg.",
"options": {
"C": "23",
"A": "211.194",
"B": "100",
"D": "86 87 Data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the number 23 is meaningless without metadata, such as an ____ indication of the unit mg.",
"reference": "For example, the number 23 is meaningless without metadata, such as an 82 indication of the unit mg.",
"options": {
"C": "82",
"A": "211.194",
"B": "100",
"D": "86 87 Data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Metadata is 79 often described as data about data....'?",
"reference": "Metadata is 79 often described as data about data.",
"options": {
"A": "Metadata",
"B": "86 87 Data",
"C": "A data value",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Metadata is ____ often described as data about data.",
"reference": "Metadata is 79 often described as data about data.",
"options": {
"C": "79",
"A": "211.194",
"B": "100",
"D": "86 87 Data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Among other things, metadata for a particular piece ____ of data could include a date /time\nstamp for when the data w ere acquired, a user ID 84 of the person who conducted the test or analysis that generated the data, the 85 instrument ID used to acquire the data, audit trails, etc.",
"reference": "Among other things, metadata for a particular piece 83 of data could include a date /time\nstamp for when the data w ere acquired, a user ID 84 of the person who conducted the test or analysis that generated the data, the 85 instrument ID used to acquire the data, audit trails, etc.",
"options": {
"B": "83",
"A": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Among other things, metadata for a particular piece 83 of data could include a date /time\nstamp for when the data w ere acquired, a user ID ____ of the person who conducted the test or analysis that generated the data, the 85 instrument ID used to acquire the data, audit trails, etc.",
"reference": "Among other things, metadata for a particular piece 83 of data could include a date /time\nstamp for when the data w ere acquired, a user ID 84 of the person who conducted the test or analysis that generated the data, the 85 instrument ID used to acquire the data, audit trails, etc.",
"options": {
"C": "84",
"A": "211.194",
"B": "100",
"D": "86 87 Data"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Among other things, metadata for a particular piece 83 of data could include a date /time\nstamp for when the data w ere acquired, a user ID 84 of the person who conducted the test or analysis that generated the data, the ____ instrument ID used to acquire the data, audit trails, etc.",
"reference": "Among other things, metadata for a particular piece 83 of data could include a date /time\nstamp for when the data w ere acquired, a user ID 84 of the person who conducted the test or analysis that generated the data, the 85 instrument ID used to acquire the data, audit trails, etc.",
"options": {
"A": "85",
"B": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: For ____ example, the audit trail for a high performance l iquid c hromatography (HPLC ) 99 run could include the user name, date/time of the run, the integration parameters 100 used, and details of a reprocessing , if any, i ncluding change justification for the 101 reprocessing .",
"reference": "For 98 example, the audit trail for a high performance l iquid c hromatography (HPLC ) 99 run could include the user name, date/time of the run, the integration parameters 100 used, and details of a reprocessing , if any, i ncluding change justification for the 101 reprocessing .",
"options": {
"C": "98",
"A": "211.194",
"B": "100",
"D": "86 87 Data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For 98 example, the audit trail for a high performance l iquid c hromatography (HPLC ) ____ run could include the user name, date/time of the run, the integration parameters 100 used, and details of a reprocessing , if any, i ncluding change justification for the 101 reprocessing .",
"reference": "For 98 example, the audit trail for a high performance l iquid c hromatography (HPLC ) 99 run could include the user name, date/time of the run, the integration parameters 100 used, and details of a reprocessing , if any, i ncluding change justification for the 101 reprocessing .",
"options": {
"C": "99",
"A": "211.194",
"B": "100",
"D": "86 87 Data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For 98 example, the audit trail for a high performance l iquid c hromatography (HPLC ) 99 run could include the user name, date/time of the run, the integration parameters ____ used, and details of a reprocessing , if any, i ncluding change justification for the 101 reprocessing .",
"reference": "For 98 example, the audit trail for a high performance l iquid c hromatography (HPLC ) 99 run could include the user name, date/time of the run, the integration parameters 100 used, and details of a reprocessing , if any, i ncluding change justification for the 101 reprocessing .",
"options": {
"A": "100",
"B": "211.194",
"C": "102 103",
"D": "86 87 Data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For 98 example, the audit trail for a high performance l iquid c hromatography (HPLC ) 99 run could include the user name, date/time of the run, the integration parameters 100 used, and details of a reprocessing , if any, i ncluding change justification for the ____ reprocessing .",
"reference": "For 98 example, the audit trail for a high performance l iquid c hromatography (HPLC ) 99 run could include the user name, date/time of the run, the integration parameters 100 used, and details of a reprocessing , if any, i ncluding change justification for the 101 reprocessing .",
"options": {
"B": "101",
"A": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Metadata is structured information that 80 describ...'?",
"reference": "Metadata is structured information that 80 describes, exp lains, or otherwise makes it easier to retrieve, use, or manage data.",
"options": {
"A": "Metadata",
"B": "86 87 Data",
"C": "A data value",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Metadata is structured information that ____ describes, exp lains, or otherwise makes it easier to retrieve, use, or manage data.",
"reference": "Metadata is structured information that 80 describes, exp lains, or otherwise makes it easier to retrieve, use, or manage data.",
"options": {
"B": "80",
"A": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The relationships between data and their metadata should be ____ preserved in a secure and traceable manner.",
"reference": "The relationships between data and their metadata should be 90 preserved in a secure and traceable manner.",
"options": {
"B": "90",
"A": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 103 Electronic audit trails include those that track creation, modification, or deletion 104 of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or 106 delete a file).",
"reference": "102 103 Electronic audit trails include those that track creation, modification, or deletion 104 of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or 106 delete a file).",
"options": {
"A": "102",
"B": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 102 ____ Electronic audit trails include those that track creation, modification, or deletion 104 of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or 106 delete a file).",
"reference": "102 103 Electronic audit trails include those that track creation, modification, or deletion 104 of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or 106 delete a file).",
"options": {
"C": "103",
"A": "211.194",
"B": "100",
"D": "86 87 Data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 102 103 Electronic audit trails include those that track creation, modification, or deletion ____ of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or 106 delete a file).",
"reference": "102 103 Electronic audit trails include those that track creation, modification, or deletion 104 of data (such as processing parameters and results) and those that track actions at 105 the record or system level (such as attempts to access the system or rename or 106 delete a file).",
"options": {
"A": "104",
"B": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For ____ example, the audit trail for a high performance l iquid c hromatography (HPLC ) 99 run could include the user name, date/time of the run, the integration parameters 100 used, and details of a reprocessing , if any, i ncluding change justification for the 101 reprocessing .",
"reference": "For 98 example, the audit trail for a high performance l iquid c hromatography (HPLC ) 99 run could include the user name, date/time of the run, the integration parameters 100 used, and details of a reprocessing , if any, i ncluding change justification for the 101 reprocessing .",
"options": {
"C": "98",
"A": "211.194",
"B": "100",
"D": "86 87 Data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For 98 example, the audit trail for a high performance l iquid c hromatography (HPLC ) ____ run could include the user name, date/time of the run, the integration parameters 100 used, and details of a reprocessing , if any, i ncluding change justification for the 101 reprocessing .",
"reference": "For 98 example, the audit trail for a high performance l iquid c hromatography (HPLC ) 99 run could include the user name, date/time of the run, the integration parameters 100 used, and details of a reprocessing , if any, i ncluding change justification for the 101 reprocessing .",
"options": {
"A": "99",
"B": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For 98 example, the audit trail for a high performance l iquid c hromatography (HPLC ) 99 run could include the user name, date/time of the run, the integration parameters ____ used, and details of a reprocessing , if any, i ncluding change justification for the 101 reprocessing .",
"reference": "For 98 example, the audit trail for a high performance l iquid c hromatography (HPLC ) 99 run could include the user name, date/time of the run, the integration parameters 100 used, and details of a reprocessing , if any, i ncluding change justification for the 101 reprocessing .",
"options": {
"D": "100",
"A": "211.194",
"B": "102 103",
"C": "86 87 Data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For 98 example, the audit trail for a high performance l iquid c hromatography (HPLC ) 99 run could include the user name, date/time of the run, the integration parameters 100 used, and details of a reprocessing , if any, i ncluding change justification for the ____ reprocessing .",
"reference": "For 98 example, the audit trail for a high performance l iquid c hromatography (HPLC ) 99 run could include the user name, date/time of the run, the integration parameters 100 used, and details of a reprocessing , if any, i ncluding change justification for the 101 reprocessing .",
"options": {
"B": "101",
"A": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the number ____ is meaningless without metadata, such as an 82 indication of the unit mg.",
"reference": "For example, the number 23 is meaningless without metadata, such as an 82 indication of the unit mg.",
"options": {
"A": "23",
"B": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the number 23 is meaningless without metadata, such as an ____ indication of the unit mg.",
"reference": "For example, the number 23 is meaningless without metadata, such as an 82 indication of the unit mg.",
"options": {
"A": "82",
"B": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is rail?",
"reference": "For purposes of t his guidance, audit t rail means a secure, computer -generated, 95 time-stamped electronic record that allows for reconstruction of the course of 96 events relating to the creation, modification, or deletion of an electronic record.",
"options": {
"C": "record",
"A": "86 87 Data",
"B": "A data value",
"D": "disk"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: For purposes of t his guidance, audit t rail means a secure, computer -generated, ____ time-stamped electronic record that allows for reconstruction of the course of 96 events relating to the creation, modification, or deletion of an electronic record.",
"reference": "For purposes of t his guidance, audit t rail means a secure, computer -generated, 95 time-stamped electronic record that allows for reconstruction of the course of 96 events relating to the creation, modification, or deletion of an electronic record.",
"options": {
"D": "95",
"A": "211.194",
"B": "100",
"C": "86 87 Data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For purposes of t his guidance, audit t rail means a secure, computer -generated, 95 time-stamped electronic record that allows for reconstruction of the course of ____ events relating to the creation, modification, or deletion of an electronic record.",
"reference": "For purposes of t his guidance, audit t rail means a secure, computer -generated, 95 time-stamped electronic record that allows for reconstruction of the course of 96 events relating to the creation, modification, or deletion of an electronic record.",
"options": {
"C": "96",
"A": "211.194",
"B": "100",
"D": "86 87 Data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the number ____ is meaningless without metadata, such as an 82 indication of the unit mg.",
"reference": "For example, the number 23 is meaningless without metadata, such as an 82 indication of the unit mg.",
"options": {
"B": "23",
"A": "211.194",
"C": "100",
"D": "86 87 Data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 4 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
When generated to satisfy a CGMP requirement , all data become a CGMP record.14 You must document, or save, the data at the time of performance to create a record in compliance with CGMP requirements , including, but not limited to, 211.100(b) and 211.160(a) . FDA expects processes to be designed so that data required to be created and maintained cannot be modified witho ut a record of the modification . For example, chromatographic data should be saved to durable media upon completion of each step or injection (e.g., peak integration or processing steps; finished, incomplete , or aborted injections) instead of at the end of an injection set, and changes to the chromatographic data or injection sequence should be documented in an audit trail. Aborted or incomplete injections should be captured in audit trails and should be investigated and justified . It is not acceptable to record data on pieces of paper that will be discarded after the data are transcribed to a permanent laboratory notebook ( see 211.100(b), 211.160(a), and 211.180(d)). Similarly, it is not acceptable to store electronic records in a manner that allows for manipulation without creating a permanent record . You may employ a combination of technical and procedural controls to meet CGMP documentation practices for electronic systems. For example, a computer system, such as a Laboratory Information Management System (LIMS) or an Electronic Batch Record (EBR) system , can be designed to automatically save after each entry. This would be similar to indelibly recording each entry contemporaneously on a paper batch record to satisfy CGMP requirements . The computer system describ ed above could be combined with a procedure requiring data be keyed in or otherwise entered immediately when generated . For PET drugs, see the Laboratory Controls section of the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'For example, a computer system, such as a Laborato...'?",
"reference": "For example, a computer system, such as a Laboratory Information Management System (LIMS) or an Electronic Batch Record (EBR) system , can be designed to automatically save after each entry.",
"options": {
"D": "Laboratory Information Management System",
"A": "CGMP",
"B": "chromatographic data",
"C": "the chromatographic data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'For example, a computer system, such as a Laborato...'?",
"reference": "For example, a computer system, such as a Laboratory Information Management System (LIMS) or an Electronic Batch Record (EBR) system , can be designed to automatically save after each entry.",
"options": {
"D": "an Electronic Batch Record",
"A": "chromatographic data",
"B": "the chromatographic data",
"C": "Laboratory Information Management System"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When generated to satisfy a CGMP requirement , all...'?",
"reference": "When generated to satisfy a CGMP requirement , all data become a CGMP record.14 You must document, or save, the data at the time of performance to create a record in compliance with CGMP requirements , including, but not limited to, 211.100(b) and 211.160(a) .",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "Laboratory Information Management System",
"D": "chromatographic data"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When generated to satisfy a CGMP requirement , all...'?",
"reference": "When generated to satisfy a CGMP requirement , all data become a CGMP record.14 You must document, or save, the data at the time of performance to create a record in compliance with CGMP requirements , including, but not limited to, 211.100(b) and 211.160(a) .",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "Laboratory Information Management System",
"D": "chromatographic data"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 8 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
CONTEXT FOR SOFTWARE VALIDATION ................................
...................
Definitions and Terminology ................................ ................................
.............................
5 3.1.1 Requirements and Specifications ................................ ................................
...................
5 3.1.2 Verification and Validation ................................ ................................
........................... 6 3.1.3 IQ/OQ/PQ ................................ ................................
................................ ......................
Software Development as Part of System Design ................................ ............................
Software is Different from Hardware ................................ ................................
................ 8 3.4. Benefits of Software Validation ................................
................................ .........................
9 3.5 Design Review ................................ ................................ ................................
...................
PRINCIPLES OF SOFTWARE VALIDATION ................................ Requirements ................................ ................................ ................................
................... Defect Prevention ................................
................................ ................................
............ 11 4.3. Time and Effort ................................ ................................ ................................
................ 11 4.4. Software Life Cycle ................................ ................................ ................................
Plans ................................ ................................ ................................
................................ ..12 4.6.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Defect Prevention ...................................'?",
"reference": "Defect Prevention ................................\n................................ ................................\n............ 11 4.3.",
"options": {
"D": "Defect Prevention",
"A": "Software Development as Part of System Design",
"B": "Software",
"C": "Software Validation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Defect Prevention ................................\n................................ ................................\n............ ____ 4.3.",
"reference": "Defect Prevention ................................\n................................ ................................\n............ 11 4.3.",
"options": {
"B": "11",
"A": "6 3.1.3",
"C": "8 3.4",
"D": "Software Validation"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Defect Prevention ................................\n................................ ................................\n............ 11 ____.",
"reference": "Defect Prevention ................................\n................................ ................................\n............ 11 4.3.",
"options": {
"C": "4.3",
"A": "6 3.1.3",
"B": "8 3.4",
"D": "Software Validation"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Benefits of Software Validation ................................\n................................ .........................\n____ 3.5 Design Review ................................ ................................ ................................\n...................\nPRINCIPLES OF SOFTWARE VALIDATION ................................",
"reference": "Benefits of Software Validation ................................\n................................ .........................\n9 3.5 Design Review ................................ ................................ ................................\n...................\nPRINCIPLES OF SOFTWARE VALIDATION ................................",
"options": {
"C": "9",
"A": "6 3.1.3",
"B": "8 3.4",
"D": "Software Validation"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Benefits of Software Validation ................................\n................................ .........................\n9 ____ Design Review ................................ ................................ ................................\n...................\nPRINCIPLES OF SOFTWARE VALIDATION ................................",
"reference": "Benefits of Software Validation ................................\n................................ .........................\n9 3.5 Design Review ................................ ................................ ................................\n...................\nPRINCIPLES OF SOFTWARE VALIDATION ................................",
"options": {
"B": "3.5",
"A": "6 3.1.3",
"C": "8 3.4",
"D": "Software Validation"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Benefits of Software Validation ................................\n................................ .........................\n____ 3.5 Design Review ................................ ................................ ................................\n...................\nPRINCIPLES OF SOFTWARE VALIDATION ................................",
"reference": "Benefits of Software Validation ................................\n................................ .........................\n9 3.5 Design Review ................................ ................................ ................................\n...................\nPRINCIPLES OF SOFTWARE VALIDATION ................................",
"options": {
"D": "9",
"A": "6 3.1.3",
"B": "8 3.4",
"C": "Software Validation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Benefits of Software Validation ................................\n................................ .........................\n9 ____ Design Review ................................ ................................ ................................\n...................\nPRINCIPLES OF SOFTWARE VALIDATION ................................",
"reference": "Benefits of Software Validation ................................\n................................ .........................\n9 3.5 Design Review ................................ ................................ ................................\n...................\nPRINCIPLES OF SOFTWARE VALIDATION ................................",
"options": {
"D": "3.5",
"A": "6 3.1.3",
"B": "8 3.4",
"C": "Software Validation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Defect Prevention ...................................'?",
"reference": "Defect Prevention ................................\n................................ ................................\n............ 11 4.3.",
"options": {
"C": "Defect Prevention",
"A": "Software Development as Part of System Design",
"B": "Software",
"D": "Software Validation"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 4 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
A root cause analysis of anomalies can identify specific quality system deficiencies. Where trends are identified (e.g., recurrence of similar software anomalies), appropriate corrective and preventive actions must be implemented and documented to avoid further recurrence of similar quality problems. (See 21 CFR 820.100.) Problem Identification and Resolution Tracking - All problems discovered during maintenance of the software should be documented. The resolution of each problem should be tracked to ensure it is fixed, for historical reference, and for trending. Proposed Change Assessment - All proposed modifications, enhancements, or additions should be assessed to determine the effect each change would have on the system. This information should determine the extent to which verification and/or validation tasks need to be iterated. Task Iteration - For approved software changes, all necessary verification and validation tasks should be performed to ensure that planned changes are implemented correctly, all documentation is complete and up to date, and no unacceptable changes have occurred in software performance. Documentation Updating Documentation should be carefully reviewed to determine which documents have been impacted by a change. All approved documents (e.g., specifications, test procedures, user manuals, etc.) that have been affected should be updated in accordance with configuration management procedures. Specifications should be updated before any maintenance and software changes are made. Page 30General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 6. VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE
The Quality System regulation requires that when computers or automated data processing systems are used as part of production or the quality system, the [device] manufacturer shall validate computer software for its intended use according to an established protocol. (See 21 CFR 820.70(i)).
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUAL...'?",
"reference": "VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE\nThe Quality System regulation requires that when computers or automated data processing systems are used as part of production or the quality system, the [device] manufacturer shall validate computer software for its intended use according to an established protocol.",
"options": {
"A": "Quality System",
"B": "any maintenance and software changes",
"C": "approved software changes",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUAL...'?",
"reference": "VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE\nThe Quality System regulation requires that when computers or automated data processing systems are used as part of production or the quality system, the [device] manufacturer shall validate computer software for its intended use according to an established protocol.",
"options": {
"A": "Quality System",
"B": "any maintenance and software changes",
"C": "approved software changes",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUAL...'?",
"reference": "VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE\nThe Quality System regulation requires that when computers or automated data processing systems are used as part of production or the quality system, the [device] manufacturer shall validate computer software for its intended use according to an established protocol.",
"options": {
"A": "Quality System",
"B": "any maintenance and software changes",
"C": "approved software changes",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 30General Principles of Software Validation G...'?",
"reference": "Page 30General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 6.",
"options": {
"A": "FDA",
"B": "Documentation Updating Documentation",
"C": "Quality System",
"D": "AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy. Manufacturers may decide to conduct different assurance activities for individual 190 features, functions, or op erations. 191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses. When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration . The intended use of the software, documen ting readings , only support s 198 maintaining the quality system record and poses a low process risk. As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome. Several functions of the software may, in turn, be applied together in an operation to perform practical work in a process. For the purposes of this gu idance, a function refers to a software function and is not to be confused with a device function. Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to 200 establish that the software is fit for its intended use and maintain s a validated state .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: The intended use of the software, documen ting readings , only support s ____ maintaining the quality system record and poses a low process risk.",
"reference": "The intended use of the software, documen ting readings , only support s 198 maintaining the quality system record and poses a low process risk.",
"options": {
"B": "198",
"A": "185",
"C": "186",
"D": "a software function"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Manufacturers may decide to conduct different assurance activities for individual ____ features, functions, or op erations.",
"reference": "Manufacturers may decide to conduct different assurance activities for individual 190 features, functions, or op erations.",
"options": {
"D": "190",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In ____ cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"reference": "In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"options": {
"B": "185",
"A": "186",
"C": "187",
"D": "a software function"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In 185 cases where the individual features, functions, and operations have different roles within ____ production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"reference": "In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"options": {
"C": "186",
"A": "185",
"B": "187",
"D": "a software function"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of ____ validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"reference": "In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"options": {
"A": "187",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the ____ individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"reference": "In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"options": {
"B": "188",
"A": "185",
"C": "186",
"D": "a software function"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance ____ strategy.",
"reference": "In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"options": {
"B": "189",
"A": "185",
"C": "186",
"D": "a software function"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, initial activities ____ 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"reference": "As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"options": {
"A": "199",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, initial activities 199 ____ That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"reference": "As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"options": {
"C": "5",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In ____ cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"reference": "In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"options": {
"D": "185",
"A": "186",
"B": "187",
"C": "a software function"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In 185 cases where the individual features, functions, and operations have different roles within ____ production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"reference": "In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"options": {
"D": "186",
"A": "185",
"B": "187",
"C": "a software function"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of ____ validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"reference": "In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"options": {
"A": "187",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When utilizing the basic input functions of the 19...'?",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"D": "COTS",
"A": "a software function",
"B": "the vendor assessment and software installation",
"C": "cot"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the ____ COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"D": "194",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature ____ readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"C": "195",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance ____ activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"D": "196",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and ____ configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"B": "197",
"A": "185",
"C": "186",
"D": "a software function"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Manufacturers may decide to conduct different assurance activities for individual ____ features, functions, or op erations.",
"reference": "Manufacturers may decide to conduct different assurance activities for individual 190 features, functions, or op erations.",
"options": {
"D": "190",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '191 192 For example, a commercial off -the-shelf (...'?",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"A": "COTS",
"B": "a software function",
"C": "the vendor assessment and software installation",
"D": "cot"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"B": "191",
"A": "185",
"C": "186",
"D": "a software function"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 191 ____ For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"C": "192",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of ____ various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"C": "193",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to ____ establish that the software is fit for its intended use and maintain s a validated state .",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to 200 establish that the software is fit for its intended use and maintain s a validated state .",
"options": {
"C": "200",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The intended use of the software, documen ting readings , only support s ____ maintaining the quality system record and poses a low process risk.",
"reference": "The intended use of the software, documen ting readings , only support s 198 maintaining the quality system record and poses a low process risk.",
"options": {
"C": "198",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '191 192 For example, a commercial off -the-shelf (...'?",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"C": "COTS",
"A": "a software function",
"B": "the vendor assessment and software installation",
"D": "cot"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 4 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
71, Room 3128 Silver Spring, MD 20993- 0002
Phone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I. INTRODUCTION............................................................................................................. 1 II. BACKGROUND ............................................................................................................... 1 III. QUESTIONS AND ANSWERS ....................................................................................... Please clarify the following terms as they relate to CGMP records: .........................................
2 a. What is data integrity? ................................................................................................................
b. What is metadata? ....................................................................................................................... 3 c.
What is an audit trail? .................................................................................................................
3 d. How does FDA use the terms static and dynamic as they relate to record formats? ............. 3 e. How does FDA use the term backup in 211.68( b)?
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: '............. 3 e. How does FDA use the term backu...'?",
"reference": "............. 3 e. How does FDA use the term backup in 211.68( b)?",
"options": {
"B": "FDA",
"A": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Pharmaceutical Quality/Manufacturing Standards",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ............. ____ e. How does FDA use the term backup in 211.68( b)?",
"reference": "............. 3 e. How does FDA use the term backup in 211.68( b)?",
"options": {
"D": "3",
"A": "800",
"B": "240",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ............. 3 e. How does FDA use the term backup in ____( b)?",
"reference": "............. 3 e. How does FDA use the term backup in 211.68( b)?",
"options": {
"C": "211.68",
"A": "800",
"B": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ....................................................................................................................... ____ c.\nWhat is an audit trail?",
"reference": "....................................................................................................................... 3 c.\nWhat is an audit trail?",
"options": {
"A": "3",
"B": "800",
"C": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 2 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
See the references in Appendix A for applicable FDA guidance documents for pre-market submissions. Page 5General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 3. CONTEXT FOR SOFTWARE VALIDATION
Many people have asked for specific guidance on what FDA expects them to do to ensure compliance with the Quality System regulation with regard to software validation. Information on software validation presented in this document is not new. Validation of software, using the principles and tasks listed in Sections 4 and 5, has been conducted in many segments of the software industry for well over 20 years. Due to the great variety of medical devices, processes, and manufacturing facilities, it is not possible to state in one document all of the specific validation elements that are applicable. However, a general application of several broad concepts can be used successfully as guidance for software validation. These broad concepts provide an acceptable framework for building a comprehensive approach to software validation. Additional specific information is available from many of the references listed in Appendix A. 3.1. DEFINITIONS AND TERMINOLOGY
Unless defined in the Quality System regulation, or otherwise specified below, all other terms used in this guidance are as defined in the current edition of the FDA Glossary of Computerized System and Software Development Terminology. The medical device Quality System regulation (21 CFR 820.3(k)) defines " establish " to mean "define, document, and implement." Where it appears in this guidance, the words "establish" and established should be interpreted to have this same meaning. Some definitions found in the medical device Quality System regulation can be confusing when compared to commonly used terminology in the software industry. Examples are requirements, specification, verification, and validation.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: Due to the great variety of medical devices, processes, and manufacturing facilities, it is not possible to state in ____ document all of the specific validation elements that are applicable.",
"reference": "Due to the great variety of medical devices, processes, and manufacturing facilities, it is not possible to state in one document all of the specific validation elements that are applicable.",
"options": {
"D": "one",
"A": "Software Validation Guidance",
"B": "software validation",
"C": "ace"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Due to the great variety of medical devices, processes, and ...'?",
"reference": "Due to the great variety of medical devices, processes, and manufacturing facilities, it is not possible to state in one document all of the specific validation elements that are applicable.",
"options": {
"D": "Due to the great variety of medical devices, processes, and manufacturing facilities, it is not poss...",
"A": "Software Validation Guidance",
"B": "software validation",
"C": "one"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
, user manuals and standard operating procedures).8 7 American National Standard for Information Systems, Dictionary for Information Systems , Ameri can National Standards Institute, 1991. 8 See guidance for industry and FDA staff General Principles of Software Validation . Contains Nonbinding Recommendations 6 2. When is it permissible to invalidate a CGMP result and exclude it from the determination of batch conformance ? Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see 211.22 and 212.70) and maintained for CGMP purposes ( e.g., 211.180).9 Electronic data generated to fulfill CGMP requirements include relevant metadata required to reconstruct the CGMP activity captured in the record. Invalidating test results to exclude them from quality unit decisions about conformance to a sp ecification requires a valid , documented, scientific ally sound justification . See, for example, 211.160(b), 211.188, 211.192, and 212.71(b) and the guidance for industry Investigating Out -of-Specification (OOS) Test Results for Pharmaceutical Production. Even if test results are legitimately invalidated on the basis of a scientifically sound investigation, the full CGMP batch record provided to the quality unit would include the original (invalidated) data , along with the investigation report that justif ies invalidating the result . The requirements for record retention and review do not differ depending on the data format ; paper-based and electronic data record -keeping systems are subject to the same requirements . 3. Does each CGMP workflow on a computer sy stem need to be validated? Yes, a CGMP workflow, such as creation of an electronic master p roduction and c ontrol r ecord (MPCR), is a n intended use of a c omputer system to be checked through validation (see 211.63, 211.68(b), and 211.110(a)) . The extent of validation studies should be commensurate with the risk posed by the automated system.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Data created as part of a CGMP record must be eval...'?",
"reference": "Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see 211.22 and 212.70) and maintained for CGMP purposes ( e.g., 211.180).9 Electronic data generated to fulfill CGMP requirements include relevant metadata required to reconstruct the CGMP activity captured in the record.",
"options": {
"D": "CGMP",
"A": "American National Standard for Information Systems",
"B": "Ameri",
"C": "paper-based and electronic data record -keeping systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Data created as part of a CGMP record must be eval...'?",
"reference": "Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see 211.22 and 212.70) and maintained for CGMP purposes ( e.g., 211.180).9 Electronic data generated to fulfill CGMP requirements include relevant metadata required to reconstruct the CGMP activity captured in the record.",
"options": {
"B": "CGMP",
"A": "American National Standard for Information Systems",
"C": "Ameri",
"D": "paper-based and electronic data record -keeping systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Data created as part of a CGMP record must be eval...'?",
"reference": "Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see 211.22 and 212.70) and maintained for CGMP purposes ( e.g., 211.180).9 Electronic data generated to fulfill CGMP requirements include relevant metadata required to reconstruct the CGMP activity captured in the record.",
"options": {
"B": "CGMP",
"A": "American National Standard for Information Systems",
"C": "Ameri",
"D": "paper-based and electronic data record -keeping systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Data created as part of a CGMP record must be eval...'?",
"reference": "Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see 211.22 and 212.70) and maintained for CGMP purposes ( e.g., 211.180).9 Electronic data generated to fulfill CGMP requirements include relevant metadata required to reconstruct the CGMP activity captured in the record.",
"options": {
"D": "CGMP",
"A": "American National Standard for Information Systems",
"B": "Ameri",
"C": "paper-based and electronic data record -keeping systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see ____ and 212.70) and maintained for CGMP purposes ( e.g., 211.180).9 Electronic data generated to fulfill CGMP requirements include relevant metadata required to reconstruct the CGMP activity captured in the record.",
"reference": "Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see 211.22 and 212.70) and maintained for CGMP purposes ( e.g., 211.180).9 Electronic data generated to fulfill CGMP requirements include relevant metadata required to reconstruct the CGMP activity captured in the record.",
"options": {
"B": "211.22",
"A": "6 2",
"C": "212.70",
"D": "paper-based and electronic data record -keeping systems"
},
"answer": "B",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Fill in the blank: Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see 211.22 and ____) and maintained for CGMP purposes ( e.g., 211.180).9 Electronic data generated to fulfill CGMP requirements include relevant metadata required to reconstruct the CGMP activity captured in the record.",
"reference": "Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see 211.22 and 212.70) and maintained for CGMP purposes ( e.g., 211.180).9 Electronic data generated to fulfill CGMP requirements include relevant metadata required to reconstruct the CGMP activity captured in the record.",
"options": {
"D": "212.70",
"A": "6 2",
"B": "211.22",
"C": "paper-based and electronic data record -keeping systems"
},
"answer": "D",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Data created as part of a CGMP record must be eval...'?",
"reference": "Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see 211.22 and 212.70) and maintained for CGMP purposes ( e.g., 211.180).9 Electronic data generated to fulfill CGMP requirements include relevant metadata required to reconstruct the CGMP activity captured in the record.",
"options": {
"D": "CGMP",
"A": "American National Standard for Information Systems",
"B": "Ameri",
"C": "paper-based and electronic data record -keeping systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Data created as part of a CGMP record must be eval...'?",
"reference": "Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see 211.22 and 212.70) and maintained for CGMP purposes ( e.g., 211.180).9 Electronic data generated to fulfill CGMP requirements include relevant metadata required to reconstruct the CGMP activity captured in the record.",
"options": {
"B": "CGMP",
"A": "American National Standard for Information Systems",
"C": "Ameri",
"D": "paper-based and electronic data record -keeping systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Data created as part of a CGMP record must be eval...'?",
"reference": "Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see 211.22 and 212.70) and maintained for CGMP purposes ( e.g., 211.180).9 Electronic data generated to fulfill CGMP requirements include relevant metadata required to reconstruct the CGMP activity captured in the record.",
"options": {
"B": "CGMP",
"A": "American National Standard for Information Systems",
"C": "Ameri",
"D": "paper-based and electronic data record -keeping systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 3 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555
Goal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror. 568 569 Conclusion: No errors were observed in the spreadsheet functions beyond the deviation. Incorrectly inputting text into the field is immediately visible and does not impact the risk 571 of the intended use. In addition, a validation rule was placed on the field to permit only 572 numeric data inputs. 573 Contains Nonbinding Recommendations Draft Not for Implementation 19574
When/Who: July 9, 2019, by J ane Smith 575 576
Advances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation. As a least burdensome method , FDA recommends the 579 use of electronic records, such as system logs, audit trails, and other data g enerated by the 580 software, as opposed to paper documentation and screenshots, in establishing the record 581 associated with the assurance activities. 582 583 Manufacturers have expressed confusion and concern regarding the application of Part 11, 584 Electronic Records; Electronic Signatures, to computers or automated data processing systems 585 used as part of production or the quality system.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: ____ 569 Conclusion: No errors were observed in the spreadsheet functions beyond the deviation.",
"reference": "568 569 Conclusion: No errors were observed in the spreadsheet functions beyond the deviation.",
"options": {
"A": "568",
"B": "550 551",
"C": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 568 ____ Conclusion: No errors were observed in the spreadsheet functions beyond the deviation.",
"reference": "568 569 Conclusion: No errors were observed in the spreadsheet functions beyond the deviation.",
"options": {
"A": "569",
"B": "550 551",
"C": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '573 Contains Nonbinding Recommendations Draft Not ...'?",
"reference": "573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"options": {
"D": "July 9, 2019",
"A": "only 572 numeric data inputs",
"B": "automated data processing systems",
"C": "573"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 5 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0, supersedes the draft document, General Principles of Software Validation, Version 1.1 , dated June 9, 1997. This guidance describes how certain provisions of the medical device Quality System regulation apply to software and the agencys current approach to evaluating a software validation system. For example, this document lists elements that are acceptable to the FDA for the validation of software; however, it does not list all of the activities and tasks that must, in all instances, be used to comply with the law. The scope of this guidance is somewhat broader than the scope of validation in the strictest definition of that term. Planning, verification, testing, traceability, configuration management, and many other aspects of good software engineering discussed in this guidance are important activities that together help to support a final conclusion that software is validated. This guidance recommends an integration of software life cycle management and risk management activities. Based on the intended use and the safety risk associated with the software to be developed, the software developer should determine the specific approach, the combination of techniques to be used, and the level of effort to be applied. While this guidance does not recommend any specific life cycle model or any specific technique or method, it does recommend that software validation and verification activities be conducted throughout the entire software life cycle. Where the software is developed by someone other than the device manufacturer (e.g., off-the-shelf software) the software developer may not be directly responsible for compliance with FDA regulations.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'This guidance outlines general validation principl...'?",
"reference": "This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices.",
"options": {
"A": "the Food and Drug Administration",
"B": "FDA",
"C": "Quality System",
"D": "software validation and verification activities"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance outlines general validation principl...'?",
"reference": "This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices.",
"options": {
"B": "FDA",
"A": "the Food and Drug Administration",
"C": "Quality System",
"D": "software validation and verification activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For example, this document lists elements that are...'?",
"reference": "For example, this document lists elements that are acceptable to the FDA for the validation of software; however, it does not list all of the activities and tasks that must, in all instances, be used to comply with the law.",
"options": {
"D": "FDA",
"A": "the Food and Drug Administration",
"B": "Quality System",
"C": "software validation and verification activities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance describes how certain provisions of ...'?",
"reference": "This guidance describes how certain provisions of the medical device Quality System regulation apply to software and the agencys current approach to evaluating a software validation system.",
"options": {
"D": "Quality System",
"A": "software validation and verification activities",
"B": "software life cycle management and risk management activities",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'Where the software is developed by someone other t...'?",
"reference": "Where the software is developed by someone other than the device manufacturer (e.g., off-the-shelf software) the software developer may not be directly responsible for compliance with FDA regulations.",
"options": {
"B": "FDA",
"A": "the Food and Drug Administration",
"C": "Quality System",
"D": "software validation and verification activities"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 4 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
In addition, we intend to exercise enforcement discretion and do not intend to take (or 44 recommend) action to enforce any part 11 requirements with regard to systems that were 45 operational before August 20, 1997, the eff ective date of part 11 (commonly known as legacy 46 systems) under the circumstances described in section III.C.3 of this guidance. 47 48 Note that part 11 remains in effect and that this exercise of enforcement discretion applies only 49 as identified in this guida nce. 50 51 FDA's guidance documents, including this guidance, do not establish legally enforceable 52 responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should 53 be viewed only as recommendations, unless specific regulatory or statutory requirements are 54 cited. The use of the word should in Agency guidances means that something is suggested or 55 recommended, but not required. BACKGROUND 59 60 In March of 1997, FDA issued final part 11 regulations that provide criteria for acce ptance by 61 FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten 62 signatures executed to electronic records as equivalent to paper records and handwritten 63 signatures executed on paper. These regulations, which apply to all FDA program areas, were 64 intended to permit the widest possible use of electronic technology, compatible with FDA's 65 responsibility to protect the public health. 66 67 After part 11 became effective in August 1997, significant discussions ensued among industry, 68 contractors, and the Agency concerning the interpretation and implementation of the regulations .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "When did this occur: 'In addition, we intend to exercise enforcement dis...'?",
"reference": "In addition, we intend to exercise enforcement discretion and do not intend to take (or 44 recommend) action to enforce any part 11 requirements with regard to systems that were 45 operational before August 20, 1997, the eff ective date of part 11 (commonly known as legacy 46 systems) under the circumstances described in section III.C.3 of this guidance.",
"options": {
"A": "August 20, 1997",
"B": "59 60",
"C": "March of 1997",
"D": "electronic records"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In addition, we intend to exercise enforcement discretion and do not intend to take (or ____ recommend) action to enforce any part 11 requirements with regard to systems that were 45 operational before August 20, 1997, the eff ective date of part 11 (commonly known as legacy 46 systems) under the circumstances described in section III.C.3 of this guidance.",
"reference": "In addition, we intend to exercise enforcement discretion and do not intend to take (or 44 recommend) action to enforce any part 11 requirements with regard to systems that were 45 operational before August 20, 1997, the eff ective date of part 11 (commonly known as legacy 46 systems) under the circumstances described in section III.C.3 of this guidance.",
"options": {
"D": "44",
"A": "only 49",
"B": "50 51",
"C": "electronic records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In addition, we intend to exercise enforcement discretion and do not intend to take (or 44 recommend) action to enforce any part ____ requirements with regard to systems that were 45 operational before August 20, 1997, the eff ective date of part 11 (commonly known as legacy 46 systems) under the circumstances described in section III.C.3 of this guidance.",
"reference": "In addition, we intend to exercise enforcement discretion and do not intend to take (or 44 recommend) action to enforce any part 11 requirements with regard to systems that were 45 operational before August 20, 1997, the eff ective date of part 11 (commonly known as legacy 46 systems) under the circumstances described in section III.C.3 of this guidance.",
"options": {
"D": "11",
"A": "only 49",
"B": "50 51",
"C": "electronic records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In addition, we intend to exercise enforcement discretion and do not intend to take (or 44 recommend) action to enforce any part 11 requirements with regard to systems that were ____ operational before August 20, 1997, the eff ective date of part 11 (commonly known as legacy 46 systems) under the circumstances described in section III.C.3 of this guidance.",
"reference": "In addition, we intend to exercise enforcement discretion and do not intend to take (or 44 recommend) action to enforce any part 11 requirements with regard to systems that were 45 operational before August 20, 1997, the eff ective date of part 11 (commonly known as legacy 46 systems) under the circumstances described in section III.C.3 of this guidance.",
"options": {
"A": "45",
"B": "only 49",
"C": "50 51",
"D": "electronic records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 3 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Table II: Application of Corrective Action and Preventive Action System Throughout the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability is explored. CAPA methodology is useful where corrective actions and preventive actions are incorporated into the iterative design and development process. CAPA can be used as an effective system for feedback, feedforward, and continual improvement. CAPA should be used, and the effectiveness of the actions should be evaluated. CAPA should continue after the product is discontinued. The impact on product remaining on the market should be considered, as well as other products that might be affected. 3. Change Management System (3.2.3) Innovation, continual improvement, the outputs of process performance and product quality monitoring, and CAPA drive change. To eval uate, approve, and implement these changes properly, a company should have an effective change management system. There is generally a difference in formality of change management processes prior to the initial regulatory submission and after submission, where changes to the regulatory filing might be required under regional requirements. The change management system ensures continua l improvement is undertaken in a timely and effective manner. It should provide a high de gree of assurance th ere are no unintended consequences of the change. The change management system should include the following, as appropriate for the stage of the lifecycle: (a) Quality risk management should be utilized to evaluate proposed changes. The level of effort and formality of the evaluation should be commensurate with the level of risk. (b) Proposed changes should be evaluated re lative to the marketing authorization, including design space, where established, and/or current product and process understanding.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Change Management System (3.2.3) Innovation, conti...'?",
"reference": "Change Management System (3.2.3) Innovation, continual improvement, the outputs of process performance and product quality monitoring, and CAPA drive change.",
"options": {
"B": "Change Management System",
"A": "CAPA",
"C": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability",
"D": "CAPA drive change"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Change Management System (3.2.3) Innovation, conti...'?",
"reference": "Change Management System (3.2.3) Innovation, continual improvement, the outputs of process performance and product quality monitoring, and CAPA drive change.",
"options": {
"A": "CAPA",
"B": "Change Management System",
"C": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability",
"D": "an effective change management system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Change Management System (____) Innovation, continual improvement, the outputs of process performance and product quality monitoring, and CAPA drive change.",
"reference": "Change Management System (3.2.3) Innovation, continual improvement, the outputs of process performance and product quality monitoring, and CAPA drive change.",
"options": {
"A": "3.2.3",
"B": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability",
"C": "an effective change management system",
"D": "Change Management System"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 50 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination
Summary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:
Error guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "Digital",
"A": "Identify",
"C": "Independent",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "Identify",
"B": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "key"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "Independent",
"A": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "freelance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "go along"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "go along"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "526",
"A": "525",
"B": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate ____ 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "525",
"A": "529",
"B": "530",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 ____ 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "526",
"A": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 ____ 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "527",
"A": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 ____ Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "528",
"A": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has ____ developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "529",
"A": "525",
"C": "530",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data ____ stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "530",
"A": "525",
"B": "529",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "Digital",
"A": "Identify",
"B": "Independent",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Identify",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"C": "key"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "Independent",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"D": "freelance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"D": "go along"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"D": "go along"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "526",
"A": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate ____ 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "525",
"B": "529",
"C": "530",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 ____ 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "526",
"A": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 ____ 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "527",
"A": "525",
"B": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 ____ Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "528",
"A": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has ____ developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "529",
"B": "525",
"C": "530",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data ____ stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "530",
"A": "525",
"B": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "Digital",
"A": "Identify",
"B": "Independent",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Digital",
"A": "Identify",
"B": "Independent",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "Identify",
"A": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "key"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Independent",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"C": "freelance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "Pass",
"B": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "go along"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "go along"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "526",
"B": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate ____ 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "525",
"A": "529",
"B": "530",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 ____ 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "526",
"A": "525",
"B": "529",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 ____ 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "527",
"A": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 ____ Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "528",
"A": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has ____ developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "529",
"B": "525",
"C": "530",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data ____ stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "530",
"A": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Digital",
"A": "Identify",
"B": "Independent",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "Identify",
"B": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "key"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Independent",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"C": "freelance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"D": "go along"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "go along"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "526",
"B": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate ____ 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "525",
"A": "529",
"C": "530",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 ____ 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "526",
"A": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 ____ 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "527",
"B": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 ____ Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "528",
"B": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has ____ developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "529",
"A": "525",
"C": "530",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data ____ stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "530",
"A": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Digital",
"A": "Identify",
"B": "Independent",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 45 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) . System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and 212.60). 350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60). All data should be included in the record that is retained 355 and subject to review unless there is documented scientific justification for its exclusion. 356 357 For more information , see also the ICH guidance for industry Q2(R1)
Validation of 358 Analytical Procedure s: Text and Methodology. Is it acceptable to only save the final results from reprocess ed laboratory 361 chromatography? Analytical methods should be capable and stable. For most lab analys es, reprocessing 364 data should not be regularly needed. If chromatography is reprocessed, written 365 procedures must be established and followed and each result retained for review (s ee 366 211.160(a) , 211.160(b) , 211.165(c) , 211.194(a)(4) , and 212.60(a) ). FDA requires 367 complete data in laboratory records, which includes raw data, graphs, charts, and spectra 368 from laboratory instruments ( 211.194(a) and 212.60(g)(3) ). Can an internal tip regarding a quality issue, such as potential data 371 falsification, be handled informally outsi de of the documented CGMP quality 372 system?
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'FDA requires 367 complete data in laboratory recor...'?",
"reference": "FDA requires 367 complete data in laboratory records, which includes raw data, graphs, charts, and spectra 368 from laboratory instruments ( 211.194(a) and 212.60(g)(3) ).",
"options": {
"D": "FDA",
"A": "the United States Phar",
"B": "CGMP",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA requires ____ complete data in laboratory records, which includes raw data, graphs, charts, and spectra 368 from laboratory instruments ( 211.194(a) and 212.60(g)(3) ).",
"reference": "FDA requires 367 complete data in laboratory records, which includes raw data, graphs, charts, and spectra 368 from laboratory instruments ( 211.194(a) and 212.60(g)(3) ).",
"options": {
"B": "367",
"A": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA requires 367 complete data in laboratory records, which includes raw data, graphs, charts, and spectra ____ from laboratory instruments ( 211.194(a) and 212.60(g)(3) ).",
"reference": "FDA requires 367 complete data in laboratory records, which includes raw data, graphs, charts, and spectra 368 from laboratory instruments ( 211.194(a) and 212.60(g)(3) ).",
"options": {
"C": "368",
"A": "344",
"B": "345",
"D": "potential data 371 falsification"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For most lab analys es, reprocessing ____ data should not be regularly needed.",
"reference": "For most lab analys es, reprocessing 364 data should not be regularly needed.",
"options": {
"B": "364",
"A": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: '356 357 For more information , see also the ICH gu...'?",
"reference": "356 357 For more information , see also the ICH guidance for industry Q2(R1)\nValidation of 358 Analytical Procedure s: Text and Methodology.",
"options": {
"B": "Q2(R1",
"A": "reprocess ed laboratory",
"C": "potential data 371 falsification",
"D": "367 complete data"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 357 For more information , see also the ICH guidance for industry Q2(R1)\nValidation of 358 Analytical Procedure s: Text and Methodology.",
"reference": "356 357 For more information , see also the ICH guidance for industry Q2(R1)\nValidation of 358 Analytical Procedure s: Text and Methodology.",
"options": {
"C": "356",
"A": "344",
"B": "345",
"D": "potential data 371 falsification"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 356 ____ For more information , see also the ICH guidance for industry Q2(R1)\nValidation of 358 Analytical Procedure s: Text and Methodology.",
"reference": "356 357 For more information , see also the ICH guidance for industry Q2(R1)\nValidation of 358 Analytical Procedure s: Text and Methodology.",
"options": {
"C": "357",
"A": "344",
"B": "345",
"D": "potential data 371 falsification"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 356 357 For more information , see also the ICH guidance for industry Q2(R1)\nValidation of ____ Analytical Procedure s: Text and Methodology.",
"reference": "356 357 For more information , see also the ICH guidance for industry Q2(R1)\nValidation of 358 Analytical Procedure s: Text and Methodology.",
"options": {
"B": "358",
"A": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: All data should be included in the record that is retained ____ and subject to review unless there is documented scientific justification for its exclusion.",
"reference": "All data should be included in the record that is retained 355 and subject to review unless there is documented scientific justification for its exclusion.",
"options": {
"B": "355",
"A": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Can an internal tip regarding a quality issue, suc...'?",
"reference": "Can an internal tip regarding a quality issue, such as potential data 371 falsification, be handled informally outsi de of the documented CGMP quality 372 system?",
"options": {
"B": "CGMP",
"A": "the United States Phar",
"C": "FDA",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Can an internal tip regarding a quality issue, such as potential data ____ falsification, be handled informally outsi de of the documented CGMP quality 372 system?",
"reference": "Can an internal tip regarding a quality issue, such as potential data 371 falsification, be handled informally outsi de of the documented CGMP quality 372 system?",
"options": {
"D": "371",
"A": "344",
"B": "345",
"C": "367 complete data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: '356 357 For more information , see also the ICH gu...'?",
"reference": "356 357 For more information , see also the ICH guidance for industry Q2(R1)\nValidation of 358 Analytical Procedure s: Text and Methodology.",
"options": {
"A": "Q2(R1",
"B": "reprocess ed laboratory",
"C": "potential data 371 falsification",
"D": "367 complete data"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 357 For more information , see also the ICH guidance for industry Q2(R1)\nValidation of 358 Analytical Procedure s: Text and Methodology.",
"reference": "356 357 For more information , see also the ICH guidance for industry Q2(R1)\nValidation of 358 Analytical Procedure s: Text and Methodology.",
"options": {
"B": "356",
"A": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 356 ____ For more information , see also the ICH guidance for industry Q2(R1)\nValidation of 358 Analytical Procedure s: Text and Methodology.",
"reference": "356 357 For more information , see also the ICH guidance for industry Q2(R1)\nValidation of 358 Analytical Procedure s: Text and Methodology.",
"options": {
"C": "357",
"A": "344",
"B": "345",
"D": "potential data 371 falsification"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 356 357 For more information , see also the ICH guidance for industry Q2(R1)\nValidation of ____ Analytical Procedure s: Text and Methodology.",
"reference": "356 357 For more information , see also the ICH guidance for industry Q2(R1)\nValidation of 358 Analytical Procedure s: Text and Methodology.",
"options": {
"A": "358",
"B": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'If chromatography is reprocessed, written 365 proc...'?",
"reference": "If chromatography is reprocessed, written 365 procedures must be established and followed and each result retained for review (s ee 366 211.160(a) , 211.160(b) , 211.165(c) , 211.194(a)(4) , and 212.60(a) ).",
"options": {
"D": "366 211.160(a",
"A": "potential data 371 falsification",
"B": "367 complete data",
"C": "365"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: If chromatography is reprocessed, written ____ procedures must be established and followed and each result retained for review (s ee 366 211.160(a) , 211.160(b) , 211.165(c) , 211.194(a)(4) , and 212.60(a) ).",
"reference": "If chromatography is reprocessed, written 365 procedures must be established and followed and each result retained for review (s ee 366 211.160(a) , 211.160(b) , 211.165(c) , 211.194(a)(4) , and 212.60(a) ).",
"options": {
"B": "365",
"A": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If chromatography is reprocessed, written 365 procedures must be established and followed and each result retained for review (s ee ____ 211.160(a) , 211.160(b) , 211.165(c) , 211.194(a)(4) , and 212.60(a) ).",
"reference": "If chromatography is reprocessed, written 365 procedures must be established and followed and each result retained for review (s ee 366 211.160(a) , 211.160(b) , 211.165(c) , 211.194(a)(4) , and 212.60(a) ).",
"options": {
"B": "366",
"A": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'According to the United States Phar macopeia (USP)...'?",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"C": "the United States Phar",
"A": "FDA",
"B": "CGMP",
"D": "potential data 371 falsification"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Phar macopeia (USP), system s uitability tests should ____ include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"A": "344",
"B": "345",
"C": "347",
"D": "potential data 371 falsification"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to ____ determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"A": "345",
"B": "344",
"C": "347",
"D": "potential data 371 falsification"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter ____ 346 Chromatography) .",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"D": "621",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: System s uitability tests, including the identity of the preparation to be ____ injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and 212.60).",
"reference": "System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and 212.60).",
"options": {
"A": "347",
"B": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms ____ established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and 212.60).",
"reference": "System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and 212.60).",
"options": {
"C": "348",
"A": "344",
"B": "345",
"D": "potential data 371 falsification"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial ____ monograph ( 211.160 and 212.60).",
"reference": "System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and 212.60).",
"options": {
"D": "349",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( ____ and 212.60).",
"reference": "System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and 212.60).",
"options": {
"D": "211.160",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and ____).",
"reference": "System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and 212.60).",
"options": {
"D": "212.60",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For most lab analys es, reprocessing ____ data should not be regularly needed.",
"reference": "For most lab analys es, reprocessing 364 data should not be regularly needed.",
"options": {
"A": "364",
"B": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'According to the United States Phar macopeia (USP)...'?",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"A": "the United States Phar",
"B": "FDA",
"C": "CGMP",
"D": "potential data 371 falsification"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Phar macopeia (USP), system s uitability tests should ____ include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"C": "344",
"A": "345",
"B": "347",
"D": "potential data 371 falsification"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to ____ determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"B": "345",
"A": "344",
"C": "347",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter ____ 346 Chromatography) .",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"A": "621",
"B": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 ____ Chromatography) .",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"A": "346",
"B": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'According to the United States Phar macopeia (USP)...'?",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"C": "the United States Phar",
"A": "FDA",
"B": "CGMP",
"D": "potential data 371 falsification"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Phar macopeia (USP), system s uitability tests should ____ include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"D": "344",
"A": "345",
"B": "347",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to ____ determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"C": "345",
"A": "344",
"B": "347",
"D": "potential data 371 falsification"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter ____ 346 Chromatography) .",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"B": "621",
"A": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 ____ Chromatography) .",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"C": "346",
"A": "344",
"B": "345",
"D": "potential data 371 falsification"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'According to the United States Phar macopeia (USP)...'?",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"B": "the United States Phar",
"A": "FDA",
"C": "CGMP",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Phar macopeia (USP), system s uitability tests should ____ include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"B": "344",
"A": "345",
"C": "347",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to ____ determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"B": "345",
"A": "344",
"C": "347",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter ____ 346 Chromatography) .",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"B": "621",
"A": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 ____ Chromatography) .",
"reference": "According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) .",
"options": {
"D": "346",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For most lab analys es, reprocessing ____ data should not be regularly needed.",
"reference": "For most lab analys es, reprocessing 364 data should not be regularly needed.",
"options": {
"B": "364",
"A": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: All data should be included in the record that is retained ____ and subject to review unless there is documented scientific justification for its exclusion.",
"reference": "All data should be included in the record that is retained 355 and subject to review unless there is documented scientific justification for its exclusion.",
"options": {
"B": "355",
"A": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Facilities and Equipment Lab facilities: 211.22(b) Staff number: 211.25(c) Under the CGMP regulations, the quality unit ( QU) has the responsibility of reviewing and approving all initial design criteria and procedures pertaining to facilities and equipment and any subsequent changes ( 211.22(c)). Under the CGMP regulations, equipment must be qualified, calibrated, cleaned, and maintained to prevent contamination a nd mix-ups ( 211.63, 211.67, 211.68). Note that the CGMP regulations require a higher standard fo r calibration and maintenance than most non- pharmaceutical quality system models. The CGMP regulations place as much emphasis on process equipment as on testing equipm ent ( 211.160, 211.63, 211.67, and 211.68) while most quality systems focus only on testing equipment.11 4. Control Outsourced Operations Outsourcing involves hiring a sec ond party under a contr act to perform the operational processes that are part of a manufacturers inherent responsibilities. For example, a manufacturer may hire another firm to package and la bel or perform CGMP regulatory training. Quality systems call for contracts (quality agreements) that clearly describe the materials or service, quality specification responsibilities, a nd communication m echanisms. Under a quality system, the manufacturer should ensure that a cont ract firm is qualified before signing a contract with that firm . The contract firms personnel should be adequately trained and monitored for performance according to their quality system, and the contract firm's and contracting manufacturers quality standards should not conflict. It is critical in a quality system to ensure that the management of the contractor be familiar with the specific requirements of the contract. However, under the CGMP requirement s, the manufacturers QU is responsible for approving or rejecting products or services provided under a contract ( 211.22(a)).
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'For example, a manufacturer may hire another firm ...'?",
"reference": "For example, a manufacturer may hire another firm to package and la bel or perform CGMP regulatory training.",
"options": {
"C": "CGMP",
"A": "Control Outsourced Operations Outsourcing",
"B": "sec",
"D": "the contract firm's and contracting manufacturers quality standards"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Facilities and Equipment Lab facilities: 211.22(b...'?",
"reference": "Facilities and Equipment Lab facilities: 211.22(b) Staff number: 211.25(c) Under the CGMP regulations, the quality unit ( QU) has the responsibility of reviewing and approving all initial design criteria and procedures pertaining to facilities and equipment and any subsequent changes ( 211.22(c)).",
"options": {
"D": "CGMP",
"A": "Control Outsourced Operations Outsourcing",
"B": "sec",
"C": "the contract firm's and contracting manufacturers quality standards"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations place as much emphasis on pro...'?",
"reference": "The CGMP regulations place as much emphasis on process equipment as on testing equipm ent ( 211.160, 211.63, 211.67, and 211.68) while most quality systems focus only on testing equipment.11 4.",
"options": {
"B": "CGMP",
"A": "Control Outsourced Operations Outsourcing",
"C": "sec",
"D": "the contract firm's and contracting manufacturers quality standards"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The CGMP regulations place as much emphasis on process equipment as on testing equipm ent ( ____, 211.63, 211.67, and 211.68) while most quality systems focus only on testing equipment.11 4.",
"reference": "The CGMP regulations place as much emphasis on process equipment as on testing equipm ent ( 211.160, 211.63, 211.67, and 211.68) while most quality systems focus only on testing equipment.11 4.",
"options": {
"B": "211.160",
"A": "211.22(b",
"C": "211.63",
"D": "the contract firm's and contracting manufacturers quality standards"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The CGMP regulations place as much emphasis on process equipment as on testing equipm ent ( 211.160, ____, 211.67, and 211.68) while most quality systems focus only on testing equipment.11 4.",
"reference": "The CGMP regulations place as much emphasis on process equipment as on testing equipm ent ( 211.160, 211.63, 211.67, and 211.68) while most quality systems focus only on testing equipment.11 4.",
"options": {
"C": "211.63",
"A": "211.22(b",
"B": "211.67",
"D": "the contract firm's and contracting manufacturers quality standards"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The CGMP regulations place as much emphasis on process equipment as on testing equipm ent ( 211.160, 211.63, ____, and 211.68) while most quality systems focus only on testing equipment.11 4.",
"reference": "The CGMP regulations place as much emphasis on process equipment as on testing equipm ent ( 211.160, 211.63, 211.67, and 211.68) while most quality systems focus only on testing equipment.11 4.",
"options": {
"C": "211.67",
"A": "211.22(b",
"B": "211.63",
"D": "the contract firm's and contracting manufacturers quality standards"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The CGMP regulations place as much emphasis on process equipment as on testing equipm ent ( 211.160, 211.63, 211.67, and ____) while most quality systems focus only on testing equipment.11 4.",
"reference": "The CGMP regulations place as much emphasis on process equipment as on testing equipm ent ( 211.160, 211.63, 211.67, and 211.68) while most quality systems focus only on testing equipment.11 4.",
"options": {
"D": "211.68",
"A": "211.22(b",
"B": "211.63",
"C": "the contract firm's and contracting manufacturers quality standards"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The CGMP regulations place as much emphasis on process equipment as on testing equipm ent ( 211.160, 211.63, 211.67, and 211.68) while most quality systems focus only on testing equipment.11 ____.",
"reference": "The CGMP regulations place as much emphasis on process equipment as on testing equipm ent ( 211.160, 211.63, 211.67, and 211.68) while most quality systems focus only on testing equipment.11 4.",
"options": {
"B": "4",
"A": "211.22(b",
"C": "211.63",
"D": "the contract firm's and contracting manufacturers quality standards"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under the CGMP regulations, equipment must be qual...'?",
"reference": "Under the CGMP regulations, equipment must be qualified, calibrated, cleaned, and maintained to prevent contamination a nd mix-ups ( 211.63, 211.67, 211.68).",
"options": {
"D": "CGMP",
"A": "Control Outsourced Operations Outsourcing",
"B": "sec",
"C": "the contract firm's and contracting manufacturers quality standards"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Management Review of the Ph armaceutical Quality System (4.1) Management should have a formal process for reviewing the pharmaceuti cal quality system on a periodic basis. The review should include: (a) Measurement of achievement of pharmaceutical quality system objectives (b) Assessment of performance indicators that can be used to monitor the effectiveness of processes within the pharmaceuti cal quality system, such as: (1) Complaint, deviation, CAPA and change management processes (2) Feedback on outsourced activities (3) Self-assessment processes including risk assessments, trending, and audits (4) External assessments such as regulatory inspections and findings and customer audits B. Monitoring of Internal and External Factors That Can Have an Impacton the Pharmaceutical Quality System (4.2) Factors monitored by management can include: (a) Emerging regulations, guidance, and quality issues that can have an impact on the Pharmaceutical Quality System (b) Innovations that might enhance the pharmaceutical quality system (c) Changes in business environment and objectives 13 (d) Changes in product ownership C. Outcomes of Management Review and Monitoring (4.3)
The outcome of management review of the pha rmaceutical quality system and monitoring of internal and external factors can include: (a) Improvements to the pharmaceutical quality system and related processes (b) Allocation or realloca tion of resources and/ or personnel training (c) Revisions to quality policy and quality objectives (d) Documentation and timely and effective communication of the results of the management review and actions, including esca lation of appropriate issues to senior management 14 VI. GLOSSARY (5) ICH and ISO definitions are used in ICH Q10 where they exist. For the purpose of ICH Q10, where the words requirement, requirements, or necessary appear in an ISO definition, they do not necessarily reflect a regulatory requirement.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'For the purpose of ICH Q10, where the words requir...'?",
"reference": "For the purpose of ICH Q10, where the words requirement, requirements, or necessary appear in an ISO definition, they do not necessarily reflect a regulatory requirement.",
"options": {
"C": "ICH Q10",
"A": "Management Review",
"B": "ISO",
"D": "This information is not provided in the context"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For the purpose of ICH Q10, where the words requir...'?",
"reference": "For the purpose of ICH Q10, where the words requirement, requirements, or necessary appear in an ISO definition, they do not necessarily reflect a regulatory requirement.",
"options": {
"B": "ISO",
"A": "Management Review of the Ph armaceutical Quality System",
"C": "CAPA",
"D": "Management Review"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'GLOSSARY (5) ICH and ISO definitions are used in I...'?",
"reference": "GLOSSARY (5) ICH and ISO definitions are used in ICH Q10 where they exist.",
"options": {
"A": "GLOSSARY",
"B": "Management Review",
"C": "gloss",
"D": "ISO"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ICH and ISO definitions are used in I...'?",
"reference": "GLOSSARY (5) ICH and ISO definitions are used in ICH Q10 where they exist.",
"options": {
"A": "ISO",
"B": "Management Review of the Ph armaceutical Quality System",
"C": "CAPA",
"D": "Management Review"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ICH and ISO definitions are used in I...'?",
"reference": "GLOSSARY (5) ICH and ISO definitions are used in ICH Q10 where they exist.",
"options": {
"C": "ICH Q10",
"A": "Management Review",
"B": "GLOSSARY",
"D": "ISO"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (____) ICH and ISO definitions are used in ICH Q10 where they exist.",
"reference": "GLOSSARY (5) ICH and ISO definitions are used in ICH Q10 where they exist.",
"options": {
"D": "5",
"A": "4.1",
"B": "4.2",
"C": "Management Review"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'GLOSSARY (5) ICH and ISO definitions are used in I...'?",
"reference": "GLOSSARY (5) ICH and ISO definitions are used in ICH Q10 where they exist.",
"options": {
"A": "GLOSSARY",
"B": "Management Review",
"C": "gloss",
"D": "ISO"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ICH and ISO definitions are used in I...'?",
"reference": "GLOSSARY (5) ICH and ISO definitions are used in ICH Q10 where they exist.",
"options": {
"D": "ISO",
"A": "Management Review of the Ph armaceutical Quality System",
"B": "CAPA",
"C": "Management Review"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ICH and ISO definitions are used in I...'?",
"reference": "GLOSSARY (5) ICH and ISO definitions are used in ICH Q10 where they exist.",
"options": {
"C": "ICH Q10",
"A": "Management Review",
"B": "GLOSSARY",
"D": "ISO"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 6 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
The QS working group mapped the relationship between CGMP regulations (parts 210 and 211 and the 1978 Preamble to the CGMP regulations 2) and various quality system models, such as the Drug Manufact uring Inspections Program (i.e., systems-based inspectional program),3
the Environmental Protection Agency's Guidance for Developing Quality Systems for Environmental Programs, ISO Quality Standards, other quality publications, and experience from regulatory cases. The QS working group determined that, although the CGMP regulations do provide great flexibility, they do not incorporate explicitly all of the elements that today constitute most quality management systems. The CGMP regulations and other quality management systems differ somewhat in organization and in certain constituent elements; however, they are very similar and share underlying principles. For example, the CGMP regulations stress quality control. More recently developed quality systems stress quality management, quality assurance , and the use of risk management tools, in addition to quality contro
l. The QS working group decided that it would be very useful to examine exactly how the CGMP regulations and the elements of a modern, comprehensive quality system fit together in today's manufactur ing world. This guidance is the result of that examination. B. Goal of the Guidance This guidance describes a compre hensive quality systems model, which, if im plemented, will allow manufacturers to support and sustain robust, modern quality systems that are consistent with CGMP regulations. The guidance dem onstrates how and where the elements of this comprehensive model can fit within the requireme nts of the CGMP regulations. The inherent flexibility of the CGMP regulations should enab le manufacturers to implement a quality system in a form that is appropriate for their specific operations.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Goal of the Guidance This guidance describes a com...'?",
"reference": "Goal of the Guidance This guidance describes a compre hensive quality systems model, which, if im plemented, will allow manufacturers to support and sustain robust, modern quality systems that are consistent with CGMP regulations.",
"options": {
"B": "Guidance",
"A": "most quality management systems",
"C": "other quality management systems",
"D": "direction"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Goal of the Guidance This guidance describes a com...'?",
"reference": "Goal of the Guidance This guidance describes a compre hensive quality systems model, which, if im plemented, will allow manufacturers to support and sustain robust, modern quality systems that are consistent with CGMP regulations.",
"options": {
"A": "CGMP",
"B": "the Drug Manufact uring Inspections Program",
"C": "the Environmental Protection Agency's",
"D": "most quality management systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The guidance dem onstrates how and where the eleme...'?",
"reference": "The guidance dem onstrates how and where the elements of this comprehensive model can fit within the requireme nts of the CGMP regulations.",
"options": {
"A": "CGMP",
"B": "the Drug Manufact uring Inspections Program",
"C": "the Environmental Protection Agency's",
"D": "most quality management systems"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'More recently developed quality systems stress qua...'?",
"reference": "More recently developed quality systems stress quality management, quality assurance , and the use of risk management tools, in addition to quality contro\nl. The QS working group decided that it would be very useful to examine exactly how the CGMP regulations and the elements of a modern, comprehensive quality system fit together in today's manufactur ing world.",
"options": {
"C": "QS",
"A": "CGMP",
"B": "most quality management systems",
"D": "other quality management systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'More recently developed quality systems stress qua...'?",
"reference": "More recently developed quality systems stress quality management, quality assurance , and the use of risk management tools, in addition to quality contro\nl. The QS working group decided that it would be very useful to examine exactly how the CGMP regulations and the elements of a modern, comprehensive quality system fit together in today's manufactur ing world.",
"options": {
"A": "CGMP",
"B": "the Drug Manufact uring Inspections Program",
"C": "the Environmental Protection Agency's",
"D": "most quality management systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'More recently developed quality systems stress qua...'?",
"reference": "More recently developed quality systems stress quality management, quality assurance , and the use of risk management tools, in addition to quality contro\nl. The QS working group decided that it would be very useful to examine exactly how the CGMP regulations and the elements of a modern, comprehensive quality system fit together in today's manufactur ing world.",
"options": {
"D": "today",
"A": "most quality management systems",
"B": "other quality management systems",
"C": "nowadays"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 35 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1. Analyze Data for Trends ............................................................................................................... 21 2. Conduct Internal Audits ................................................................................................................. 21 3. Quality Risk Management ..............................................................................................................
Corrective Action ...........................................................................................................................
22 Contains Nonbinding Recommendations 5. Preventive Actions ......................................................................................................................... 23 6. Promote Improvement ....................................................................................................................
23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................
25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any pe rson and does not operate to bind FDA or the public.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Quality Risk Management .............................'?",
"reference": "Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n22 Contains Nonbinding Recommendations 5.",
"options": {
"D": "Quality Risk Management",
"A": "Analyze Data",
"B": "Conduct Internal Audits",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n____ Contains Nonbinding Recommendations 5.",
"reference": "Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n22 Contains Nonbinding Recommendations 5.",
"options": {
"B": "22",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n22 Contains Nonbinding Recommendations ____.",
"reference": "Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n22 Contains Nonbinding Recommendations 5.",
"options": {
"D": "5",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Address Nonconformities .............................'?",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"D": "21 1",
"A": "21 3",
"B": "Nonbinding Recommendations Guidance",
"C": "Pharmaceutical Current Good Manufacturing Practice Regulations"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... ____ D. Evaluation Activities .................................................................................................................... 21 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"D": "19",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... ____ 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"A": "21",
"B": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... ____9 D. Evaluation Activities .................................................................................................................... 21 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"D": "1",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Preventive Actions ..................................'?",
"reference": "Preventive Actions ......................................................................................................................... 23 6.",
"options": {
"B": "Preventive Actions",
"A": "Analyze Data",
"C": "Conduct Internal Audits",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Preventive Actions ..................................'?",
"reference": "Preventive Actions ......................................................................................................................... 23 6.",
"options": {
"D": "23 6",
"A": "21 2",
"B": "Nonbinding Recommendations Guidance",
"C": "Pharmaceutical Current Good Manufacturing Practice Regulations"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Preventive Actions ......................................................................................................................... ____ 6.",
"reference": "Preventive Actions ......................................................................................................................... 23 6.",
"options": {
"D": "23",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Preventive Actions ......................................................................................................................... 23 ____.",
"reference": "Preventive Actions ......................................................................................................................... 23 6.",
"options": {
"A": "6",
"B": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Address Nonconformities .............................'?",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"C": "21 1",
"A": "21 3",
"B": "Nonbinding Recommendations Guidance",
"D": "Pharmaceutical Current Good Manufacturing Practice Regulations"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... ____ D. Evaluation Activities .................................................................................................................... 21 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"A": "19",
"B": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... ____ 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"D": "21",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... ____9 D. Evaluation Activities .................................................................................................................... 21 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"B": "1",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Conduct Internal Audits .............................'?",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"C": "21 3",
"A": "21 2",
"B": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Conduct Internal Audits ................................................................................................................. ____ 3.",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"C": "21",
"A": "21 2",
"B": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Conduct Internal Audits ................................................................................................................. 21 ____.",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"D": "3",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Address Nonconformities .............................'?",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"A": "21 1",
"B": "21 3",
"C": "Nonbinding Recommendations Guidance",
"D": "Pharmaceutical Current Good Manufacturing Practice Regulations"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... ____ D. Evaluation Activities .................................................................................................................... 21 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"A": "19",
"B": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... ____ 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"C": "21",
"A": "21 2",
"B": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities ............................................................................................................... ____9 D. Evaluation Activities .................................................................................................................... 21 1.",
"reference": "Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1.",
"options": {
"C": "1",
"A": "21 2",
"B": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Conduct Internal Audits .............................'?",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"A": "21 3",
"B": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Conduct Internal Audits .............................'?",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"C": "21 3",
"A": "21 2",
"B": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Conduct Internal Audits ................................................................................................................. ____ 3.",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"C": "21",
"A": "21 2",
"B": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Conduct Internal Audits ................................................................................................................. 21 ____.",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"B": "3",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Promote Improvement .................................'?",
"reference": "Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"options": {
"A": "Quality Systems Approach",
"B": "Analyze Data",
"C": "Conduct Internal Audits",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Promote Improvement .................................'?",
"reference": "Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"options": {
"D": "the Food and Drug Administrati",
"A": "Analyze Data",
"B": "Conduct Internal Audits",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Promote Improvement .................................'?",
"reference": "Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"options": {
"A": "FDA",
"B": "Analyze Data",
"C": "Conduct Internal Audits",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Promote Improvement ....................................................................................................................\n____ V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"reference": "Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"options": {
"D": "23",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... ____ USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"reference": "Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"options": {
"B": "24",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n____ GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"reference": "Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"options": {
"C": "25",
"A": "21 2",
"B": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. ____ Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"reference": "Promote Improvement ....................................................................................................................\n23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................\n25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic.",
"options": {
"A": "27",
"B": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It does not create or confer any rights for or on ...'?",
"reference": "It does not create or confer any rights for or on any pe rson and does not operate to bind FDA or the public.",
"options": {
"C": "FDA",
"A": "Analyze Data",
"B": "Conduct Internal Audits",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Quality Risk Management .............................'?",
"reference": "Quality Risk Management ..............................................................................................................\nCorrective Action ...........................................................................................................................\n22 Contains Nonbinding Recommendations 5.",
"options": {
"A": "Quality Risk Management",
"B": "Analyze Data",
"C": "Conduct Internal Audits",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 1 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) December 2018 Pharmaceutical Quality/Manufacturing Standards (CGMP) Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry Additional copies are available from: Office of Communication s, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave. , Hillandale Bldg., 4th Floor Silver Spring, MD 20993- 0002
Phone: 855-543-3784 or 301- 796-3400; Fax: 301 -431-6353 Email: druginfofda.hhs.gov https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or Office of Communication, Outreach and Development Center for Biologics Evaluation and Research Food and Drug Administration 10903
New Hampshire Ave., Bldg. 71, Room 3128 Silver Spring, MD 20993- 0002
Phone : 800 -835-4709 or 240- 402-8010 Email: ocodfda.hhs.gov https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7500 Standish Place, Rockville, MD 20855 https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Se rvices Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) December 2018 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION............................................................................................................. 1 II.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: INTRODUCTION............................................................................................................. ____ II.",
"reference": "INTRODUCTION............................................................................................................. 1 II.",
"options": {
"B": "1",
"A": "855",
"C": "796-3400",
"D": "Research Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 2 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
It should be noted that im plementing an effective quality system in a manufacturing organization will require a significant investment of time and resources. However, we believe the long-term benefits of implementing a quality system will outweigh the costs.10
This section describes a robust quality systems model that, if properly implemented, can provide the controls to consistently produce a product of acceptable quality. Wh ere applicable, the relationship between elements of this model and CG MP regulations is noted. At the end of each section, a table shows how the specific CGMP regulat ions correlate to the elements in the quality systems model. As already explained, many of the quality systems elements correlate closely with the CGMP regulations. It is important to emphasize that this gui dance is not recommending new regulatory requirements. The guidance is intended to provide recommendations to manufacturers who are implementing, or plan to implement, a quality systems model to help them comply with CGMP regulations. FDA re gulatory and inspectional coverage will remain focused on the specific CGMP regulations. The model is described according to four major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described. When elements of the qual ity systems model correlate with specific CGMP regulations, this corre lation is noted. A. Management Responsibilities Modern robust quality systems models call for manageme nt to play a key role in the design, implementation, and management of the quality system. For example, management is responsible for establishing the qua lity system structure appropri ate for the specific organization. Management has ultimate responsibility to provide the leadership needed for the successful functioning of a quality system.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'At the end of each section, a table shows how the ...'?",
"reference": "At the end of each section, a table shows how the specific CGMP regulat ions correlate to the elements in the quality systems model.",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'At the end of each section, a table shows how the ...'?",
"reference": "At the end of each section, a table shows how the specific CGMP regulat ions correlate to the elements in the quality systems model.",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 8 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
On the other hand, when 166 persons use computers to generate paper printouts of electronic records, and those paper records 167 meet all the requirements of the applicable predicate rules and persons rely on the paper records 168 to perform their regulated activities, FDA would generally not co nsider persons to be "using 169 electronic records in lieu of paper records" under 11.2(a) and 11.2(b). In these instances, the 170 use of computer systems in the generation of paper records would not trigger part 11. Definition of Part 11 Records 173 174 Under this narrow interpretation, FDA considers part 11 to be applicable to the following records 175 or signatures in electronic format (part 11 records or signatures): 176 177 Records that are required to be maintained under predicate rule requirements and that are 178 maintained in electronic format in place of paper format . On the other hand, records (and 179 any associated signatures) that are not required to be retained under predicate rules, but 180 that are nonetheless maintained in electronic format, are not part 11 records . We recommend that you determine, based on the predicate rules, whether specific records 182 are part 11 records. We recommend that you document such decisions. 183 184 Records that are required to be maintained under predicate rules, that are maintained in 185 electro nic format in addition to paper format, and that are relied on to perform regulated 186 activities . In some cases, actual business practices may dictate whether you are using electronic 188 records instead of paper records under 11.2(a). For example, if a reco rd is required to 189 be maintained under a predicate rule and you use a computer to generate a paper printout 190 of the electronic records, but you nonetheless rely on the electronic record to perform 191 regulated activities, the Agency may consider you to be using the electronic record 192 instead of the paper record.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: In these instances, the ____ use of computer systems in the generation of paper records would not trigger part 11.",
"reference": "In these instances, the 170 use of computer systems in the generation of paper records would not trigger part 11.",
"options": {
"A": "170",
"B": "166",
"C": "167",
"D": "those paper records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In these instances, the 170 use of computer systems in the generation of paper records would not trigger part ____.",
"reference": "In these instances, the 170 use of computer systems in the generation of paper records would not trigger part 11.",
"options": {
"C": "11",
"A": "166",
"B": "167",
"D": "those paper records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For example, if a reco rd is required to 189 be ma...'?",
"reference": "For example, if a reco rd is required to 189 be maintained under a predicate rule and you use a computer to generate a paper printout 190 of the electronic records, but you nonetheless rely on the electronic record to perform 191 regulated activities, the Agency may consider you to be using the electronic record 192 instead of the paper record.",
"options": {
"D": "Agency",
"A": "those paper records",
"B": "the paper records",
"C": "government agency"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, if a reco rd is required to ____ be maintained under a predicate rule and you use a computer to generate a paper printout 190 of the electronic records, but you nonetheless rely on the electronic record to perform 191 regulated activities, the Agency may consider you to be using the electronic record 192 instead of the paper record.",
"reference": "For example, if a reco rd is required to 189 be maintained under a predicate rule and you use a computer to generate a paper printout 190 of the electronic records, but you nonetheless rely on the electronic record to perform 191 regulated activities, the Agency may consider you to be using the electronic record 192 instead of the paper record.",
"options": {
"B": "189",
"A": "166",
"C": "167",
"D": "those paper records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, if a reco rd is required to 189 be maintained under a predicate rule and you use a computer to generate a paper printout ____ of the electronic records, but you nonetheless rely on the electronic record to perform 191 regulated activities, the Agency may consider you to be using the electronic record 192 instead of the paper record.",
"reference": "For example, if a reco rd is required to 189 be maintained under a predicate rule and you use a computer to generate a paper printout 190 of the electronic records, but you nonetheless rely on the electronic record to perform 191 regulated activities, the Agency may consider you to be using the electronic record 192 instead of the paper record.",
"options": {
"C": "190",
"A": "166",
"B": "167",
"D": "those paper records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, if a reco rd is required to 189 be maintained under a predicate rule and you use a computer to generate a paper printout 190 of the electronic records, but you nonetheless rely on the electronic record to perform ____ regulated activities, the Agency may consider you to be using the electronic record 192 instead of the paper record.",
"reference": "For example, if a reco rd is required to 189 be maintained under a predicate rule and you use a computer to generate a paper printout 190 of the electronic records, but you nonetheless rely on the electronic record to perform 191 regulated activities, the Agency may consider you to be using the electronic record 192 instead of the paper record.",
"options": {
"C": "191",
"A": "166",
"B": "167",
"D": "those paper records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, if a reco rd is required to 189 be maintained under a predicate rule and you use a computer to generate a paper printout 190 of the electronic records, but you nonetheless rely on the electronic record to perform 191 regulated activities, the Agency may consider you to be using the electronic record ____ instead of the paper record.",
"reference": "For example, if a reco rd is required to 189 be maintained under a predicate rule and you use a computer to generate a paper printout 190 of the electronic records, but you nonetheless rely on the electronic record to perform 191 regulated activities, the Agency may consider you to be using the electronic record 192 instead of the paper record.",
"options": {
"C": "192",
"A": "166",
"B": "167",
"D": "those paper records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 184 Records that are required to be maintained under predicate rules, that are maintained in 185 electro nic format in addition to paper format, and that are relied on to perform regulated 186 activities .",
"reference": "183 184 Records that are required to be maintained under predicate rules, that are maintained in 185 electro nic format in addition to paper format, and that are relied on to perform regulated 186 activities .",
"options": {
"D": "183",
"A": "166",
"B": "167",
"C": "those paper records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
For example, industry documents and other FDA validation guidance sometimes describe user site software validation in terms of installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995. While IQ/OQ/PQ terminology has served its purpose well and is one of many legitimate ways to organize software validation tasks at the user site, this terminology may not be well understood among many software professionals, and it is not used elsewhere in this document. However, both FDA personnel and device manufacturers need to be aware of these differences in terminology as they ask for and provide information regarding software validation. SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN The decision to implement system functionality using software is one that is typically made during system design. Software requirements are typically derived from the overall system requirements and design for those aspects in the system that are to be implemented using software. There are user needs and intended uses for a finished device, but users typically do not specify whether those requirements are to be met by hardware, software, or some combination of both. Therefore, software validation must be considered within the context of the overall design validation for the system. A documented requirements specification represents the user's needs and intended uses from which the product is developed. A primary goal of software validation is to then demonstrate that all completed software products comply with all documented software and system requirements.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN The ...'?",
"reference": "SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN The decision to implement system functionality using software is one that is typically made during system design.",
"options": {
"D": "SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN",
"A": "FDA",
"B": "Glossary of Computerized System",
"C": "user site software validation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN The decision to implement system functionality using software is ____ that is typically made during system design.",
"reference": "SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN The decision to implement system functionality using software is one that is typically made during system design.",
"options": {
"B": "one",
"A": "user site software validation",
"C": "software validation tasks",
"D": "ace"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software requirements are typically derived from t...'?",
"reference": "Software requirements are typically derived from the overall system requirements and design for those aspects in the system that are to be implemented using software.",
"options": {
"B": "Software",
"A": "FDA",
"C": "Glossary of Computerized System",
"D": "the overall design validation"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For example, industry documents and other FDA vali...'?",
"reference": "For example, industry documents and other FDA validation guidance sometimes describe user site software validation in terms of installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).",
"options": {
"A": "FDA",
"B": "Glossary of Computerized System",
"C": "SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN",
"D": "user site software validation"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN The ...'?",
"reference": "SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN The decision to implement system functionality using software is one that is typically made during system design.",
"options": {
"C": "SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN",
"A": "FDA",
"B": "Glossary of Computerized System",
"D": "user site software validation"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN The decision to implement system functionality using software is ____ that is typically made during system design.",
"reference": "SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN The decision to implement system functionality using software is one that is typically made during system design.",
"options": {
"A": "one",
"B": "user site software validation",
"C": "software validation tasks",
"D": "ace"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Therefore, software validation must be considered within the...'?",
"reference": "Therefore, software validation must be considered within the context of the overall design validation for the system.",
"options": {
"C": "Therefore, software validation must be considered within the context of the overall design validatio...",
"A": "user site software validation",
"B": "software validation tasks",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Definitions of these terms and additional informat...'?",
"reference": "Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"options": {
"B": "May 11, 1987",
"A": "August 1995",
"C": "user site software validation",
"D": "software validation tasks"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Definitions of these terms and additional informat...'?",
"reference": "Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"options": {
"C": "Glossary of Computerized System",
"A": "user site software validation",
"B": "software validation tasks",
"D": "Guideline"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Definitions of these terms and additional informat...'?",
"reference": "Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"options": {
"C": "August 1995",
"A": "May 11, 1987",
"B": "user site software validation",
"D": "software validation tasks"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May ____, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"reference": "Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"options": {
"D": "11",
"A": "user site software validation",
"B": "software validation tasks",
"C": "Guideline"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, ____, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"reference": "Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"options": {
"B": "1987",
"A": "May 11, 1987",
"C": "August 1995",
"D": "user site software validation"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August ____.",
"reference": "Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"options": {
"D": "1995",
"A": "May 11, 1987",
"B": "August 1995",
"C": "user site software validation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Definitions of these terms and additional informat...'?",
"reference": "Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"options": {
"C": "May 11, 1987",
"A": "August 1995",
"B": "user site software validation",
"D": "software validation tasks"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Definitions of these terms and additional informat...'?",
"reference": "Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"options": {
"D": "Glossary of Computerized System",
"A": "user site software validation",
"B": "software validation tasks",
"C": "Guideline"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Definitions of these terms and additional informat...'?",
"reference": "Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"options": {
"B": "August 1995",
"A": "May 11, 1987",
"C": "user site software validation",
"D": "software validation tasks"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May ____, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"reference": "Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"options": {
"D": "11",
"A": "user site software validation",
"B": "software validation tasks",
"C": "Guideline"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, ____, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"reference": "Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"options": {
"D": "1987",
"A": "May 11, 1987",
"B": "August 1995",
"C": "user site software validation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August ____.",
"reference": "Definitions of these terms and additional information regarding IQ/OQ/PQ may be found in FDAs Guideline on General Principles of Process Validation , dated May 11, 1987, and in FDAs Glossary of Computerized System and Software Development Terminology, dated August 1995.",
"options": {
"A": "1995",
"B": "May 11, 1987",
"C": "August 1995",
"D": "user site software validation"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN The ...'?",
"reference": "SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN The decision to implement system functionality using software is one that is typically made during system design.",
"options": {
"D": "SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN",
"A": "FDA",
"B": "Glossary of Computerized System",
"C": "user site software validation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN The decision to implement system functionality using software is ____ that is typically made during system design.",
"reference": "SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN The decision to implement system functionality using software is one that is typically made during system design.",
"options": {
"D": "one",
"A": "user site software validation",
"B": "software validation tasks",
"C": "ace"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: While IQ/OQ/PQ terminology has served its purpose well and is ____ of many legitimate ways to organize software validation tasks at the user site, this terminology may not be well understood among many software professionals, and it is not used elsewhere in this document.",
"reference": "While IQ/OQ/PQ terminology has served its purpose well and is one of many legitimate ways to organize software validation tasks at the user site, this terminology may not be well understood among many software professionals, and it is not used elsewhere in this document.",
"options": {
"D": "one",
"A": "user site software validation",
"B": "software validation tasks",
"C": "ace"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: While IQ/OQ/PQ terminology has served its purpose well and is ____ of many legitimate ways to organize software validation tasks at the user site, this terminology may not be well understood among many software professionals, and it is not used elsewhere in this document.",
"reference": "While IQ/OQ/PQ terminology has served its purpose well and is one of many legitimate ways to organize software validation tasks at the user site, this terminology may not be well understood among many software professionals, and it is not used elsewhere in this document.",
"options": {
"B": "one",
"A": "user site software validation",
"C": "software validation tasks",
"D": "ace"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For example, industry documents and other FDA vali...'?",
"reference": "For example, industry documents and other FDA validation guidance sometimes describe user site software validation in terms of installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).",
"options": {
"C": "FDA",
"A": "Glossary of Computerized System",
"B": "SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN",
"D": "user site software validation"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'However, both FDA personnel and device manufacture...'?",
"reference": "However, both FDA personnel and device manufacturers need to be aware of these differences in terminology as they ask for and provide information regarding software validation.",
"options": {
"C": "FDA",
"A": "Glossary of Computerized System",
"B": "SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN",
"D": "user site software validation"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 2 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Data Integrity and Compliance W ith CGMP Guidance for Industry DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publicat ion in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA -305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register . For questions regarding this draft document , contact (CDER) Karen Takahashi 301- 796-3191; (CBER) Office of Communication, Outreach and Development, 800- 835-4709 or 240- 402-8010; or (CVM) Jonathan Bray 240- 402-5623. U.S. Department of Health and Human Services Food and Drug Adminis tration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Data Integrity and Compliance W ith CGMP Guida nce for Industry Additional copies are available from:
Office of Communication s, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave. , Hillandale Bldg., 4th Floor Silver Spring, MD 20993 -0002 Phone: 855-543-3784 or 301- 796-3400;
Fax: 301 -431-6353 Email: druginfofda.hhs.gov http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or Office of Communication, Outreach and Development Center for Biologics Evaluation and Research Food and Drug Administration 10903
New Hampshire Ave., Bldg.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Who is mentioned in the context: 'For questions regarding this draft document , cont...'?",
"reference": "For questions regarding this draft document , contact (CDER) Karen Takahashi 301- 796-3191; (CBER) Office of Communication, Outreach and Development, 800- 835-4709 or 240- 402-8010; or (CVM) Jonathan Bray 240- 402-5623.",
"options": {
"A": "Karen Takahashi",
"B": "Fishers Lane",
"C": "Jonathan Bray 240- 402-5623",
"D": "Biologics Evaluation and Research Food and Drug Administration 10903\nNew Hampshire Ave"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'For questions regarding this draft document , cont...'?",
"reference": "For questions regarding this draft document , contact (CDER) Karen Takahashi 301- 796-3191; (CBER) Office of Communication, Outreach and Development, 800- 835-4709 or 240- 402-8010; or (CVM) Jonathan Bray 240- 402-5623.",
"options": {
"A": "Jonathan Bray 240- 402-5623",
"B": "Fishers Lane",
"C": "Karen Takahashi",
"D": "Biologics Evaluation and Research Food and Drug Administration 10903\nNew Hampshire Ave"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 7 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
It is also recommended that, when operating under a quality system, manufa cturers develop and docum ent control procedures to complete, secure, protect, and archive records, including data, wh ich provide evidence of operational and quality system activities. This approach is consiste nt with the CGMP regulations, which require manufacturers to establish and follow scientifically sound and a ppropriate written controls for specifications, plans, and procedures that direct operational and quality system activities and to ensure that these directives are accurate, appropr iately reviewed and approved, and available for use (see the CGMPs at 211.22 (c) and (d)). 4. Establish Policies, Objectives, and Plans Policies, objectives, and plans under a modern qual ity system provide the means by which senior m anagers articulate their vision of and comm itment to quality to all levels of the organization. Under a quality system, senior managem ent should incorporate a strong commitment to quality into the organizational mission. Senior managers should develop an organizational quality policy that aligns with th is mission; commit to meeting requirements a nd improving the quality system; and propose objectives to fulfill the quality policy. Under a quality system, to make the policy relevant, it must be communicated t o, and understood by, personne l and contractors (if applicable) and revised, as needed. Managers operating within a quality system shoul d define the quality obj ectives identified for implementing the quality policy. Senior m anagement should ensure that the quality objectives are created at the top level of the organizati on (and other levels as needed) through a for mal quality planning process. Objectives are typi cally aligned with the manufacturers strategic plans. A quality system seeks to ensure that managers support the objectives with necessary resources and have measurable go als that are monitored regularly.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'This approach is consiste nt with the CGMP regulat...'?",
"reference": "This approach is consiste nt with the CGMP regulations, which require manufacturers to establish and follow scientifically sound and a ppropriate written controls for specifications, plans, and procedures that direct operational and quality system activities and to ensure that these directives are accurate, appropr iately reviewed and approved, and available for use (see the CGMPs at 211.22 (c) and (d)).",
"options": {
"D": "CGMP",
"A": "Establish Policies",
"B": "Objectives",
"C": "the quality objectives"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This approach is consiste nt with the CGMP regulations, which require manufacturers to establish and follow scientifically sound and a ppropriate written controls for specifications, plans, and procedures that direct operational and quality system activities and to ensure that these directives are accurate, appropr iately reviewed and approved, and available for use (see the CGMPs at ____ (c) and (d)).",
"reference": "This approach is consiste nt with the CGMP regulations, which require manufacturers to establish and follow scientifically sound and a ppropriate written controls for specifications, plans, and procedures that direct operational and quality system activities and to ensure that these directives are accurate, appropr iately reviewed and approved, and available for use (see the CGMPs at 211.22 (c) and (d)).",
"options": {
"B": "211.22",
"A": "the quality objectives",
"C": "an organizational quality policy",
"D": "CGMP"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This approach is consiste nt with the CGMP regulat...'?",
"reference": "This approach is consiste nt with the CGMP regulations, which require manufacturers to establish and follow scientifically sound and a ppropriate written controls for specifications, plans, and procedures that direct operational and quality system activities and to ensure that these directives are accurate, appropr iately reviewed and approved, and available for use (see the CGMPs at 211.22 (c) and (d)).",
"options": {
"A": "CGMP",
"B": "Establish Policies",
"C": "Objectives",
"D": "the quality objectives"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This approach is consiste nt with the CGMP regulations, which require manufacturers to establish and follow scientifically sound and a ppropriate written controls for specifications, plans, and procedures that direct operational and quality system activities and to ensure that these directives are accurate, appropr iately reviewed and approved, and available for use (see the CGMPs at ____ (c) and (d)).",
"reference": "This approach is consiste nt with the CGMP regulations, which require manufacturers to establish and follow scientifically sound and a ppropriate written controls for specifications, plans, and procedures that direct operational and quality system activities and to ensure that these directives are accurate, appropr iately reviewed and approved, and available for use (see the CGMPs at 211.22 (c) and (d)).",
"options": {
"A": "211.22",
"B": "the quality objectives",
"C": "an organizational quality policy",
"D": "CGMP"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Establish Policies, Objectives, and Plans Policies...'?",
"reference": "Establish Policies, Objectives, and Plans Policies, objectives, and plans under a modern qual ity system provide the means by which senior m anagers articulate their vision of and comm itment to quality to all levels of the organization.",
"options": {
"D": "Establish Policies",
"A": "CGMP",
"B": "Objectives",
"C": "the quality objectives"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Establish Policies, Objectives, and Plans Policies...'?",
"reference": "Establish Policies, Objectives, and Plans Policies, objectives, and plans under a modern qual ity system provide the means by which senior m anagers articulate their vision of and comm itment to quality to all levels of the organization.",
"options": {
"A": "Objectives",
"B": "CGMP",
"C": "Establish Policies",
"D": "an organizational quality policy"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This approach is consiste nt with the CGMP regulat...'?",
"reference": "This approach is consiste nt with the CGMP regulations, which require manufacturers to establish and follow scientifically sound and a ppropriate written controls for specifications, plans, and procedures that direct operational and quality system activities and to ensure that these directives are accurate, appropr iately reviewed and approved, and available for use (see the CGMPs at 211.22 (c) and (d)).",
"options": {
"C": "CGMP",
"A": "Establish Policies",
"B": "Objectives",
"D": "the quality objectives"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 45 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
IC H Q10 is not intended to create any new expectations beyond current regula tory requirements. Consequentl y, the content of ICH Q10 that is additional to current regiona l GMP requirements is optional. This guidance was developed within the Expert Working Group (Quality) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process. This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008. At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States . 2 Arabic numbers reflect the organiza tional breakdown of the document endors ed by the ICH Steering Committee at Step 4 of the ICH process, June 2008. These guidances are available on the Internet at http://www.fda.gov/cder/guidance/index.htm . We update guidances periodically. To make sure you have the most recent version of a guidance, check the CDER guidance page at http://www.fda.gov/cder/guidance/index.htm 1 ICH Q10 demonstrates industry and regulator y authorities support of an effective pharmaceutical quality system to enhance the qua lity and availability of medicines around the world in the interest of p ublic health. Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities. FDA's guidance documents, including this guida nce, do not establish legally enforceable responsibilities. Instead, guidances describe th e Agencys current thinki ng on a topic and should be viewed only as recommendations, unless spec ific regulatory or stat utory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'This document has been endorsed by the ICH Steerin...'?",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"C": "the ICH Steering Committee",
"A": "IC H Q10",
"B": "Consequentl",
"D": "the ICH process"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'This document has been endorsed by the ICH Steerin...'?",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"C": "June 2008",
"A": "the ICH process",
"B": "the ICH Steering Committee",
"D": "This information is not provided in the context"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This document has been endorsed by the ICH Steering Committee at Step ____ of the ICH process, June 2008.",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"A": "4",
"B": "the ICH process",
"C": "quaternity",
"D": "quadruplet"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June ____.",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"B": "2008",
"A": "June 2008",
"C": "the ICH process",
"D": "the ICH Steering Committee"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'IC H Q10 is not intended to create any new expecta...'?",
"reference": "IC H Q10 is not intended to create any new expectations beyond current regula tory requirements.",
"options": {
"B": "IC H Q10",
"A": "Consequentl",
"C": "ICH Q10",
"D": "the ICH process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'IC H Q10 is not intended to create any new expecta...'?",
"reference": "IC H Q10 is not intended to create any new expectations beyond current regula tory requirements.",
"options": {
"B": "IC H Q10",
"A": "Consequentl",
"C": "ICH Q10",
"D": "the ICH process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This document has been endorsed by the ICH Steerin...'?",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"C": "the ICH Steering Committee",
"A": "IC H Q10",
"B": "Consequentl",
"D": "the ICH process"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'This document has been endorsed by the ICH Steerin...'?",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"A": "June 2008",
"B": "the ICH process",
"C": "the ICH Steering Committee",
"D": "This information is not provided in the context"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This document has been endorsed by the ICH Steering Committee at Step ____ of the ICH process, June 2008.",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"D": "4",
"A": "the ICH process",
"B": "quaternity",
"C": "quadruplet"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June ____.",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"B": "2008",
"A": "June 2008",
"C": "the ICH process",
"D": "the ICH Steering Committee"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Consequentl y, the content of ICH Q10 that is addi...'?",
"reference": "Consequentl y, the content of ICH Q10 that is additional to current regiona l GMP requirements is optional.",
"options": {
"C": "Consequentl",
"A": "IC H Q10",
"B": "ICH Q10",
"D": "the ICH process"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This document has been endorsed by the ICH Steerin...'?",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"A": "the ICH Steering Committee",
"B": "IC H Q10",
"C": "Consequentl",
"D": "the ICH process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'This document has been endorsed by the ICH Steerin...'?",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"A": "June 2008",
"B": "the ICH process",
"C": "the ICH Steering Committee",
"D": "This information is not provided in the context"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This document has been endorsed by the ICH Steering Committee at Step ____ of the ICH process, June 2008.",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"C": "4",
"A": "the ICH process",
"B": "quaternity",
"D": "quadruplet"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June ____.",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"A": "2008",
"B": "June 2008",
"C": "the ICH process",
"D": "the ICH Steering Committee"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'IC H Q10 is not intended to create any new expecta...'?",
"reference": "IC H Q10 is not intended to create any new expectations beyond current regula tory requirements.",
"options": {
"C": "IC H Q10",
"A": "Consequentl",
"B": "ICH Q10",
"D": "the ICH process"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This document has been endorsed by the ICH Steerin...'?",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"C": "the ICH Steering Committee",
"A": "IC H Q10",
"B": "Consequentl",
"D": "the ICH process"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'This document has been endorsed by the ICH Steerin...'?",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"D": "June 2008",
"A": "the ICH process",
"B": "the ICH Steering Committee",
"C": "This information is not provided in the context"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This document has been endorsed by the ICH Steering Committee at Step ____ of the ICH process, June 2008.",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"B": "4",
"A": "the ICH process",
"C": "quaternity",
"D": "quadruplet"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June ____.",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"C": "2008",
"A": "June 2008",
"B": "the ICH process",
"D": "the ICH Steering Committee"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Consequentl y, the content of ICH Q10 that is addi...'?",
"reference": "Consequentl y, the content of ICH Q10 that is additional to current regiona l GMP requirements is optional.",
"options": {
"D": "Consequentl",
"A": "IC H Q10",
"B": "ICH Q10",
"C": "the ICH process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Consequentl y, the content of ICH Q10 that is addi...'?",
"reference": "Consequentl y, the content of ICH Q10 that is additional to current regiona l GMP requirements is optional.",
"options": {
"D": "ICH Q10",
"A": "the ICH process",
"B": "Consequentl",
"C": "regiona l GMP"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Consequentl y, the content of ICH Q10 that is addi...'?",
"reference": "Consequentl y, the content of ICH Q10 that is additional to current regiona l GMP requirements is optional.",
"options": {
"D": "regiona l GMP",
"A": "IC H Q10",
"B": "Consequentl",
"C": "the ICH process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'At Step 4 of the process, the final draft is recom...'?",
"reference": "At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States .",
"options": {
"C": "the European Union",
"A": "IC H Q10",
"B": "Consequentl",
"D": "the ICH process"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'At Step 4 of the process, the final draft is recom...'?",
"reference": "At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States .",
"options": {
"C": "Japan",
"A": "the United States",
"B": "the ICH process",
"D": "Nihon"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'At Step 4 of the process, the final draft is recom...'?",
"reference": "At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States .",
"options": {
"D": "the United States",
"A": "Japan",
"B": "the ICH process",
"C": "the European Union"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: At Step ____ of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States .",
"reference": "At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States .",
"options": {
"A": "4",
"B": "the ICH process",
"C": "quaternity",
"D": "quadruplet"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'At Step 4 of the process, the final draft is recom...'?",
"reference": "At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States .",
"options": {
"D": "the European Union",
"A": "IC H Q10",
"B": "Consequentl",
"C": "the ICH process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'At Step 4 of the process, the final draft is recom...'?",
"reference": "At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States .",
"options": {
"D": "Japan",
"A": "the United States",
"B": "the ICH process",
"C": "Nihon"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'At Step 4 of the process, the final draft is recom...'?",
"reference": "At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States .",
"options": {
"C": "the United States",
"A": "Japan",
"B": "the ICH process",
"D": "the European Union"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: At Step ____ of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States .",
"reference": "At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States .",
"options": {
"B": "4",
"A": "the ICH process",
"C": "quaternity",
"D": "quadruplet"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'IC H Q10 is not intended to create any new expecta...'?",
"reference": "IC H Q10 is not intended to create any new expectations beyond current regula tory requirements.",
"options": {
"B": "IC H Q10",
"A": "Consequentl",
"C": "ICH Q10",
"D": "the ICH process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 Arabic numbers reflect the organiza tional break...'?",
"reference": "2 Arabic numbers reflect the organiza tional breakdown of the document endors ed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"C": "the ICH Steering Committee",
"A": "IC H Q10",
"B": "Consequentl",
"D": "the ICH process"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '2 Arabic numbers reflect the organiza tional break...'?",
"reference": "2 Arabic numbers reflect the organiza tional breakdown of the document endors ed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"B": "June 2008",
"A": "the ICH process",
"C": "the ICH Steering Committee",
"D": "This information is not provided in the context"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance was developed within the Expert Work...'?",
"reference": "This guidance was developed within the Expert Working Group (Quality) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process.",
"options": {
"A": "the Expert Working Group (Quality",
"B": "IC H Q10",
"C": "Consequentl",
"D": "the ICH process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance was developed within the Expert Work...'?",
"reference": "This guidance was developed within the Expert Working Group (Quality) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process.",
"options": {
"B": "the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (",
"A": "IC H Q10",
"C": "Consequentl",
"D": "the ICH process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This document has been endorsed by the ICH Steerin...'?",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"A": "the ICH Steering Committee",
"B": "IC H Q10",
"C": "Consequentl",
"D": "the ICH process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'This document has been endorsed by the ICH Steerin...'?",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"C": "June 2008",
"A": "the ICH process",
"B": "the ICH Steering Committee",
"D": "This information is not provided in the context"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This document has been endorsed by the ICH Steering Committee at Step ____ of the ICH process, June 2008.",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"C": "4",
"A": "the ICH process",
"B": "quaternity",
"D": "quadruplet"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June ____.",
"reference": "This document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, June 2008.",
"options": {
"A": "2008",
"B": "June 2008",
"C": "the ICH process",
"D": "the ICH Steering Committee"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Consequentl y, the content of ICH Q10 that is addi...'?",
"reference": "Consequentl y, the content of ICH Q10 that is additional to current regiona l GMP requirements is optional.",
"options": {
"D": "Consequentl",
"A": "IC H Q10",
"B": "ICH Q10",
"C": "the ICH process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Consequentl y, the content of ICH Q10 that is addi...'?",
"reference": "Consequentl y, the content of ICH Q10 that is additional to current regiona l GMP requirements is optional.",
"options": {
"D": "ICH Q10",
"A": "the ICH process",
"B": "Consequentl",
"C": "regiona l GMP"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Consequentl y, the content of ICH Q10 that is addi...'?",
"reference": "Consequentl y, the content of ICH Q10 that is additional to current regiona l GMP requirements is optional.",
"options": {
"B": "regiona l GMP",
"A": "IC H Q10",
"C": "Consequentl",
"D": "the ICH process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance was developed within the Expert Work...'?",
"reference": "This guidance was developed within the Expert Working Group (Quality) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process.",
"options": {
"A": "the Expert Working Group (Quality",
"B": "IC H Q10",
"C": "Consequentl",
"D": "the ICH process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance was developed within the Expert Work...'?",
"reference": "This guidance was developed within the Expert Working Group (Quality) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process.",
"options": {
"B": "the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (",
"A": "IC H Q10",
"C": "Consequentl",
"D": "the ICH process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 40 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Wilburn, Handbook of Software Quality Assurance Techniques Applicable to the Nuclear Industry , NUREG/CR-4640, U.S. Nuclear Regulatory Commission, 1987. H. Hecht, et.al., Verification and Validation Guidelines for High Integrity Systems . Prepared for U.S. Nuclear Regulatory Commission, 1995. H. Hecht, et.al., Review Guidelines on Software Languages for Use in Nuclear Power Plant Safety Systems, Final Report . Prepared for U.S. Nuclear Regulatory Commission, 1996. J.D. Lawrence, W.L. Persons , Survey of Industry Methods for Producing Highly Reliable Software , NUREG/CR-6278, U.S. Nuclear Regulatory Commission, 1994. J.D. Lawrence, G.G. Preckshot, Design Factors for Safety-Critical Software , NUREG/CR-6294, U.S. Nuclear Regulatory Commission, 1994. Patricia B. Powell, Editor. NBS Special Publication 500-98, Planning for Software Validation, Verification, and Testing, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, November 1982. Patricia B. Powell, Editor. NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982. Delores R. Wallace, Roger U. Fujii, NIST Special Publication 500-165, Software Verification and Validation: Its Role in Computer Assurance and Its Relationship with Software Project Management Standards , National Computer Systems Laboratory, National Institute of Standards and Technology, U.S. Department of Commerce, September 1995.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Wilburn, Handbook of Software Quality Assurance Te...'?",
"reference": "Wilburn, Handbook of Software Quality Assurance Techniques Applicable to the Nuclear Industry , NUREG/CR-4640, U.S. Nuclear Regulatory Commission, 1987.",
"options": {
"A": "the Nuclear Industry",
"B": "NUREG",
"C": "U.S. Nuclear Regulatory Commission",
"D": "This information is not provided in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Wilburn, Handbook of Software Quality Assurance Te...'?",
"reference": "Wilburn, Handbook of Software Quality Assurance Techniques Applicable to the Nuclear Industry , NUREG/CR-4640, U.S. Nuclear Regulatory Commission, 1987.",
"options": {
"D": "NUREG",
"A": "the Nuclear Industry",
"B": "U.S. Nuclear Regulatory Commission",
"C": "This information is not provided in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Wilburn, Handbook of Software Quality Assurance Te...'?",
"reference": "Wilburn, Handbook of Software Quality Assurance Techniques Applicable to the Nuclear Industry , NUREG/CR-4640, U.S. Nuclear Regulatory Commission, 1987.",
"options": {
"A": "U.S. Nuclear Regulatory Commission",
"B": "the Nuclear Industry",
"C": "NUREG",
"D": "Software Project Management Standards"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Wilburn, Handbook of Software Quality Assurance Te...'?",
"reference": "Wilburn, Handbook of Software Quality Assurance Techniques Applicable to the Nuclear Industry , NUREG/CR-4640, U.S. Nuclear Regulatory Commission, 1987.",
"options": {
"A": "1987",
"B": "1995",
"C": "1996",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Wilburn, Handbook of Software Quality Assurance Techniques Applicable to the Nuclear Industry , NUREG/CR-4640, U.S. Nuclear Regulatory Commission, ____.",
"reference": "Wilburn, Handbook of Software Quality Assurance Techniques Applicable to the Nuclear Industry , NUREG/CR-4640, U.S. Nuclear Regulatory Commission, 1987.",
"options": {
"D": "1987",
"A": "1995",
"B": "1996",
"C": "U.S. Nuclear Regulatory Commission"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Persons , Survey of Industry Methods for Producing...'?",
"reference": "Persons , Survey of Industry Methods for Producing Highly Reliable Software , NUREG/CR-6278, U.S. Nuclear Regulatory Commission, 1994.",
"options": {
"A": "NUREG",
"B": "the Nuclear Industry",
"C": "U.S. Nuclear Regulatory Commission",
"D": "1994"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Persons , Survey of Industry Methods for Producing...'?",
"reference": "Persons , Survey of Industry Methods for Producing Highly Reliable Software , NUREG/CR-6278, U.S. Nuclear Regulatory Commission, 1994.",
"options": {
"A": "U.S. Nuclear Regulatory Commission",
"B": "the Nuclear Industry",
"C": "NUREG",
"D": "Software Project Management Standards"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Persons , Survey of Industry Methods for Producing...'?",
"reference": "Persons , Survey of Industry Methods for Producing Highly Reliable Software , NUREG/CR-6278, U.S. Nuclear Regulatory Commission, 1994.",
"options": {
"B": "1994",
"A": "1987",
"C": "1995",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Persons , Survey of Industry Methods for Producing Highly Reliable Software , NUREG/CR-6278, U.S. Nuclear Regulatory Commission, ____.",
"reference": "Persons , Survey of Industry Methods for Producing Highly Reliable Software , NUREG/CR-6278, U.S. Nuclear Regulatory Commission, 1994.",
"options": {
"B": "1994",
"A": "1987",
"C": "1995",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Persons , Survey of Industry Methods for Producing...'?",
"reference": "Persons , Survey of Industry Methods for Producing Highly Reliable Software , NUREG/CR-6278, U.S. Nuclear Regulatory Commission, 1994.",
"options": {
"D": "NUREG",
"A": "the Nuclear Industry",
"B": "U.S. Nuclear Regulatory Commission",
"C": "1994"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-93, Software Validatio...'?",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"D": "Software Validation",
"A": "the Nuclear Industry",
"B": "NUREG",
"C": "U.S. Nuclear Regulatory Commission"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-93, Software Validatio...'?",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"A": "Testing Technique",
"B": "U.S. Nuclear Regulatory Commission",
"C": "500",
"D": "Software Validation"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-93, Software Validatio...'?",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"C": "Institute for Computer Sciences and Technology",
"A": "the Nuclear Industry",
"B": "NUREG",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-93, Software Validatio...'?",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"C": "National Bureau of Standards",
"A": "the Nuclear Industry",
"B": "NUREG",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-93, Software Validatio...'?",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"C": "U.S. Department of Commerce",
"A": "the Nuclear Industry",
"B": "NUREG",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'NBS Special Publication 500-93, Software Validatio...'?",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"B": "September 1982",
"A": "1987",
"C": "1995",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: NBS Special Publication ____-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"C": "500",
"A": "U.S. Nuclear Regulatory Commission",
"B": "five hundred",
"D": "Software Validation"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: NBS Special Publication 500-____, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"A": "93",
"B": "500",
"C": "U.S. Nuclear Regulatory Commission",
"D": "xciii"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September ____.",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"B": "1982",
"A": "1987",
"C": "1995",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'H. Hecht, et.al., Verification and Validation Guid...'?",
"reference": "H. Hecht, et.al., Verification and Validation Guidelines for High Integrity Systems .",
"options": {
"D": "H. Hecht",
"A": "Review Guidelines",
"B": "J.D. Lawrence",
"C": "U.S. Nuclear Regulatory Commission"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'H. Hecht, et.al., Verification and Validation Guid...'?",
"reference": "H. Hecht, et.al., Verification and Validation Guidelines for High Integrity Systems .",
"options": {
"D": "H. Hecht",
"A": "Review Guidelines",
"B": "J.D. Lawrence",
"C": "U.S. Nuclear Regulatory Commission"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'H. Hecht, et.al., Verification and Validation Guid...'?",
"reference": "H. Hecht, et.al., Verification and Validation Guidelines for High Integrity Systems .",
"options": {
"C": "Verification and Validation Guidelines for High Integrity Systems",
"A": "U.S. Nuclear Regulatory Commission",
"B": "H. Hecht",
"D": "This information is not provided in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Delores R. Wallace, Roger U. Fujii, NIST Special P...'?",
"reference": "Delores R. Wallace, Roger U. Fujii, NIST Special Publication 500-165, Software Verification and Validation: Its Role in Computer Assurance and Its Relationship with Software Project Management Standards , National Computer Systems Laboratory, National Institute of Standards and Technology, U.S. Department of Commerce, September 1995.",
"options": {
"D": "Delores R. Wallace",
"A": "H. Hecht",
"B": "U.S. Nuclear Regulatory Commission",
"C": "Roger U. Fujii"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Delores R. Wallace, Roger U. Fujii, NIST Special P...'?",
"reference": "Delores R. Wallace, Roger U. Fujii, NIST Special Publication 500-165, Software Verification and Validation: Its Role in Computer Assurance and Its Relationship with Software Project Management Standards , National Computer Systems Laboratory, National Institute of Standards and Technology, U.S. Department of Commerce, September 1995.",
"options": {
"A": "Roger U. Fujii",
"B": "H. Hecht",
"C": "U.S. Nuclear Regulatory Commission",
"D": "Delores R. Wallace"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Delores R. Wallace, Roger U. Fujii, NIST Special P...'?",
"reference": "Delores R. Wallace, Roger U. Fujii, NIST Special Publication 500-165, Software Verification and Validation: Its Role in Computer Assurance and Its Relationship with Software Project Management Standards , National Computer Systems Laboratory, National Institute of Standards and Technology, U.S. Department of Commerce, September 1995.",
"options": {
"A": "Software Verification and Validation",
"B": "the Nuclear Industry",
"C": "NUREG",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Delores R. Wallace, Roger U. Fujii, NIST Special P...'?",
"reference": "Delores R. Wallace, Roger U. Fujii, NIST Special Publication 500-165, Software Verification and Validation: Its Role in Computer Assurance and Its Relationship with Software Project Management Standards , National Computer Systems Laboratory, National Institute of Standards and Technology, U.S. Department of Commerce, September 1995.",
"options": {
"C": "National Computer Systems Laboratory",
"A": "the Nuclear Industry",
"B": "NUREG",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Delores R. Wallace, Roger U. Fujii, NIST Special P...'?",
"reference": "Delores R. Wallace, Roger U. Fujii, NIST Special Publication 500-165, Software Verification and Validation: Its Role in Computer Assurance and Its Relationship with Software Project Management Standards , National Computer Systems Laboratory, National Institute of Standards and Technology, U.S. Department of Commerce, September 1995.",
"options": {
"D": "National Institute of Standards and Technology",
"A": "the Nuclear Industry",
"B": "NUREG",
"C": "U.S. Nuclear Regulatory Commission"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Delores R. Wallace, Roger U. Fujii, NIST Special P...'?",
"reference": "Delores R. Wallace, Roger U. Fujii, NIST Special Publication 500-165, Software Verification and Validation: Its Role in Computer Assurance and Its Relationship with Software Project Management Standards , National Computer Systems Laboratory, National Institute of Standards and Technology, U.S. Department of Commerce, September 1995.",
"options": {
"B": "U.S. Department of Commerce",
"A": "the Nuclear Industry",
"C": "NUREG",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Delores R. Wallace, Roger U. Fujii, NIST Special P...'?",
"reference": "Delores R. Wallace, Roger U. Fujii, NIST Special Publication 500-165, Software Verification and Validation: Its Role in Computer Assurance and Its Relationship with Software Project Management Standards , National Computer Systems Laboratory, National Institute of Standards and Technology, U.S. Department of Commerce, September 1995.",
"options": {
"A": "September 1995",
"B": "1987",
"C": "1995",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Delores R. Wallace, Roger U. Fujii, NIST Special Publication ____-165, Software Verification and Validation: Its Role in Computer Assurance and Its Relationship with Software Project Management Standards , National Computer Systems Laboratory, National Institute of Standards and Technology, U.S. Department of Commerce, September 1995.",
"reference": "Delores R. Wallace, Roger U. Fujii, NIST Special Publication 500-165, Software Verification and Validation: Its Role in Computer Assurance and Its Relationship with Software Project Management Standards , National Computer Systems Laboratory, National Institute of Standards and Technology, U.S. Department of Commerce, September 1995.",
"options": {
"C": "500",
"A": "U.S. Nuclear Regulatory Commission",
"B": "five hundred",
"D": "Delores R. Wallace"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-93, Software Validatio...'?",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"A": "Software Validation",
"B": "the Nuclear Industry",
"C": "NUREG",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-93, Software Validatio...'?",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"B": "Testing Technique",
"A": "U.S. Nuclear Regulatory Commission",
"C": "500",
"D": "Software Validation"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-93, Software Validatio...'?",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"B": "Institute for Computer Sciences and Technology",
"A": "the Nuclear Industry",
"C": "NUREG",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-93, Software Validatio...'?",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"B": "National Bureau of Standards",
"A": "the Nuclear Industry",
"C": "NUREG",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-93, Software Validatio...'?",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"D": "U.S. Department of Commerce",
"A": "the Nuclear Industry",
"B": "NUREG",
"C": "U.S. Nuclear Regulatory Commission"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'NBS Special Publication 500-93, Software Validatio...'?",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"B": "September 1982",
"A": "1987",
"C": "1995",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: NBS Special Publication ____-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"D": "500",
"A": "U.S. Nuclear Regulatory Commission",
"B": "five hundred",
"C": "Software Validation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: NBS Special Publication 500-____, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"D": "93",
"A": "500",
"B": "U.S. Nuclear Regulatory Commission",
"C": "xciii"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September ____.",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"A": "1982",
"B": "1987",
"C": "1995",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Preckshot, Design Factors for Safety-Critical Soft...'?",
"reference": "Preckshot, Design Factors for Safety-Critical Software , NUREG/CR-6294, U.S. Nuclear Regulatory Commission, 1994.",
"options": {
"B": "Preckshot, Design Factors for Safety-Critical Software",
"A": "the Nuclear Industry",
"C": "NUREG",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 50 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
ISBN 0-471-01009-X. Tom Gilb, Dorothy Graham, Software Inspection , Addison-Wesley Publishing Company, 1993. ISBN 0-201-63181-4. Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992. ISBN 0-13-720384-5. Les Hatton, Safer C: Developing Software for High-integrity and Safety-critical Systems, McGraw-Hill Book Company, 1994. ISBN 0-07-707640-0. Janis V. Halvorsen, A Software Requirements Specification Document Model for the Medical Device Industry , Proceedings IEEE SOUTHEASTCON '93, Banking on Technology, April 4th
-7th, 1993, Charlotte, North Carolina. Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999. ISBN 0-7695-0299-7. Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988. ISBN 0-471-56567-9. Watts S. Humphrey, A Discipline for Software Engineering . Addison-Wesley Longman, 1995. ISBN 0-201-54610-8. Watts S. Humphrey, Managing the Software Process , Addison-Wesley Publishing Company, 1989. ISBN 0-201-18095-2. Capers Jones, Software Quality, Analysis and Guidelines for Success , International Thomson Computer Press, 1997. ISBN 1-85032-867-6. Page 41General Principles of Software Validation Guidance for Industry and FDA Staff J.M. Juran, Frank M. Gryna, Quality Planning and Analysis , Third Edition, , McGraw-Hill, 1993. ISBN 0-07-033183-9. Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, 1995. ISBN 0-201-63339-6. Cem Kaner, Jack Falk, Hung Quoc Nguyen, Testing Computer Software , Second Edition, Vsn Nostrand Reinhold, 1993. ISBN 0-442-01361-2. Craig Kaplan, Ralph Clark, Victor Tang, Secrets of Software Quality, 40 Innovations from IBM , McGraw-Hill, 1995. ISBN 0-07-911795-3. Edward Kit, Software Testing in the Real World , Addison-Wesley Longman, 1995. ISBN 0-201- 87756-2.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Who is mentioned in the context: 'Stephen H. Kan, Metrics and Models in Software Qua...'?",
"reference": "Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, 1995.",
"options": {
"A": "Stephen H. Kan",
"B": "X. Tom Gilb",
"C": "Dorothy Graham",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Stephen H. Kan, Metrics and Models in Software Qua...'?",
"reference": "Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, 1995.",
"options": {
"D": "Models",
"A": "Software Quality Engineering",
"B": "Testing Computer Software",
"C": "pattern"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Stephen H. Kan, Metrics and Models in Software Qua...'?",
"reference": "Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, 1995.",
"options": {
"A": "Quality Engineering",
"B": "Software Inspection",
"C": "Addison-Wesley Publishing Company",
"D": "Testing Computer Software"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Stephen H. Kan, Metrics and Models in Software Qua...'?",
"reference": "Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, 1995.",
"options": {
"B": "Addison-Wesley Publishing Company",
"A": "Software Inspection",
"C": "Practical Software Metrics",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Stephen H. Kan, Metrics and Models in Software Qua...'?",
"reference": "Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, 1995.",
"options": {
"A": "1995",
"B": "1993",
"C": "1992",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, ____.",
"reference": "Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, 1995.",
"options": {
"D": "1995",
"A": "1993",
"B": "1992",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Robert B. Grady, Practical Software Metrics for Pr...'?",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"D": "Robert B. Grady",
"A": "X. Tom Gilb",
"B": "Dorothy Graham",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robert B. Grady, Practical Software Metrics for Pr...'?",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"B": "Practical Software Metrics",
"A": "Software Inspection",
"C": "Addison-Wesley Publishing Company",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robert B. Grady, Practical Software Metrics for Pr...'?",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"A": "Project Management and Process Improvement",
"B": "Software Inspection",
"C": "Addison-Wesley Publishing Company",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robert B. Grady, Practical Software Metrics for Pr...'?",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"D": "Prentice-Hall Inc.",
"A": "Software Inspection",
"B": "Addison-Wesley Publishing Company",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Robert B. Grady, Practical Software Metrics for Pr...'?",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"A": "1992",
"B": "1993",
"C": "1994",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., ____.",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"B": "1992",
"A": "1993",
"C": "1994",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Robert B. Grady, Practical Software Metrics for Pr...'?",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"A": "Robert B. Grady",
"B": "X. Tom Gilb",
"C": "Dorothy Graham",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robert B. Grady, Practical Software Metrics for Pr...'?",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"D": "Practical Software Metrics",
"A": "Software Inspection",
"B": "Addison-Wesley Publishing Company",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robert B. Grady, Practical Software Metrics for Pr...'?",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"B": "Project Management and Process Improvement",
"A": "Software Inspection",
"C": "Addison-Wesley Publishing Company",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robert B. Grady, Practical Software Metrics for Pr...'?",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"B": "Prentice-Hall Inc.",
"A": "Software Inspection",
"C": "Addison-Wesley Publishing Company",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Robert B. Grady, Practical Software Metrics for Pr...'?",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"D": "1992",
"A": "1993",
"B": "1994",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., ____.",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"A": "1992",
"B": "1993",
"C": "1994",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Robert B. Grady, Practical Software Metrics for Pr...'?",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"D": "Robert B. Grady",
"A": "X. Tom Gilb",
"B": "Dorothy Graham",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robert B. Grady, Practical Software Metrics for Pr...'?",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"B": "Practical Software Metrics",
"A": "Software Inspection",
"C": "Addison-Wesley Publishing Company",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robert B. Grady, Practical Software Metrics for Pr...'?",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"D": "Project Management and Process Improvement",
"A": "Software Inspection",
"B": "Addison-Wesley Publishing Company",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robert B. Grady, Practical Software Metrics for Pr...'?",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"D": "Prentice-Hall Inc.",
"A": "Software Inspection",
"B": "Addison-Wesley Publishing Company",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Robert B. Grady, Practical Software Metrics for Pr...'?",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"C": "1992",
"A": "1993",
"B": "1994",
"D": "Software Quality Engineering"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., ____.",
"reference": "Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992.",
"options": {
"D": "1992",
"A": "1993",
"B": "1994",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Stephen H. Kan, Metrics and Models in Software Qua...'?",
"reference": "Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, 1995.",
"options": {
"D": "Stephen H. Kan",
"A": "X. Tom Gilb",
"B": "Dorothy Graham",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Stephen H. Kan, Metrics and Models in Software Qua...'?",
"reference": "Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, 1995.",
"options": {
"D": "Models",
"A": "Software Quality Engineering",
"B": "Testing Computer Software",
"C": "pattern"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Stephen H. Kan, Metrics and Models in Software Qua...'?",
"reference": "Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, 1995.",
"options": {
"B": "Quality Engineering",
"A": "Software Inspection",
"C": "Addison-Wesley Publishing Company",
"D": "Testing Computer Software"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Stephen H. Kan, Metrics and Models in Software Qua...'?",
"reference": "Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, 1995.",
"options": {
"C": "Addison-Wesley Publishing Company",
"A": "Software Inspection",
"B": "Practical Software Metrics",
"D": "Software Quality Engineering"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Stephen H. Kan, Metrics and Models in Software Qua...'?",
"reference": "Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, 1995.",
"options": {
"B": "1995",
"A": "1993",
"C": "1992",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, ____.",
"reference": "Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, 1995.",
"options": {
"C": "1995",
"A": "1993",
"B": "1992",
"D": "Software Quality Engineering"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Tom Gilb, Dorothy Graham, Software Inspection , Ad...'?",
"reference": "Tom Gilb, Dorothy Graham, Software Inspection , Addison-Wesley Publishing Company, 1993.",
"options": {
"D": "Tom Gilb",
"A": "X. Tom Gilb",
"B": "Dorothy Graham",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Tom Gilb, Dorothy Graham, Software Inspection , Ad...'?",
"reference": "Tom Gilb, Dorothy Graham, Software Inspection , Addison-Wesley Publishing Company, 1993.",
"options": {
"B": "Dorothy Graham",
"A": "X. Tom Gilb",
"C": "Robert B. Grady",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Tom Gilb, Dorothy Graham, Software Inspection , Ad...'?",
"reference": "Tom Gilb, Dorothy Graham, Software Inspection , Addison-Wesley Publishing Company, 1993.",
"options": {
"C": "Software Inspection",
"A": "Software Quality Engineering",
"B": "Testing Computer Software",
"D": "Tom Gilb"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Tom Gilb, Dorothy Graham, Software Inspection , Ad...'?",
"reference": "Tom Gilb, Dorothy Graham, Software Inspection , Addison-Wesley Publishing Company, 1993.",
"options": {
"A": "Addison-Wesley Publishing Company",
"B": "Software Inspection",
"C": "Practical Software Metrics",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Tom Gilb, Dorothy Graham, Software Inspection , Ad...'?",
"reference": "Tom Gilb, Dorothy Graham, Software Inspection , Addison-Wesley Publishing Company, 1993.",
"options": {
"C": "1993",
"A": "1992",
"B": "1994",
"D": "Software Quality Engineering"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Tom Gilb, Dorothy Graham, Software Inspection , Addison-Wesley Publishing Company, ____.",
"reference": "Tom Gilb, Dorothy Graham, Software Inspection , Addison-Wesley Publishing Company, 1993.",
"options": {
"D": "1993",
"A": "1992",
"B": "1994",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Bill Hetzel, The Complete Guide to Software Testin...'?",
"reference": "Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"options": {
"B": "Bill Hetzel",
"A": "X. Tom Gilb",
"C": "Dorothy Graham",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 41General Principles of Software Validation G...'?",
"reference": "Page 41General Principles of Software Validation Guidance for Industry and FDA Staff J.M.",
"options": {
"C": "FDA",
"A": "Software Inspection",
"B": "Addison-Wesley Publishing Company",
"D": "Software Quality Engineering"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Page 41General Principles of Software Validation G...'?",
"reference": "Page 41General Principles of Software Validation Guidance for Industry and FDA Staff J.M.",
"options": {
"B": "J.M.",
"A": "X. Tom Gilb",
"C": "Dorothy Graham",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Bill Hetzel, The Complete Guide to Software Testin...'?",
"reference": "Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"options": {
"D": "Bill Hetzel",
"A": "X. Tom Gilb",
"B": "Dorothy Graham",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Bill Hetzel, The Complete Guide to Software Testin...'?",
"reference": "Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"options": {
"A": "The Complete Guide to Software Testing",
"B": "Software Inspection",
"C": "Addison-Wesley Publishing Company",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Bill Hetzel, The Complete Guide to Software Testin...'?",
"reference": "Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"options": {
"A": "Wiley-QED Publication",
"B": "Software Inspection",
"C": "Addison-Wesley Publishing Company",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Bill Hetzel, The Complete Guide to Software Testin...'?",
"reference": "Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"options": {
"B": "John Wiley Sons",
"A": "X. Tom Gilb",
"C": "Dorothy Graham",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Bill Hetzel, The Complete Guide to Software Testin...'?",
"reference": "Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"options": {
"B": "1988",
"A": "1993",
"C": "1992",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Bill Hetzel, The Complete Guide to Software Testing , ____ Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"reference": "Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"options": {
"A": "Second",
"B": "Software Quality Engineering",
"C": "Testing Computer Software",
"D": "secondly"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., ____.",
"reference": "Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"options": {
"C": "1988",
"A": "1993",
"B": "1992",
"D": "Software Quality Engineering"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Cem Kaner, Jack Falk, Hung Quoc Nguyen, Testing Co...'?",
"reference": "Cem Kaner, Jack Falk, Hung Quoc Nguyen, Testing Computer Software , Second Edition, Vsn Nostrand Reinhold, 1993.",
"options": {
"A": "Cem Kaner",
"B": "X. Tom Gilb",
"C": "Dorothy Graham",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Cem Kaner, Jack Falk, Hung Quoc Nguyen, Testing Co...'?",
"reference": "Cem Kaner, Jack Falk, Hung Quoc Nguyen, Testing Computer Software , Second Edition, Vsn Nostrand Reinhold, 1993.",
"options": {
"C": "Jack Falk",
"A": "X. Tom Gilb",
"B": "Dorothy Graham",
"D": "Software Quality Engineering"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Cem Kaner, Jack Falk, Hung Quoc Nguyen, Testing Co...'?",
"reference": "Cem Kaner, Jack Falk, Hung Quoc Nguyen, Testing Computer Software , Second Edition, Vsn Nostrand Reinhold, 1993.",
"options": {
"D": "Vsn Nostrand Reinhold",
"A": "X. Tom Gilb",
"B": "Dorothy Graham",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Cem Kaner, Jack Falk, Hung Quoc Nguyen, Testing Co...'?",
"reference": "Cem Kaner, Jack Falk, Hung Quoc Nguyen, Testing Computer Software , Second Edition, Vsn Nostrand Reinhold, 1993.",
"options": {
"B": "1993",
"A": "1992",
"C": "1994",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Process Performance and Product Quality Monitoring System 3.2.1 Pharmaceutical companies should plan and exec ute a system for the monitoring of process performance and product quality to ensure a st ate of control is maintained. An effective monitoring system provides assurance of the cont inued capability of processes and controls to produce a product of desired quality and to id entify areas for continual improvement. The process performance and product qual ity monitoring system should: 9 (a) Use quality risk management to establish the control strategy. This can include parameters and attributes related to dr ug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control. The control strate gy should facilitate timely feedback/feedforward and appropriate corrective acti on and preventive action. (b) Provide the tools for measurement and analysis of parameters and attributes identified in the control strategy (e.g., data ma nagement and statistical tools). (c) Analyze parameters and attributes identified in the control strategy to verify continued operation within a state of control. (d) Identify sources of variation affecting pr ocess performance and product quality for potential continual improvement activit ies to reduce or control variation. (e) Include feedback on product quality from both internal and external sources (e.g., complaints, product rejections, nonconformances, recalls, deviations, audits and regulatory inspections, and findings). (f) Provide knowledge to enhance pr ocess understanding, enrich the design space (where established), and enable innovative a pproaches to process validation.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: Process Performance and Product Quality Monitoring System ____ Pharmaceutical companies should plan and exec ute a system for the monitoring of process performance and product quality to ensure a st ate of control is maintained.",
"reference": "Process Performance and Product Quality Monitoring System 3.2.1 Pharmaceutical companies should plan and exec ute a system for the monitoring of process performance and product quality to ensure a st ate of control is maintained.",
"options": {
"C": "3.2.1",
"A": "Product Quality Monitoring System",
"B": "product qual ity monitoring system",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The process performance and product qual ity monitoring system should: ____ (a) Use quality risk management to establish the control strategy.",
"reference": "The process performance and product qual ity monitoring system should: 9 (a) Use quality risk management to establish the control strategy.",
"options": {
"A": "9",
"B": "Product Quality Monitoring System",
"C": "product qual ity monitoring system",
"D": "nine"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The process performance and product qual ity monitoring system should: ____ (a) Use quality risk management to establish the control strategy.",
"reference": "The process performance and product qual ity monitoring system should: 9 (a) Use quality risk management to establish the control strategy.",
"options": {
"B": "9",
"A": "Product Quality Monitoring System",
"C": "product qual ity monitoring system",
"D": "nine"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The process performance and product qual ity monitoring system should: ____ (a) Use quality risk management to establish the control strategy.",
"reference": "The process performance and product qual ity monitoring system should: 9 (a) Use quality risk management to establish the control strategy.",
"options": {
"C": "9",
"A": "Product Quality Monitoring System",
"B": "product qual ity monitoring system",
"D": "nine"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The process performance and product qual ity monitoring system should: ____ (a) Use quality risk management to establish the control strategy.",
"reference": "The process performance and product qual ity monitoring system should: 9 (a) Use quality risk management to establish the control strategy.",
"options": {
"A": "9",
"B": "Product Quality Monitoring System",
"C": "product qual ity monitoring system",
"D": "nine"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The process performance and product qual ity monitoring system should: ____ (a) Use quality risk management to establish the control strategy.",
"reference": "The process performance and product qual ity monitoring system should: 9 (a) Use quality risk management to establish the control strategy.",
"options": {
"D": "9",
"A": "Product Quality Monitoring System",
"B": "product qual ity monitoring system",
"C": "nine"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The process performance and product qual ity monitoring system should: ____ (a) Use quality risk management to establish the control strategy.",
"reference": "The process performance and product qual ity monitoring system should: 9 (a) Use quality risk management to establish the control strategy.",
"options": {
"D": "9",
"A": "Product Quality Monitoring System",
"B": "product qual ity monitoring system",
"C": "nine"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 50 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Firms should implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models. 3 Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product. Managements involvement 1
This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration. 2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. We update guidances periodic ally. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm . 3 See ICH guidance for industry Q9 Quality Risk Management . Contains Nonbinding Recommendations 2 in and influence on these strategies is essential in preventing and correcting conditions that can lead to data integrity problems. It is the role of management with executive responsibility to create a quality culture where employees understand that data integrity i s an organizational core value and employees are encoura ged to identify and promptly report data integrity issues. In the absence of management support of a quality culture, quality systems can break down and lead to CGMP noncompliance. In general, FDA s guidance documents do not establish legally enforceable responsibilities. Instead , guidances describe the Agency s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"B": "FDA Drugs",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"D": "RegulatoryInformation/Guidances",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Instead , guidances describe the Agency s current ...'?",
"reference": "Instead , guidances describe the Agency s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.",
"options": {
"B": "Agency",
"A": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "government agency"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '3 See ICH guidance for industry Q9 Quality Risk Ma...'?",
"reference": "3 See ICH guidance for industry Q9 Quality Risk Management .",
"options": {
"A": "Q9 Quality Risk Management",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "the FDA Drugs guidance web page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ See ICH guidance for industry Q9 Quality Risk Management .",
"reference": "3 See ICH guidance for industry Q9 Quality Risk Management .",
"options": {
"A": "3",
"B": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "troika"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"A": "the International Council for Harmonisation (ICH",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"D": "Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"B": "2",
"A": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "two"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the absence of management support of a quality ...'?",
"reference": "In the absence of management support of a quality culture, quality systems can break down and lead to CGMP noncompliance.",
"options": {
"D": "CGMP",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '3 See ICH guidance for industry Q9 Quality Risk Ma...'?",
"reference": "3 See ICH guidance for industry Q9 Quality Risk Management .",
"options": {
"A": "Q9 Quality Risk Management",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "the FDA Drugs guidance web page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ See ICH guidance for industry Q9 Quality Risk Management .",
"reference": "3 See ICH guidance for industry Q9 Quality Risk Management .",
"options": {
"A": "3",
"B": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "troika"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the absence of management support of a quality ...'?",
"reference": "In the absence of management support of a quality culture, quality systems can break down and lead to CGMP noncompliance.",
"options": {
"A": "CGMP",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Office of Pharmaceutical Quality",
"A": "the Office of Compliance",
"B": "the Center for Drug Evaluation and Research",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Office of Pharmaceutical Quality",
"A": "the Office of Compliance",
"B": "the Center for Drug Evaluation and Research",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"A": "the Office of Compliance",
"B": "the Office of Pharmaceutical Quality",
"C": "the Center for Drug Evaluation and Research",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"A": "the Center for Drug Evaluation and Research",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"A": "the Center for Biologics Evaluation and Research",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Center for Veterinary Medicine",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Office of Regulatory Affairs",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Food and Drug Administration",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Managements involvement ____\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "1",
"A": "industry Q9 Quality Risk Management",
"B": "the FDA Drugs guidance web page",
"D": "ace"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Office of Pharmaceutical Quality",
"A": "the Office of Compliance",
"B": "the Center for Drug Evaluation and Research",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"B": "the Office of Compliance",
"A": "the Office of Pharmaceutical Quality",
"C": "the Center for Drug Evaluation and Research",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Center for Drug Evaluation and Research",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Center for Biologics Evaluation and Research",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the absence of management support of a quality ...'?",
"reference": "In the absence of management support of a quality culture, quality systems can break down and lead to CGMP noncompliance.",
"options": {
"A": "CGMP",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the absence of management support of a quality ...'?",
"reference": "In the absence of management support of a quality culture, quality systems can break down and lead to CGMP noncompliance.",
"options": {
"C": "CGMP",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"B": "the Office of Pharmaceutical Quality",
"A": "the Office of Compliance",
"C": "the Center for Drug Evaluation and Research",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Office of Compliance",
"A": "the Office of Pharmaceutical Quality",
"B": "the Center for Drug Evaluation and Research",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Center for Drug Evaluation and Research",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Center for Biologics Evaluation and Research",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"B": "the Center for Veterinary Medicine",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Office of Regulatory Affairs",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"A": "the Food and Drug Administration",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Managements involvement ____\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"A": "1",
"B": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "ace"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Instead , guidances describe the Agency s current ...'?",
"reference": "Instead , guidances describe the Agency s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.",
"options": {
"A": "Agency",
"B": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "government agency"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"C": "the International Council for Harmonisation (ICH",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"A": "Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ in and influence on these strategies is essential in preventing and correcting conditions that can lead to data integrity problems.",
"reference": "Contains Nonbinding Recommendations 2 in and influence on these strategies is essential in preventing and correcting conditions that can lead to data integrity problems.",
"options": {
"C": "2",
"A": "industry Q9 Quality Risk Management",
"B": "the FDA Drugs guidance web page",
"D": "two"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Office of Pharmaceutical Quality",
"A": "the Office of Compliance",
"B": "the Center for Drug Evaluation and Research",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"A": "the Office of Compliance",
"B": "the Office of Pharmaceutical Quality",
"C": "the Center for Drug Evaluation and Research",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"A": "the Center for Drug Evaluation and Research",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Center for Biologics Evaluation and Research",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Center for Veterinary Medicine",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"A": "the Office of Regulatory Affairs",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Food and Drug Administration",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Managements involvement ____\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "1",
"A": "industry Q9 Quality Risk Management",
"B": "the FDA Drugs guidance web page",
"D": "ace"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Office of Pharmaceutical Quality",
"A": "the Office of Compliance",
"B": "the Center for Drug Evaluation and Research",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"B": "the Office of Compliance",
"A": "the Office of Pharmaceutical Quality",
"C": "the Center for Drug Evaluation and Research",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Center for Drug Evaluation and Research",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 4 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
The QS working group mapped the relationship between CGMP regulations (parts 210 and 211 and the 1978 Preamble to the CGMP regulations 2) and various quality system models, such as the Drug Manufact uring Inspections Program (i.e., systems-based inspectional program),3
the Environmental Protection Agency's Guidance for Developing Quality Systems for Environmental Programs, ISO Quality Standards, other quality publications, and experience from regulatory cases. The QS working group determined that, although the CGMP regulations do provide great flexibility, they do not incorporate explicitly all of the elements that today constitute most quality management systems. The CGMP regulations and other quality management systems differ somewhat in organization and in certain constituent elements; however, they are very similar and share underlying principles. For example, the CGMP regulations stress quality control. More recently developed quality systems stress quality management, quality assurance , and the use of risk management tools, in addition to quality contro
l. The QS working group decided that it would be very useful to examine exactly how the CGMP regulations and the elements of a modern, comprehensive quality system fit together in today's manufactur ing world. This guidance is the result of that examination. B. Goal of the Guidance This guidance describes a compre hensive quality systems model, which, if im plemented, will allow manufacturers to support and sustain robust, modern quality systems that are consistent with CGMP regulations. The guidance dem onstrates how and where the elements of this comprehensive model can fit within the requireme nts of the CGMP regulations. The inherent flexibility of the CGMP regulations should enab le manufacturers to implement a quality system in a form that is appropriate for their specific operations.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'The QS working group mapped the relationship betwe...'?",
"reference": "The QS working group mapped the relationship between CGMP regulations (parts 210 and 211 and the 1978 Preamble to the CGMP regulations 2) and various quality system models, such as the Drug Manufact uring Inspections Program (i.e., systems-based inspectional program),3\nthe Environmental Protection Agency's Guidance for Developing Quality Systems for Environmental Programs, ISO Quality Standards, other quality publications, and experience from regulatory cases.",
"options": {
"B": "QS",
"A": "CGMP",
"C": "most quality management systems",
"D": "other quality management systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The QS working group mapped the relationship betwe...'?",
"reference": "The QS working group mapped the relationship between CGMP regulations (parts 210 and 211 and the 1978 Preamble to the CGMP regulations 2) and various quality system models, such as the Drug Manufact uring Inspections Program (i.e., systems-based inspectional program),3\nthe Environmental Protection Agency's Guidance for Developing Quality Systems for Environmental Programs, ISO Quality Standards, other quality publications, and experience from regulatory cases.",
"options": {
"A": "CGMP",
"B": "the Drug Manufact uring Inspections Program",
"C": "the Environmental Protection Agency's",
"D": "most quality management systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The QS working group mapped the relationship betwe...'?",
"reference": "The QS working group mapped the relationship between CGMP regulations (parts 210 and 211 and the 1978 Preamble to the CGMP regulations 2) and various quality system models, such as the Drug Manufact uring Inspections Program (i.e., systems-based inspectional program),3\nthe Environmental Protection Agency's Guidance for Developing Quality Systems for Environmental Programs, ISO Quality Standards, other quality publications, and experience from regulatory cases.",
"options": {
"B": "CGMP",
"A": "the Drug Manufact uring Inspections Program",
"C": "the Environmental Protection Agency's",
"D": "most quality management systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The QS working group mapped the relationship betwe...'?",
"reference": "The QS working group mapped the relationship between CGMP regulations (parts 210 and 211 and the 1978 Preamble to the CGMP regulations 2) and various quality system models, such as the Drug Manufact uring Inspections Program (i.e., systems-based inspectional program),3\nthe Environmental Protection Agency's Guidance for Developing Quality Systems for Environmental Programs, ISO Quality Standards, other quality publications, and experience from regulatory cases.",
"options": {
"C": "the Drug Manufact uring Inspections Program",
"A": "CGMP",
"B": "most quality management systems",
"D": "other quality management systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
GLOSSARY (5) ...............................................................................................................
Annex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic. It does not create or confer any rights for or on any pe rson and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alterna tive approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. INTRODUCTION (1, 1.1)2
This internationally harmonized guidance is in tended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system . Throughout this guidance, the term pharmaceutical quality system refers to the ICH Q10 model. ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Who is mentioned in the context: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"B": "GLOSSARY",
"A": "Annex",
"C": "the ICH Q10 Ph armaceutical Quality System Model",
"D": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"C": "Annex",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"C": "the Food and Drug Administration'",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"A": "Q10 Pharmaceutical Quality System",
"B": "Risk-Based Regulatory Approaches",
"C": "the Food and Drug Administration'",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"C": "the Food and Drug Administration'",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (____) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"D": "5",
"A": "one",
"B": "the ICH Q10 Ph armaceutical Quality System Model",
"C": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... ____ Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"A": "18",
"B": "one",
"C": "the ICH Q10 Ph armaceutical Quality System Model",
"D": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex ____: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"C": "2",
"A": "one",
"B": "the ICH Q10 Ph armaceutical Quality System Model",
"D": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..____ i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"D": "19",
"A": "one",
"B": "the ICH Q10 Ph armaceutical Quality System Model",
"C": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION (____, 1.1)2\nThis internationally harmonized guidance is in tended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system .",
"reference": "INTRODUCTION (1, 1.1)2\nThis internationally harmonized guidance is in tended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system .",
"options": {
"C": "1",
"A": "one",
"B": "an effective pharmaceutical quality system",
"D": "the term pharmaceutical quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Much of the content of ICH Q10 applicable to manuf...'?",
"reference": "Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements.",
"options": {
"D": "GMP",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"C": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'If you cannot identify the appropriate FDA staff, ...'?",
"reference": "If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.",
"options": {
"B": "FDA",
"A": "Risk-Based Regulatory Approaches",
"C": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Much of the content of ICH Q10 applicable to manuf...'?",
"reference": "Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements.",
"options": {
"D": "GMP",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"C": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Much of the content of ICH Q10 applicable to manuf...'?",
"reference": "Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements.",
"options": {
"A": "GMP",
"B": "Risk-Based Regulatory Approaches",
"C": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It does not create or confer any rights for or on ...'?",
"reference": "It does not create or confer any rights for or on any pe rson and does not operate to bind FDA or the public.",
"options": {
"C": "FDA",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION (____, 1.1)2\nThis internationally harmonized guidance is in tended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system .",
"reference": "INTRODUCTION (1, 1.1)2\nThis internationally harmonized guidance is in tended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system .",
"options": {
"C": "1",
"A": "one",
"B": "an effective pharmaceutical quality system",
"D": "the term pharmaceutical quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"D": "GLOSSARY",
"A": "Annex",
"B": "the ICH Q10 Ph armaceutical Quality System Model",
"C": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"A": "Annex",
"B": "Risk-Based Regulatory Approaches",
"C": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"C": "Risk-Based Regulatory Approaches",
"A": "Q10 Pharmaceutical Quality System",
"B": "the Food and Drug Administration'",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"C": "Q10 Pharmaceutical Quality System",
"A": "Risk-Based Regulatory Approaches",
"B": "the Food and Drug Administration'",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"D": "the Food and Drug Administration'",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"C": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (____) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"D": "5",
"A": "one",
"B": "the ICH Q10 Ph armaceutical Quality System Model",
"C": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... ____ Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"A": "18",
"B": "one",
"C": "the ICH Q10 Ph armaceutical Quality System Model",
"D": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex ____: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"A": "2",
"B": "one",
"C": "the ICH Q10 Ph armaceutical Quality System Model",
"D": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..____ i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"C": "19",
"A": "one",
"B": "the ICH Q10 Ph armaceutical Quality System Model",
"D": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 2 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, September 1999. Guideline on General Principles of Process Validation , Center for Drugs and Biologics, Center For Devices and Radiological Health, Food and Drug Administration, May 1987. Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation , 61 Federal Register 52602 (October 7, 1996). Reviewer Guidance for a Pre-Market Notification Submission for Blood Establishment Computer Software , Center for Biologics Evaluation and Research, Food and Drug Administration, January 1997 Student Manual 1, Course INV545, Computer System Validation , Division of Human Resource Development, Office of Regulatory Affairs, Food and Drug Administration, 1997. Technical Report, Software Development Activities, Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, Food and Drug Administration, July 1987. Page 36General Principles of Software Validation Guidance for Industry and FDA Staff Other Government References W. Richards Adrion, Martha A. Branstad, John C. Cherniavsky. NBS Special Publication 500-75, Validation, Verification, and Testing of Computer Software, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1981. Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980. J.L. Bryant, N.P.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Guidance for Industry, FDA Reviewers and Complianc...'?",
"reference": "Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, September 1999.",
"options": {
"D": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"A": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"B": "Center For Devices and Radiological Health, Food and Drug Administration",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry, FDA Reviewers and Complianc...'?",
"reference": "Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, September 1999.",
"options": {
"C": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Center For Devices and Radiological Health, Food and Drug Administration",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 8 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record . 167 168 Both kinds of software are used as part of production or the quality system and must be 169 validated under 21 CFR 820.70(i). However , as further discussed below, supporting software 170 often carries lower risk, such that under a risk -based computer software assurance approach, the 171 effort of validation may be reduced accordingly without compromising safety . 172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations . 181 182 FDA recognizes that software used in production or the quality system is often complex and 183 comprised of several features, functions, and operations;5 software may have one or more 184 intended uses depending on the individual features, functions, and operat ions of that software.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "When did this occur: '172 173 On the other hand, software with the follo...'?",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"D": "21 175",
"A": "under 21",
"B": "a risk -based computer software assurance approach",
"C": "161 162 Software"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '172 173 On the other hand, software with the follo...'?",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"B": "Software",
"A": "FDA",
"C": "the quality 166 record",
"D": "the quality 164 system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '172 173 On the other hand, software with the follo...'?",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"C": "Software",
"A": "FDA",
"B": "the quality 166 record",
"D": "the quality 164 system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"D": "172",
"A": "158",
"B": "160",
"C": "a risk -based computer software assurance approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 172 ____ On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"B": "173",
"A": "158",
"C": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 172 173 On the other hand, software with the following intended uses generally are not considered to be ____ used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"B": "174",
"A": "158",
"C": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in ____ 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"B": "21",
"A": "158",
"C": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 ____ CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"A": "175",
"B": "158",
"C": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 5 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
They should identify the schedules, environments, resources (personnel, tools, etc. ), methodologies, cases (inputs, procedures, outputs, expected results), documentation, and reporting criteria. The magnitude of effort to be applied throughout the testing process can be linked to complexity, criticality, reliability, and/or safety issues (e.g., requiring functions or modules that produce critical outcomes to be challenged with intensive testing of their fault tolerance features). Descriptions of categories of software and software testing effort appear in the literature, for example:
NIST Special Publication 500-235, Structured Testing: A Testing Methodology Using the Cyclomatic Complexity Metric ; NUREG/CR-6293, Verification and Validation Guidelines for High Integrity Systems ; and IEEE Computer Society Press, Handbook of Software Reliability Engineering . Page 22General Principles of Software Validation Guidance for Industry and FDA Staff Software test plans should identify the particular tasks to be conducted at each stage of development and include justification of the level of effort represented by their corresponding completion criteria. Software testing has limitations that must be recognized and considered when planning the testing of a particular software product. Except for the simplest of programs, software cannot be exhaustively tested. Generally it is not feasible to test a software product with all possible inputs, nor is it possible to test all possible data processing paths that can occur during program execution. There is no one type of testing or testing methodology that can ensure a particular software product has been thoroughly tested. Testing of all program functionality does not mean all of the program has been tested. Testing of all of a program's code does not mean all necessary functionality is present in the program. Testing of all program functionality and all program code does not mean the program is 100 correct!
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Page 22General Principles of Software Validation G...'?",
"reference": "Page 22General Principles of Software Validation Guidance for Industry and FDA Staff Software test plans should identify the particular tasks to be conducted at each stage of development and include justification of the level of effort represented by their corresponding completion criteria.",
"options": {
"C": "FDA",
"A": "the Cyclomatic Complexity Metric",
"B": "NUREG",
"D": "software and software testing effort"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 22General Principles of Software Validation G...'?",
"reference": "Page 22General Principles of Software Validation Guidance for Industry and FDA Staff Software test plans should identify the particular tasks to be conducted at each stage of development and include justification of the level of effort represented by their corresponding completion criteria.",
"options": {
"A": "Software",
"B": "the Cyclomatic Complexity Metric",
"C": "NUREG",
"D": "A Testing Methodology"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software testing has limitations that must be reco...'?",
"reference": "Software testing has limitations that must be recognized and considered when planning the testing of a particular software product.",
"options": {
"D": "Software",
"A": "the Cyclomatic Complexity Metric",
"B": "NUREG",
"C": "A Testing Methodology"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Descriptions of categories of software and softwar...'?",
"reference": "Descriptions of categories of software and software testing effort appear in the literature, for example:\nNIST Special Publication 500-235, Structured Testing: A Testing Methodology Using the Cyclomatic Complexity Metric ; NUREG/CR-6293, Verification and Validation Guidelines for High Integrity Systems ; and IEEE Computer Society Press, Handbook of Software Reliability Engineering .",
"options": {
"A": "the Cyclomatic Complexity Metric",
"B": "NUREG",
"C": "Verification and Validation Guidelines for High Integrity Systems",
"D": "software and software testing effort"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Descriptions of categories of software and softwar...'?",
"reference": "Descriptions of categories of software and software testing effort appear in the literature, for example:\nNIST Special Publication 500-235, Structured Testing: A Testing Methodology Using the Cyclomatic Complexity Metric ; NUREG/CR-6293, Verification and Validation Guidelines for High Integrity Systems ; and IEEE Computer Society Press, Handbook of Software Reliability Engineering .",
"options": {
"D": "NUREG",
"A": "the Cyclomatic Complexity Metric",
"B": "Verification and Validation Guidelines for High Integrity Systems",
"C": "software and software testing effort"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 8 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
See the references in Appendix A for applicable FDA guidance documents for pre-market submissions. Page 5General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 3. CONTEXT FOR SOFTWARE VALIDATION
Many people have asked for specific guidance on what FDA expects them to do to ensure compliance with the Quality System regulation with regard to software validation. Information on software validation presented in this document is not new. Validation of software, using the principles and tasks listed in Sections 4 and 5, has been conducted in many segments of the software industry for well over 20 years. Due to the great variety of medical devices, processes, and manufacturing facilities, it is not possible to state in one document all of the specific validation elements that are applicable. However, a general application of several broad concepts can be used successfully as guidance for software validation. These broad concepts provide an acceptable framework for building a comprehensive approach to software validation. Additional specific information is available from many of the references listed in Appendix A. 3.1. DEFINITIONS AND TERMINOLOGY
Unless defined in the Quality System regulation, or otherwise specified below, all other terms used in this guidance are as defined in the current edition of the FDA Glossary of Computerized System and Software Development Terminology. The medical device Quality System regulation (21 CFR 820.3(k)) defines " establish " to mean "define, document, and implement." Where it appears in this guidance, the words "establish" and established should be interpreted to have this same meaning. Some definitions found in the medical device Quality System regulation can be confusing when compared to commonly used terminology in the software industry. Examples are requirements, specification, verification, and validation.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Some definitions found in the medical device Quali...'?",
"reference": "Some definitions found in the medical device Quality System regulation can be confusing when compared to commonly used terminology in the software industry.",
"options": {
"A": "Quality System",
"B": "Software Validation Guidance",
"C": "software validation",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Additional specific information is available from ...'?",
"reference": "Additional specific information is available from many of the references listed in Appendix A.",
"options": {
"C": "Appendix A.",
"A": "Appendix A. 3.1",
"B": "Software Validation Guidance",
"D": "software validation"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The medical device Quality System regulation (21 C...'?",
"reference": "The medical device Quality System regulation (21 CFR 820.3(k)) defines \" establish \" to mean \"define, document, and implement.\"",
"options": {
"A": "Quality System",
"B": "Software Validation Guidance",
"C": "software validation",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The medical device Quality System regulation (____ CFR 820.3(k)) defines \" establish \" to mean \"define, document, and implement.\"",
"reference": "The medical device Quality System regulation (21 CFR 820.3(k)) defines \" establish \" to mean \"define, document, and implement.\"",
"options": {
"C": "21",
"A": "one",
"B": "Software Validation Guidance",
"D": "software validation"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'DEFINITIONS AND TERMINOLOGY\nUnless defined in the ...'?",
"reference": "DEFINITIONS AND TERMINOLOGY\nUnless defined in the Quality System regulation, or otherwise specified below, all other terms used in this guidance are as defined in the current edition of the FDA Glossary of Computerized System and Software Development Terminology.",
"options": {
"D": "DEFINITIONS",
"A": "FDA",
"B": "Software Validation Guidance",
"C": "software validation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'DEFINITIONS AND TERMINOLOGY\nUnless defined in the ...'?",
"reference": "DEFINITIONS AND TERMINOLOGY\nUnless defined in the Quality System regulation, or otherwise specified below, all other terms used in this guidance are as defined in the current edition of the FDA Glossary of Computerized System and Software Development Terminology.",
"options": {
"A": "Quality System",
"B": "Software Validation Guidance",
"C": "software validation",
"D": "DEFINITIONS"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'DEFINITIONS AND TERMINOLOGY\nUnless defined in the ...'?",
"reference": "DEFINITIONS AND TERMINOLOGY\nUnless defined in the Quality System regulation, or otherwise specified below, all other terms used in this guidance are as defined in the current edition of the FDA Glossary of Computerized System and Software Development Terminology.",
"options": {
"A": "the FDA Glossary of Computerized System",
"B": "FDA",
"C": "Software Validation Guidance",
"D": "software validation"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'See the references in Appendix A for applicable FD...'?",
"reference": "See the references in Appendix A for applicable FDA guidance documents for pre-market submissions.",
"options": {
"C": "FDA",
"A": "Quality System",
"B": "DEFINITIONS",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
System s uitability tests should be performed according to the firms established written procedures which should include the identity of the preparation to be injected and the rationale for its selection and the approved application or applicable compendial monograph ( 211.160 and 212.60). If an actual sample is to be used for system suitability testing, it should be a properly characterized secondary standard , written procedures should be es tablished and followed, and the sample should be from a different batch than the sample (s) being tested ( 211.160, 211.165, and 212.60). CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)). Transparency is necessary. A ll data including obvious errors and failing, passing, and suspect datamust be in the CGMP records that are retained and subject to review and oversight. An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) . For more information , see the ICH guidance for industry Q2(R1)
Validation of Analytical Procedure s: Text and Methodology and VICH guidances for industry GL1
Validation of Analytical Procedures: Definition and Terminology and GL2 Validation of Analytical Procedures: Methodology . Is it acceptable to only save the final results from reprocess ed laboratory chromatography? Analytical methods should be accurate and precise.16
For most lab analys es, reprocessing data should not be regularly needed. If chromatography is reprocessed, writ ten procedures
must be established and followed and each result retained for review (s ee 211.160, 211.165(c) , 211.194(a)(4) , and 212.60(a) ). FDA requires complete data in laboratory records, which includes 15 VICHVeteri nary International Conference on Harmonisation.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'FDA requires complete data in laboratory records, ...'?",
"reference": "FDA requires complete data in laboratory records, which includes 15 VICHVeteri nary International Conference on Harmonisation.",
"options": {
"A": "FDA",
"B": "CGMP",
"C": "Analytical Procedures",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA requires complete data in laboratory records, ...'?",
"reference": "FDA requires complete data in laboratory records, which includes 15 VICHVeteri nary International Conference on Harmonisation.",
"options": {
"C": "VICHVeteri",
"A": "CGMP",
"B": "Analytical Procedures",
"D": "FDA"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA requires complete data in laboratory records, ...'?",
"reference": "FDA requires complete data in laboratory records, which includes 15 VICHVeteri nary International Conference on Harmonisation.",
"options": {
"C": "International Conference on Harmonisation",
"A": "Analytical Procedures",
"B": "FDA",
"D": "VICHVeteri"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA requires complete data in laboratory records, which includes ____ VICHVeteri nary International Conference on Harmonisation.",
"reference": "FDA requires complete data in laboratory records, which includes 15 VICHVeteri nary International Conference on Harmonisation.",
"options": {
"B": "15",
"A": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'For more information , see the ICH guidance for in...'?",
"reference": "For more information , see the ICH guidance for industry Q2(R1)\nValidation of Analytical Procedure s: Text and Methodology and VICH guidances for industry GL1\nValidation of Analytical Procedures: Definition and Terminology and GL2 Validation of Analytical Procedures: Methodology .",
"options": {
"D": "Q2(R1",
"A": "reprocess ed laboratory chromatography",
"B": "Analytical Procedures",
"C": "Terminology"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For more information , see the ICH guidance for in...'?",
"reference": "For more information , see the ICH guidance for industry Q2(R1)\nValidation of Analytical Procedure s: Text and Methodology and VICH guidances for industry GL1\nValidation of Analytical Procedures: Definition and Terminology and GL2 Validation of Analytical Procedures: Methodology .",
"options": {
"A": "Terminology",
"B": "Analytical Procedures",
"C": "language",
"D": "nomenclature"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see ____, 211.165, 211.188, and 211.192) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"C": "211.160",
"A": "212.60",
"B": "211.165",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, ____, 211.188, and 211.192) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"C": "211.165",
"A": "211.160",
"B": "212.60",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, ____, and 211.192) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"C": "211.188",
"A": "211.160",
"B": "212.60",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and ____) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"A": "211.192",
"B": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see ____, 211.165, 211.188, and 211.192) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"C": "211.160",
"A": "212.60",
"B": "211.165",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, ____, 211.188, and 211.192) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"B": "211.165",
"A": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, ____, and 211.192) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"D": "211.188",
"A": "211.160",
"B": "212.60",
"C": "Analytical Procedures"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and ____) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"A": "211.192",
"B": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CGMP original records must be complete (e.g., 211...'?",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"D": "CGMP",
"A": "Terminology",
"B": "FDA",
"C": "Analytical Procedures"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP original records must be complete (e.g., 211.68(b), ____, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"C": "211.188",
"A": "211.160",
"B": "212.60",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP original records must be complete (e.g., 211.68(b), 211.188, ____) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"C": "211.194",
"A": "211.160",
"B": "212.60",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), ____, and 211.194(a)(8)).",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"A": "211.192",
"B": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'For more information , see the ICH guidance for in...'?",
"reference": "For more information , see the ICH guidance for industry Q2(R1)\nValidation of Analytical Procedure s: Text and Methodology and VICH guidances for industry GL1\nValidation of Analytical Procedures: Definition and Terminology and GL2 Validation of Analytical Procedures: Methodology .",
"options": {
"D": "Q2(R1",
"A": "reprocess ed laboratory chromatography",
"B": "Analytical Procedures",
"C": "Terminology"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For more information , see the ICH guidance for in...'?",
"reference": "For more information , see the ICH guidance for industry Q2(R1)\nValidation of Analytical Procedure s: Text and Methodology and VICH guidances for industry GL1\nValidation of Analytical Procedures: Definition and Terminology and GL2 Validation of Analytical Procedures: Methodology .",
"options": {
"B": "Terminology",
"A": "Analytical Procedures",
"C": "language",
"D": "nomenclature"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CGMP original records must be complete (e.g., 211...'?",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"D": "CGMP",
"A": "Terminology",
"B": "FDA",
"C": "Analytical Procedures"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP original records must be complete (e.g., 211.68(b), ____, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"C": "211.188",
"A": "211.160",
"B": "212.60",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP original records must be complete (e.g., 211.68(b), 211.188, ____) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"B": "211.194",
"A": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), ____, and 211.194(a)(8)).",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"C": "211.192",
"A": "211.160",
"B": "212.60",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'A ll data including obvious errors and failing, pa...'?",
"reference": "A ll data including obvious errors and failing, passing, and suspect datamust be in the CGMP records that are retained and subject to review and oversight.",
"options": {
"B": "CGMP",
"A": "Terminology",
"C": "FDA",
"D": "Analytical Procedures"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If an actual sample is to be used for system suitability testing, it should be a properly characterized secondary standard , written procedures should be es tablished and followed, and the sample should be from a different batch than the sample (s) being tested ( ____, 211.165, and 212.60).",
"reference": "If an actual sample is to be used for system suitability testing, it should be a properly characterized secondary standard , written procedures should be es tablished and followed, and the sample should be from a different batch than the sample (s) being tested ( 211.160, 211.165, and 212.60).",
"options": {
"B": "211.160",
"A": "212.60",
"C": "211.165",
"D": "Analytical Procedures"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If an actual sample is to be used for system suitability testing, it should be a properly characterized secondary standard , written procedures should be es tablished and followed, and the sample should be from a different batch than the sample (s) being tested ( 211.160, ____, and 212.60).",
"reference": "If an actual sample is to be used for system suitability testing, it should be a properly characterized secondary standard , written procedures should be es tablished and followed, and the sample should be from a different batch than the sample (s) being tested ( 211.160, 211.165, and 212.60).",
"options": {
"A": "211.165",
"B": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If an actual sample is to be used for system suitability testing, it should be a properly characterized secondary standard , written procedures should be es tablished and followed, and the sample should be from a different batch than the sample (s) being tested ( 211.160, 211.165, and ____).",
"reference": "If an actual sample is to be used for system suitability testing, it should be a properly characterized secondary standard , written procedures should be es tablished and followed, and the sample should be from a different batch than the sample (s) being tested ( 211.160, 211.165, and 212.60).",
"options": {
"B": "212.60",
"A": "211.160",
"C": "Analytical Procedures",
"D": "211.165"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CGMP original records must be complete (e.g., 211...'?",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"A": "CGMP",
"B": "Terminology",
"C": "FDA",
"D": "Analytical Procedures"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP original records must be complete (e.g., 211.68(b), ____, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"reference": "CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)).",
"options": {
"A": "211.188",
"B": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 3 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
For more information regarding FDAs 109 recommendations for design verification or validation of SiMD or SaMD, see the Software 110 Validation guidance . Computer Software Assurance 113 Computer software assurance is a risk -based approach for establishing and maintaining 114 confidence that software is fit for its intended use. This approach considers the risk of 115 Contains Nonbinding Recommendations Draft Not for Implementation 7compromised safety and/or quality of the device (should the software fail to per form as intended ) 116 to determine the level of assurance effort and activities appropriate to establish confidence in the 117 software. Because the computer software assurance effort is risk -based, it follows a least - 118 burdensome approach, where the burden of valid ation is no more than necessary to address the 119 risk. Such an approach supports the efficient use of resources, in turn promoting product quality. 120 121 In addition, computer software assurance establishes and maintains that the software used in 122 production or th e quality system is in a state of control throughout its lifecycle (validated 123 state). This is important because manufacturers increasingly rely on computers and automated 124 processing systems to monitor and operate production, alert responsible personnel, and transfer 125 and analyze production data, among other uses. By allowing manufacturers to leverage 126 principles such as risk -based testing, unscripted testing, continuous performance monitoring, and 127 data monitoring, as well as validation activities performed by other entities (e.g., developers, 128 suppliers), the computer software assurance approach provides flexibility and agility in helping 129 to assure that the software maintains a validated state consistent with 21 CFR 820.70(i).
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: By allowing manufacturers to leverage ____ principles such as risk -based testing, unscripted testing, continuous performance monitoring, and 127 data monitoring, as well as validation activities performed by other entities (e.g., developers, 128 suppliers), the computer software assurance approach provides flexibility and agility in helping 129 to assure that the software maintains a validated state consistent with 21 CFR 820.70(i).",
"reference": "By allowing manufacturers to leverage 126 principles such as risk -based testing, unscripted testing, continuous performance monitoring, and 127 data monitoring, as well as validation activities performed by other entities (e.g., developers, 128 suppliers), the computer software assurance approach provides flexibility and agility in helping 129 to assure that the software maintains a validated state consistent with 21 CFR 820.70(i).",
"options": {
"C": "126",
"A": "109",
"B": "113",
"D": "Computer Software Assurance 113 Computer software assurance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: By allowing manufacturers to leverage 126 principles such as risk -based testing, unscripted testing, continuous performance monitoring, and ____ data monitoring, as well as validation activities performed by other entities (e.g., developers, 128 suppliers), the computer software assurance approach provides flexibility and agility in helping 129 to assure that the software maintains a validated state consistent with 21 CFR 820.70(i).",
"reference": "By allowing manufacturers to leverage 126 principles such as risk -based testing, unscripted testing, continuous performance monitoring, and 127 data monitoring, as well as validation activities performed by other entities (e.g., developers, 128 suppliers), the computer software assurance approach provides flexibility and agility in helping 129 to assure that the software maintains a validated state consistent with 21 CFR 820.70(i).",
"options": {
"A": "127",
"B": "109",
"C": "113",
"D": "Computer Software Assurance 113 Computer software assurance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: By allowing manufacturers to leverage 126 principles such as risk -based testing, unscripted testing, continuous performance monitoring, and 127 data monitoring, as well as validation activities performed by other entities (e.g., developers, ____ suppliers), the computer software assurance approach provides flexibility and agility in helping 129 to assure that the software maintains a validated state consistent with 21 CFR 820.70(i).",
"reference": "By allowing manufacturers to leverage 126 principles such as risk -based testing, unscripted testing, continuous performance monitoring, and 127 data monitoring, as well as validation activities performed by other entities (e.g., developers, 128 suppliers), the computer software assurance approach provides flexibility and agility in helping 129 to assure that the software maintains a validated state consistent with 21 CFR 820.70(i).",
"options": {
"C": "128",
"A": "109",
"B": "113",
"D": "Computer Software Assurance 113 Computer software assurance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 45 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3
The guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products. QUESTIONS AND ANSWERS 66 67 1. Please clarify the following terms as they relate to CGMP records: 68 69 a. What is data integrity ? For the purpose s of this guidance, data integrity refers to the complete ness, 72 consisten cy, and accura cy of data. Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)
.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess . 3 CDER updates guidanc es periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance W eb page at www.fda.gov/Drugs/GuidanceComplianc eRegulatoryInformation/Guidances/default.htm . For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g). Contains Nonbinding Recommendations Draft Not for Implementation 3 b. What is metadata ?
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"D": "Electronic Records",
"A": "the FDA Drugs guidance W eb page",
"B": "Complete, consistent, and accurate data",
"C": "Electronic Signatures Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"B": "Electronic Signatures Scope",
"A": "accura",
"C": "the FDA Drugs guidance W eb page",
"D": "Complete, consistent, and accurate data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"B": "11 63",
"A": "67 1",
"C": "the FDA Drugs guidance W eb page",
"D": "Complete, consistent, and accurate data"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"A": "FDA",
"B": "Electronic Records",
"C": "Electronic Signatures Scope",
"D": "Complete, consistent, and accurate data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part ____, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"C": "11",
"A": "68 69",
"B": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part 11, Electronic Records; ____ Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"D": "61",
"A": "68 69",
"B": "75 2",
"C": "the FDA Drugs guidance W eb page"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking ____ regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"C": "62",
"A": "68 69",
"B": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part ____, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"D": "11",
"A": "68 69",
"B": "75 2",
"C": "the FDA Drugs guidance W eb page"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part ____, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"D": "11",
"A": "68 69",
"B": "75 2",
"C": "the FDA Drugs guidance W eb page"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 ____ as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"B": "63",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Please clarify the following terms as they relate ...'?",
"reference": "Please clarify the following terms as they relate to CGMP records: 68 69 a.",
"options": {
"C": "CGMP",
"A": "Electronic Records",
"B": "Electronic Signatures Scope",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"D": "Electronic Records",
"A": "the FDA Drugs guidance W eb page",
"B": "Complete, consistent, and accurate data",
"C": "Electronic Signatures Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"C": "Electronic Signatures Scope",
"A": "accura",
"B": "the FDA Drugs guidance W eb page",
"D": "Complete, consistent, and accurate data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"D": "11 63",
"A": "67 1",
"B": "the FDA Drugs guidance W eb page",
"C": "Complete, consistent, and accurate data"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"A": "FDA",
"B": "Electronic Records",
"C": "Electronic Signatures Scope",
"D": "Complete, consistent, and accurate data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part ____, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"C": "11",
"A": "68 69",
"B": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part 11, Electronic Records; ____ Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"B": "61",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking ____ regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"B": "62",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part ____, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"C": "11",
"A": "68 69",
"B": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part ____, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"D": "11",
"A": "68 69",
"B": "75 2",
"C": "the FDA Drugs guidance W eb page"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 ____ as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"A": "63",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For attributable, see 211.101(d), ____, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"reference": "For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"options": {
"A": "211.122",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Complete, consistent, and accurate data should 73 ...'?",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"C": "ALCOA",
"A": "Electronic Records",
"B": "Electronic Signatures Scope",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Complete, consistent, and accurate data should 73 ...'?",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"D": "CGMP",
"A": "Electronic Records",
"B": "Electronic Signatures Scope",
"C": "the FDA Drugs guidance W eb page"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Complete, consistent, and accurate data should 73 ...'?",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"A": "FD C Act section 501(a",
"B": "the FDA Drugs guidance W eb page",
"C": "Complete, consistent, and accurate data",
"D": "ALCOA"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should ____ be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"B": "73",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and ____ accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"A": "74",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n____ 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"C": ".4",
"A": "the FDA Drugs guidance W eb page",
"B": "Complete, consistent, and accurate data",
"D": "ALCOA"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 ____ 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"B": "75",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 ____ FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"B": "2",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For attributable, see 211.101(d), ____, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"reference": "For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"options": {
"A": "211.122",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For attributable, see 211.101(d), 211.122, ____ , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"reference": "For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"options": {
"A": "211.186",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see ____(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"reference": "For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"options": {
"C": "211.180",
"A": "68 69",
"B": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Complete, consistent, and accurate data should 73 ...'?",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"D": "ALCOA",
"A": "Electronic Records",
"B": "Electronic Signatures Scope",
"C": "the FDA Drugs guidance W eb page"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Complete, consistent, and accurate data should 73 ...'?",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"B": "CGMP",
"A": "Electronic Records",
"C": "Electronic Signatures Scope",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Complete, consistent, and accurate data should 73 ...'?",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"C": "FD C Act section 501(a",
"A": "the FDA Drugs guidance W eb page",
"B": "Complete, consistent, and accurate data",
"D": "ALCOA"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should ____ be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"B": "73",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and ____ accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"D": "74",
"A": "68 69",
"B": "75 2",
"C": "the FDA Drugs guidance W eb page"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n____ 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"D": ".4",
"A": "the FDA Drugs guidance W eb page",
"B": "Complete, consistent, and accurate data",
"C": "ALCOA"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 ____ 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"A": "75",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 ____ FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"B": "2",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation ____ b.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 3 b.",
"options": {
"B": "3",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation ____ b.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 3 b.",
"options": {
"A": "3",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"C": "Electronic Records",
"A": "the FDA Drugs guidance W eb page",
"B": "Complete, consistent, and accurate data",
"D": "Electronic Signatures Scope"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"D": "Electronic Signatures Scope",
"A": "accura",
"B": "the FDA Drugs guidance W eb page",
"C": "Complete, consistent, and accurate data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Is it acceptable to retain paper printouts or static records instead of original 260 electronic records from stand -alone computerized laboratory instruments, 261 such as an FT -IR instrum ent? 262 263 A paper printout or static record may satisfy retention requirements if it is a complete 264 copy of the original record ( see 211.68(b) , 211.188, 211.194, and 212.60). For 265 example, pH meters and balances may create a paper printout or static image du ring data 266 acquisition as the original record. In this case , the paper printout or static image created 267 during acquisition, or a true copy , should be retained ( 211.180). 268 269 However, electronic records from certain types of laboratory instruments are dynamic 270 records, and a printout or a static record does not preserve the dynamic format which is 271 part of the complete original record. For example, the spectral file created by FT -IR 272 (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or 273 printout is fixed, which would not satisfy CGMP requirements to retain original records 274 or true copies ( 211.180(d)) . Also, if the full spectrum is not displayed, contaminants 275 may be excluded. 276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported. 280 281 For PET drugs, see the guidance for industry PET Drugs Current Good Manufacturing 282 Practice (CGMP) for discussion of e quipment and l aboratory c ontrols, including 283 regulatory r equirements for records . 284 285 Contains Nonbinding Recommendations Draft Not for Implementation 8 11. Can electronic signatures be used instead of handwritten signatures for 286 master production and control records?
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "What amount is specified: '276 277 Control strategies must ensure that origin...'?",
"reference": "276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"options": {
"D": "211.194(a)(8",
"A": "262 263 A paper printout or static record",
"B": "a paper printout or static image du ring data 266 acquisition",
"C": "276"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"reference": "276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"options": {
"B": "276",
"A": "260",
"C": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 276 ____ Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"reference": "276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"options": {
"B": "277",
"A": "260",
"C": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 276 277 Control strategies must ensure that original laboratory records, including paper and ____ electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"reference": "276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"options": {
"C": "278",
"A": "260",
"B": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to ____ -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"reference": "276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"options": {
"B": "second",
"A": "262 263 A paper printout or static record",
"C": "a paper printout or static image du ring data 266 acquisition",
"D": "secondly"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain ____ that all test results are appropriately reported.",
"reference": "276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"options": {
"B": "279",
"A": "260",
"C": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For example, the spectral file created by FT -IR 2...'?",
"reference": "For example, the spectral file created by FT -IR 272 (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or 273 printout is fixed, which would not satisfy CGMP requirements to retain original records 274 or true copies ( 211.180(d)) .",
"options": {
"C": "CGMP",
"A": "PET",
"B": "PET Drugs Current Good Manufacturing 282 Practice",
"D": "262 263 A paper printout or static record"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the spectral file created by FT -IR ____ (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or 273 printout is fixed, which would not satisfy CGMP requirements to retain original records 274 or true copies ( 211.180(d)) .",
"reference": "For example, the spectral file created by FT -IR 272 (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or 273 printout is fixed, which would not satisfy CGMP requirements to retain original records 274 or true copies ( 211.180(d)) .",
"options": {
"B": "272",
"A": "260",
"C": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the spectral file created by FT -IR 272 (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or ____ printout is fixed, which would not satisfy CGMP requirements to retain original records 274 or true copies ( 211.180(d)) .",
"reference": "For example, the spectral file created by FT -IR 272 (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or 273 printout is fixed, which would not satisfy CGMP requirements to retain original records 274 or true copies ( 211.180(d)) .",
"options": {
"A": "273",
"B": "260",
"C": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the spectral file created by FT -IR 272 (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or 273 printout is fixed, which would not satisfy CGMP requirements to retain original records ____ or true copies ( 211.180(d)) .",
"reference": "For example, the spectral file created by FT -IR 272 (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or 273 printout is fixed, which would not satisfy CGMP requirements to retain original records 274 or true copies ( 211.180(d)) .",
"options": {
"A": "274",
"B": "260",
"C": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 269 However, electronic records from certain types of laboratory instruments are dynamic 270 records, and a printout or a static record does not preserve the dynamic format which is 271 part of the complete original record.",
"reference": "268 269 However, electronic records from certain types of laboratory instruments are dynamic 270 records, and a printout or a static record does not preserve the dynamic format which is 271 part of the complete original record.",
"options": {
"A": "268",
"B": "260",
"C": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: 268 ____ However, electronic records from certain types of laboratory instruments are dynamic 270 records, and a printout or a static record does not preserve the dynamic format which is 271 part of the complete original record.",
"reference": "268 269 However, electronic records from certain types of laboratory instruments are dynamic 270 records, and a printout or a static record does not preserve the dynamic format which is 271 part of the complete original record.",
"options": {
"D": "269",
"A": "260",
"B": "261",
"C": "262 263 A paper printout or static record"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'For example, the spectral file created by FT -IR 2...'?",
"reference": "For example, the spectral file created by FT -IR 272 (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or 273 printout is fixed, which would not satisfy CGMP requirements to retain original records 274 or true copies ( 211.180(d)) .",
"options": {
"B": "CGMP",
"A": "PET",
"C": "PET Drugs Current Good Manufacturing 282 Practice",
"D": "262 263 A paper printout or static record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the spectral file created by FT -IR ____ (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or 273 printout is fixed, which would not satisfy CGMP requirements to retain original records 274 or true copies ( 211.180(d)) .",
"reference": "For example, the spectral file created by FT -IR 272 (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or 273 printout is fixed, which would not satisfy CGMP requirements to retain original records 274 or true copies ( 211.180(d)) .",
"options": {
"D": "272",
"A": "260",
"B": "261",
"C": "262 263 A paper printout or static record"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the spectral file created by FT -IR 272 (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or ____ printout is fixed, which would not satisfy CGMP requirements to retain original records 274 or true copies ( 211.180(d)) .",
"reference": "For example, the spectral file created by FT -IR 272 (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or 273 printout is fixed, which would not satisfy CGMP requirements to retain original records 274 or true copies ( 211.180(d)) .",
"options": {
"B": "273",
"A": "260",
"C": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the spectral file created by FT -IR 272 (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or 273 printout is fixed, which would not satisfy CGMP requirements to retain original records ____ or true copies ( 211.180(d)) .",
"reference": "For example, the spectral file created by FT -IR 272 (Fourier transform infrared spectroscopy ) can be reprocessed , but a static reco rd or 273 printout is fixed, which would not satisfy CGMP requirements to retain original records 274 or true copies ( 211.180(d)) .",
"options": {
"C": "274",
"A": "260",
"B": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this case , the paper printout or static image created ____ during acquisition, or a true copy , should be retained ( 211.180).",
"reference": "In this case , the paper printout or static image created 267 during acquisition, or a true copy , should be retained ( 211.180).",
"options": {
"D": "267",
"A": "260",
"B": "261",
"C": "262 263 A paper printout or static record"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this case , the paper printout or static image created 267 during acquisition, or a true copy , should be retained ( ____).",
"reference": "In this case , the paper printout or static image created 267 during acquisition, or a true copy , should be retained ( 211.180).",
"options": {
"D": "211.180",
"A": "260",
"B": "261",
"C": "262 263 A paper printout or static record"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: '276 277 Control strategies must ensure that origin...'?",
"reference": "276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"options": {
"D": "211.194(a)(8",
"A": "262 263 A paper printout or static record",
"B": "a paper printout or static image du ring data 266 acquisition",
"C": "276"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"reference": "276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"options": {
"C": "276",
"A": "260",
"B": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 276 ____ Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"reference": "276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"options": {
"A": "277",
"B": "260",
"C": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 276 277 Control strategies must ensure that original laboratory records, including paper and ____ electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"reference": "276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"options": {
"B": "278",
"A": "260",
"C": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to ____ -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"reference": "276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"options": {
"D": "second",
"A": "262 263 A paper printout or static record",
"B": "a paper printout or static image du ring data 266 acquisition",
"C": "secondly"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain ____ that all test results are appropriately reported.",
"reference": "276 277 Control strategies must ensure that original laboratory records, including paper and 278 electronic records, are subject to second -person review ( 211.194(a)(8)) to make certain 279 that all test results are appropriately reported.",
"options": {
"C": "279",
"A": "260",
"B": "261",
"D": "262 263 A paper printout or static record"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Can electronic signatures be used instead of handwritten signatures for ____ master production and control records?",
"reference": "Can electronic signatures be used instead of handwritten signatures for 286 master production and control records?",
"options": {
"D": "286",
"A": "260",
"B": "261",
"C": "262 263 A paper printout or static record"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 3 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Annual Rev iew An evaluation, conducted at least annua lly, that assesses the quality standards of each drug product to determine the need fo r ch anges in drug product specifications or manufacturing or control procedures CAPA Corrective and preventive ac tion: A systematic approach that includes actions needed to correct (correction), prevent recurrence ( corrective action), and eliminate the cause of potential nonconforming product and other quali ty problems (preventive action) (21CFR 820.100) Continual Improvement Ongoing activities to evaluate and positively change products, processes, and the quality system to increase effectiveness Correction Repair, rework, or adjustment relating to the disposition of an existing discrepancy Corrective Action Action taken to eliminate the causes of an existing discrepancy or other undesirable situation to prevent recurrence Customer A person or organization (internal or ex ternal) that receives a product or service anywhere along the pr oducts life cycle Discrepancy Datum or result outside of the expected range; an unfulfilled requirement; may be called non-confor mity, defect, deviation, out-o f-specification, out-of-limit, out-of-trend Harm Dam age to health, including the damage that can occur from the loss of product quality or availability Non-conformity A deficiency in a characteristic, produc t specification, process parameter, record, or procedure that rende rs the quality of a product unaccep table, indeterminate, or not according to specified requirements Preventive Action Action taken to eliminate the cause of a potential disc repancy or other undesirable situation to prev ent such an occurrence Product/Service The intended results of activities or processes; products/services can be tangible or intangible Quality A measure of a products or se rvices ability to satisfy the customers stated or im plied needs Quality Assurance Proactive and retrospective activ ities that provide confidence that requirements are fulfilled 27 Contains Nonbinding Recommendations Quality Control
The steps taken during the generation of a product or se rvice to ensure that it meets requirements and that the prod uct or service is reproducible Quality Management Accountability for the successful im plementatio n of the quality syst em Quality Ob jectives Specific measurable activities or proc esses to meet the intentions and directions as defined in the quality policy Quality P lan The documented result of quality planni ng that is disseminated to all relevant levels of the organization Quality P lanning A m anagement activity that sets quality objectives and defines the operational and/or quality system processes and the resources needed to fulfill the objectives Quality Po licy A statement of intentions and direc tion issued by the highest level of the organization related to satisfying cus tomer needs.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "When did this occur: 'Annual Rev iew An evaluation, conducted at least ...'?",
"reference": "Annual Rev iew An evaluation, conducted at least annua lly, that assesses the quality standards of each drug product to determine the need fo r ch anges in drug product specifications or manufacturing or control procedures CAPA Corrective and preventive ac tion: A systematic approach that includes actions needed to correct (correction), prevent recurrence ( corrective action), and eliminate the cause of potential nonconforming product and other quali ty problems (preventive action) (21CFR 820.100) Continual Improvement Ongoing activities to evaluate and positively change products, processes, and the quality system to increase effectiveness Correction Repair, rework, or adjustment relating to the disposition of an existing discrepancy Corrective Action Action taken to eliminate the causes of an existing discrepancy or other undesirable situation to prevent recurrence Customer A person or organization (internal or ex ternal) that receives a product or service anywhere along the pr oducts life cycle Discrepancy Datum or result outside of the expected range; an unfulfilled requirement; may be called non-confor mity, defect, deviation, out-o f-specification, out-of-limit, out-of-trend Harm Dam age to health, including the damage that can occur from the loss of product quality or availability Non-conformity A deficiency in a characteristic, produc t specification, process parameter, record, or procedure that rende rs the quality of a product unaccep table, indeterminate, or not according to specified requirements Preventive Action Action taken to eliminate the cause of a potential disc repancy or other undesirable situation to prev ent such an occurrence Product/Service The intended results of activities or processes; products/services can be tangible or intangible Quality A measure of a products or se rvices ability to satisfy the customers stated or im plied needs Quality Assurance Proactive and retrospective activ ities that provide confidence that requirements are fulfilled 27 Contains Nonbinding Recommendations Quality Control\nThe steps taken during the generation of a product or se rvice to ensure that it meets requirements and that the prod uct or service is reproducible Quality Management Accountability for the successful im plementatio n of the quality syst em Quality Ob jectives Specific measurable activities or proc esses to meet the intentions and directions as defined in the quality policy Quality P lan The documented result of quality planni ng that is disseminated to all relevant levels of the organization Quality P lanning A m anagement activity that sets quality objectives and defines the operational and/or quality system processes and the resources needed to fulfill the objectives Quality Po licy A statement of intentions and direc tion issued by the highest level of the organization related to satisfying cus tomer needs.",
"options": {
"B": "Annual",
"A": "product quality",
"C": "the operational and/or quality system processes",
"D": "yearly"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Annual Rev iew An evaluation, conducted at least ...'?",
"reference": "Annual Rev iew An evaluation, conducted at least annua lly, that assesses the quality standards of each drug product to determine the need fo r ch anges in drug product specifications or manufacturing or control procedures CAPA Corrective and preventive ac tion: A systematic approach that includes actions needed to correct (correction), prevent recurrence ( corrective action), and eliminate the cause of potential nonconforming product and other quali ty problems (preventive action) (21CFR 820.100) Continual Improvement Ongoing activities to evaluate and positively change products, processes, and the quality system to increase effectiveness Correction Repair, rework, or adjustment relating to the disposition of an existing discrepancy Corrective Action Action taken to eliminate the causes of an existing discrepancy or other undesirable situation to prevent recurrence Customer A person or organization (internal or ex ternal) that receives a product or service anywhere along the pr oducts life cycle Discrepancy Datum or result outside of the expected range; an unfulfilled requirement; may be called non-confor mity, defect, deviation, out-o f-specification, out-of-limit, out-of-trend Harm Dam age to health, including the damage that can occur from the loss of product quality or availability Non-conformity A deficiency in a characteristic, produc t specification, process parameter, record, or procedure that rende rs the quality of a product unaccep table, indeterminate, or not according to specified requirements Preventive Action Action taken to eliminate the cause of a potential disc repancy or other undesirable situation to prev ent such an occurrence Product/Service The intended results of activities or processes; products/services can be tangible or intangible Quality A measure of a products or se rvices ability to satisfy the customers stated or im plied needs Quality Assurance Proactive and retrospective activ ities that provide confidence that requirements are fulfilled 27 Contains Nonbinding Recommendations Quality Control\nThe steps taken during the generation of a product or se rvice to ensure that it meets requirements and that the prod uct or service is reproducible Quality Management Accountability for the successful im plementatio n of the quality syst em Quality Ob jectives Specific measurable activities or proc esses to meet the intentions and directions as defined in the quality policy Quality P lan The documented result of quality planni ng that is disseminated to all relevant levels of the organization Quality P lanning A m anagement activity that sets quality objectives and defines the operational and/or quality system processes and the resources needed to fulfill the objectives Quality Po licy A statement of intentions and direc tion issued by the highest level of the organization related to satisfying cus tomer needs.",
"options": {
"A": "CAPA",
"B": "Correction Repair",
"C": "Corrective Action Action",
"D": "product quality"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: 'Annual Rev iew An evaluation, conducted at least ...'?",
"reference": "Annual Rev iew An evaluation, conducted at least annua lly, that assesses the quality standards of each drug product to determine the need fo r ch anges in drug product specifications or manufacturing or control procedures CAPA Corrective and preventive ac tion: A systematic approach that includes actions needed to correct (correction), prevent recurrence ( corrective action), and eliminate the cause of potential nonconforming product and other quali ty problems (preventive action) (21CFR 820.100) Continual Improvement Ongoing activities to evaluate and positively change products, processes, and the quality system to increase effectiveness Correction Repair, rework, or adjustment relating to the disposition of an existing discrepancy Corrective Action Action taken to eliminate the causes of an existing discrepancy or other undesirable situation to prevent recurrence Customer A person or organization (internal or ex ternal) that receives a product or service anywhere along the pr oducts life cycle Discrepancy Datum or result outside of the expected range; an unfulfilled requirement; may be called non-confor mity, defect, deviation, out-o f-specification, out-of-limit, out-of-trend Harm Dam age to health, including the damage that can occur from the loss of product quality or availability Non-conformity A deficiency in a characteristic, produc t specification, process parameter, record, or procedure that rende rs the quality of a product unaccep table, indeterminate, or not according to specified requirements Preventive Action Action taken to eliminate the cause of a potential disc repancy or other undesirable situation to prev ent such an occurrence Product/Service The intended results of activities or processes; products/services can be tangible or intangible Quality A measure of a products or se rvices ability to satisfy the customers stated or im plied needs Quality Assurance Proactive and retrospective activ ities that provide confidence that requirements are fulfilled 27 Contains Nonbinding Recommendations Quality Control\nThe steps taken during the generation of a product or se rvice to ensure that it meets requirements and that the prod uct or service is reproducible Quality Management Accountability for the successful im plementatio n of the quality syst em Quality Ob jectives Specific measurable activities or proc esses to meet the intentions and directions as defined in the quality policy Quality P lan The documented result of quality planni ng that is disseminated to all relevant levels of the organization Quality P lanning A m anagement activity that sets quality objectives and defines the operational and/or quality system processes and the resources needed to fulfill the objectives Quality Po licy A statement of intentions and direc tion issued by the highest level of the organization related to satisfying cus tomer needs.",
"options": {
"D": "21CFR 820.100",
"A": "product quality",
"B": "the operational and/or quality system processes",
"C": "Annual"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 15 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Do the tasks and expected results, outputs, or products of each software life cycle activity: ü
Comply with the requirements of other software life cycle activities in terms of correctness, completeness, consistency, and accuracy? Satisfy the standards, practices, and conventions of that activity? Establish a proper basis for initiating tasks for the next software life cycle activity? Page 11General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 4. PRINCIPLES OF SOFTWARE VALIDATION
This section lists the general principles that should be considered for the validation of software. 4.1. REQUIREMENTS A documented software requirements specification provides a baseline for both validation and verification. The software validation process cannot be completed without an established software requirements specification (Ref: 21 CFR 820.3(z) and (aa) and 820.30(f) and (g)). DEFECT PREVENTION Software quality assurance needs to focus on preventing the introduction of defects into the software development process and not on trying to test quality into the software code after it is written. Software testing is very limited in its ability to surface all latent defects in software code. For example, the complexity of most software prevents it from being exhaustively tested. Software testing is a necessary activity. However, in most cases software testing by itself is not sufficient to establish confidence that the software is fit for its intended use. In order to establish that confidence, software developers should use a mixture of methods and techniques to prevent software errors and to detect software errors that do occur. The best mix of methods depends on many factors including the development environment, application, size of project, language, and risk. TIME AND EFFORT To build a case that the software is validated requires time and effort.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Page 11General Principles of Software Validation G...'?",
"reference": "Page 11General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 4.",
"options": {
"C": "FDA",
"A": "CFR 820.3(z",
"B": "each software life cycle activity",
"D": "the next software life cycle activity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 11General Principles of Software Validation Guidance for Industry and FDA Staff SECTION ____.",
"reference": "Page 11General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 4.",
"options": {
"D": "4",
"A": "11General",
"B": "4.1",
"C": "each software life cycle activity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software testing is very limited in its ability to...'?",
"reference": "Software testing is very limited in its ability to surface all latent defects in software code.",
"options": {
"A": "Software",
"B": "FDA",
"C": "CFR 820.3(z",
"D": "package"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The software validation process cannot be complete...'?",
"reference": "The software validation process cannot be completed without an established software requirements specification (Ref: 21 CFR 820.3(z) and (aa) and 820.30(f) and (g)).",
"options": {
"A": "CFR 820.3(z",
"B": "FDA",
"C": "each software life cycle activity",
"D": "the next software life cycle activity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The software validation process cannot be completed without an established software requirements specification (Ref: ____ CFR 820.3(z) and (aa) and 820.30(f) and (g)).",
"reference": "The software validation process cannot be completed without an established software requirements specification (Ref: 21 CFR 820.3(z) and (aa) and 820.30(f) and (g)).",
"options": {
"A": "21",
"B": "11General",
"C": "4.1",
"D": "each software life cycle activity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software testing is very limited in its ability to...'?",
"reference": "Software testing is very limited in its ability to surface all latent defects in software code.",
"options": {
"C": "Software",
"A": "FDA",
"B": "CFR 820.3(z",
"D": "package"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software testing is very limited in its ability to...'?",
"reference": "Software testing is very limited in its ability to surface all latent defects in software code.",
"options": {
"A": "Software",
"B": "FDA",
"C": "CFR 820.3(z",
"D": "package"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 11General Principles of Software Validation G...'?",
"reference": "Page 11General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 4.",
"options": {
"A": "FDA",
"B": "CFR 820.3(z",
"C": "each software life cycle activity",
"D": "the next software life cycle activity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 11General Principles of Software Validation Guidance for Industry and FDA Staff SECTION ____.",
"reference": "Page 11General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 4.",
"options": {
"A": "4",
"B": "11General",
"C": "4.1",
"D": "each software life cycle activity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software testing is very limited in its ability to...'?",
"reference": "Software testing is very limited in its ability to surface all latent defects in software code.",
"options": {
"B": "Software",
"A": "FDA",
"C": "CFR 820.3(z",
"D": "package"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 11General Principles of Software Validation G...'?",
"reference": "Page 11General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 4.",
"options": {
"B": "FDA",
"A": "CFR 820.3(z",
"C": "each software life cycle activity",
"D": "the next software life cycle activity"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 11General Principles of Software Validation Guidance for Industry and FDA Staff SECTION ____.",
"reference": "Page 11General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 4.",
"options": {
"B": "4",
"A": "11General",
"C": "4.1",
"D": "each software life cycle activity"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 11General Principles of Software Validation G...'?",
"reference": "Page 11General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 4.",
"options": {
"C": "FDA",
"A": "CFR 820.3(z",
"B": "each software life cycle activity",
"D": "the next software life cycle activity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 11General Principles of Software Validation Guidance for Industry and FDA Staff SECTION ____.",
"reference": "Page 11General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 4.",
"options": {
"D": "4",
"A": "11General",
"B": "4.1",
"C": "each software life cycle activity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software testing is very limited in its ability to...'?",
"reference": "Software testing is very limited in its ability to surface all latent defects in software code.",
"options": {
"C": "Software",
"A": "FDA",
"B": "CFR 820.3(z",
"D": "package"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 6 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Goal of the Guidance ..................................................................................................................... 2 C. Scope of the Guidance ...................................................................................................................
3 D. Organization of this Guidance ...................................................................................................... 4 III. CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS ...................
4 A. Quality .............................................................................................................................................
4 B. Quality by Design and Product Development .............................................................................
4 C. Quality Risk Management ............................................................................................................ 5 D. CAPA (Corrective and Preventive Action) ..................................................................................
5 E. Change Control .............................................................................................................................. 5 F. The Quality Unit ............................................................................................................................
5 G. Six-system Inspection Model ......................................................................................................... 6 IV. THE QUALITY SYSTEMS MODEL .............................................................................
8 A. Management Responsibilities ....................................................................................................... 8 1. Provide Leadership .......................................................................................................................... 8 2.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: Management Responsibilities ....................................................................................................... ____ 1.",
"reference": "Management Responsibilities ....................................................................................................... 8 1.",
"options": {
"C": "8",
"A": "Six",
"B": "8 1",
"D": "MODERN QUALITY SYSTEMS"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Management Responsibilities ....................................................................................................... 8 ____.",
"reference": "Management Responsibilities ....................................................................................................... 8 1.",
"options": {
"D": "1",
"A": "Six",
"B": "8 1",
"C": "THE QUALITY SYSTEMS MODEL .............................................................................\n8 A. Management Responsibilities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Quality by Design and Product Development ...........'?",
"reference": "Quality by Design and Product Development .............................................................................\n4 C. Quality Risk Management ............................................................................................................ 5 D. CAPA (Corrective and Preventive Action) ..................................................................................\n5 E. Change Control .............................................................................................................................. 5 F. The Quality Unit ............................................................................................................................\n5 G. Six-system Inspection Model ......................................................................................................... 6 IV.",
"options": {
"A": "Preventive Action",
"B": "3 D. Organization",
"C": "QUALITY",
"D": "THE QUALITY SYSTEMS MODEL .............................................................................\n8 A. Management Responsibilities"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Quality by Design and Product Development ...........'?",
"reference": "Quality by Design and Product Development .............................................................................\n4 C. Quality Risk Management ............................................................................................................ 5 D. CAPA (Corrective and Preventive Action) ..................................................................................\n5 E. Change Control .............................................................................................................................. 5 F. The Quality Unit ............................................................................................................................\n5 G. Six-system Inspection Model ......................................................................................................... 6 IV.",
"options": {
"A": "Inspection Model",
"B": "THE QUALITY SYSTEMS MODEL .............................................................................\n8 A. Management Responsibilities",
"C": "MODERN QUALITY SYSTEMS",
"D": "Preventive Action"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality by Design and Product Development .............................................................................\n____ C. Quality Risk Management ............................................................................................................ 5 D. CAPA (Corrective and Preventive Action) ..................................................................................\n5 E. Change Control .............................................................................................................................. 5 F. The Quality Unit ............................................................................................................................\n5 G. Six-system Inspection Model ......................................................................................................... 6 IV.",
"reference": "Quality by Design and Product Development .............................................................................\n4 C. Quality Risk Management ............................................................................................................ 5 D. CAPA (Corrective and Preventive Action) ..................................................................................\n5 E. Change Control .............................................................................................................................. 5 F. The Quality Unit ............................................................................................................................\n5 G. Six-system Inspection Model ......................................................................................................... 6 IV.",
"options": {
"B": "4",
"A": "Six",
"C": "8 1",
"D": "THE QUALITY SYSTEMS MODEL .............................................................................\n8 A. Management Responsibilities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Quality by Design and Product Development .............................................................................\n4 C. Quality Risk Management ............................................................................................................ ____ D. CAPA (Corrective and Preventive Action) ..................................................................................\n5 E. Change Control .............................................................................................................................. 5 F. The Quality Unit ............................................................................................................................\n5 G. Six-system Inspection Model ......................................................................................................... 6 IV.",
"reference": "Quality by Design and Product Development .............................................................................\n4 C. Quality Risk Management ............................................................................................................ 5 D. CAPA (Corrective and Preventive Action) ..................................................................................\n5 E. Change Control .............................................................................................................................. 5 F. The Quality Unit ............................................................................................................................\n5 G. Six-system Inspection Model ......................................................................................................... 6 IV.",
"options": {
"D": "5",
"A": "Six",
"B": "8 1",
"C": "THE QUALITY SYSTEMS MODEL .............................................................................\n8 A. Management Responsibilities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Table II: Application of Corrective Action and Preventive Action System Throughout the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability is explored. CAPA methodology is useful where corrective actions and preventive actions are incorporated into the iterative design and development process. CAPA can be used as an effective system for feedback, feedforward, and continual improvement. CAPA should be used, and the effectiveness of the actions should be evaluated. CAPA should continue after the product is discontinued. The impact on product remaining on the market should be considered, as well as other products that might be affected. 3. Change Management System (3.2.3) Innovation, continual improvement, the outputs of process performance and product quality monitoring, and CAPA drive change. To eval uate, approve, and implement these changes properly, a company should have an effective change management system. There is generally a difference in formality of change management processes prior to the initial regulatory submission and after submission, where changes to the regulatory filing might be required under regional requirements. The change management system ensures continua l improvement is undertaken in a timely and effective manner. It should provide a high de gree of assurance th ere are no unintended consequences of the change. The change management system should include the following, as appropriate for the stage of the lifecycle: (a) Quality risk management should be utilized to evaluate proposed changes. The level of effort and formality of the evaluation should be commensurate with the level of risk. (b) Proposed changes should be evaluated re lative to the marketing authorization, including design space, where established, and/or current product and process understanding.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'CAPA should continue after the product is disconti...'?",
"reference": "CAPA should continue after the product is discontinued.",
"options": {
"D": "CAPA",
"A": "Change Management System",
"B": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability",
"C": "an effective change management system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CAPA can be used as an effective system for feedba...'?",
"reference": "CAPA can be used as an effective system for feedback, feedforward, and continual improvement.",
"options": {
"C": "CAPA",
"A": "Change Management System",
"B": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability",
"D": "an effective change management system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CAPA should continue after the product is disconti...'?",
"reference": "CAPA should continue after the product is discontinued.",
"options": {
"D": "CAPA",
"A": "Change Management System",
"B": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability",
"C": "an effective change management system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CAPA methodology is useful where corrective action...'?",
"reference": "CAPA methodology is useful where corrective actions and preventive actions are incorporated into the iterative design and development process.",
"options": {
"A": "CAPA",
"B": "Change Management System",
"C": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability",
"D": "an effective change management system"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CAPA should be used, and the effectiveness of the ...'?",
"reference": "CAPA should be used, and the effectiveness of the actions should be evaluated.",
"options": {
"D": "CAPA",
"A": "Change Management System",
"B": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability",
"C": "an effective change management system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CAPA should be used, and the effectiveness of the ...'?",
"reference": "CAPA should be used, and the effectiveness of the actions should be evaluated.",
"options": {
"D": "CAPA",
"A": "Change Management System",
"B": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability",
"C": "an effective change management system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CAPA methodology is useful where corrective action...'?",
"reference": "CAPA methodology is useful where corrective actions and preventive actions are incorporated into the iterative design and development process.",
"options": {
"B": "CAPA",
"A": "Change Management System",
"C": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability",
"D": "an effective change management system"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CAPA methodology is useful where corrective action...'?",
"reference": "CAPA methodology is useful where corrective actions and preventive actions are incorporated into the iterative design and development process.",
"options": {
"A": "CAPA",
"B": "Change Management System",
"C": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability",
"D": "an effective change management system"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CAPA should be used, and the effectiveness of the ...'?",
"reference": "CAPA should be used, and the effectiveness of the actions should be evaluated.",
"options": {
"A": "CAPA",
"B": "Change Management System",
"C": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability",
"D": "an effective change management system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 35 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
The use of off-the-shelf software in automated medical devices and in automated manufacturing and quality system operations is increasing. Off-the-shelf software may have many capabilities, only a few of which are needed by the device manufacturer. Device manufacturers are responsible for the adequacy of the software used in their devices, and used to produce devices. When device manufacturers purchase "off-the-shelf'' software, they must ensure that it will perform as intended in their chosen application. For off-the-shelf software used in manufacturing or in the quality system, additional guidance is included in Section 6.3 of this document. For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices. 2.4. QUALITY SYSTEM REGULATION VS PRE-MARKET SUBMISSIONS This document addresses Quality System regulation issues that involve the implementation of software validation. It provides guidance for the management and control of the software validation process. The management and control of the software validation process should not be confused with any other validation requirements, such as process validation for an automated manufacturing process. Device manufacturers may use the same procedures and records for compliance with quality system and design control requirements, as well as for pre-market submissions to FDA. This document does not cover any specific safety or efficacy issues related to software validation. Design issues and documentation requirements for pre-market submissions of regulated software are not addressed by this document. Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"A": "the Office of Device Evaluation",
"B": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"A": "Center for Devices and Radiological Health",
"B": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"B": "the Office of Blood Research and Review, Center for Biologics Evaluation and Research",
"A": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"B": "Guidance for Industry",
"A": "the software validation process",
"C": "FDA Reviewers",
"D": "Compliance on Off-The-Shelf Software Use in Medical Devices"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"C": "FDA Reviewers",
"A": "Guidance for Industry",
"B": "Quality System",
"D": "the software validation process"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Device manufacturers may use the same procedures a...'?",
"reference": "Device manufacturers may use the same procedures and records for compliance with quality system and design control requirements, as well as for pre-market submissions to FDA.",
"options": {
"D": "FDA",
"A": "Guidance for Industry",
"B": "FDA Reviewers",
"C": "the software validation process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'QUALITY SYSTEM REGULATION VS PRE-MARKET SUBMISSION...'?",
"reference": "QUALITY SYSTEM REGULATION VS PRE-MARKET SUBMISSIONS This document addresses Quality System regulation issues that involve the implementation of software validation.",
"options": {
"C": "Quality System",
"A": "the software validation process",
"B": "This information is not mentioned in the context",
"D": "The context does not provide this detail"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Device manufacturers may use the same procedures a...'?",
"reference": "Device manufacturers may use the same procedures and records for compliance with quality system and design control requirements, as well as for pre-market submissions to FDA.",
"options": {
"A": "FDA",
"B": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"D": "Guidance for Industry",
"A": "the software validation process",
"B": "FDA Reviewers",
"C": "Compliance on Off-The-Shelf Software Use in Medical Devices"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"A": "FDA Reviewers",
"B": "Guidance for Industry",
"C": "Quality System",
"D": "the software validation process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"B": "Guidance for Industry",
"A": "the software validation process",
"C": "FDA Reviewers",
"D": "Compliance on Off-The-Shelf Software Use in Medical Devices"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"A": "the Office of Device Evaluation",
"B": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"A": "Center for Devices and Radiological Health",
"B": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"D": "the Office of Blood Research and Review, Center for Biologics Evaluation and Research",
"A": "Guidance for Industry",
"B": "FDA Reviewers",
"C": "the software validation process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Device manufacturers may use the same procedures a...'?",
"reference": "Device manufacturers may use the same procedures and records for compliance with quality system and design control requirements, as well as for pre-market submissions to FDA.",
"options": {
"A": "FDA",
"B": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Device manufacturers may use the same procedures a...'?",
"reference": "Device manufacturers may use the same procedures and records for compliance with quality system and design control requirements, as well as for pre-market submissions to FDA.",
"options": {
"B": "FDA",
"A": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"D": "Guidance for Industry",
"A": "the software validation process",
"B": "FDA Reviewers",
"C": "Compliance on Off-The-Shelf Software Use in Medical Devices"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"A": "FDA Reviewers",
"B": "Guidance for Industry",
"C": "Quality System",
"D": "the software validation process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For off-the-shelf software used in manufacturing or in the quality system, additional guidance is included in Section ____ of this document.",
"reference": "For off-the-shelf software used in manufacturing or in the quality system, additional guidance is included in Section 6.3 of this document.",
"options": {
"B": "6.3",
"A": "2.4",
"C": "the software validation process",
"D": "Section 6.3"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For off-the-shelf software used in manufacturing or in the quality system, additional guidance is included in Section ____ of this document.",
"reference": "For off-the-shelf software used in manufacturing or in the quality system, additional guidance is included in Section 6.3 of this document.",
"options": {
"C": "6.3",
"A": "2.4",
"B": "the software validation process",
"D": "Section 6.3"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Device manufacturers may use the same procedures a...'?",
"reference": "Device manufacturers may use the same procedures and records for compliance with quality system and design control requirements, as well as for pre-market submissions to FDA.",
"options": {
"B": "FDA",
"A": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'QUALITY SYSTEM REGULATION VS PRE-MARKET SUBMISSION...'?",
"reference": "QUALITY SYSTEM REGULATION VS PRE-MARKET SUBMISSIONS This document addresses Quality System regulation issues that involve the implementation of software validation.",
"options": {
"A": "Quality System",
"B": "the software validation process",
"C": "This information is not mentioned in the context",
"D": "The context does not provide this detail"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For off-the-shelf software used in manufacturing or in the quality system, additional guidance is included in Section ____ of this document.",
"reference": "For off-the-shelf software used in manufacturing or in the quality system, additional guidance is included in Section 6.3 of this document.",
"options": {
"C": "6.3",
"A": "2.4",
"B": "the software validation process",
"D": "Section 6.3"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"A": "the Office of Device Evaluation",
"B": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"D": "Center for Devices and Radiological Health",
"A": "Guidance for Industry",
"B": "FDA Reviewers",
"C": "the software validation process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"B": "the Office of Blood Research and Review, Center for Biologics Evaluation and Research",
"A": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"D": "the Office of Device Evaluation",
"A": "Guidance for Industry",
"B": "FDA Reviewers",
"C": "the software validation process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"A": "Center for Devices and Radiological Health",
"B": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"B": "the Office of Blood Research and Review, Center for Biologics Evaluation and Research",
"A": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Device manufacturers may use the same procedures a...'?",
"reference": "Device manufacturers may use the same procedures and records for compliance with quality system and design control requirements, as well as for pre-market submissions to FDA.",
"options": {
"D": "FDA",
"A": "Guidance for Industry",
"B": "FDA Reviewers",
"C": "the software validation process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Device manufacturers may use the same procedures a...'?",
"reference": "Device manufacturers may use the same procedures and records for compliance with quality system and design control requirements, as well as for pre-market submissions to FDA.",
"options": {
"D": "FDA",
"A": "Guidance for Industry",
"B": "FDA Reviewers",
"C": "the software validation process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"A": "Guidance for Industry",
"B": "the software validation process",
"C": "FDA Reviewers",
"D": "Compliance on Off-The-Shelf Software Use in Medical Devices"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"D": "FDA Reviewers",
"A": "Guidance for Industry",
"B": "Quality System",
"C": "the software validation process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"D": "Guidance for Industry",
"A": "the software validation process",
"B": "FDA Reviewers",
"C": "Compliance on Off-The-Shelf Software Use in Medical Devices"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"B": "FDA Reviewers",
"A": "Guidance for Industry",
"C": "Quality System",
"D": "the software validation process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 35 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Firms should implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models. 3 Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product. Managements involvement 1
This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration. 2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. We update guidances periodic ally. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm . 3 See ICH guidance for industry Q9 Quality Risk Management . Contains Nonbinding Recommendations 2 in and influence on these strategies is essential in preventing and correcting conditions that can lead to data integrity problems. It is the role of management with executive responsibility to create a quality culture where employees understand that data integrity i s an organizational core value and employees are encoura ged to identify and promptly report data integrity issues. In the absence of management support of a quality culture, quality systems can break down and lead to CGMP noncompliance. In general, FDA s guidance documents do not establish legally enforceable responsibilities. Instead , guidances describe the Agency s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Instead , guidances describe the Agency s current ...'?",
"reference": "Instead , guidances describe the Agency s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.",
"options": {
"A": "Agency",
"B": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "government agency"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.",
"reference": "3 Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.",
"options": {
"B": "3",
"A": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "troika"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"D": "the International Council for Harmonisation (ICH",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"D": "Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"A": "2",
"B": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "two"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"A": "the International Council for Harmonisation (ICH",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"B": "Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"B": "2",
"A": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "two"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.",
"reference": "3 Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.",
"options": {
"A": "3",
"B": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "troika"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In general, FDA s guidance documents do not establ...'?",
"reference": "In general, FDA s guidance documents do not establish legally enforceable responsibilities.",
"options": {
"D": "FDA",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"A": "FDA Drugs",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"B": "RegulatoryInformation/Guidances",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Instead , guidances describe the Agency s current ...'?",
"reference": "Instead , guidances describe the Agency s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.",
"options": {
"C": "Agency",
"A": "industry Q9 Quality Risk Management",
"B": "the FDA Drugs guidance web page",
"D": "government agency"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.",
"reference": "3 Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.",
"options": {
"D": "3",
"A": "industry Q9 Quality Risk Management",
"B": "the FDA Drugs guidance web page",
"C": "troika"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Instead , guidances describe the Agency s current ...'?",
"reference": "Instead , guidances describe the Agency s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.",
"options": {
"D": "Agency",
"A": "industry Q9 Quality Risk Management",
"B": "the FDA Drugs guidance web page",
"C": "government agency"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ in and influence on these strategies is essential in preventing and correcting conditions that can lead to data integrity problems.",
"reference": "Contains Nonbinding Recommendations 2 in and influence on these strategies is essential in preventing and correcting conditions that can lead to data integrity problems.",
"options": {
"C": "2",
"A": "industry Q9 Quality Risk Management",
"B": "the FDA Drugs guidance web page",
"D": "two"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the absence of management support of a quality ...'?",
"reference": "In the absence of management support of a quality culture, quality systems can break down and lead to CGMP noncompliance.",
"options": {
"B": "CGMP",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Office of Pharmaceutical Quality",
"A": "the Office of Compliance",
"B": "the Center for Drug Evaluation and Research",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Office of Compliance",
"A": "the Office of Pharmaceutical Quality",
"B": "the Center for Drug Evaluation and Research",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Center for Drug Evaluation and Research",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"A": "the Center for Biologics Evaluation and Research",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Center for Veterinary Medicine",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"B": "the Office of Regulatory Affairs",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Instead , guidances describe the Agency s current ...'?",
"reference": "Instead , guidances describe the Agency s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.",
"options": {
"C": "Agency",
"A": "industry Q9 Quality Risk Management",
"B": "the FDA Drugs guidance web page",
"D": "government agency"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ in and influence on these strategies is essential in preventing and correcting conditions that can lead to data integrity problems.",
"reference": "Contains Nonbinding Recommendations 2 in and influence on these strategies is essential in preventing and correcting conditions that can lead to data integrity problems.",
"options": {
"D": "2",
"A": "industry Q9 Quality Risk Management",
"B": "the FDA Drugs guidance web page",
"C": "two"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"D": "the International Council for Harmonisation (ICH",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"B": "Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"B": "2",
"A": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "two"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"A": "the International Council for Harmonisation (ICH",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"B": "Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"C": "2",
"A": "industry Q9 Quality Risk Management",
"B": "the FDA Drugs guidance web page",
"D": "two"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ in and influence on these strategies is essential in preventing and correcting conditions that can lead to data integrity problems.",
"reference": "Contains Nonbinding Recommendations 2 in and influence on these strategies is essential in preventing and correcting conditions that can lead to data integrity problems.",
"options": {
"A": "2",
"B": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "two"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In general, FDA s guidance documents do not establ...'?",
"reference": "In general, FDA s guidance documents do not establish legally enforceable responsibilities.",
"options": {
"B": "FDA",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In general, FDA s guidance documents do not establ...'?",
"reference": "In general, FDA s guidance documents do not establish legally enforceable responsibilities.",
"options": {
"C": "FDA",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.",
"reference": "3 Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.",
"options": {
"A": "3",
"B": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "troika"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
PDA Journal of Pharmaceutical Science and Technology, Volume 49, Number 1, January-February 1995 Supplement. Validation Compliance Annual 1995 , International Validation Forum, Inc.
General Software Quality References Boris Beizer, Black Box Testing, Techniques for Functional Testing of Software and Systems , John Wiley Sons, 1995. ISBN 0-471-12094-4. Boris Beizer, Software System Testing and Quality Assurance , International Thomson Computer Press, 1996. ISBN 1-85032-821-8. Boris Beizer, Software Testing Techniques , Second Edition, Van Nostrand Reinhold, 1990. ISBN 0- 442-20672-0. Richard Bender, Writing Testable Requirements, Version 1.0 , Bender Associates, Inc., Larkspur, CA 94777, 1996. Frederick P. Brooks, Jr., The Mythical Man-Month, Essays on Software Engineering , Addison-
Wesley Longman, Anniversary Edition, 1995. ISBN 0-201-83595-9. Silvana Castano, et.al., Database Security , ACM Press, Addison-Wesley Publishing Company, 1995. ISBN 0-201-59375-0. Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance , Drug Information Association, Maple Glen, PA, September 1988. Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982. Robert H. Dunn and Richard S. Ullman, TQM for Computer Software , Second Edition, McGraw- Hill, Inc., 1994. ISBN 0-07-018314-7. Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999. ISBN 0-201-43287-0. Robert G. Ebenau and Susan H. Strauss, Software Inspection Process , McGraw-Hill, 1994. ISBN 0-07-062166-7. Richard E. Fairley, Software Engineering Concepts , McGraw-Hill Publishing Company, 1985. ISBN 0-07-019902-7. Michael A. Friedman and Jeffrey M. Voas, Software Assessment - Reliability, Safety, Testability , Wiley-
Interscience, John Wiley Sons Inc., 1995.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Who is mentioned in the context: 'Elfriede Dustin, Jeff Rashka, and John Paul, Autom...'?",
"reference": "Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999.",
"options": {
"A": "Elfriede Dustin",
"B": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Elfriede Dustin, Jeff Rashka, and John Paul, Autom...'?",
"reference": "Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999.",
"options": {
"B": "Jeff Rashka",
"A": "Boris Beizer",
"C": "John Wiley Sons",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Elfriede Dustin, Jeff Rashka, and John Paul, Autom...'?",
"reference": "Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999.",
"options": {
"C": "John Paul",
"A": "Boris Beizer",
"B": "John Wiley Sons",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Elfriede Dustin, Jeff Rashka, and John Paul, Autom...'?",
"reference": "Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999.",
"options": {
"A": "Addison Wesley Longman",
"B": "Boris Beizer",
"C": "John Wiley Sons",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Elfriede Dustin, Jeff Rashka, and John Paul, Autom...'?",
"reference": "Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999.",
"options": {
"D": "1999",
"A": "Number 1",
"B": "January-February 1995",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., ____.",
"reference": "Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999.",
"options": {
"D": "1999",
"A": "Number 1",
"B": "January-February 1995",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"D": "Page 40General Principles of Software Validation Guidance for Industry",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"B": "International Validation Forum",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"C": "FDA",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"B": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"A": "M. S. Deutsch",
"B": "Boris Beizer",
"C": "John Wiley Sons",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"D": "Software Verification and Validation, Realistic Project Approaches",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"B": "International Validation Forum",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"B": "Prentice Hall",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"D": "1982",
"A": "Number 1",
"B": "January-February 1995",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Computerized Data Systems for Nonclinical Safety A...'?",
"reference": "Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance , Drug Information Association, Maple Glen, PA, September 1988.",
"options": {
"A": "Computerized Data Systems",
"B": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Computerized Data Systems for Nonclinical Safety A...'?",
"reference": "Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance , Drug Information Association, Maple Glen, PA, September 1988.",
"options": {
"B": "Quality Assurance , Drug Information Association",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Computerized Data Systems for Nonclinical Safety A...'?",
"reference": "Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance , Drug Information Association, Maple Glen, PA, September 1988.",
"options": {
"B": "Maple Glen",
"A": "Boris Beizer",
"C": "John Wiley Sons",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Computerized Data Systems for Nonclinical Safety A...'?",
"reference": "Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance , Drug Information Association, Maple Glen, PA, September 1988.",
"options": {
"C": "September 1988",
"A": "Number 1",
"B": "January-February 1995",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance , Drug Information Association, Maple Glen, PA, September ____.",
"reference": "Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance , Drug Information Association, Maple Glen, PA, September 1988.",
"options": {
"A": "1988",
"B": "Number 1",
"C": "January-February 1995",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Elfriede Dustin, Jeff Rashka, and John Paul, Autom...'?",
"reference": "Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999.",
"options": {
"A": "Elfriede Dustin",
"B": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Elfriede Dustin, Jeff Rashka, and John Paul, Autom...'?",
"reference": "Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999.",
"options": {
"B": "Jeff Rashka",
"A": "Boris Beizer",
"C": "John Wiley Sons",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Elfriede Dustin, Jeff Rashka, and John Paul, Autom...'?",
"reference": "Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999.",
"options": {
"D": "John Paul",
"A": "Boris Beizer",
"B": "John Wiley Sons",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Elfriede Dustin, Jeff Rashka, and John Paul, Autom...'?",
"reference": "Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999.",
"options": {
"D": "Addison Wesley Longman",
"A": "Boris Beizer",
"B": "John Wiley Sons",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Elfriede Dustin, Jeff Rashka, and John Paul, Autom...'?",
"reference": "Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999.",
"options": {
"D": "1999",
"A": "Number 1",
"B": "January-February 1995",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., ____.",
"reference": "Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999.",
"options": {
"A": "1999",
"B": "Number 1",
"C": "January-February 1995",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Elfriede Dustin, Jeff Rashka, and John Paul, Autom...'?",
"reference": "Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999.",
"options": {
"B": "Elfriede Dustin",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Elfriede Dustin, Jeff Rashka, and John Paul, Autom...'?",
"reference": "Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999.",
"options": {
"D": "Jeff Rashka",
"A": "Boris Beizer",
"B": "John Wiley Sons",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 15 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Page 2General Principles of Software Validation Guidance for Industry and FDA Staff
In that case, the party with regulatory responsibility (i.e., the device manufacturer) needs to assess the adequacy of the off-the-shelf software developers activities and determine what additional efforts are needed to establish that the software is validated for the device manufacturers intended use. This guidance applies to: Software used as a component, part, or accessory of a medical device; Software that is itself a medical device (e.g., blood establishment software);
Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record). This document is based on generally recognized software validation principles and, therefore, can be applied to any software. For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy. This document does not specifically identify which software is or is not regulated. This guidance provides useful information and recommendations to the following individuals:
Persons subject to the medical device Quality System regulat ion Persons responsible for the design, development, or production of medical device software Persons responsible for the design, development, production, or procurement of automated tools used for the design, development, or manufacture of medical devices or software tools used to implement the quality system itself FDA Investigators FDA Compliance Officers FDA Scientific Reviewers 2.3. THE LEAST BURDENSOME APPROACH We believe we should consider the least burdensome approach in all areas of medical device regulation.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Page 2General Principles of Software Validation Gu...'?",
"reference": "Page 2General Principles of Software Validation Guidance for Industry and FDA Staff\nIn that case, the party with regulatory responsibility (i.e., the device manufacturer) needs to assess the adequacy of the off-the-shelf software developers activities and determine what additional efforts are needed to establish that the software is validated for the device manufacturers intended use.",
"options": {
"D": "FDA",
"A": "Software",
"B": "medical device software Persons",
"C": "medical devices or software tools"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For FDA purposes, this guidance applies to any sof...'?",
"reference": "For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy.",
"options": {
"C": "FDA",
"A": "Software",
"B": "medical device software Persons",
"D": "medical devices or software tools"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For FDA purposes, this guidance applies to any sof...'?",
"reference": "For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy.",
"options": {
"B": "the Federal Food, Drug",
"A": "FDA",
"C": "Software",
"D": "medical device software Persons"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For FDA purposes, this guidance applies to any sof...'?",
"reference": "For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy.",
"options": {
"C": "FDA",
"A": "Software",
"B": "medical device software Persons",
"D": "medical devices or software tools"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'THE LEAST BURDENSOME APPROACH We believe we should...'?",
"reference": "THE LEAST BURDENSOME APPROACH We believe we should consider the least burdensome approach in all areas of medical device regulation.",
"options": {
"D": "THE LEAST BURDENSOME APPROACH",
"A": "FDA",
"B": "Software",
"C": "medical device software Persons"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For FDA purposes, this guidance applies to any sof...'?",
"reference": "For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy.",
"options": {
"D": "FDA",
"A": "Software",
"B": "medical device software Persons",
"C": "medical devices or software tools"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For FDA purposes, this guidance applies to any sof...'?",
"reference": "For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy.",
"options": {
"C": "the Federal Food, Drug",
"A": "FDA",
"B": "Software",
"D": "medical device software Persons"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For FDA purposes, this guidance applies to any sof...'?",
"reference": "For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy.",
"options": {
"B": "FDA",
"A": "Software",
"C": "medical device software Persons",
"D": "medical devices or software tools"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance provides useful information and reco...'?",
"reference": "This guidance provides useful information and recommendations to the following individuals:\nPersons subject to the medical device Quality System regulat ion Persons responsible for the design, development, or production of medical device software Persons responsible for the design, development, production, or procurement of automated tools used for the design, development, or manufacture of medical devices or software tools used to implement the quality system itself FDA Investigators FDA Compliance Officers FDA Scientific Reviewers 2.3.",
"options": {
"C": "Quality System",
"A": "medical device software Persons",
"B": "medical devices or software tools",
"D": "FDA Investigators"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance provides useful information and reco...'?",
"reference": "This guidance provides useful information and recommendations to the following individuals:\nPersons subject to the medical device Quality System regulat ion Persons responsible for the design, development, or production of medical device software Persons responsible for the design, development, production, or procurement of automated tools used for the design, development, or manufacture of medical devices or software tools used to implement the quality system itself FDA Investigators FDA Compliance Officers FDA Scientific Reviewers 2.3.",
"options": {
"B": "FDA Investigators",
"A": "FDA",
"C": "Software",
"D": "medical device software Persons"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance provides useful information and reco...'?",
"reference": "This guidance provides useful information and recommendations to the following individuals:\nPersons subject to the medical device Quality System regulat ion Persons responsible for the design, development, or production of medical device software Persons responsible for the design, development, production, or procurement of automated tools used for the design, development, or manufacture of medical devices or software tools used to implement the quality system itself FDA Investigators FDA Compliance Officers FDA Scientific Reviewers 2.3.",
"options": {
"B": "FDA",
"A": "Software",
"C": "medical device software Persons",
"D": "medical devices or software tools"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance provides useful information and reco...'?",
"reference": "This guidance provides useful information and recommendations to the following individuals:\nPersons subject to the medical device Quality System regulat ion Persons responsible for the design, development, or production of medical device software Persons responsible for the design, development, production, or procurement of automated tools used for the design, development, or manufacture of medical devices or software tools used to implement the quality system itself FDA Investigators FDA Compliance Officers FDA Scientific Reviewers 2.3.",
"options": {
"A": "FDA Scientific Reviewers",
"B": "FDA",
"C": "Software",
"D": "medical device software Persons"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This guidance provides useful information and recommendations to the following individuals:\nPersons subject to the medical device Quality System regulat ion Persons responsible for the design, development, or production of medical device software Persons responsible for the design, development, production, or procurement of automated tools used for the design, development, or manufacture of medical devices or software tools used to implement the quality system itself FDA Investigators FDA Compliance Officers FDA Scientific Reviewers ____.",
"reference": "This guidance provides useful information and recommendations to the following individuals:\nPersons subject to the medical device Quality System regulat ion Persons responsible for the design, development, or production of medical device software Persons responsible for the design, development, production, or procurement of automated tools used for the design, development, or manufacture of medical devices or software tools used to implement the quality system itself FDA Investigators FDA Compliance Officers FDA Scientific Reviewers 2.3.",
"options": {
"B": "2.3",
"A": "medical device software Persons",
"C": "medical devices or software tools",
"D": "Quality System"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'THE LEAST BURDENSOME APPROACH We believe we should...'?",
"reference": "THE LEAST BURDENSOME APPROACH We believe we should consider the least burdensome approach in all areas of medical device regulation.",
"options": {
"B": "THE LEAST BURDENSOME APPROACH",
"A": "FDA",
"C": "Software",
"D": "medical device software Persons"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 2General Principles of Software Validation Gu...'?",
"reference": "Page 2General Principles of Software Validation Guidance for Industry and FDA Staff\nIn that case, the party with regulatory responsibility (i.e., the device manufacturer) needs to assess the adequacy of the off-the-shelf software developers activities and determine what additional efforts are needed to establish that the software is validated for the device manufacturers intended use.",
"options": {
"D": "FDA",
"A": "Software",
"B": "medical device software Persons",
"C": "medical devices or software tools"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Under a quality systems approach, ma nagers would use quality planning to identify and allocate resources and define methods to achieve the quality objectives. Quality system plans should be documented and communicated to personnel to ensure awareness of how their operational activities are aligned with st rategic and quality goals. 5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness. U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule. Such a review typically includes assessments of the pr ocess, product, and customer needs (in this section, customer is defined as the reci pient of the produc t and the product is the goods or services provided). Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)
Product characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured. Outside of scheduled reviews, the quality system should typically be included as a standing age nda item in general m anagement meetings. In addition, a periodic review performed by a qualif ied source, external to the organization, may also be useful in assessing the suitab ility and effectiveness of the system.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"A": "5",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"A": "U",
"B": "a periodic review",
"C": "the System System review",
"D": "uracil"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"B": "10",
"A": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "tenner"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"C": "U",
"A": "a periodic review",
"B": "the System System review",
"D": "uracil"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"A": "U",
"B": "a periodic review",
"C": "the System System review",
"D": "uracil"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"B": "5",
"A": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"A": "10",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "tenner"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"C": "10",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"D": "tenner"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"A": "U",
"B": "a periodic review",
"C": "the System System review",
"D": "uracil"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"D": "U",
"A": "a periodic review",
"B": "the System System review",
"C": "uracil"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"C": "U",
"A": "a periodic review",
"B": "the System System review",
"D": "uracil"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"C": "U",
"A": "a periodic review",
"B": "the System System review",
"D": "uracil"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"A": "5",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"B": "5",
"A": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"A": "5",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"C": "10",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"D": "tenner"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"D": "U",
"A": "a periodic review",
"B": "the System System review",
"C": "uracil"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"A": "5",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"D": "5",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"C": "Little Phoebe"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"A": "5",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"C": "U",
"A": "a periodic review",
"B": "the System System review",
"D": "uracil"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"D": "U",
"A": "a periodic review",
"B": "the System System review",
"C": "uracil"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"C": "5",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"A": "5",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"C": "10",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"D": "tenner"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"B": "5",
"A": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"B": "5",
"A": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"D": "5",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"C": "Little Phoebe"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"A": "10",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "tenner"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"C": "10",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"D": "tenner"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Alan Kusinitz, Software Validation , Current Issues in Medical Device Quality Systems, Association for the Advancement of Medical Instrumentation, 1997. ISBN 1-57020-075-0. Nancy G. Leveson, Safeware, System Safety and Computers , Addison-Wesley Publishing Company, 1995. ISBN 0-201-11972-2. Michael R. Lyu, Editor, Handbook of Software Reliability Engineering , IEEE Computer Society Press, McGraw-Hill, 1996. ISBN 0-07-039400-8. Steven R. Mallory, Software Development and Quality Assurance for the Healthcare Manufacturing Industries , Interpharm Press,Inc., 1994. ISBN 0-935184-58-9. Brian Marick, The Craft of Software Testing , Prentice Hall PTR, 1995. ISBN 0-13-177411-5. Steve McConnell, Rapid Development , Microsoft Press, 1996. ISBN 1-55615-900-5. Glenford J. Myers, The Art of Software Testing , John Wiley Sons, 1979. ISBN 0-471-04328-1. Peter G. Neumann, Computer Related Risks , ACM Press/Addison-Wesley Publishing Co., 1995. ISBN 0-201-55805-X. Daniel Olivier, Conducting Software Audits, Auditing Software for Conformance to FDA Requirements , Computer Application Specialists, San Diego, CA, 1994. William Perry, Effective Methods for Software Testing , John Wiley Sons, Inc. 1995. ISBN 0- 471-06097-6. William E. Perry, Randall W. Rice, Surviving the Top Ten Challenges of Software Testing , Dorset Page 42General Principles of Software Validation Guidance for Industry and FDA Staff House Publishing, 1997. ISBN 0-932633-38-2. Roger S. Pressman, Software Engineering, A Practitioner's Approach , Third Edition, McGraw-Hill Inc., 1992. ISBN 0-07-050814-3. Roger S. Pressman, A Managers Guide to Software Engineering , McGraw-Hill Inc., 1993 ISBN 0-07-050820-8. A. P. Sage, J. D. Palmer , Software Systems Engineering , John Wiley Sons, 1990. Joc Sanders, Eugene Curran, Software Quality , Addison-Wesley Publishing Co., 1994. ISBN 0- 201-63198-9.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Who is mentioned in the context: 'Roger S. Pressman, Software Engineering, A Practit...'?",
"reference": "Roger S. Pressman, Software Engineering, A Practitioner's Approach , Third Edition, McGraw-Hill Inc., 1992.",
"options": {
"D": "Roger S. Pressman",
"A": "Alan Kusinitz",
"B": "Nancy G. Leveson",
"C": "Software Systems Engineering"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Roger S. Pressman, Software Engineering, A Practit...'?",
"reference": "Roger S. Pressman, Software Engineering, A Practitioner's Approach , Third Edition, McGraw-Hill Inc., 1992.",
"options": {
"C": "Software Engineering",
"A": "Software Validation",
"B": "the Advancement of Medical Instrumentation",
"D": "Software Systems Engineering"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Roger S. Pressman, Software Engineering, A Practit...'?",
"reference": "Roger S. Pressman, Software Engineering, A Practitioner's Approach , Third Edition, McGraw-Hill Inc., 1992.",
"options": {
"B": "Practitioner's Approach",
"A": "Software Validation",
"C": "the Advancement of Medical Instrumentation",
"D": "Software Systems Engineering"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Roger S. Pressman, Software Engineering, A Practit...'?",
"reference": "Roger S. Pressman, Software Engineering, A Practitioner's Approach , Third Edition, McGraw-Hill Inc., 1992.",
"options": {
"A": "McGraw-Hill Inc.",
"B": "Software Validation",
"C": "the Advancement of Medical Instrumentation",
"D": "Software Systems Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Roger S. Pressman, Software Engineering, A Practit...'?",
"reference": "Roger S. Pressman, Software Engineering, A Practitioner's Approach , Third Edition, McGraw-Hill Inc., 1992.",
"options": {
"B": "1992",
"A": "1997",
"C": "1995",
"D": "Software Systems Engineering"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Roger S. Pressman, Software Engineering, A Practitioner's Approach , ____ Edition, McGraw-Hill Inc., 1992.",
"reference": "Roger S. Pressman, Software Engineering, A Practitioner's Approach , Third Edition, McGraw-Hill Inc., 1992.",
"options": {
"A": "Third",
"B": "Software Systems Engineering",
"C": "Software Reliability Engineering",
"D": "3rd"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Roger S. Pressman, Software Engineering, A Practitioner's Approach , Third Edition, McGraw-Hill Inc., ____.",
"reference": "Roger S. Pressman, Software Engineering, A Practitioner's Approach , Third Edition, McGraw-Hill Inc., 1992.",
"options": {
"A": "1992",
"B": "1997",
"C": "1995",
"D": "Software Systems Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Roger S. Pressman, A Managers Guide to Software En...'?",
"reference": "Roger S. Pressman, A Managers Guide to Software Engineering , McGraw-Hill Inc., 1993 ISBN 0-07-050820-8.",
"options": {
"B": "Roger S. Pressman",
"A": "Alan Kusinitz",
"C": "Nancy G. Leveson",
"D": "Software Systems Engineering"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Roger S. Pressman, A Managers Guide to Software En...'?",
"reference": "Roger S. Pressman, A Managers Guide to Software Engineering , McGraw-Hill Inc., 1993 ISBN 0-07-050820-8.",
"options": {
"D": "Software Engineering",
"A": "Software Validation",
"B": "the Advancement of Medical Instrumentation",
"C": "Software Systems Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Roger S. Pressman, A Managers Guide to Software En...'?",
"reference": "Roger S. Pressman, A Managers Guide to Software Engineering , McGraw-Hill Inc., 1993 ISBN 0-07-050820-8.",
"options": {
"A": "McGraw-Hill Inc.",
"B": "Software Validation",
"C": "the Advancement of Medical Instrumentation",
"D": "Software Systems Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Roger S. Pressman, A Managers Guide to Software En...'?",
"reference": "Roger S. Pressman, A Managers Guide to Software Engineering , McGraw-Hill Inc., 1993 ISBN 0-07-050820-8.",
"options": {
"A": "1993",
"B": "1997",
"C": "1995",
"D": "Software Systems Engineering"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Roger S. Pressman, A Managers Guide to Software Engineering , McGraw-Hill Inc., ____ ISBN 0-07-050820-8.",
"reference": "Roger S. Pressman, A Managers Guide to Software Engineering , McGraw-Hill Inc., 1993 ISBN 0-07-050820-8.",
"options": {
"A": "1993",
"B": "1997",
"C": "1995",
"D": "Software Systems Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Joc Sanders, Eugene Curran, Software Quality , Add...'?",
"reference": "Joc Sanders, Eugene Curran, Software Quality , Addison-Wesley Publishing Co., 1994.",
"options": {
"A": "Eugene Curran",
"B": "Alan Kusinitz",
"C": "Nancy G. Leveson",
"D": "Software Systems Engineering"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Joc Sanders, Eugene Curran, Software Quality , Add...'?",
"reference": "Joc Sanders, Eugene Curran, Software Quality , Addison-Wesley Publishing Co., 1994.",
"options": {
"D": "Software Quality",
"A": "Software Validation",
"B": "the Advancement of Medical Instrumentation",
"C": "Software Systems Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Joc Sanders, Eugene Curran, Software Quality , Add...'?",
"reference": "Joc Sanders, Eugene Curran, Software Quality , Addison-Wesley Publishing Co., 1994.",
"options": {
"B": "Addison-Wesley Publishing Co.",
"A": "Software Validation",
"C": "the Advancement of Medical Instrumentation",
"D": "Software Systems Engineering"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Joc Sanders, Eugene Curran, Software Quality , Add...'?",
"reference": "Joc Sanders, Eugene Curran, Software Quality , Addison-Wesley Publishing Co., 1994.",
"options": {
"D": "1994",
"A": "1997",
"B": "1995",
"C": "Software Systems Engineering"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Joc Sanders, Eugene Curran, Software Quality , Addison-Wesley Publishing Co., ____.",
"reference": "Joc Sanders, Eugene Curran, Software Quality , Addison-Wesley Publishing Co., 1994.",
"options": {
"C": "1994",
"A": "1997",
"B": "1995",
"D": "Software Systems Engineering"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Glenford J. Myers, The Art of Software Testing , J...'?",
"reference": "Glenford J. Myers, The Art of Software Testing , John Wiley Sons, 1979.",
"options": {
"B": "Glenford J. Myers",
"A": "Alan Kusinitz",
"C": "Nancy G. Leveson",
"D": "Software Systems Engineering"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Glenford J. Myers, The Art of Software Testing , J...'?",
"reference": "Glenford J. Myers, The Art of Software Testing , John Wiley Sons, 1979.",
"options": {
"D": "The Art of Software Testing",
"A": "Software Systems Engineering",
"B": "Software Reliability Engineering",
"C": "Glenford J. Myers"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Glenford J. Myers, The Art of Software Testing , J...'?",
"reference": "Glenford J. Myers, The Art of Software Testing , John Wiley Sons, 1979.",
"options": {
"B": "John Wiley Sons",
"A": "Alan Kusinitz",
"C": "Nancy G. Leveson",
"D": "Software Systems Engineering"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Glenford J. Myers, The Art of Software Testing , J...'?",
"reference": "Glenford J. Myers, The Art of Software Testing , John Wiley Sons, 1979.",
"options": {
"A": "1979",
"B": "1997",
"C": "1995",
"D": "Software Systems Engineering"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Glenford J. Myers, The Art of Software Testing , John Wiley Sons, ____.",
"reference": "Glenford J. Myers, The Art of Software Testing , John Wiley Sons, 1979.",
"options": {
"B": "1979",
"A": "1997",
"C": "1995",
"D": "Software Systems Engineering"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Joc Sanders, Eugene Curran, Software Quality , Add...'?",
"reference": "Joc Sanders, Eugene Curran, Software Quality , Addison-Wesley Publishing Co., 1994.",
"options": {
"C": "Eugene Curran",
"A": "Alan Kusinitz",
"B": "Nancy G. Leveson",
"D": "Software Systems Engineering"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Joc Sanders, Eugene Curran, Software Quality , Add...'?",
"reference": "Joc Sanders, Eugene Curran, Software Quality , Addison-Wesley Publishing Co., 1994.",
"options": {
"D": "Software Quality",
"A": "Software Validation",
"B": "the Advancement of Medical Instrumentation",
"C": "Software Systems Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Joc Sanders, Eugene Curran, Software Quality , Add...'?",
"reference": "Joc Sanders, Eugene Curran, Software Quality , Addison-Wesley Publishing Co., 1994.",
"options": {
"A": "Addison-Wesley Publishing Co.",
"B": "Software Validation",
"C": "the Advancement of Medical Instrumentation",
"D": "Software Systems Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 40 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device. If so, c hanges 370 affecting this specific operation would require a 30 -day notice . 371 372 6 Available at https://www.fda.gov/regulatory -information/search -fda-guidance -documents/30 -day-notices -135-day- premarket -approval -pma-supplements -and-75-day-humanitarian -device -exemption . 7 21 CFR 814.39(b), 814.126(b) (1), and https://www.fda.gov/regulatory -information/search -fda-guidance - documents/annual -reports -approved -premarket -approval -applications -pma. 8 21 CFR 814.39(b), 814.126(b)(1) . Changes in manufacturing/sterilization site or to design or performance specifications do not qualify for a 30 -day notice. Contains Nonbinding Recommendations Draft Not for Implementation 13 Determining the Appropriate Assurance Activities 373
Once the manufacturer has determined whether a software feature, function, or operation poses a 374 high process risk (a quality problem that may foreseeably compromise safety) ,the manufacturer 375 should identify theassurance activities commensu rate with the medical device risk or the process 376 risk. In cases where the quality problem may foreseeably compromise safety (high process risk) , 377 the level of assurance should be commensurate with the medical device risk .In
cases where the 378 quality problem may not foreseeably compromise safety (not high process risk) , the level of 379 assurance rigor should be commensurate with the process risk. In either cas e, heightened risksof 380 software features, functions, or operations gen erally entail greater rigor , i.e., a greater amount of 381 objective evidence .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: If so, c hanges ____ affecting this specific operation would require a 30 -day notice .",
"reference": "If so, c hanges 370 affecting this specific operation would require a 30 -day notice .",
"options": {
"B": "370",
"A": "368",
"C": "369",
"D": "a 374 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If so, c hanges 370 affecting this specific operation would require a ____ -day notice .",
"reference": "If so, c hanges 370 affecting this specific operation would require a 30 -day notice .",
"options": {
"D": "30",
"A": "368",
"B": "369",
"C": "a 374 high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '8 21 CFR 814.39(b), 814.126(b)(1) ....'?",
"reference": "8 21 CFR 814.39(b), 814.126(b)(1) .",
"options": {
"C": "8 21",
"A": "7 21",
"B": "annual",
"D": "a 374 high process risk"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '8 21 CFR 814.39(b), 814.126(b)(1) ....'?",
"reference": "8 21 CFR 814.39(b), 814.126(b)(1) .",
"options": {
"A": "CFR 814.39(b",
"B": "MES",
"C": "814.126(b",
"D": "a 374 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 21 CFR 814.39(b), 814.126(b)(1) .",
"reference": "8 21 CFR 814.39(b), 814.126(b)(1) .",
"options": {
"A": "8",
"B": "368",
"C": "369",
"D": "a 374 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 8 ____ CFR 814.39(b), 814.126(b)(1) .",
"reference": "8 21 CFR 814.39(b), 814.126(b)(1) .",
"options": {
"A": "21",
"B": "368",
"C": "369",
"D": "a 374 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If so, c hanges ____ affecting this specific operation would require a 30 -day notice .",
"reference": "If so, c hanges 370 affecting this specific operation would require a 30 -day notice .",
"options": {
"A": "370",
"B": "368",
"C": "369",
"D": "a 374 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If so, c hanges 370 affecting this specific operation would require a ____ -day notice .",
"reference": "If so, c hanges 370 affecting this specific operation would require a 30 -day notice .",
"options": {
"D": "30",
"A": "368",
"B": "369",
"C": "a 374 high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In cases where the quality problem may foreseeably compromise safety (high process risk) , ____ the level of assurance should be commensurate with the medical device risk .In\ncases where the 378 quality problem may not foreseeably compromise safety (not high process risk) , the level of 379 assurance rigor should be commensurate with the process risk.",
"reference": "In cases where the quality problem may foreseeably compromise safety (high process risk) , 377 the level of assurance should be commensurate with the medical device risk .In\ncases where the 378 quality problem may not foreseeably compromise safety (not high process risk) , the level of 379 assurance rigor should be commensurate with the process risk.",
"options": {
"C": "377",
"A": "368",
"B": "369",
"D": "a 374 high process risk"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In cases where the quality problem may foreseeably compromise safety (high process risk) , 377 the level of assurance should be commensurate with the medical device risk .In\ncases where the ____ quality problem may not foreseeably compromise safety (not high process risk) , the level of 379 assurance rigor should be commensurate with the process risk.",
"reference": "In cases where the quality problem may foreseeably compromise safety (high process risk) , 377 the level of assurance should be commensurate with the medical device risk .In\ncases where the 378 quality problem may not foreseeably compromise safety (not high process risk) , the level of 379 assurance rigor should be commensurate with the process risk.",
"options": {
"D": "378",
"A": "368",
"B": "369",
"C": "a 374 high process risk"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: If so, c hanges ____ affecting this specific operation would require a 30 -day notice .",
"reference": "If so, c hanges 370 affecting this specific operation would require a 30 -day notice .",
"options": {
"C": "370",
"A": "368",
"B": "369",
"D": "a 374 high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If so, c hanges 370 affecting this specific operation would require a ____ -day notice .",
"reference": "If so, c hanges 370 affecting this specific operation would require a 30 -day notice .",
"options": {
"C": "30",
"A": "368",
"B": "369",
"D": "a 374 high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If so, c hanges ____ affecting this specific operation would require a 30 -day notice .",
"reference": "If so, c hanges 370 affecting this specific operation would require a 30 -day notice .",
"options": {
"A": "370",
"B": "368",
"C": "369",
"D": "a 374 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If so, c hanges 370 affecting this specific operation would require a ____ -day notice .",
"reference": "If so, c hanges 370 affecting this specific operation would require a 30 -day notice .",
"options": {
"B": "30",
"A": "368",
"C": "369",
"D": "a 374 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In either cas e, heightened risksof ____ software features, functions, or operations gen erally entail greater rigor , i.e., a greater amount of 381 objective evidence .",
"reference": "In either cas e, heightened risksof 380 software features, functions, or operations gen erally entail greater rigor , i.e., a greater amount of 381 objective evidence .",
"options": {
"A": "380",
"B": "368",
"C": "369",
"D": "a 374 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In either cas e, heightened risksof 380 software features, functions, or operations gen erally entail greater rigor , i.e., a greater amount of ____ objective evidence .",
"reference": "In either cas e, heightened risksof 380 software features, functions, or operations gen erally entail greater rigor , i.e., a greater amount of 381 objective evidence .",
"options": {
"A": "381",
"B": "368",
"C": "369",
"D": "a 374 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Changes in manufacturing/sterilization site or to design or performance specifications do not qualify for a ____ -day notice.",
"reference": "Changes in manufacturing/sterilization site or to design or performance specifications do not qualify for a 30 -day notice.",
"options": {
"C": "30",
"A": "368",
"B": "369",
"D": "a 374 high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In contrast, an MES used to automatically control ...'?",
"reference": "In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"options": {
"B": "MES",
"A": "CFR 814.39(b",
"C": "814.126(b",
"D": "a 374 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'In contrast, an MES used to automatically control ...'?",
"reference": "In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"options": {
"C": "e. g.",
"A": "a 374 high process risk",
"B": "the medical device risk .In\ncases",
"D": "MES"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In contrast, an MES used to automatically control and adjust established critical ____ production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"reference": "In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"options": {
"D": "368",
"A": "369",
"B": "370",
"C": "a 374 high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In contrast, an MES used to automatically control ...'?",
"reference": "In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"options": {
"B": "MES",
"A": "CFR 814.39(b",
"C": "814.126(b",
"D": "a 374 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'In contrast, an MES used to automatically control ...'?",
"reference": "In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"options": {
"D": "e. g.",
"A": "a 374 high process risk",
"B": "the medical device risk .In\ncases",
"C": "MES"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In contrast, an MES used to automatically control and adjust established critical ____ production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"reference": "In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"options": {
"D": "368",
"A": "369",
"B": "370",
"C": "a 374 high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a ____ manufacturing procedure that affects the safety or effectiveness of the device.",
"reference": "In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"options": {
"A": "369",
"B": "368",
"C": "370",
"D": "a 374 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In contrast, an MES used to automatically control ...'?",
"reference": "In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"options": {
"B": "MES",
"A": "CFR 814.39(b",
"C": "814.126(b",
"D": "a 374 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'In contrast, an MES used to automatically control ...'?",
"reference": "In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"options": {
"A": "e. g.",
"B": "a 374 high process risk",
"C": "the medical device risk .In\ncases",
"D": "MES"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In contrast, an MES used to automatically control and adjust established critical ____ production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"reference": "In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"options": {
"C": "368",
"A": "369",
"B": "370",
"D": "a 374 high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a ____ manufacturing procedure that affects the safety or effectiveness of the device.",
"reference": "In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"options": {
"C": "369",
"A": "368",
"B": "370",
"D": "a 374 high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In contrast, an MES used to automatically control ...'?",
"reference": "In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"options": {
"C": "MES",
"A": "CFR 814.39(b",
"B": "814.126(b",
"D": "a 374 high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'In contrast, an MES used to automatically control ...'?",
"reference": "In contrast, an MES used to automatically control and adjust established critical 368 production parameters (e. g.,temperature, pressure, process time) may be a change to a 369 manufacturing procedure that affects the safety or effectiveness of the device.",
"options": {
"D": "e. g.",
"A": "a 374 high process risk",
"B": "the medical device risk .In\ncases",
"C": "MES"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In cases where the quality problem may foreseeably compromise safety (high process risk) , ____ the level of assurance should be commensurate with the medical device risk .In\ncases where the 378 quality problem may not foreseeably compromise safety (not high process risk) , the level of 379 assurance rigor should be commensurate with the process risk.",
"reference": "In cases where the quality problem may foreseeably compromise safety (high process risk) , 377 the level of assurance should be commensurate with the medical device risk .In\ncases where the 378 quality problem may not foreseeably compromise safety (not high process risk) , the level of 379 assurance rigor should be commensurate with the process risk.",
"options": {
"D": "377",
"A": "368",
"B": "369",
"C": "a 374 high process risk"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In cases where the quality problem may foreseeably compromise safety (high process risk) , 377 the level of assurance should be commensurate with the medical device risk .In\ncases where the ____ quality problem may not foreseeably compromise safety (not high process risk) , the level of 379 assurance rigor should be commensurate with the process risk.",
"reference": "In cases where the quality problem may foreseeably compromise safety (high process risk) , 377 the level of assurance should be commensurate with the medical device risk .In\ncases where the 378 quality problem may not foreseeably compromise safety (not high process risk) , the level of 379 assurance rigor should be commensurate with the process risk.",
"options": {
"A": "378",
"B": "368",
"C": "369",
"D": "a 374 high process risk"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In cases where the quality problem may foreseeably compromise safety (high process risk) , 377 the level of assurance should be commensurate with the medical device risk .In\ncases where the 378 quality problem may not foreseeably compromise safety (not high process risk) , the level of ____ assurance rigor should be commensurate with the process risk.",
"reference": "In cases where the quality problem may foreseeably compromise safety (high process risk) , 377 the level of assurance should be commensurate with the medical device risk .In\ncases where the 378 quality problem may not foreseeably compromise safety (not high process risk) , the level of 379 assurance rigor should be commensurate with the process risk.",
"options": {
"C": "379",
"A": "368",
"B": "369",
"D": "a 374 high process risk"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In either cas e, heightened risksof ____ software features, functions, or operations gen erally entail greater rigor , i.e., a greater amount of 381 objective evidence .",
"reference": "In either cas e, heightened risksof 380 software features, functions, or operations gen erally entail greater rigor , i.e., a greater amount of 381 objective evidence .",
"options": {
"A": "380",
"B": "368",
"C": "369",
"D": "a 374 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In either cas e, heightened risksof 380 software features, functions, or operations gen erally entail greater rigor , i.e., a greater amount of ____ objective evidence .",
"reference": "In either cas e, heightened risksof 380 software features, functions, or operations gen erally entail greater rigor , i.e., a greater amount of 381 objective evidence .",
"options": {
"A": "381",
"B": "368",
"C": "369",
"D": "a 374 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Changes in manufacturing/sterilization site or to design or performance specifications do not qualify for a ____ -day notice.",
"reference": "Changes in manufacturing/sterilization site or to design or performance specifications do not qualify for a 30 -day notice.",
"options": {
"B": "30",
"A": "368",
"C": "369",
"D": "a 374 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation ____ Determining the Appropriate Assurance Activities 373\nOnce the manufacturer has determined whether a software feature, function, or operation poses a 374 high process risk (a quality problem that may foreseeably compromise safety) ,the manufacturer 375 should identify theassurance activities commensu rate with the medical device risk or the process 376 risk.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 13 Determining the Appropriate Assurance Activities 373\nOnce the manufacturer has determined whether a software feature, function, or operation poses a 374 high process risk (a quality problem that may foreseeably compromise safety) ,the manufacturer 375 should identify theassurance activities commensu rate with the medical device risk or the process 376 risk.",
"options": {
"B": "13",
"A": "368",
"C": "369",
"D": "a 374 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 13 Determining the Appropriate Assurance Activities ____\nOnce the manufacturer has determined whether a software feature, function, or operation poses a 374 high process risk (a quality problem that may foreseeably compromise safety) ,the manufacturer 375 should identify theassurance activities commensu rate with the medical device risk or the process 376 risk.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 13 Determining the Appropriate Assurance Activities 373\nOnce the manufacturer has determined whether a software feature, function, or operation poses a 374 high process risk (a quality problem that may foreseeably compromise safety) ,the manufacturer 375 should identify theassurance activities commensu rate with the medical device risk or the process 376 risk.",
"options": {
"A": "373",
"B": "368",
"C": "369",
"D": "a 374 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 13 Determining the Appropriate Assurance Activities 373\nOnce the manufacturer has determined whether a software feature, function, or operation poses a ____ high process risk (a quality problem that may foreseeably compromise safety) ,the manufacturer 375 should identify theassurance activities commensu rate with the medical device risk or the process 376 risk.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 13 Determining the Appropriate Assurance Activities 373\nOnce the manufacturer has determined whether a software feature, function, or operation poses a 374 high process risk (a quality problem that may foreseeably compromise safety) ,the manufacturer 375 should identify theassurance activities commensu rate with the medical device risk or the process 376 risk.",
"options": {
"D": "374",
"A": "368",
"B": "369",
"C": "the medical device risk .In\ncases"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 13 Determining the Appropriate Assurance Activities 373\nOnce the manufacturer has determined whether a software feature, function, or operation poses a 374 high process risk (a quality problem that may foreseeably compromise safety) ,the manufacturer ____ should identify theassurance activities commensu rate with the medical device risk or the process 376 risk.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 13 Determining the Appropriate Assurance Activities 373\nOnce the manufacturer has determined whether a software feature, function, or operation poses a 374 high process risk (a quality problem that may foreseeably compromise safety) ,the manufacturer 375 should identify theassurance activities commensu rate with the medical device risk or the process 376 risk.",
"options": {
"D": "375",
"A": "368",
"B": "369",
"C": "a 374 high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 10 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance. The device manufacturer has latitude and flexibility in defining how validation of that software will be accomplished, but validation should be a key consideration in deciding how and by whom the software will be developed or from whom it will be purchased. The software developer defines a life cycle model. Validation is typically supported by: verifications of the outputs from each stage of that software development life cycle; and checking for proper operation of the finished software in the device manufacturers intended use environment. HOW MUCH VALIDATION EVIDENCE IS NEEDED? The level of validation effort should be commensurate with the risk posed by the automated operation. In addition to risk other factors, such as the complexity of the process software and the degree to which the device manufacturer is dependent upon that automated process to produce a safe and effective device, determine the nature and extent of testing needed as part of the validation effort. Documented requirements and risk analysis of the automated process help to define the scope of the evidence needed to show that the software is validated for its intended use. For example, an automated milling machine may require very little testing if the device manufacturer can show that the output of the operation is subsequently fully verified against the specification before release.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "What is developer?",
"reference": "The software developer defines a life cycle model.",
"options": {
"A": "model",
"B": "Software Validation Guidance",
"C": "that software development life cycle",
"D": "pattern"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"B": "Page 31General Principles of Software Validation Guidance for Industry",
"A": "that software development life cycle",
"C": "the process software",
"D": "FDA"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"D": "FDA",
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"B": "Software Validation Guidance",
"C": "that software development life cycle"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
How does FDA use the terms static and dynamic as they relate to record formats? For the purpose s of this guidance, static is used to indicate a fixed -data record such as a paper record or a n electronic image, and dynamic means that the record format allows interaction between the user and the record content. For example, a dynamic chromatographic record may allow the user to change the baseline and reprocess chromatographic data so that the resulting peaks may appear smaller or larger . It also may allow the user to modify formulas or entries i n a spreadsheet used to compute test results or other information such as calculated yield . e. How does FDA use the term backup in 211.68(b)? FDA uses the term backup in 211.68(b) to refer to a true copy of the original record that is maintained securely throughout the record retention period ( e.g., 211.180). Backup data must be exact, complete , and secure from alteration, inadvert ent erasures, or loss ( 211.68(b)) . The backup file should contain the data (which includes associated metadata) and should be in the original format or in a format compatible with the original format. FDAs use of the term backup is consistent with the term archive as used in guidance for industry and FDA staff General Principles of Software Validation. Temporary backup copies ( e.g., in case of a computer crash or other interruption) would not satisfy the requirement in 211.68( b) to maintain a backup file of data. What are the systems in computer or related systems in 211.68? The American National Standards Institute (ANSI) defines systems as people, machines, and methods organized to accomplish a set of specific func tions. 7 Computer or related systems can refer to computer hardware, software, peripheral devices, networks , cloud infrastructure , personnel , and associated documents (e.g.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: What are the systems in computer or related systems in ____?",
"reference": "What are the systems in computer or related systems in 211.68?",
"options": {
"C": "211.68",
"A": "211.68(b",
"B": "Backup data",
"D": "the record format"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Computer or related systems can refer to computer hardware, software, peripheral devices, networks , cloud infrastructure , personnel , and associated documents (e.g.",
"reference": "7 Computer or related systems can refer to computer hardware, software, peripheral devices, networks , cloud infrastructure , personnel , and associated documents (e.g.",
"options": {
"A": "7",
"B": "211.68(b",
"C": "Backup data",
"D": "the record format"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Computer or related systems can refer to computer hardware, software, peripheral devices, networks , cloud infrastructure , personnel , and associated documents (e.g.",
"reference": "7 Computer or related systems can refer to computer hardware, software, peripheral devices, networks , cloud infrastructure , personnel , and associated documents (e.g.",
"options": {
"B": "7",
"A": "211.68(b",
"C": "Backup data",
"D": "the record format"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDAs use of the term backup is consistent with the...'?",
"reference": "FDAs use of the term backup is consistent with the term archive as used in guidance for industry and FDA staff General Principles of Software Validation.",
"options": {
"C": "FDA",
"A": "e. How does",
"B": "The American National Standards Institute",
"D": "Backup data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Computer or related systems can refer to computer hardware, software, peripheral devices, networks , cloud infrastructure , personnel , and associated documents (e.g.",
"reference": "7 Computer or related systems can refer to computer hardware, software, peripheral devices, networks , cloud infrastructure , personnel , and associated documents (e.g.",
"options": {
"C": "7",
"A": "211.68(b",
"B": "Backup data",
"D": "the record format"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'e. How does FDA use the term backup in 211.68(b)...'?",
"reference": "e. How does FDA use the term backup in 211.68(b)?",
"options": {
"D": "FDA",
"A": "e. How does",
"B": "The American National Standards Institute",
"C": "Backup data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: Temporary backup copies ( e.g., in case of a computer crash or other interruption) would not satisfy the requirement in ____( b) to maintain a backup file of data.",
"reference": "Temporary backup copies ( e.g., in case of a computer crash or other interruption) would not satisfy the requirement in 211.68( b) to maintain a backup file of data.",
"options": {
"C": "211.68",
"A": "211.68(b",
"B": "Backup data",
"D": "the record format"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Temporary backup copies ( e.g., in case of a computer crash or other interruption) would not satisfy the requirement in ____( b) to maintain a backup file of data.",
"reference": "Temporary backup copies ( e.g., in case of a computer crash or other interruption) would not satisfy the requirement in 211.68( b) to maintain a backup file of data.",
"options": {
"B": "211.68",
"A": "211.68(b",
"C": "Backup data",
"D": "the record format"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Temporary backup copies ( e.g., in case of a computer crash or other interruption) would not satisfy the requirement in ____( b) to maintain a backup file of data.",
"reference": "Temporary backup copies ( e.g., in case of a computer crash or other interruption) would not satisfy the requirement in 211.68( b) to maintain a backup file of data.",
"options": {
"D": "211.68",
"A": "211.68(b",
"B": "Backup data",
"C": "the record format"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: What are the systems in computer or related systems in ____?",
"reference": "What are the systems in computer or related systems in 211.68?",
"options": {
"A": "211.68",
"B": "211.68(b",
"C": "Backup data",
"D": "the record format"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'How does FDA use the terms static and dynamic as t...'?",
"reference": "How does FDA use the terms static and dynamic as they relate to record formats?",
"options": {
"C": "FDA",
"A": "e. How does",
"B": "The American National Standards Institute",
"D": "Backup data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'FDAs use of the term backup is consistent with the...'?",
"reference": "FDAs use of the term backup is consistent with the term archive as used in guidance for industry and FDA staff General Principles of Software Validation.",
"options": {
"A": "FDA",
"B": "e. How does",
"C": "The American National Standards Institute",
"D": "Backup data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'How does FDA use the terms static and dynamic as t...'?",
"reference": "How does FDA use the terms static and dynamic as they relate to record formats?",
"options": {
"C": "FDA",
"A": "e. How does",
"B": "The American National Standards Institute",
"D": "Backup data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'e. How does FDA use the term backup in 211.68(b)...'?",
"reference": "e. How does FDA use the term backup in 211.68(b)?",
"options": {
"A": "FDA",
"B": "e. How does",
"C": "The American National Standards Institute",
"D": "Backup data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'FDA uses the term backup in 211.68(b) to refer to...'?",
"reference": "FDA uses the term backup in 211.68(b) to refer to a true copy of the original record that is maintained securely throughout the record retention period ( e.g., 211.180).",
"options": {
"B": "FDA",
"A": "e. How does",
"C": "The American National Standards Institute",
"D": "Backup data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA uses the term backup in 211.68(b) to refer to a true copy of the original record that is maintained securely throughout the record retention period ( e.g., ____).",
"reference": "FDA uses the term backup in 211.68(b) to refer to a true copy of the original record that is maintained securely throughout the record retention period ( e.g., 211.180).",
"options": {
"C": "211.180",
"A": "211.68(b",
"B": "Backup data",
"D": "the record format"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'How does FDA use the terms static and dynamic as t...'?",
"reference": "How does FDA use the terms static and dynamic as they relate to record formats?",
"options": {
"D": "FDA",
"A": "e. How does",
"B": "The American National Standards Institute",
"C": "Backup data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: Temporary backup copies ( e.g., in case of a computer crash or other interruption) would not satisfy the requirement in ____( b) to maintain a backup file of data.",
"reference": "Temporary backup copies ( e.g., in case of a computer crash or other interruption) would not satisfy the requirement in 211.68( b) to maintain a backup file of data.",
"options": {
"A": "211.68",
"B": "211.68(b",
"C": "Backup data",
"D": "the record format"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Temporary backup copies ( e.g., in case of a computer crash or other interruption) would not satisfy the requirement in ____( b) to maintain a backup file of data.",
"reference": "Temporary backup copies ( e.g., in case of a computer crash or other interruption) would not satisfy the requirement in 211.68( b) to maintain a backup file of data.",
"options": {
"D": "211.68",
"A": "211.68(b",
"B": "Backup data",
"C": "the record format"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDAs use of the term backup is consistent with the...'?",
"reference": "FDAs use of the term backup is consistent with the term archive as used in guidance for industry and FDA staff General Principles of Software Validation.",
"options": {
"A": "FDA",
"B": "e. How does",
"C": "The American National Standards Institute",
"D": "Backup data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The American National Standards Institute (ANSI) d...'?",
"reference": "The American National Standards Institute (ANSI) defines systems as people, machines, and methods organized to accomplish a set of specific func tions.",
"options": {
"D": "The American National Standards Institute",
"A": "FDA",
"B": "e. How does",
"C": "Backup data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The American National Standards Institute (ANSI) d...'?",
"reference": "The American National Standards Institute (ANSI) defines systems as people, machines, and methods organized to accomplish a set of specific func tions.",
"options": {
"C": "ANSI",
"A": "FDA",
"B": "e. How does",
"D": "Backup data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is Institute?",
"reference": "The American National Standards Institute (ANSI) defines systems as people, machines, and methods organized to accomplish a set of specific func tions.",
"options": {
"D": "systems",
"A": "Backup data",
"B": "the record format",
"C": "organisation"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA uses the term backup in 211.68(b) to refer to...'?",
"reference": "FDA uses the term backup in 211.68(b) to refer to a true copy of the original record that is maintained securely throughout the record retention period ( e.g., 211.180).",
"options": {
"B": "FDA",
"A": "e. How does",
"C": "The American National Standards Institute",
"D": "Backup data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA uses the term backup in 211.68(b) to refer to a true copy of the original record that is maintained securely throughout the record retention period ( e.g., ____).",
"reference": "FDA uses the term backup in 211.68(b) to refer to a true copy of the original record that is maintained securely throughout the record retention period ( e.g., 211.180).",
"options": {
"D": "211.180",
"A": "211.68(b",
"B": "Backup data",
"C": "the record format"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'How does FDA use the terms static and dynamic as t...'?",
"reference": "How does FDA use the terms static and dynamic as they relate to record formats?",
"options": {
"D": "FDA",
"A": "e. How does",
"B": "The American National Standards Institute",
"C": "Backup data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'FDAs use of the term backup is consistent with the...'?",
"reference": "FDAs use of the term backup is consistent with the term archive as used in guidance for industry and FDA staff General Principles of Software Validation.",
"options": {
"C": "FDA",
"A": "e. How does",
"B": "The American National Standards Institute",
"D": "Backup data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'How does FDA use the terms static and dynamic as t...'?",
"reference": "How does FDA use the terms static and dynamic as they relate to record formats?",
"options": {
"D": "FDA",
"A": "e. How does",
"B": "The American National Standards Institute",
"C": "Backup data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ____ Computer or related systems can refer to computer hardware, software, peripheral devices, networks , cloud infrastructure , personnel , and associated documents (e.g.",
"reference": "7 Computer or related systems can refer to computer hardware, software, peripheral devices, networks , cloud infrastructure , personnel , and associated documents (e.g.",
"options": {
"B": "7",
"A": "211.68(b",
"C": "Backup data",
"D": "the record format"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The American National Standards Institute (ANSI) d...'?",
"reference": "The American National Standards Institute (ANSI) defines systems as people, machines, and methods organized to accomplish a set of specific func tions.",
"options": {
"D": "The American National Standards Institute",
"A": "FDA",
"B": "e. How does",
"C": "Backup data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 7 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
On the other hand, extensive testing may be needed for: a plant-wide electronic record and electronic signature system; an automated controller for a sterilization cycle; or automated test equipment used for inspection and acceptance of finished circuit boards in a life- sustaining / life-supporting device. Numerous commercial software applications may be used as part of the quality system (e.g., a spreadsheet or statistical package used for quality system calculations, a graphics package used for trend analysis, or a commercial database used for recording device history records or for complaint management). The extent of validation evidence needed for such software depends on the device manufacturers documented intended use of that software. For example, a device manufacturer who chooses not to use all the vendor-supplied capabilities of the software only needs to validate those functions that will be used and for which the device manufacturer is dependent upon the software results as part of production or the quality system. However, high risk applications should not be running in the same operating environment with non-validated software functions, even if those software functions are not used. Risk mitigation techniques such as memory partitioning or other approaches to resource protection may need to be considered when high risk applications and lower risk applications are to be used in the same operating environment. When software is upgraded or any changes are made to the software, the device manufacturer should consider how those changes may impact the used portions of the software and must reconfirm the validation of those portions of the software that are used. (See 21 CFR 820.70(i).) Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Page 32General Principles of Software Validation G...'?",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"D": "FDA",
"A": "Numerous commercial software applications",
"B": "Software Validation Guidance",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"C": "6.2",
"A": "Numerous commercial software applications",
"B": "Software Validation Guidance",
"D": "FDA"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 32General Principles of Software Validation G...'?",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"B": "FDA",
"A": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"A": "6.2",
"B": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "FDA"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 32General Principles of Software Validation G...'?",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"C": "FDA",
"A": "Numerous commercial software applications",
"B": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"A": "6.2",
"B": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "FDA"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 7 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
FDA Compliance Policy Guide 7132c.08 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingred ients Subject to Pre-Market Approva l, updated 03-12-2004 http://www.fda.gov/ora/complianc e_ref/cpg/cpgdrg/cpg490-100.html 7. Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice September 2004. See also the draft guidance on investigating Out-of-Specification ( OOS) Test Results for Ph armaceutical Production. FDA Compliance Policy Guide Sec. 130.300, FDA Access to Results of Quality Assurance Program Audits and Inspections , (CPG 7151.02)
http://www.fda.gov/ora/compliance_ref/c pg/cpggenl/cpg130-300.html 9. Criteria for Performance Excellence, Business (Baldrige National Quality Program, NIST 2003) http://baldrige.nist.gov/PDF_
files/2003_Business_Criteria.pdf 10. ANSI/ISO/ASQ Q9001-2000: Quality management systems Requirements (American Society for Quality, 2000) 11. ANSI/ISO/ASQ Q9004-2000: Quality management systems Guidelines for performance improvement (American Society for Quality, 2000) 12. ANSI/ISO 17025-1999: General requirements for the competence of testing an d calibration laboratories (American Society for Quality, 1999) 13. CMMI-SE/SW, V1.1: Capability Maturity Model Integr ation for Systems Engineering and Software Engineering, Staged Representation (Software Engineering Institute, Carnegie Mellon University, 2002) http://www.sei.cmu.edu/pub/docum
ents/02.reports/pdf/02tr002.pdf 14. The Balanced Scorecard Institute: http://balancedscorecard.org 15. Guidance for Developing Quality Systems for Environmental Program (EPA QA/G-1, Nov 2002) http://www.epa.gov/qual ity/qs-docs/g1-final.pdf 16. Guidance for Industry Q7A
Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (U.S. Department of Health and Human Services/ Food and Drug Administration, August 2001) . 25 Contains Nonbinding Recommendations 17.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: ____ Contains Nonbinding Recommendations 17.",
"reference": "25 Contains Nonbinding Recommendations 17.",
"options": {
"A": "25",
"B": "03-12-2004",
"C": "130.300",
"D": "Quality management systems Requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 25 Contains Nonbinding Recommendations ____.",
"reference": "25 Contains Nonbinding Recommendations 17.",
"options": {
"A": "17",
"B": "03-12-2004",
"C": "130.300",
"D": "Quality management systems Requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ANSI/ISO 17025-1999: General requirements for the ...'?",
"reference": "ANSI/ISO 17025-1999: General requirements for the competence of testing an d calibration laboratories (American Society for Quality, 1999) 13.",
"options": {
"A": "ANSI",
"B": "FDA Compliance Policy Guide 7132c.08 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingred",
"C": "Industry - Sterile Drug Products",
"D": "Quality management systems Requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'ANSI/ISO 17025-1999: General requirements for the ...'?",
"reference": "ANSI/ISO 17025-1999: General requirements for the competence of testing an d calibration laboratories (American Society for Quality, 1999) 13.",
"options": {
"A": "17025-1999",
"B": "September 2004",
"C": "300.html 9",
"D": "Quality management systems Requirements"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ANSI/ISO 17025-1999: General requirements for the ...'?",
"reference": "ANSI/ISO 17025-1999: General requirements for the competence of testing an d calibration laboratories (American Society for Quality, 1999) 13.",
"options": {
"A": "American Society for Quality",
"B": "FDA Compliance Policy Guide 7132c.08 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingred",
"C": "Industry - Sterile Drug Products",
"D": "Quality management systems Requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'ANSI/ISO 17025-1999: General requirements for the ...'?",
"reference": "ANSI/ISO 17025-1999: General requirements for the competence of testing an d calibration laboratories (American Society for Quality, 1999) 13.",
"options": {
"D": "1999",
"A": "September 2004",
"B": "300.html 9",
"C": "Quality management systems Requirements"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ANSI/ISO ____-1999: General requirements for the competence of testing an d calibration laboratories (American Society for Quality, 1999) 13.",
"reference": "ANSI/ISO 17025-1999: General requirements for the competence of testing an d calibration laboratories (American Society for Quality, 1999) 13.",
"options": {
"D": "17025",
"A": "September 2004",
"B": "300.html 9",
"C": "Quality management systems Requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Address Nonconformities Discrepancy investigation: 211.22(a), 211.100, 211.115, 211.192, 211.198 Recalls: 21 CFR Part 7 D. Evaluation Activities As in the previous section, the elements of a quality system correlate closely with the requirements in the CGMP regulations. See the ta ble at the end of the section for the specifics. 1. Analyze Data for Trends Quality systems call for continually monitoring trends and improving systems. This can be achieved by monitoring data and informati on, identifying and resolving problems, and anticipating and pr eventing problems. Quality systems procedures involve collecting data from monitoring, measurement, complaint handling, or other activities, and tr acking this data over time, as a ppropriate. Analysis of data can provide indications that controls are losing e ffectiveness. The information generated will be essential to achieving problem resoluti on or problem prevention (see IV.D.3.). Although the CGMP regulations ( 211.180(e)) require product review on at least an annual basis, a quality systems approach calls for tren ding on a more frequent basis as determined by risk. Trending enables the detec tion of potential problems as early as possible to plan corrective and preventive actions. Another important conc ept of modern quality systems is the use of trending to examine processes as a whole; this is consistent with the a nnual review approach. Trending analyses can help focus internal audits (see IV.D.2.). 2. Conduct Internal Audits
A quality systems approach calls for audits to be conducted at planned intervals to evaluate effective implementation and maintenance of the quality system and to determine if processes and products meet established parameters and sp ecifications.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Although the CGMP regulations ( 211.180(e)) requir...'?",
"reference": "Although the CGMP regulations ( 211.180(e)) require product review on at least an annual basis, a quality systems approach calls for tren ding on a more frequent basis as determined by risk.",
"options": {
"A": "CGMP",
"B": "CFR",
"C": "7 D. Evaluation Activities",
"D": "a quality systems approach"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Although the CGMP regulations ( 211.180(e)) requir...'?",
"reference": "Although the CGMP regulations ( 211.180(e)) require product review on at least an annual basis, a quality systems approach calls for tren ding on a more frequent basis as determined by risk.",
"options": {
"A": "annual",
"B": "a quality systems approach",
"C": "A quality systems approach",
"D": "yearly"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Analyze Data for Trends Quality systems call for c...'?",
"reference": "Analyze Data for Trends Quality systems call for continually monitoring trends and improving systems.",
"options": {
"A": "Analyze Data",
"B": "CFR",
"C": "7 D. Evaluation Activities",
"D": "a quality systems approach"
},
"answer": "A",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Although the CGMP regulations ( 211.180(e)) requir...'?",
"reference": "Although the CGMP regulations ( 211.180(e)) require product review on at least an annual basis, a quality systems approach calls for tren ding on a more frequent basis as determined by risk.",
"options": {
"D": "CGMP",
"A": "CFR",
"B": "7 D. Evaluation Activities",
"C": "a quality systems approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Although the CGMP regulations ( 211.180(e)) requir...'?",
"reference": "Although the CGMP regulations ( 211.180(e)) require product review on at least an annual basis, a quality systems approach calls for tren ding on a more frequent basis as determined by risk.",
"options": {
"A": "annual",
"B": "a quality systems approach",
"C": "A quality systems approach",
"D": "yearly"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Although the CGMP regulations ( 211.180(e)) requir...'?",
"reference": "Although the CGMP regulations ( 211.180(e)) require product review on at least an annual basis, a quality systems approach calls for tren ding on a more frequent basis as determined by risk.",
"options": {
"C": "CGMP",
"A": "CFR",
"B": "7 D. Evaluation Activities",
"D": "a quality systems approach"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Although the CGMP regulations ( 211.180(e)) requir...'?",
"reference": "Although the CGMP regulations ( 211.180(e)) require product review on at least an annual basis, a quality systems approach calls for tren ding on a more frequent basis as determined by risk.",
"options": {
"B": "annual",
"A": "a quality systems approach",
"C": "A quality systems approach",
"D": "yearly"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Address Nonconformities Discrepancy investigation:...'?",
"reference": "Address Nonconformities Discrepancy investigation: 211.22(a), 211.100, 211.115, 211.192, 211.198 Recalls: 21 CFR Part 7 D. Evaluation Activities As in the previous section, the elements of a quality system correlate closely with the requirements in the CGMP regulations.",
"options": {
"A": "CFR",
"B": "7 D. Evaluation Activities",
"C": "CGMP",
"D": "a quality systems approach"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Address Nonconformities Discrepancy investigation:...'?",
"reference": "Address Nonconformities Discrepancy investigation: 211.22(a), 211.100, 211.115, 211.192, 211.198 Recalls: 21 CFR Part 7 D. Evaluation Activities As in the previous section, the elements of a quality system correlate closely with the requirements in the CGMP regulations.",
"options": {
"D": "7 D. Evaluation Activities",
"A": "CFR",
"B": "CGMP",
"C": "a quality systems approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Address Nonconformities Discrepancy investigation:...'?",
"reference": "Address Nonconformities Discrepancy investigation: 211.22(a), 211.100, 211.115, 211.192, 211.198 Recalls: 21 CFR Part 7 D. Evaluation Activities As in the previous section, the elements of a quality system correlate closely with the requirements in the CGMP regulations.",
"options": {
"A": "CGMP",
"B": "CFR",
"C": "7 D. Evaluation Activities",
"D": "a quality systems approach"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Analyze Data for Trends Quality systems call for c...'?",
"reference": "Analyze Data for Trends Quality systems call for continually monitoring trends and improving systems.",
"options": {
"C": "Analyze Data",
"A": "CFR",
"B": "7 D. Evaluation Activities",
"D": "a quality systems approach"
},
"answer": "C",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Although the CGMP regulations ( 211.180(e)) requir...'?",
"reference": "Although the CGMP regulations ( 211.180(e)) require product review on at least an annual basis, a quality systems approach calls for tren ding on a more frequent basis as determined by risk.",
"options": {
"C": "CGMP",
"A": "CFR",
"B": "7 D. Evaluation Activities",
"D": "a quality systems approach"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Although the CGMP regulations ( 211.180(e)) requir...'?",
"reference": "Although the CGMP regulations ( 211.180(e)) require product review on at least an annual basis, a quality systems approach calls for tren ding on a more frequent basis as determined by risk.",
"options": {
"D": "annual",
"A": "a quality systems approach",
"B": "A quality systems approach",
"C": "yearly"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Address Nonconformities Discrepancy investigation:...'?",
"reference": "Address Nonconformities Discrepancy investigation: 211.22(a), 211.100, 211.115, 211.192, 211.198 Recalls: 21 CFR Part 7 D. Evaluation Activities As in the previous section, the elements of a quality system correlate closely with the requirements in the CGMP regulations.",
"options": {
"D": "CFR",
"A": "7 D. Evaluation Activities",
"B": "CGMP",
"C": "a quality systems approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Address Nonconformities Discrepancy investigation:...'?",
"reference": "Address Nonconformities Discrepancy investigation: 211.22(a), 211.100, 211.115, 211.192, 211.198 Recalls: 21 CFR Part 7 D. Evaluation Activities As in the previous section, the elements of a quality system correlate closely with the requirements in the CGMP regulations.",
"options": {
"D": "7 D. Evaluation Activities",
"A": "CFR",
"B": "CGMP",
"C": "a quality systems approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Address Nonconformities Discrepancy investigation:...'?",
"reference": "Address Nonconformities Discrepancy investigation: 211.22(a), 211.100, 211.115, 211.192, 211.198 Recalls: 21 CFR Part 7 D. Evaluation Activities As in the previous section, the elements of a quality system correlate closely with the requirements in the CGMP regulations.",
"options": {
"A": "CGMP",
"B": "CFR",
"C": "7 D. Evaluation Activities",
"D": "a quality systems approach"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities Discrepancy investigation: 211.22(a), ____, 211.115, 211.192, 211.198 Recalls: 21 CFR Part 7 D. Evaluation Activities As in the previous section, the elements of a quality system correlate closely with the requirements in the CGMP regulations.",
"reference": "Address Nonconformities Discrepancy investigation: 211.22(a), 211.100, 211.115, 211.192, 211.198 Recalls: 21 CFR Part 7 D. Evaluation Activities As in the previous section, the elements of a quality system correlate closely with the requirements in the CGMP regulations.",
"options": {
"B": "211.100",
"A": "211.22(a",
"C": "211.115",
"D": "a quality systems approach"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities Discrepancy investigation: 211.22(a), 211.100, ____, 211.192, 211.198 Recalls: 21 CFR Part 7 D. Evaluation Activities As in the previous section, the elements of a quality system correlate closely with the requirements in the CGMP regulations.",
"reference": "Address Nonconformities Discrepancy investigation: 211.22(a), 211.100, 211.115, 211.192, 211.198 Recalls: 21 CFR Part 7 D. Evaluation Activities As in the previous section, the elements of a quality system correlate closely with the requirements in the CGMP regulations.",
"options": {
"A": "211.115",
"B": "211.22(a",
"C": "211.100",
"D": "a quality systems approach"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities Discrepancy investigation: 211.22(a), 211.100, 211.115, ____, 211.198 Recalls: 21 CFR Part 7 D. Evaluation Activities As in the previous section, the elements of a quality system correlate closely with the requirements in the CGMP regulations.",
"reference": "Address Nonconformities Discrepancy investigation: 211.22(a), 211.100, 211.115, 211.192, 211.198 Recalls: 21 CFR Part 7 D. Evaluation Activities As in the previous section, the elements of a quality system correlate closely with the requirements in the CGMP regulations.",
"options": {
"D": "211.192",
"A": "211.22(a",
"B": "211.100",
"C": "a quality systems approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Address Nonconformities Discrepancy investigation: 211.22(a), 211.100, 211.115, 211.192, ____ Recalls: 21 CFR Part 7 D. Evaluation Activities As in the previous section, the elements of a quality system correlate closely with the requirements in the CGMP regulations.",
"reference": "Address Nonconformities Discrepancy investigation: 211.22(a), 211.100, 211.115, 211.192, 211.198 Recalls: 21 CFR Part 7 D. Evaluation Activities As in the previous section, the elements of a quality system correlate closely with the requirements in the CGMP regulations.",
"options": {
"D": "211.198",
"A": "211.22(a",
"B": "211.100",
"C": "a quality systems approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 45 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Contains Nonbinding Recommendations 4 As described in more detail below, the approach outlined in this guidance is based on three main 116 elements: 117 118 Part 11 will be interpreted narrowly; we are now clarifying that fewer recor ds will be 119 considered subject to part 11. 120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems). 125 We will enforce all predicate rule requirements, including predicate rule record an d 126 recordkeeping requirements. It is important to note that FDA's exercise of enforcement discretion as described in this 128 guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which 129 the extent of enforcement discretion, under certain circumstances, will be more broad). We 130 intend to enforce all other provisions of part 11 including, but not limited to, certain controls for 131 closed systems in 11.10.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: We ____ intend to enforce all other provisions of part 11 including, but not limited to, certain controls for 131 closed systems in 11.10.",
"reference": "We 130 intend to enforce all other provisions of part 11 including, but not limited to, certain controls for 131 closed systems in 11.10.",
"options": {
"C": "130",
"A": "three",
"B": "116",
"D": "11 123 requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: We 130 intend to enforce all other provisions of part ____ including, but not limited to, certain controls for 131 closed systems in 11.10.",
"reference": "We 130 intend to enforce all other provisions of part 11 including, but not limited to, certain controls for 131 closed systems in 11.10.",
"options": {
"D": "11",
"A": "three",
"B": "116",
"C": "all predicate rule requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: We 130 intend to enforce all other provisions of part 11 including, but not limited to, certain controls for ____ closed systems in 11.10.",
"reference": "We 130 intend to enforce all other provisions of part 11 including, but not limited to, certain controls for 131 closed systems in 11.10.",
"options": {
"B": "131",
"A": "three",
"C": "116",
"D": "11 123 requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: We 130 intend to enforce all other provisions of part 11 including, but not limited to, certain controls for 131 closed systems in ____.",
"reference": "We 130 intend to enforce all other provisions of part 11 including, but not limited to, certain controls for 131 closed systems in 11.10.",
"options": {
"A": "11.10",
"B": "three",
"C": "116",
"D": "11 123 requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: We ____ intend to enforce all other provisions of part 11 including, but not limited to, certain controls for 131 closed systems in 11.10.",
"reference": "We 130 intend to enforce all other provisions of part 11 including, but not limited to, certain controls for 131 closed systems in 11.10.",
"options": {
"B": "130",
"A": "three",
"C": "116",
"D": "11 123 requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: We 130 intend to enforce all other provisions of part ____ including, but not limited to, certain controls for 131 closed systems in 11.10.",
"reference": "We 130 intend to enforce all other provisions of part 11 including, but not limited to, certain controls for 131 closed systems in 11.10.",
"options": {
"C": "11",
"A": "three",
"B": "116",
"D": "all predicate rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: We 130 intend to enforce all other provisions of part 11 including, but not limited to, certain controls for ____ closed systems in 11.10.",
"reference": "We 130 intend to enforce all other provisions of part 11 including, but not limited to, certain controls for 131 closed systems in 11.10.",
"options": {
"B": "131",
"A": "three",
"C": "116",
"D": "11 123 requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: We 130 intend to enforce all other provisions of part 11 including, but not limited to, certain controls for 131 closed systems in ____.",
"reference": "We 130 intend to enforce all other provisions of part 11 including, but not limited to, certain controls for 131 closed systems in 11.10.",
"options": {
"C": "11.10",
"A": "three",
"B": "116",
"D": "11 123 requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"B": "120",
"A": "three",
"C": "116",
"D": "11 123 requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part ____, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"A": "11",
"B": "three",
"C": "116",
"D": "all predicate rule requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part 11, we intend to exercise enforcement ____ discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"B": "121",
"A": "three",
"C": "116",
"D": "11 123 requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It is important to note that FDA's exercise of enf...'?",
"reference": "It is important to note that FDA's exercise of enforcement discretion as described in this 128 guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which 129 the extent of enforcement discretion, under certain circumstances, will be more broad).",
"options": {
"C": "FDA",
"A": "11 123 requirements",
"B": "all predicate rule requirements",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is important to note that FDA's exercise of enforcement discretion as described in this ____ guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which 129 the extent of enforcement discretion, under certain circumstances, will be more broad).",
"reference": "It is important to note that FDA's exercise of enforcement discretion as described in this 128 guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which 129 the extent of enforcement discretion, under certain circumstances, will be more broad).",
"options": {
"B": "128",
"A": "three",
"C": "116",
"D": "11 123 requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is important to note that FDA's exercise of enforcement discretion as described in this 128 guidance is limited to specified part ____ requirements (setting aside legacy systems, as to which 129 the extent of enforcement discretion, under certain circumstances, will be more broad).",
"reference": "It is important to note that FDA's exercise of enforcement discretion as described in this 128 guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which 129 the extent of enforcement discretion, under certain circumstances, will be more broad).",
"options": {
"D": "11",
"A": "three",
"B": "116",
"C": "all predicate rule requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is important to note that FDA's exercise of enforcement discretion as described in this 128 guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which ____ the extent of enforcement discretion, under certain circumstances, will be more broad).",
"reference": "It is important to note that FDA's exercise of enforcement discretion as described in this 128 guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which 129 the extent of enforcement discretion, under certain circumstances, will be more broad).",
"options": {
"A": "129",
"B": "three",
"C": "116",
"D": "11 123 requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"B": "120",
"A": "three",
"C": "116",
"D": "11 123 requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part ____, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"C": "11",
"A": "three",
"B": "116",
"D": "all predicate rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part 11, we intend to exercise enforcement ____ discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"D": "121",
"A": "three",
"B": "116",
"C": "11 123 requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part ____, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"C": "11",
"A": "three",
"B": "116",
"D": "all predicate rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, ____ and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"B": "122",
"A": "three",
"C": "116",
"D": "11 123 requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part ____, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"B": "11",
"A": "three",
"C": "116",
"D": "all predicate rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 ____ requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"D": "123",
"A": "three",
"B": "116",
"C": "all predicate rule requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"D": "120",
"A": "three",
"B": "116",
"C": "11 123 requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part ____, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"A": "11",
"B": "three",
"C": "116",
"D": "all predicate rule requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part 11, we intend to exercise enforcement ____ discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"C": "121",
"A": "three",
"B": "116",
"D": "11 123 requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part ____, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"C": "11",
"A": "three",
"B": "116",
"D": "all predicate rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, ____ and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"C": "122",
"A": "three",
"B": "116",
"D": "11 123 requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part ____, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"B": "11",
"A": "three",
"C": "116",
"D": "all predicate rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 ____ requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"C": "123",
"A": "three",
"B": "116",
"D": "all predicate rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part ____, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"D": "11",
"A": "three",
"B": "116",
"C": "all predicate rule requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also ____ known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"B": "124",
"A": "three",
"C": "116",
"D": "11 123 requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It is important to note that FDA's exercise of enf...'?",
"reference": "It is important to note that FDA's exercise of enforcement discretion as described in this 128 guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which 129 the extent of enforcement discretion, under certain circumstances, will be more broad).",
"options": {
"C": "FDA",
"A": "11 123 requirements",
"B": "all predicate rule requirements",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is important to note that FDA's exercise of enforcement discretion as described in this ____ guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which 129 the extent of enforcement discretion, under certain circumstances, will be more broad).",
"reference": "It is important to note that FDA's exercise of enforcement discretion as described in this 128 guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which 129 the extent of enforcement discretion, under certain circumstances, will be more broad).",
"options": {
"A": "128",
"B": "three",
"C": "116",
"D": "11 123 requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"C": "120",
"A": "three",
"B": "116",
"D": "11 123 requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part ____, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"B": "11",
"A": "three",
"C": "116",
"D": "all predicate rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part 11, we intend to exercise enforcement ____ discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"C": "121",
"A": "three",
"B": "116",
"D": "11 123 requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part ____, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"C": "11",
"A": "three",
"B": "116",
"D": "all predicate rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, ____ and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"D": "122",
"A": "three",
"B": "116",
"C": "11 123 requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part ____, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"D": "11",
"A": "three",
"B": "116",
"C": "all predicate rule requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 ____ requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"C": "123",
"A": "three",
"B": "116",
"D": "all predicate rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part ____, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"C": "11",
"A": "three",
"B": "116",
"D": "all predicate rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also ____ known as legacy systems).",
"reference": "120 For those records that remain subject to part 11, we intend to exercise enforcement 121 discretion with regard to part 11 requirements for validation, audit trails, record retention, 122 and record copying in the manner de scribed in this guidance and with regard to all part 11 123 requirements for systems that were operational before the effective date of part 11 (also 124 known as legacy systems).",
"options": {
"C": "124",
"A": "three",
"B": "116",
"D": "11 123 requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It is important to note that FDA's exercise of enf...'?",
"reference": "It is important to note that FDA's exercise of enforcement discretion as described in this 128 guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which 129 the extent of enforcement discretion, under certain circumstances, will be more broad).",
"options": {
"C": "FDA",
"A": "11 123 requirements",
"B": "all predicate rule requirements",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is important to note that FDA's exercise of enforcement discretion as described in this ____ guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which 129 the extent of enforcement discretion, under certain circumstances, will be more broad).",
"reference": "It is important to note that FDA's exercise of enforcement discretion as described in this 128 guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which 129 the extent of enforcement discretion, under certain circumstances, will be more broad).",
"options": {
"A": "128",
"B": "three",
"C": "116",
"D": "11 123 requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is important to note that FDA's exercise of enforcement discretion as described in this 128 guidance is limited to specified part ____ requirements (setting aside legacy systems, as to which 129 the extent of enforcement discretion, under certain circumstances, will be more broad).",
"reference": "It is important to note that FDA's exercise of enforcement discretion as described in this 128 guidance is limited to specified part 11 requirements (setting aside legacy systems, as to which 129 the extent of enforcement discretion, under certain circumstances, will be more broad).",
"options": {
"A": "11",
"B": "three",
"C": "116",
"D": "all predicate rule requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 10 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
As described in the Part 11, Electronic 586 Records; Electronic Signatures Scope and Application guidance,16 the Agency intends to 587 exercise enforcement discretion regarding Part 11 requirements for validation of computerized 588 systems used to create, modify, maintain, or transmit electronic records (see 21 CFR 11.10(a) 589 and 11.30). In general, Part 11 applies to rec ords in electronic form that are created, modified, 590 maintained, archived, retrieved, or transmitted under any records requirements set forth in 591 Agency regulations (see 21 CFR 11.1(b)). Part 11 also applies to electronic records submitted to 592 the Agency unde r requirements of the Federal Food, Drug, and Cosmetic Act (FDC Act) and 593 the Public Health Service Act (PHS Act), even if such records are not specifically identified in 594 Agency regulations (see 21 CFR 11.1(b)). In the context of computer or automated da ta processing systems , for computer software used as 597 part of production or the quality system, a document required under Part 820 and maintained in 598 electronic form would generally be an electronic record within the meaning of Part 11 (see 21 599 CFR 11.3(b)( 6)). For example, if a document requires a signature under Part 820 and is 600 maintained in electronic form, then Part 11 applies (see, e.g., 21 CFR 820.40 (requiring 601 signatures for control of required documents)) . 602 16 https://www.fda.gov/regulatory -information/search -fda-guidance -documents/part -11-electronic -records - electronic -signatures -scope -and-application . Contains Nonbinding Recommendations Draft Not for Implementation 20Appendix A. Examples 603
The examples in this section outline possible application of the principles in this draft guidance to various software assurance 604 situations cases .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'For example, if a document requires a signature un...'?",
"reference": "For example, if a document requires a signature under Part 820 and is 600 maintained in electronic form, then Part 11 applies (see, e.g., 21 CFR 820.40 (requiring 601 signatures for control of required documents)) .",
"options": {
"D": "CFR 820.40",
"A": "Agency",
"B": "electronic records",
"C": "820"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, if a document requires a signature under Part ____ and is 600 maintained in electronic form, then Part 11 applies (see, e.g., 21 CFR 820.40 (requiring 601 signatures for control of required documents)) .",
"reference": "For example, if a document requires a signature under Part 820 and is 600 maintained in electronic form, then Part 11 applies (see, e.g., 21 CFR 820.40 (requiring 601 signatures for control of required documents)) .",
"options": {
"B": "820",
"A": "586",
"C": "587",
"D": "electronic records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, if a document requires a signature under Part 820 and is ____ maintained in electronic form, then Part 11 applies (see, e.g., 21 CFR 820.40 (requiring 601 signatures for control of required documents)) .",
"reference": "For example, if a document requires a signature under Part 820 and is 600 maintained in electronic form, then Part 11 applies (see, e.g., 21 CFR 820.40 (requiring 601 signatures for control of required documents)) .",
"options": {
"B": "600",
"A": "586",
"C": "587",
"D": "electronic records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, if a document requires a signature under Part 820 and is 600 maintained in electronic form, then Part ____ applies (see, e.g., 21 CFR 820.40 (requiring 601 signatures for control of required documents)) .",
"reference": "For example, if a document requires a signature under Part 820 and is 600 maintained in electronic form, then Part 11 applies (see, e.g., 21 CFR 820.40 (requiring 601 signatures for control of required documents)) .",
"options": {
"B": "11",
"A": "586",
"C": "587",
"D": "electronic records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, if a document requires a signature under Part 820 and is 600 maintained in electronic form, then Part 11 applies (see, e.g., ____ CFR 820.40 (requiring 601 signatures for control of required documents)) .",
"reference": "For example, if a document requires a signature under Part 820 and is 600 maintained in electronic form, then Part 11 applies (see, e.g., 21 CFR 820.40 (requiring 601 signatures for control of required documents)) .",
"options": {
"D": "21",
"A": "586",
"B": "587",
"C": "electronic records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, if a document requires a signature under Part 820 and is 600 maintained in electronic form, then Part 11 applies (see, e.g., 21 CFR ____ (requiring 601 signatures for control of required documents)) .",
"reference": "For example, if a document requires a signature under Part 820 and is 600 maintained in electronic form, then Part 11 applies (see, e.g., 21 CFR 820.40 (requiring 601 signatures for control of required documents)) .",
"options": {
"D": "820.40",
"A": "586",
"B": "587",
"C": "electronic records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, if a document requires a signature under Part 820 and is 600 maintained in electronic form, then Part 11 applies (see, e.g., 21 CFR 820.40 (requiring ____ signatures for control of required documents)) .",
"reference": "For example, if a document requires a signature under Part 820 and is 600 maintained in electronic form, then Part 11 applies (see, e.g., 21 CFR 820.40 (requiring 601 signatures for control of required documents)) .",
"options": {
"C": "601",
"A": "586",
"B": "587",
"D": "electronic records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the context of computer or automated da ta proc...'?",
"reference": "In the context of computer or automated da ta processing systems , for computer software used as 597 part of production or the quality system, a document required under Part 820 and maintained in 598 electronic form would generally be an electronic record within the meaning of Part 11 (see 21 599 CFR 11.3(b)( 6)).",
"options": {
"D": "CFR 11.3(b",
"A": "Agency",
"B": "electronic records",
"C": "597"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In the context of computer or automated da ta processing systems , for computer software used as ____ part of production or the quality system, a document required under Part 820 and maintained in 598 electronic form would generally be an electronic record within the meaning of Part 11 (see 21 599 CFR 11.3(b)( 6)).",
"reference": "In the context of computer or automated da ta processing systems , for computer software used as 597 part of production or the quality system, a document required under Part 820 and maintained in 598 electronic form would generally be an electronic record within the meaning of Part 11 (see 21 599 CFR 11.3(b)( 6)).",
"options": {
"B": "597",
"A": "586",
"C": "587",
"D": "electronic records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In the context of computer or automated da ta processing systems , for computer software used as 597 part of production or the quality system, a document required under Part ____ and maintained in 598 electronic form would generally be an electronic record within the meaning of Part 11 (see 21 599 CFR 11.3(b)( 6)).",
"reference": "In the context of computer or automated da ta processing systems , for computer software used as 597 part of production or the quality system, a document required under Part 820 and maintained in 598 electronic form would generally be an electronic record within the meaning of Part 11 (see 21 599 CFR 11.3(b)( 6)).",
"options": {
"C": "820",
"A": "586",
"B": "587",
"D": "electronic records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 8 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Under section 704(a) of the FDC Act, FDA inspections of manufacturing facilities shall extend to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs [and] nonprescription drugs intended for human use ... are adulterated or misbranded ... or otherwise bearing on violation of this chapter . Accordingly, FDA routinely requests and reviews records not intended to satisfy a CGMP requirement but which nonetheless contain CGMP information (e.g., shipping or other records that may be used to reconstruct an activity). Contains Nonbinding Recommendations 11 13. Why has FDA cited use of actual samples during s ystem s uitability or test, prep, or equilibration runs in warning letters? FDA prohibits sampling and testing with the goal of achieving a specific result or to overcome an unacceptable result ( e.g., testing different samples until the desired passing result is obtained ). This practice, also referred to as testing into compliance , is not consistent with CGMP (see the guidance for i ndustry Investigating Out -of-Specification (OOS) Test Results for Pharmaceutical Production) . In some situations, use of actual samples to perform system suitability testing has been used as a means of testing into compliance . FDA consider s it a violative practice to use an actual sample in test, prep, or equilibration runs as a means of disguising testing into compliance. According to the United States Pharmacopeia (USP), system s uitability tests must include replicate injections of a standard preparation or other standard solutions to determine if requirements for precision are satisfied (see USP General Chapter 621 Chromatography ).
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'FDA consider s it a violative practice to use an a...'?",
"reference": "FDA consider s it a violative practice to use an actual sample in test, prep, or equilibration runs as a means of disguising testing into compliance.",
"options": {
"A": "FDA",
"B": "CGMP",
"C": "actual samples",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'According to the United States Pharmacopeia (USP),...'?",
"reference": "According to the United States Pharmacopeia (USP), system s uitability tests must include replicate injections of a standard preparation or other standard solutions to determine if requirements for precision are satisfied (see USP General Chapter 621 Chromatography ).",
"options": {
"B": "the United States",
"A": "actual samples",
"C": "Chapter 621 Chromatography",
"D": "This information is not provided in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Pharmacopeia (USP), system s uitability tests must include replicate injections of a standard preparation or other standard solutions to determine if requirements for precision are satisfied (see USP General Chapter ____ Chromatography ).",
"reference": "According to the United States Pharmacopeia (USP), system s uitability tests must include replicate injections of a standard preparation or other standard solutions to determine if requirements for precision are satisfied (see USP General Chapter 621 Chromatography ).",
"options": {
"C": "621",
"A": "actual samples",
"B": "the United States",
"D": "Chapter 621 Chromatography"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'According to the United States Pharmacopeia (USP),...'?",
"reference": "According to the United States Pharmacopeia (USP), system s uitability tests must include replicate injections of a standard preparation or other standard solutions to determine if requirements for precision are satisfied (see USP General Chapter 621 Chromatography ).",
"options": {
"D": "the United States",
"A": "actual samples",
"B": "Chapter 621 Chromatography",
"C": "This information is not provided in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: According to the United States Pharmacopeia (USP), system s uitability tests must include replicate injections of a standard preparation or other standard solutions to determine if requirements for precision are satisfied (see USP General Chapter ____ Chromatography ).",
"reference": "According to the United States Pharmacopeia (USP), system s uitability tests must include replicate injections of a standard preparation or other standard solutions to determine if requirements for precision are satisfied (see USP General Chapter 621 Chromatography ).",
"options": {
"D": "621",
"A": "actual samples",
"B": "the United States",
"C": "Chapter 621 Chromatography"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This practice, also referred to as testing into co...'?",
"reference": "This practice, also referred to as testing into compliance , is not consistent with CGMP (see the guidance for i ndustry Investigating Out -of-Specification (OOS) Test Results for Pharmaceutical Production) .",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "actual samples",
"D": "Investigating Out -of-Specification"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Accordingly, FDA routinely requests and reviews re...'?",
"reference": "Accordingly, FDA routinely requests and reviews records not intended to satisfy a CGMP requirement but which nonetheless contain CGMP information (e.g., shipping or other records that may be used to reconstruct an activity).",
"options": {
"A": "FDA",
"B": "CGMP",
"C": "actual samples",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Accordingly, FDA routinely requests and reviews re...'?",
"reference": "Accordingly, FDA routinely requests and reviews records not intended to satisfy a CGMP requirement but which nonetheless contain CGMP information (e.g., shipping or other records that may be used to reconstruct an activity).",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "actual samples",
"D": "This information is not provided in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 3 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Firms may use manual (desk) checking with appropriate controls to ensure consistency and independence. Source code evaluations should be extended to verification of internal linkages between modules and layers (horizontal and vertical interfaces), and compliance with their design specifications. Documentation of the procedures used and the results of source code evaluations should be maintained as part of design verification. Page 21General Principles of Software Validation Guidance for Industry and FDA Staff A source code traceability analysis is an important tool to verify that all code is linked to established specifications and established test procedures. A source code traceability analysis should be conducted and documented to verify that: Each element of the software design specification has been implemented in code; Modules and functions implemented in code can be traced back to an element in the software design specification and to the risk analysis; Tests for modules and functions can be traced back to an element in the software design specification and to the risk analysis; and Tests for modules and functions can be traced to source code for the same modules and functions. Typical Tasks Construction or Coding Traceability Analyses Source Code to Design Specification (and vice versa) Test Cases to Source Code and to Design Specification Source Code and Source Code Documentation Evaluation Source Code Interface Analysis Test Procedure and Test Case Generation (module, integration, system, and acceptance) 5.2.5. Testing by the Software Developer Software testing entails running software products under known conditions with defined inputs and documented outcomes that can be compared to their predefined expectations. It is a time consuming, difficult, and imperfect activity. As such, it requires early planning in order to be effective and efficient. Test plans and test cases should be created as early in the software development process as feasible.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Who is mentioned in the context: 'A source code traceability analysis should be cond...'?",
"reference": "A source code traceability analysis should be conducted and documented to verify that: Each element of the software design specification has been implemented in code; Modules and functions implemented in code can be traced back to an element in the software design specification and to the risk analysis; Tests for modules and functions can be traced back to an element in the software design specification and to the risk analysis; and Tests for modules and functions can be traced to source code for the same modules and functions.",
"options": {
"D": "Modules",
"A": "FDA Staff A source code traceability analysis",
"B": "A source code traceability analysis",
"C": "mental faculty"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Construction or Coding Traceabilit...'?",
"reference": "Typical Tasks Construction or Coding Traceability Analyses Source Code to Design Specification (and vice versa) Test Cases to Source Code and to Design Specification Source Code and Source Code Documentation Evaluation Source Code Interface Analysis Test Procedure and Test Case Generation (module, integration, system, and acceptance) 5.2.5.",
"options": {
"C": "Traceability",
"A": "FDA",
"B": "Typical Tasks Construction or Coding",
"D": "Source code evaluations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Construction or Coding Traceabilit...'?",
"reference": "Typical Tasks Construction or Coding Traceability Analyses Source Code to Design Specification (and vice versa) Test Cases to Source Code and to Design Specification Source Code and Source Code Documentation Evaluation Source Code Interface Analysis Test Procedure and Test Case Generation (module, integration, system, and acceptance) 5.2.5.",
"options": {
"D": "Design Specification Source Code and",
"A": "FDA Staff A source code traceability analysis",
"B": "A source code traceability analysis",
"C": "Traceability"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 40 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
According to section 501(a)(2)(B) of the FDC Act, a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity a nd strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess. Contains Nonbinding Recommendations 3 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ). 211.182, 211.186(a), 211.188(b)(11), and 211.194(a)(8) ( requir ing that records be checked, verified, or reviewed ). When considering how to meet many of these regulatory requirements , it may be useful to ask the following questions: Are controls in place to ensure that data is complete? Are activities documented at the time of performance? Are activities attributable to a specific individual? Can only authorized individuals make changes to records? Is there a record of changes to data? Are records reviewed for accuracy, completeness, and compliance with established standards? Are data maintained securely from data creation through disposition after the records retention period? This guidance helps answer these questions and enable s an understanding of key concepts behind the regulatory requirements . While not in the scope of this guidance, data integrity -related CGMP violations can also impact or be directly linked to application filing , review , and regulatory actions . Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: ____, 211.186(a), 211.188(b)(11), and 211.194(a)(8) ( requir ing that records be checked, verified, or reviewed ).",
"reference": "211.182, 211.186(a), 211.188(b)(11), and 211.194(a)(8) ( requir ing that records be checked, verified, or reviewed ).",
"options": {
"A": "211.182",
"B": "211.22",
"C": "211.192",
"D": "records requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"reference": "Contains Nonbinding Recommendations 3 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"options": {
"C": "3",
"A": "211.22",
"B": "211.192",
"D": "records requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations 3 ____, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"reference": "Contains Nonbinding Recommendations 3 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"options": {
"C": "211.22",
"A": "211.192",
"B": "211.194(a",
"D": "records requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations 3 211.22, ____, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"reference": "Contains Nonbinding Recommendations 3 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"options": {
"B": "211.192",
"A": "211.22",
"C": "211.194(a",
"D": "records requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"reference": "Contains Nonbinding Recommendations 3 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"options": {
"B": "3",
"A": "211.22",
"C": "211.192",
"D": "records requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations 3 ____, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"reference": "Contains Nonbinding Recommendations 3 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"options": {
"D": "211.22",
"A": "211.192",
"B": "211.194(a",
"C": "records requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations 3 211.22, ____, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"reference": "Contains Nonbinding Recommendations 3 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"options": {
"D": "211.192",
"A": "211.22",
"B": "211.194(a",
"C": "records requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Electronic signature and record -keeping requireme...'?",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"A": "CFR",
"B": "records requirements",
"C": "production and control records",
"D": "210"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in ____ CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"A": "21",
"B": "211.22",
"C": "211.192",
"D": "records requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in 21 CFR part ____ and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"A": "11",
"B": "211.22",
"C": "211.192",
"D": "records requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____, 211.186(a), 211.188(b)(11), and 211.194(a)(8) ( requir ing that records be checked, verified, or reviewed ).",
"reference": "211.182, 211.186(a), 211.188(b)(11), and 211.194(a)(8) ( requir ing that records be checked, verified, or reviewed ).",
"options": {
"B": "211.182",
"A": "211.22",
"C": "211.192",
"D": "records requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____, 211.186(a), 211.188(b)(11), and 211.194(a)(8) ( requir ing that records be checked, verified, or reviewed ).",
"reference": "211.182, 211.186(a), 211.188(b)(11), and 211.194(a)(8) ( requir ing that records be checked, verified, or reviewed ).",
"options": {
"A": "211.182",
"B": "211.22",
"C": "211.192",
"D": "records requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____, 211.186(a), 211.188(b)(11), and 211.194(a)(8) ( requir ing that records be checked, verified, or reviewed ).",
"reference": "211.182, 211.186(a), 211.188(b)(11), and 211.194(a)(8) ( requir ing that records be checked, verified, or reviewed ).",
"options": {
"D": "211.182",
"A": "211.22",
"B": "211.192",
"C": "records requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"reference": "Contains Nonbinding Recommendations 3 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"options": {
"B": "3",
"A": "211.22",
"C": "211.192",
"D": "records requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations 3 ____, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"reference": "Contains Nonbinding Recommendations 3 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"options": {
"A": "211.22",
"B": "211.192",
"C": "211.194(a",
"D": "records requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations 3 211.22, ____, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"reference": "Contains Nonbinding Recommendations 3 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"options": {
"C": "211.192",
"A": "211.22",
"B": "211.194(a",
"D": "records requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Electronic signature and record -keeping requireme...'?",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"B": "CFR",
"A": "records requirements",
"C": "production and control records",
"D": "210"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in ____ CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"D": "21",
"A": "211.22",
"B": "211.192",
"C": "records requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in 21 CFR part ____ and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"C": "11",
"A": "211.22",
"B": "211.192",
"D": "records requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts ____, 211, and 212.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"B": "210",
"A": "211.22",
"C": "211.192",
"D": "records requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, ____, and 212.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"B": "211",
"A": "211.22",
"C": "211.192",
"D": "records requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and ____.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"C": "212",
"A": "211.22",
"B": "211.192",
"D": "records requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____, 211.186(a), 211.188(b)(11), and 211.194(a)(8) ( requir ing that records be checked, verified, or reviewed ).",
"reference": "211.182, 211.186(a), 211.188(b)(11), and 211.194(a)(8) ( requir ing that records be checked, verified, or reviewed ).",
"options": {
"B": "211.182",
"A": "211.22",
"C": "211.192",
"D": "records requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Electronic signature and record -keeping requireme...'?",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"D": "CFR",
"A": "records requirements",
"B": "production and control records",
"C": "210"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in ____ CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"C": "21",
"A": "211.22",
"B": "211.192",
"D": "records requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in 21 CFR part ____ and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"B": "11",
"A": "211.22",
"C": "211.192",
"D": "records requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Electronic signature and record -keeping requireme...'?",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"D": "CFR",
"A": "records requirements",
"B": "production and control records",
"C": "210"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in ____ CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"B": "21",
"A": "211.22",
"C": "211.192",
"D": "records requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in 21 CFR part ____ and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"C": "11",
"A": "211.22",
"B": "211.192",
"D": "records requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts ____, 211, and 212.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"A": "210",
"B": "211.22",
"C": "211.192",
"D": "records requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, ____, and 212.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"C": "211",
"A": "211.22",
"B": "211.192",
"D": "records requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and ____.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"D": "212",
"A": "211.22",
"B": "211.192",
"C": "records requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Electronic signature and record -keeping requireme...'?",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"D": "CFR",
"A": "records requirements",
"B": "production and control records",
"C": "210"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in ____ CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"C": "21",
"A": "211.22",
"B": "211.192",
"D": "records requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in 21 CFR part ____ and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"B": "11",
"A": "211.22",
"C": "211.192",
"D": "records requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts ____, 211, and 212.",
"reference": "Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.",
"options": {
"C": "210",
"A": "211.22",
"B": "211.192",
"D": "records requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
As described in the Part 11, Electronic 586 Records; Electronic Signatures Scope and Application guidance,16 the Agency intends to 587 exercise enforcement discretion regarding Part 11 requirements for validation of computerized 588 systems used to create, modify, maintain, or transmit electronic records (see 21 CFR 11.10(a) 589 and 11.30). In general, Part 11 applies to rec ords in electronic form that are created, modified, 590 maintained, archived, retrieved, or transmitted under any records requirements set forth in 591 Agency regulations (see 21 CFR 11.1(b)). Part 11 also applies to electronic records submitted to 592 the Agency unde r requirements of the Federal Food, Drug, and Cosmetic Act (FDC Act) and 593 the Public Health Service Act (PHS Act), even if such records are not specifically identified in 594 Agency regulations (see 21 CFR 11.1(b)). In the context of computer or automated da ta processing systems , for computer software used as 597 part of production or the quality system, a document required under Part 820 and maintained in 598 electronic form would generally be an electronic record within the meaning of Part 11 (see 21 599 CFR 11.3(b)( 6)). For example, if a document requires a signature under Part 820 and is 600 maintained in electronic form, then Part 11 applies (see, e.g., 21 CFR 820.40 (requiring 601 signatures for control of required documents)) . 602 16 https://www.fda.gov/regulatory -information/search -fda-guidance -documents/part -11-electronic -records - electronic -signatures -scope -and-application . Contains Nonbinding Recommendations Draft Not for Implementation 20Appendix A. Examples 603
The examples in this section outline possible application of the principles in this draft guidance to various software assurance 604 situations cases .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: Examples ____\nThe examples in this section outline possible application of the principles in this draft guidance to various software assurance 604 situations cases .",
"reference": "Examples 603\nThe examples in this section outline possible application of the principles in this draft guidance to various software assurance 604 situations cases .",
"options": {
"A": "603",
"B": "586",
"C": "587",
"D": "electronic records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Examples 603\nThe examples in this section outline possible application of the principles in this draft guidance to various software assurance ____ situations cases .",
"reference": "Examples 603\nThe examples in this section outline possible application of the principles in this draft guidance to various software assurance 604 situations cases .",
"options": {
"D": "604",
"A": "586",
"B": "587",
"C": "electronic records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Part 11 also applies to electronic records submitt...'?",
"reference": "Part 11 also applies to electronic records submitted to 592 the Agency unde r requirements of the Federal Food, Drug, and Cosmetic Act (FDC Act) and 593 the Public Health Service Act (PHS Act), even if such records are not specifically identified in 594 Agency regulations (see 21 CFR 11.1(b)).",
"options": {
"A": "Agency",
"B": "electronic records",
"C": "government agency",
"D": "way"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Part 11 also applies to electronic records submitt...'?",
"reference": "Part 11 also applies to electronic records submitted to 592 the Agency unde r requirements of the Federal Food, Drug, and Cosmetic Act (FDC Act) and 593 the Public Health Service Act (PHS Act), even if such records are not specifically identified in 594 Agency regulations (see 21 CFR 11.1(b)).",
"options": {
"B": "the Federal Food, Drug",
"A": "Agency",
"C": "electronic records",
"D": "592"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Part 11 also applies to electronic records submitt...'?",
"reference": "Part 11 also applies to electronic records submitted to 592 the Agency unde r requirements of the Federal Food, Drug, and Cosmetic Act (FDC Act) and 593 the Public Health Service Act (PHS Act), even if such records are not specifically identified in 594 Agency regulations (see 21 CFR 11.1(b)).",
"options": {
"D": "the Public Health Service Act",
"A": "Agency",
"B": "electronic records",
"C": "592"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: 'Part 11 also applies to electronic records submitt...'?",
"reference": "Part 11 also applies to electronic records submitted to 592 the Agency unde r requirements of the Federal Food, Drug, and Cosmetic Act (FDC Act) and 593 the Public Health Service Act (PHS Act), even if such records are not specifically identified in 594 Agency regulations (see 21 CFR 11.1(b)).",
"options": {
"A": "594 Agency regulations",
"B": "586",
"C": "587",
"D": "electronic records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Part ____ also applies to electronic records submitted to 592 the Agency unde r requirements of the Federal Food, Drug, and Cosmetic Act (FDC Act) and 593 the Public Health Service Act (PHS Act), even if such records are not specifically identified in 594 Agency regulations (see 21 CFR 11.1(b)).",
"reference": "Part 11 also applies to electronic records submitted to 592 the Agency unde r requirements of the Federal Food, Drug, and Cosmetic Act (FDC Act) and 593 the Public Health Service Act (PHS Act), even if such records are not specifically identified in 594 Agency regulations (see 21 CFR 11.1(b)).",
"options": {
"B": "11",
"A": "586",
"C": "587",
"D": "electronic records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Part 11 also applies to electronic records submitted to ____ the Agency unde r requirements of the Federal Food, Drug, and Cosmetic Act (FDC Act) and 593 the Public Health Service Act (PHS Act), even if such records are not specifically identified in 594 Agency regulations (see 21 CFR 11.1(b)).",
"reference": "Part 11 also applies to electronic records submitted to 592 the Agency unde r requirements of the Federal Food, Drug, and Cosmetic Act (FDC Act) and 593 the Public Health Service Act (PHS Act), even if such records are not specifically identified in 594 Agency regulations (see 21 CFR 11.1(b)).",
"options": {
"B": "592",
"A": "586",
"C": "587",
"D": "electronic records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Part 11 also applies to electronic records submitted to 592 the Agency unde r requirements of the Federal Food, Drug, and Cosmetic Act (FDC Act) and ____ the Public Health Service Act (PHS Act), even if such records are not specifically identified in 594 Agency regulations (see 21 CFR 11.1(b)).",
"reference": "Part 11 also applies to electronic records submitted to 592 the Agency unde r requirements of the Federal Food, Drug, and Cosmetic Act (FDC Act) and 593 the Public Health Service Act (PHS Act), even if such records are not specifically identified in 594 Agency regulations (see 21 CFR 11.1(b)).",
"options": {
"C": "593",
"A": "586",
"B": "587",
"D": "electronic records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system. For an addition or change to 355 software used in production or the quality system of devices subject to a PMA or HDE, FDA 356 recommends that manufacturers apply the principles outlined above in determining whether the 357 change may affect the safety or effectiveness of the device. In general, if a change may result in a 358 quality problem that foreseeably compromise s safety, then it should be submitted in a 30 -day 359 notic e. If a change would not result in a quality problem that foreseeably compromise s safety, an 360 annual report may be appropriate. For example, a Manufacturing Execution System (MES) may be used to manage workflow, track 363 progress, record data, and establish alerts or thresholds based on validated parameters, which are 364 part of maintaining the quality system. Failure of such an MES to perform as intended may 365 disrupt operations but not affect the process parameters established to produce a safe and 366 effective dev ice. Changes affecting these MES operations are generally considered annual ly 367 reportable.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Changes affecting these MES operations are general...'?",
"reference": "Changes affecting these MES operations are generally considered annual ly 367 reportable.",
"options": {
"B": "MES",
"A": "PMA",
"C": "348 Manufacturing Method",
"D": "a 358 quality problem"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Changes affecting these MES operations are general...'?",
"reference": "Changes affecting these MES operations are generally considered annual ly 367 reportable.",
"options": {
"A": "annual",
"B": "30-Day Notices",
"C": "135 Day",
"D": "348 Manufacturing Method"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Changes affecting these MES operations are generally considered annual ly ____ reportable.",
"reference": "Changes affecting these MES operations are generally considered annual ly 367 reportable.",
"options": {
"C": "367",
"A": "345",
"B": "347",
"D": "348 Manufacturing Method"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In general, if a change may result in a ____ quality problem that foreseeably compromise s safety, then it should be submitted in a 30 -day 359 notic e. If a change would not result in a quality problem that foreseeably compromise s safety, an 360 annual report may be appropriate.",
"reference": "In general, if a change may result in a 358 quality problem that foreseeably compromise s safety, then it should be submitted in a 30 -day 359 notic e. If a change would not result in a quality problem that foreseeably compromise s safety, an 360 annual report may be appropriate.",
"options": {
"C": "358",
"A": "345",
"B": "347",
"D": "348 Manufacturing Method"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In general, if a change may result in a 358 quality problem that foreseeably compromise s safety, then it should be submitted in a ____ -day 359 notic e. If a change would not result in a quality problem that foreseeably compromise s safety, an 360 annual report may be appropriate.",
"reference": "In general, if a change may result in a 358 quality problem that foreseeably compromise s safety, then it should be submitted in a 30 -day 359 notic e. If a change would not result in a quality problem that foreseeably compromise s safety, an 360 annual report may be appropriate.",
"options": {
"C": "30",
"A": "345",
"B": "347",
"D": "348 Manufacturing Method"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In general, if a change may result in a 358 quality problem that foreseeably compromise s safety, then it should be submitted in a 30 -day ____ notic e. If a change would not result in a quality problem that foreseeably compromise s safety, an 360 annual report may be appropriate.",
"reference": "In general, if a change may result in a 358 quality problem that foreseeably compromise s safety, then it should be submitted in a 30 -day 359 notic e. If a change would not result in a quality problem that foreseeably compromise s safety, an 360 annual report may be appropriate.",
"options": {
"C": "359",
"A": "345",
"B": "347",
"D": "348 Manufacturing Method"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In general, if a change may result in a 358 quality problem that foreseeably compromise s safety, then it should be submitted in a 30 -day 359 notic e. If a change would not result in a quality problem that foreseeably compromise s safety, an ____ annual report may be appropriate.",
"reference": "In general, if a change may result in a 358 quality problem that foreseeably compromise s safety, then it should be submitted in a 30 -day 359 notic e. If a change would not result in a quality problem that foreseeably compromise s safety, an 360 annual report may be appropriate.",
"options": {
"B": "360",
"A": "345",
"C": "347",
"D": "348 Manufacturing Method"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In general, if a change may result in a ____ quality problem that foreseeably compromise s safety, then it should be submitted in a 30 -day 359 notic e. If a change would not result in a quality problem that foreseeably compromise s safety, an 360 annual report may be appropriate.",
"reference": "In general, if a change may result in a 358 quality problem that foreseeably compromise s safety, then it should be submitted in a 30 -day 359 notic e. If a change would not result in a quality problem that foreseeably compromise s safety, an 360 annual report may be appropriate.",
"options": {
"A": "358",
"B": "345",
"C": "347",
"D": "348 Manufacturing Method"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In general, if a change may result in a 358 quality problem that foreseeably compromise s safety, then it should be submitted in a ____ -day 359 notic e. If a change would not result in a quality problem that foreseeably compromise s safety, an 360 annual report may be appropriate.",
"reference": "In general, if a change may result in a 358 quality problem that foreseeably compromise s safety, then it should be submitted in a 30 -day 359 notic e. If a change would not result in a quality problem that foreseeably compromise s safety, an 360 annual report may be appropriate.",
"options": {
"A": "30",
"B": "345",
"C": "347",
"D": "348 Manufacturing Method"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In general, if a change may result in a 358 quality problem that foreseeably compromise s safety, then it should be submitted in a 30 -day ____ notic e. If a change would not result in a quality problem that foreseeably compromise s safety, an 360 annual report may be appropriate.",
"reference": "In general, if a change may result in a 358 quality problem that foreseeably compromise s safety, then it should be submitted in a 30 -day 359 notic e. If a change would not result in a quality problem that foreseeably compromise s safety, an 360 annual report may be appropriate.",
"options": {
"B": "359",
"A": "345",
"C": "347",
"D": "348 Manufacturing Method"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Changes affecting these MES operations are general...'?",
"reference": "Changes affecting these MES operations are generally considered annual ly 367 reportable.",
"options": {
"B": "MES",
"A": "PMA",
"C": "348 Manufacturing Method",
"D": "a 358 quality problem"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Changes affecting these MES operations are general...'?",
"reference": "Changes affecting these MES operations are generally considered annual ly 367 reportable.",
"options": {
"B": "annual",
"A": "30-Day Notices",
"C": "135 Day",
"D": "348 Manufacturing Method"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Changes affecting these MES operations are generally considered annual ly ____ reportable.",
"reference": "Changes affecting these MES operations are generally considered annual ly 367 reportable.",
"options": {
"C": "367",
"A": "345",
"B": "347",
"D": "348 Manufacturing Method"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Changes affecting these MES operations are general...'?",
"reference": "Changes affecting these MES operations are generally considered annual ly 367 reportable.",
"options": {
"D": "MES",
"A": "PMA",
"B": "348 Manufacturing Method",
"C": "a 358 quality problem"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Changes affecting these MES operations are general...'?",
"reference": "Changes affecting these MES operations are generally considered annual ly 367 reportable.",
"options": {
"D": "annual",
"A": "30-Day Notices",
"B": "135 Day",
"C": "348 Manufacturing Method"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Changes affecting these MES operations are generally considered annual ly ____ reportable.",
"reference": "Changes affecting these MES operations are generally considered annual ly 367 reportable.",
"options": {
"A": "367",
"B": "345",
"C": "347",
"D": "348 Manufacturing Method"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '345 346 As noted in FDAs guidance, 30-Day Notices...'?",
"reference": "345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"options": {
"B": "30-Day Notices",
"A": "135 Day",
"C": "annual",
"D": "348 Manufacturing Method"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: '345 346 As noted in FDAs guidance, 30-Day Notices...'?",
"reference": "345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"options": {
"D": "135 Day",
"A": "30-Day Notices",
"B": "annual",
"C": "348 Manufacturing Method"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '345 346 As noted in FDAs guidance, 30-Day Notices...'?",
"reference": "345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"options": {
"B": "PMA",
"A": "HDE",
"C": "348 Manufacturing Method",
"D": "a 358 quality problem"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '345 346 As noted in FDAs guidance, 30-Day Notices...'?",
"reference": "345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"options": {
"C": "PMA",
"A": "HDE",
"B": "348 Manufacturing Method",
"D": "a 358 quality problem"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '345 346 As noted in FDAs guidance, 30-Day Notices...'?",
"reference": "345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"options": {
"A": "30-Day Notices",
"B": "135 Day",
"C": "annual",
"D": "348 Manufacturing Method"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: '345 346 As noted in FDAs guidance, 30-Day Notices...'?",
"reference": "345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"options": {
"B": "135 Day",
"A": "30-Day Notices",
"C": "annual",
"D": "348 Manufacturing Method"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '345 346 As noted in FDAs guidance, 30-Day Notices...'?",
"reference": "345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"options": {
"B": "PMA",
"A": "HDE",
"C": "348 Manufacturing Method",
"D": "a 358 quality problem"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '345 346 As noted in FDAs guidance, 30-Day Notices...'?",
"reference": "345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"options": {
"A": "PMA",
"B": "HDE",
"C": "348 Manufacturing Method",
"D": "a 358 quality problem"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '345 346 As noted in FDAs guidance, 30-Day Notices...'?",
"reference": "345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"options": {
"A": "HDE",
"B": "PMA",
"C": "348 Manufacturing Method",
"D": "a 358 quality problem"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"reference": "345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"options": {
"C": "345",
"A": "347",
"B": "348",
"D": "348 Manufacturing Method"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 345 ____ As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"reference": "345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"options": {
"C": "346",
"A": "345",
"B": "347",
"D": "348 Manufacturing Method"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 345 346 As noted in FDAs guidance, ____-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"reference": "345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"options": {
"B": "30",
"A": "345",
"C": "347",
"D": "348 Manufacturing Method"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 345 346 As noted in FDAs guidance, 30-Day Notices, ____ Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"reference": "345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"options": {
"B": "135",
"A": "345",
"C": "347",
"D": "348 Manufacturing Method"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) ____ Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"reference": "345 346 As noted in FDAs guidance, 30-Day Notices, 135 Day Premarket Approval (PMA) 347 Supplements and 75 -Day Humanitarian Device Exemption (HDE) Supplements for 348 Manufacturing Method or Process Changes ,6for devices subject to a PMA or HDE, changes to 349 the manufacturing procedure or method of manufacturing that do not affect the safety or 350 effectiveness of the device must be submitted in a periodic report (usually referred to as an 351 annual report).7 In contrast, modifications to manufa cturing procedures or methods of 352 manufacture that affect the safety and effectiveness of the device must be submitted in a 30 -day 353 notice.8 Changes to the manufacturing procedure or method of manufacturing may include 354 changes to software used in production or the quality system.",
"options": {
"B": "347",
"A": "345",
"C": "348",
"D": "348 Manufacturing Method"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 7 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ). 26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance . This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA). 2 Available at https://www.fda.gov/regulatory -information/search -fda-guidance -documents/general -principles - software -validation . Contains Nonbinding Recommendations Draft Not for Implementation 5For
the current edition of the FDA -recognized consensus standard referenced in this document, 33 see the FDA Recognized Consensus Standards Database .334 35
In general, FDA s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 37 as recommendations, unless specific regulatory or statutory requirements are cited. T he use of 38 the word should in Agency guidances means that something is suggested or recommended, but 39 not required .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'T he use of 38 the word should in Agency guidances...'?",
"reference": "T he use of 38 the word should in Agency guidances means that something is suggested or recommended, but 39 not required .",
"options": {
"B": "Agency",
"A": "the Software 30 Validation guidance",
"C": "computer software validation requirements",
"D": "government agency"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: T he use of ____ the word should in Agency guidances means that something is suggested or recommended, but 39 not required .",
"reference": "T he use of 38 the word should in Agency guidances means that something is suggested or recommended, but 39 not required .",
"options": {
"A": "38",
"B": "18 19",
"C": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: T he use of 38 the word should in Agency guidances means that something is suggested or recommended, but ____ not required .",
"reference": "T he use of 38 the word should in Agency guidances means that something is suggested or recommended, but 39 not required .",
"options": {
"C": "39",
"A": "18 19",
"B": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Available at https://www.fda.gov/regulatory -information/search -fda-guidance -documents/general -principles - software -validation .",
"reference": "2 Available at https://www.fda.gov/regulatory -information/search -fda-guidance -documents/general -principles - software -validation .",
"options": {
"A": "2",
"B": "18 19",
"C": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This draft guidance is intended to: 18 19 Describe...'?",
"reference": "This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"options": {
"C": "CFR",
"A": "General Principles of",
"B": "Automated Process Equipment and",
"D": "the Software 30 Validation guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This draft guidance is intended to: ____ 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"reference": "This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"options": {
"C": "18",
"A": "18 19",
"B": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This draft guidance is intended to: 18 ____ Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"reference": "This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"options": {
"A": "19",
"B": "18 19",
"C": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 1 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Documentation includes: Resources and facilities used Resources and facilities used Procedures to carry out the process Identification of the process owner who will maintain and update the process as needed Identification and control of important variables Quality control measures, necessary data collection, monitoring, and appropriate controls for the product and process Any validation activities, including operating ranges and acceptance criteria Effects on related process, functions, or personnel As discussed under section IV.A., above, the mode l calls for managers to ensure that product specifications and process parameters are determ ined by the appropriate technical experts (e.g., engineers, development scientists). In the pharmaceutical environment, experts would have an understanding of pharmaceutical science, equipmen t, facilities, and proc ess types and of how variations in materials and processes can ultimately aff ect the finished product. Packaging and labeling controls, critical stages in the pharmaceu tical manufacturing process, are not specifically addressed in quality systems models. However, the Agency recommends that manufacturers always refer to th e packaging and labeling control re gulations at 211 Subpart G.
In addition and this is consistent with modern quality systems FDA recommends that, as 15 Contains Nonbinding Recommendations part of the design process, before commercial production, the controls fo r all processes within the packaging and labeling system be planned and documented in written procedures. The procedures should outline quality control activities and the responsible positions. Specifications and controls for the packaging and labeling ma terials should also be determined before commercial production. Distinct labe ls with discriminating features for different products, such as a product marketed with different strengths, should be included to prevent mislabeling and resulting recalls. 2.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'However, the Agency recommends that manufacturers ...'?",
"reference": "However, the Agency recommends that manufacturers always refer to th e packaging and labeling control re gulations at 211 Subpart G.\nIn addition and this is consistent with modern quality systems FDA recommends that, as 15 Contains Nonbinding Recommendations part of the design process, before commercial production, the controls fo r all processes within the packaging and labeling system be planned and documented in written procedures.",
"options": {
"C": "Agency",
"A": "product specifications and process parameters",
"B": "Packaging and labeling controls",
"D": "government agency"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 35 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
That is, the Agency may take your business practices into 193 account in determining whether part 11 applies. Accordingly, we recommend that, for each record required to be maintained under 195 predicate rules , you determine in advance whether you plan to rely on the electronic 196 record or paper record to perform regulated activities. We recommend that you 197 document this decision (e.g., in a Standard Operating Procedure (SOP), or specification 198 document). 199 Records submitted to FDA, under predicate rules (even if such records are not 200 specifically identified in Agency regulations) in electronic format (assuming the records 201 have been identified in docket number 92S -0251 as the types of submissions the Agency 202 accepts i n electronic format). However, a record that is not itself submitted, but is used 203 Contains Nonbinding Recommendations 6 in generating a submission, is not a part 11 record unless it is otherwise required to be 204 maintained under a predicate rule and it is maintained in electronic format. Electr onic signatures that are intended to be the equivalent of handwritten signatures, 206 initials, and other general signings required by predicate rules. Part 11 signatures include 207 electronic signatures that are used, for example, to document the fact that cert ain events 208 or actions occurred in accordance with the predicate rule (e.g. approved , reviewed , and 209 verified ). 210 211 C. Approach to Specific Part 11 Requirements 212 213 1. Validation 214 215 The Agency intends to exercise enforcement discretion regarding specific part 11 re quirements 216 for validation of computerized systems ( 11.10(a) and corresponding requirements in 11.30). Although persons must still comply with all applicable predicate rule requirements for validation 218 (e.g., 21 CFR 820.70(i)), this guidance should not be read to impose any additional requirements 219 for validation.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: ____ 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"reference": "210 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"options": {
"D": "210",
"A": "193",
"B": "195",
"C": "the electronic 196 record or paper record"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 210 ____ C. Approach to Specific Part 11 Requirements 212 213 1.",
"reference": "210 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"options": {
"A": "211",
"B": "193",
"C": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 210 2____ C. Approach to Specific Part 11 Requirements 212 213 1.",
"reference": "210 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"options": {
"B": "11",
"A": "193",
"C": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 210 211 C. Approach to Specific Part 11 Requirements ____ 213 1.",
"reference": "210 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"options": {
"C": "212",
"A": "193",
"B": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 210 211 C. Approach to Specific Part 11 Requirements 212 ____ 1.",
"reference": "210 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"options": {
"C": "213",
"A": "193",
"B": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 2____0 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"reference": "210 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"options": {
"A": "1",
"B": "193",
"C": "195",
"D": "all applicable predicate rule requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Validation 214 215 The Agency intends to exercise ...'?",
"reference": "Validation 214 215 The Agency intends to exercise enforcement discretion regarding specific part 11 re quirements 216 for validation of computerized systems ( 11.10(a) and corresponding requirements in 11.30).",
"options": {
"C": "Agency",
"A": "the electronic 196 record or paper record",
"B": "all applicable predicate rule requirements",
"D": "government agency"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Validation ____ 215 The Agency intends to exercise enforcement discretion regarding specific part 11 re quirements 216 for validation of computerized systems ( 11.10(a) and corresponding requirements in 11.30).",
"reference": "Validation 214 215 The Agency intends to exercise enforcement discretion regarding specific part 11 re quirements 216 for validation of computerized systems ( 11.10(a) and corresponding requirements in 11.30).",
"options": {
"D": "214",
"A": "193",
"B": "195",
"C": "the electronic 196 record or paper record"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Validation 214 ____ The Agency intends to exercise enforcement discretion regarding specific part 11 re quirements 216 for validation of computerized systems ( 11.10(a) and corresponding requirements in 11.30).",
"reference": "Validation 214 215 The Agency intends to exercise enforcement discretion regarding specific part 11 re quirements 216 for validation of computerized systems ( 11.10(a) and corresponding requirements in 11.30).",
"options": {
"B": "215",
"A": "193",
"C": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Validation 214 215 The Agency intends to exercise enforcement discretion regarding specific part ____ re quirements 216 for validation of computerized systems ( 11.10(a) and corresponding requirements in 11.30).",
"reference": "Validation 214 215 The Agency intends to exercise enforcement discretion regarding specific part 11 re quirements 216 for validation of computerized systems ( 11.10(a) and corresponding requirements in 11.30).",
"options": {
"A": "11",
"B": "193",
"C": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Validation 214 215 The Agency intends to exercise enforcement discretion regarding specific part 11 re quirements ____ for validation of computerized systems ( 11.10(a) and corresponding requirements in 11.30).",
"reference": "Validation 214 215 The Agency intends to exercise enforcement discretion regarding specific part 11 re quirements 216 for validation of computerized systems ( 11.10(a) and corresponding requirements in 11.30).",
"options": {
"C": "216",
"A": "193",
"B": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Validation 214 215 The Agency intends to exercise enforcement discretion regarding specific part 11 re quirements 216 for validation of computerized systems ( 11.10(a) and corresponding requirements in ____).",
"reference": "Validation 214 215 The Agency intends to exercise enforcement discretion regarding specific part 11 re quirements 216 for validation of computerized systems ( 11.10(a) and corresponding requirements in 11.30).",
"options": {
"B": "11.30",
"A": "193",
"C": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"reference": "210 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"options": {
"C": "210",
"A": "193",
"B": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 210 ____ C. Approach to Specific Part 11 Requirements 212 213 1.",
"reference": "210 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"options": {
"B": "211",
"A": "193",
"C": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 210 2____ C. Approach to Specific Part 11 Requirements 212 213 1.",
"reference": "210 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"options": {
"A": "11",
"B": "193",
"C": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 210 211 C. Approach to Specific Part 11 Requirements ____ 213 1.",
"reference": "210 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"options": {
"A": "212",
"B": "193",
"C": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 210 211 C. Approach to Specific Part 11 Requirements 212 ____ 1.",
"reference": "210 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"options": {
"D": "213",
"A": "193",
"B": "195",
"C": "the electronic 196 record or paper record"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 2____0 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"reference": "210 211 C. Approach to Specific Part 11 Requirements 212 213 1.",
"options": {
"D": "1",
"A": "193",
"B": "195",
"C": "all applicable predicate rule requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Accordingly, we recommend that, for each record required to be maintained under ____ predicate rules , you determine in advance whether you plan to rely on the electronic 196 record or paper record to perform regulated activities.",
"reference": "Accordingly, we recommend that, for each record required to be maintained under 195 predicate rules , you determine in advance whether you plan to rely on the electronic 196 record or paper record to perform regulated activities.",
"options": {
"A": "195",
"B": "193",
"C": "196",
"D": "the electronic 196 record or paper record"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Accordingly, we recommend that, for each record required to be maintained under 195 predicate rules , you determine in advance whether you plan to rely on the electronic ____ record or paper record to perform regulated activities.",
"reference": "Accordingly, we recommend that, for each record required to be maintained under 195 predicate rules , you determine in advance whether you plan to rely on the electronic 196 record or paper record to perform regulated activities.",
"options": {
"C": "196",
"A": "193",
"B": "195",
"D": "all applicable predicate rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '199 Records submitted to FDA, under predicate rul...'?",
"reference": "199 Records submitted to FDA, under predicate rules (even if such records are not 200 specifically identified in Agency regulations) in electronic format (assuming the records 201 have been identified in docket number 92S -0251 as the types of submissions the Agency 202 accepts i n electronic format).",
"options": {
"D": "FDA",
"A": "Agency",
"B": "SOP",
"C": "the electronic 196 record or paper record"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '199 Records submitted to FDA, under predicate rul...'?",
"reference": "199 Records submitted to FDA, under predicate rules (even if such records are not 200 specifically identified in Agency regulations) in electronic format (assuming the records 201 have been identified in docket number 92S -0251 as the types of submissions the Agency 202 accepts i n electronic format).",
"options": {
"B": "Agency",
"A": "the electronic 196 record or paper record",
"C": "all applicable predicate rule requirements",
"D": "government agency"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '199 Records submitted to FDA, under predicate rul...'?",
"reference": "199 Records submitted to FDA, under predicate rules (even if such records are not 200 specifically identified in Agency regulations) in electronic format (assuming the records 201 have been identified in docket number 92S -0251 as the types of submissions the Agency 202 accepts i n electronic format).",
"options": {
"C": "Agency",
"A": "the electronic 196 record or paper record",
"B": "all applicable predicate rule requirements",
"D": "government agency"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Records submitted to FDA, under predicate rules (even if such records are not 200 specifically identified in Agency regulations) in electronic format (assuming the records 201 have been identified in docket number 92S -0251 as the types of submissions the Agency 202 accepts i n electronic format).",
"reference": "199 Records submitted to FDA, under predicate rules (even if such records are not 200 specifically identified in Agency regulations) in electronic format (assuming the records 201 have been identified in docket number 92S -0251 as the types of submissions the Agency 202 accepts i n electronic format).",
"options": {
"B": "199",
"A": "193",
"C": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Accordingly, we recommend that, for each record required to be maintained under ____ predicate rules , you determine in advance whether you plan to rely on the electronic 196 record or paper record to perform regulated activities.",
"reference": "Accordingly, we recommend that, for each record required to be maintained under 195 predicate rules , you determine in advance whether you plan to rely on the electronic 196 record or paper record to perform regulated activities.",
"options": {
"D": "195",
"A": "193",
"B": "196",
"C": "the electronic 196 record or paper record"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Accordingly, we recommend that, for each record required to be maintained under 195 predicate rules , you determine in advance whether you plan to rely on the electronic ____ record or paper record to perform regulated activities.",
"reference": "Accordingly, we recommend that, for each record required to be maintained under 195 predicate rules , you determine in advance whether you plan to rely on the electronic 196 record or paper record to perform regulated activities.",
"options": {
"B": "196",
"A": "193",
"C": "195",
"D": "all applicable predicate rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'That is, the Agency may take your business practic...'?",
"reference": "That is, the Agency may take your business practices into 193 account in determining whether part 11 applies.",
"options": {
"C": "Agency",
"A": "the electronic 196 record or paper record",
"B": "all applicable predicate rule requirements",
"D": "government agency"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: That is, the Agency may take your business practices into ____ account in determining whether part 11 applies.",
"reference": "That is, the Agency may take your business practices into 193 account in determining whether part 11 applies.",
"options": {
"B": "193",
"A": "195",
"C": "196",
"D": "the electronic 196 record or paper record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: That is, the Agency may take your business practices into 193 account in determining whether part ____ applies.",
"reference": "That is, the Agency may take your business practices into 193 account in determining whether part 11 applies.",
"options": {
"D": "11",
"A": "193",
"B": "195",
"C": "the electronic 196 record or paper record"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: However, a record that is not itself submitted, but is used ____ Contains Nonbinding Recommendations 6 in generating a submission, is not a part 11 record unless it is otherwise required to be 204 maintained under a predicate rule and it is maintained in electronic format.",
"reference": "However, a record that is not itself submitted, but is used 203 Contains Nonbinding Recommendations 6 in generating a submission, is not a part 11 record unless it is otherwise required to be 204 maintained under a predicate rule and it is maintained in electronic format.",
"options": {
"A": "203",
"B": "193",
"C": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: However, a record that is not itself submitted, but is used 203 Contains Nonbinding Recommendations ____ in generating a submission, is not a part 11 record unless it is otherwise required to be 204 maintained under a predicate rule and it is maintained in electronic format.",
"reference": "However, a record that is not itself submitted, but is used 203 Contains Nonbinding Recommendations 6 in generating a submission, is not a part 11 record unless it is otherwise required to be 204 maintained under a predicate rule and it is maintained in electronic format.",
"options": {
"C": "6",
"A": "193",
"B": "195",
"D": "all applicable predicate rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: However, a record that is not itself submitted, but is used 203 Contains Nonbinding Recommendations 6 in generating a submission, is not a part ____ record unless it is otherwise required to be 204 maintained under a predicate rule and it is maintained in electronic format.",
"reference": "However, a record that is not itself submitted, but is used 203 Contains Nonbinding Recommendations 6 in generating a submission, is not a part 11 record unless it is otherwise required to be 204 maintained under a predicate rule and it is maintained in electronic format.",
"options": {
"B": "11",
"A": "193",
"C": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: However, a record that is not itself submitted, but is used 203 Contains Nonbinding Recommendations 6 in generating a submission, is not a part 11 record unless it is otherwise required to be ____ maintained under a predicate rule and it is maintained in electronic format.",
"reference": "However, a record that is not itself submitted, but is used 203 Contains Nonbinding Recommendations 6 in generating a submission, is not a part 11 record unless it is otherwise required to be 204 maintained under a predicate rule and it is maintained in electronic format.",
"options": {
"B": "204",
"A": "193",
"C": "195",
"D": "the electronic 196 record or paper record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'That is, the Agency may take your business practic...'?",
"reference": "That is, the Agency may take your business practices into 193 account in determining whether part 11 applies.",
"options": {
"C": "Agency",
"A": "the electronic 196 record or paper record",
"B": "all applicable predicate rule requirements",
"D": "government agency"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: That is, the Agency may take your business practices into ____ account in determining whether part 11 applies.",
"reference": "That is, the Agency may take your business practices into 193 account in determining whether part 11 applies.",
"options": {
"B": "193",
"A": "195",
"C": "196",
"D": "the electronic 196 record or paper record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to d iscuss an alternativ e approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify th e appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s 210 and 211). The guidance describes a comprehensive quality systems (QS) model, highlighting the model's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products. The guidance also explains how manufacturers implem enting such quality systems can be in full compliance with parts 210 and 211. This guidance is not intended to place new expectations on manufacturers, nor to replac e the CGMP requirements. Readers are advised to always refer to parts 210 and 211 to ensu re full compliance with the regulations. FDA's guidance documents, including this guida nce, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinki ng on a topic and should be viewed only as recommendations, unless spec ific regulatory or stat utory requireme nts are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. BACKGROUND AND PURPOSE A. Background In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative. In that announcement, the FDA explaine d the Agencys intent to integrate quality systems and risk management approaches into its existing programs with the goal of encouraging industry to adopt modern and innovative manufacturing technologies.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'The guidance describes a comprehensive quality sys...'?",
"reference": "The guidance describes a comprehensive quality systems (QS) model, highlighting the model's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products.",
"options": {
"B": "QS",
"A": "FDA",
"C": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The guidance describes a comprehensive quality sys...'?",
"reference": "The guidance describes a comprehensive quality systems (QS) model, highlighting the model's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products.",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Instead, guidances describe the Agency's current t...'?",
"reference": "Instead, guidances describe the Agency's current thinki ng on a topic and should be viewed only as recommendations, unless spec ific regulatory or stat utory requireme nts are cited.",
"options": {
"D": "Agency",
"A": "FDA's guidance documents",
"B": "this guidance",
"C": "government agency"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Background In August 2002, the FDA announced the P...'?",
"reference": "Background In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative.",
"options": {
"A": "August 2002",
"B": "the 21st Century",
"C": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Background In August 2002, the FDA announced the P...'?",
"reference": "Background In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative.",
"options": {
"C": "FDA",
"A": "Agency",
"B": "CGMP",
"D": "this guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Background In August 2002, the FDA announced the P...'?",
"reference": "Background In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative.",
"options": {
"D": "the 21st Century",
"A": "August 2002",
"B": "FDA's guidance documents",
"C": "this guidance"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Background In August ____, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative.",
"reference": "Background In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative.",
"options": {
"D": "2002",
"A": "August 2002",
"B": "the 21st Century",
"C": "FDA's guidance documents"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Background In August 2002, the FDA announced the Pharmaceutical CGMPs for the ____ Century Initiative.",
"reference": "Background In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative.",
"options": {
"A": "21st",
"B": "FDA's guidance documents",
"C": "this guidance",
"D": "twenty-first"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The use of the word should in Agency guidances mea...'?",
"reference": "The use of the word should in Agency guidances means that something is suggested or recommended, but not required.",
"options": {
"B": "Agency",
"A": "FDA's guidance documents",
"C": "this guidance",
"D": "government agency"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Background In August 2002, the FDA announced the P...'?",
"reference": "Background In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative.",
"options": {
"B": "August 2002",
"A": "the 21st Century",
"C": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INTRODUCTION This guidance is intended to he lp ma...'?",
"reference": "INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s 210 and 211).",
"options": {
"C": "Agency",
"A": "FDA's guidance documents",
"B": "this guidance",
"D": "government agency"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INTRODUCTION This guidance is intended to he lp ma...'?",
"reference": "INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s 210 and 211).",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INTRODUCTION This guidance is intended to he lp ma...'?",
"reference": "INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s 210 and 211).",
"options": {
"C": "CFR",
"A": "FDA",
"B": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s ____ and 211).",
"reference": "INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s 210 and 211).",
"options": {
"A": "210",
"B": "211",
"C": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s 210 and ____).",
"reference": "INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s 210 and 211).",
"options": {
"B": "211",
"A": "210",
"C": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INTRODUCTION This guidance is intended to he lp ma...'?",
"reference": "INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s 210 and 211).",
"options": {
"C": "Agency",
"A": "FDA's guidance documents",
"B": "this guidance",
"D": "government agency"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INTRODUCTION This guidance is intended to he lp ma...'?",
"reference": "INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s 210 and 211).",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INTRODUCTION This guidance is intended to he lp ma...'?",
"reference": "INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s 210 and 211).",
"options": {
"B": "CFR",
"A": "FDA",
"C": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s ____ and 211).",
"reference": "INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s 210 and 211).",
"options": {
"B": "210",
"A": "211",
"C": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s 210 and ____).",
"reference": "INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s 210 and 211).",
"options": {
"A": "211",
"B": "210",
"C": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 6 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
On the other hand, when 166 persons use computers to generate paper printouts of electronic records, and those paper records 167 meet all the requirements of the applicable predicate rules and persons rely on the paper records 168 to perform their regulated activities, FDA would generally not co nsider persons to be "using 169 electronic records in lieu of paper records" under 11.2(a) and 11.2(b). In these instances, the 170 use of computer systems in the generation of paper records would not trigger part 11. Definition of Part 11 Records 173 174 Under this narrow interpretation, FDA considers part 11 to be applicable to the following records 175 or signatures in electronic format (part 11 records or signatures): 176 177 Records that are required to be maintained under predicate rule requirements and that are 178 maintained in electronic format in place of paper format . On the other hand, records (and 179 any associated signatures) that are not required to be retained under predicate rules, but 180 that are nonetheless maintained in electronic format, are not part 11 records . We recommend that you determine, based on the predicate rules, whether specific records 182 are part 11 records. We recommend that you document such decisions. 183 184 Records that are required to be maintained under predicate rules, that are maintained in 185 electro nic format in addition to paper format, and that are relied on to perform regulated 186 activities . In some cases, actual business practices may dictate whether you are using electronic 188 records instead of paper records under 11.2(a). For example, if a reco rd is required to 189 be maintained under a predicate rule and you use a computer to generate a paper printout 190 of the electronic records, but you nonetheless rely on the electronic record to perform 191 regulated activities, the Agency may consider you to be using the electronic record 192 instead of the paper record.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Definition of Part 11 Records 173 174 Under this n...'?",
"reference": "Definition of Part 11 Records 173 174 Under this narrow interpretation, FDA considers part 11 to be applicable to the following records 175 or signatures in electronic format (part 11 records or signatures): 176 177 Records that are required to be maintained under predicate rule requirements and that are 178 maintained in electronic format in place of paper format .",
"options": {
"C": "FDA",
"A": "Agency",
"B": "those paper records",
"D": "the paper records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part ____ Records 173 174 Under this narrow interpretation, FDA considers part 11 to be applicable to the following records 175 or signatures in electronic format (part 11 records or signatures): 176 177 Records that are required to be maintained under predicate rule requirements and that are 178 maintained in electronic format in place of paper format .",
"reference": "Definition of Part 11 Records 173 174 Under this narrow interpretation, FDA considers part 11 to be applicable to the following records 175 or signatures in electronic format (part 11 records or signatures): 176 177 Records that are required to be maintained under predicate rule requirements and that are 178 maintained in electronic format in place of paper format .",
"options": {
"D": "11",
"A": "166",
"B": "167",
"C": "those paper records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part 11 Records ____ 174 Under this narrow interpretation, FDA considers part 11 to be applicable to the following records 175 or signatures in electronic format (part 11 records or signatures): 176 177 Records that are required to be maintained under predicate rule requirements and that are 178 maintained in electronic format in place of paper format .",
"reference": "Definition of Part 11 Records 173 174 Under this narrow interpretation, FDA considers part 11 to be applicable to the following records 175 or signatures in electronic format (part 11 records or signatures): 176 177 Records that are required to be maintained under predicate rule requirements and that are 178 maintained in electronic format in place of paper format .",
"options": {
"C": "173",
"A": "166",
"B": "167",
"D": "those paper records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part 11 Records 173 ____ Under this narrow interpretation, FDA considers part 11 to be applicable to the following records 175 or signatures in electronic format (part 11 records or signatures): 176 177 Records that are required to be maintained under predicate rule requirements and that are 178 maintained in electronic format in place of paper format .",
"reference": "Definition of Part 11 Records 173 174 Under this narrow interpretation, FDA considers part 11 to be applicable to the following records 175 or signatures in electronic format (part 11 records or signatures): 176 177 Records that are required to be maintained under predicate rule requirements and that are 178 maintained in electronic format in place of paper format .",
"options": {
"C": "174",
"A": "166",
"B": "167",
"D": "those paper records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part ____ Records 173 174 Under this narrow interpretation, FDA considers part 11 to be applicable to the following records 175 or signatures in electronic format (part 11 records or signatures): 176 177 Records that are required to be maintained under predicate rule requirements and that are 178 maintained in electronic format in place of paper format .",
"reference": "Definition of Part 11 Records 173 174 Under this narrow interpretation, FDA considers part 11 to be applicable to the following records 175 or signatures in electronic format (part 11 records or signatures): 176 177 Records that are required to be maintained under predicate rule requirements and that are 178 maintained in electronic format in place of paper format .",
"options": {
"D": "11",
"A": "166",
"B": "167",
"C": "those paper records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part 11 Records 173 174 Under this narrow interpretation, FDA considers part 11 to be applicable to the following records ____ or signatures in electronic format (part 11 records or signatures): 176 177 Records that are required to be maintained under predicate rule requirements and that are 178 maintained in electronic format in place of paper format .",
"reference": "Definition of Part 11 Records 173 174 Under this narrow interpretation, FDA considers part 11 to be applicable to the following records 175 or signatures in electronic format (part 11 records or signatures): 176 177 Records that are required to be maintained under predicate rule requirements and that are 178 maintained in electronic format in place of paper format .",
"options": {
"B": "175",
"A": "166",
"C": "167",
"D": "those paper records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 50 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation . This approach may apply scripted testing for high -risk features or operations and 431 unscripted testing for low - to medium -risk items as part of the same assurance effort . In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities. In contrast, for software features, 439 functions ,and operations that are not high -risk, manufacture rs may consider using unscripted 440 testing methods such as ad -hoc testing, error -guessing, exploratory testing, or a combination of 441 methods that is suitable for the risk of the intended use. 442 443 When deciding on the appropriate assurance activities, manufacture rs should consider whether 444 there are any additional controls or mechanisms in place throughout the quality system that may 445 decrease the impact of compromised safety and/or quality if failure of the software feature, 446 function or operation were to occur. For example, as part of a comprehensive assurance 447 approach, manufacturers can leverage the following to reduce the effort of additional assurance 448 activities : 449 450 Activities, people, and established processes that provide control in production. Such 451 activities ma
y include procedures to ensure integrity in the data supporting production or 452 software quality assurance processes performed by other organizational units.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: '427 428 Limited scripted testing A hybrid approa...'?",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"A": "Limited",
"B": "scripted and unscripted testing",
"C": "452 software quality assurance processes",
"D": "determine"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"D": "427",
"A": "427 428",
"B": "429",
"C": "scripted and unscripted testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 427 ____ Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"C": "428",
"A": "427 428",
"B": "429",
"D": "scripted and unscripted testing"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that ____ is app ropriately scaled according to the risk of the computer system or automation .",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"B": "429",
"A": "427 428",
"C": "431",
"D": "427 428 Limited scripted testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '427 428 Limited scripted testing A hybrid approa...'?",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"B": "Limited",
"A": "scripted and unscripted testing",
"C": "452 software quality assurance processes",
"D": "determine"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"B": "427",
"A": "427 428",
"C": "429",
"D": "scripted and unscripted testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 427 ____ Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"B": "428",
"A": "427 428",
"C": "429",
"D": "scripted and unscripted testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that ____ is app ropriately scaled according to the risk of the computer system or automation .",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"D": "429",
"A": "427 428",
"B": "431",
"C": "427 428 Limited scripted testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '427 428 Limited scripted testing A hybrid approa...'?",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"B": "Limited",
"A": "scripted and unscripted testing",
"C": "452 software quality assurance processes",
"D": "determine"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"A": "427",
"B": "427 428",
"C": "429",
"D": "scripted and unscripted testing"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 427 ____ Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"B": "428",
"A": "427 428",
"C": "429",
"D": "scripted and unscripted testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that ____ is app ropriately scaled according to the risk of the computer system or automation .",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"D": "429",
"A": "427 428",
"B": "431",
"C": "427 428 Limited scripted testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In contrast, for software features, ____ functions ,and operations that are not high -risk, manufacture rs may consider using unscripted 440 testing methods such as ad -hoc testing, error -guessing, exploratory testing, or a combination of 441 methods that is suitable for the risk of the intended use.",
"reference": "In contrast, for software features, 439 functions ,and operations that are not high -risk, manufacture rs may consider using unscripted 440 testing methods such as ad -hoc testing, error -guessing, exploratory testing, or a combination of 441 methods that is suitable for the risk of the intended use.",
"options": {
"D": "439",
"A": "427 428",
"B": "429",
"C": "427 428 Limited scripted testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In contrast, for software features, 439 functions ,and operations that are not high -risk, manufacture rs may consider using unscripted ____ testing methods such as ad -hoc testing, error -guessing, exploratory testing, or a combination of 441 methods that is suitable for the risk of the intended use.",
"reference": "In contrast, for software features, 439 functions ,and operations that are not high -risk, manufacture rs may consider using unscripted 440 testing methods such as ad -hoc testing, error -guessing, exploratory testing, or a combination of 441 methods that is suitable for the risk of the intended use.",
"options": {
"C": "440",
"A": "427 428",
"B": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In contrast, for software features, 439 functions ,and operations that are not high -risk, manufacture rs may consider using unscripted 440 testing methods such as ad -hoc testing, error -guessing, exploratory testing, or a combination of ____ methods that is suitable for the risk of the intended use.",
"reference": "In contrast, for software features, 439 functions ,and operations that are not high -risk, manufacture rs may consider using unscripted 440 testing methods such as ad -hoc testing, error -guessing, exploratory testing, or a combination of 441 methods that is suitable for the risk of the intended use.",
"options": {
"B": "441",
"A": "427 428",
"C": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Such ____ activities ma\ny include procedures to ensure integrity in the data supporting production or 452 software quality assurance processes performed by other organizational units.",
"reference": "Such 451 activities ma\ny include procedures to ensure integrity in the data supporting production or 452 software quality assurance processes performed by other organizational units.",
"options": {
"C": "451",
"A": "427 428",
"B": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Such 451 activities ma\ny include procedures to ensure integrity in the data supporting production or ____ software quality assurance processes performed by other organizational units.",
"reference": "Such 451 activities ma\ny include procedures to ensure integrity in the data supporting production or 452 software quality assurance processes performed by other organizational units.",
"options": {
"C": "452",
"A": "427 428",
"B": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is 444?",
"reference": "442 443 When deciding on the appropriate assurance activities, manufacture rs should consider whether 444 there are any additional controls or mechanisms in place throughout the quality system that may 445 decrease the impact of compromised safety and/or quality if failure of the software feature, 446 function or operation were to occur.",
"options": {
"A": "controls",
"B": "427 428 Limited scripted testing",
"C": "scripted and unscripted testing",
"D": "control condition"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 443 When deciding on the appropriate assurance activities, manufacture rs should consider whether 444 there are any additional controls or mechanisms in place throughout the quality system that may 445 decrease the impact of compromised safety and/or quality if failure of the software feature, 446 function or operation were to occur.",
"reference": "442 443 When deciding on the appropriate assurance activities, manufacture rs should consider whether 444 there are any additional controls or mechanisms in place throughout the quality system that may 445 decrease the impact of compromised safety and/or quality if failure of the software feature, 446 function or operation were to occur.",
"options": {
"D": "442",
"A": "427 428",
"B": "429",
"C": "427 428 Limited scripted testing"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 442 ____ When deciding on the appropriate assurance activities, manufacture rs should consider whether 444 there are any additional controls or mechanisms in place throughout the quality system that may 445 decrease the impact of compromised safety and/or quality if failure of the software feature, 446 function or operation were to occur.",
"reference": "442 443 When deciding on the appropriate assurance activities, manufacture rs should consider whether 444 there are any additional controls or mechanisms in place throughout the quality system that may 445 decrease the impact of compromised safety and/or quality if failure of the software feature, 446 function or operation were to occur.",
"options": {
"C": "443",
"A": "427 428",
"B": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 442 443 When deciding on the appropriate assurance activities, manufacture rs should consider whether ____ there are any additional controls or mechanisms in place throughout the quality system that may 445 decrease the impact of compromised safety and/or quality if failure of the software feature, 446 function or operation were to occur.",
"reference": "442 443 When deciding on the appropriate assurance activities, manufacture rs should consider whether 444 there are any additional controls or mechanisms in place throughout the quality system that may 445 decrease the impact of compromised safety and/or quality if failure of the software feature, 446 function or operation were to occur.",
"options": {
"A": "444",
"B": "427 428",
"C": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 442 443 When deciding on the appropriate assurance activities, manufacture rs should consider whether 444 there are any additional controls or mechanisms in place throughout the quality system that may ____ decrease the impact of compromised safety and/or quality if failure of the software feature, 446 function or operation were to occur.",
"reference": "442 443 When deciding on the appropriate assurance activities, manufacture rs should consider whether 444 there are any additional controls or mechanisms in place throughout the quality system that may 445 decrease the impact of compromised safety and/or quality if failure of the software feature, 446 function or operation were to occur.",
"options": {
"C": "445",
"A": "427 428",
"B": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 442 443 When deciding on the appropriate assurance activities, manufacture rs should consider whether 444 there are any additional controls or mechanisms in place throughout the quality system that may 445 decrease the impact of compromised safety and/or quality if failure of the software feature, ____ function or operation were to occur.",
"reference": "442 443 When deciding on the appropriate assurance activities, manufacture rs should consider whether 444 there are any additional controls or mechanisms in place throughout the quality system that may 445 decrease the impact of compromised safety and/or quality if failure of the software feature, 446 function or operation were to occur.",
"options": {
"D": "446",
"A": "427 428",
"B": "429",
"C": "427 428 Limited scripted testing"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What percentage is mentioned: 'For example, as part of a comprehensive assurance ...'?",
"reference": "For example, as part of a comprehensive assurance 447 approach, manufacturers can leverage the following to reduce the effort of additional assurance 448 activities : 449 450 Activities, people, and established processes that provide control in production.",
"options": {
"A": "449 450 Activities",
"B": "427 428",
"C": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '427 428 Limited scripted testing A hybrid approa...'?",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"D": "Limited",
"A": "scripted and unscripted testing",
"B": "452 software quality assurance processes",
"C": "determine"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"B": "427",
"A": "427 428",
"C": "429",
"D": "scripted and unscripted testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 427 ____ Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"A": "428",
"B": "427 428",
"C": "429",
"D": "scripted and unscripted testing"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that ____ is app ropriately scaled according to the risk of the computer system or automation .",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"C": "429",
"A": "427 428",
"B": "431",
"D": "427 428 Limited scripted testing"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'In gener al, FDA recommends that manufacturers app...'?",
"reference": "In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"options": {
"B": "al",
"A": "427 428 Limited scripted testing",
"C": "scripted and unscripted testing",
"D": "Alabama"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In gener al, FDA recommends that manufacturers app...'?",
"reference": "In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"options": {
"D": "FDA",
"A": "Limited",
"B": "427 428 Limited scripted testing",
"C": "scripted and unscripted testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which ____ the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"reference": "In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"options": {
"C": "434",
"A": "427 428",
"B": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are ____ consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"reference": "In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"options": {
"A": "435",
"B": "427 428",
"C": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the ____ appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"reference": "In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"options": {
"A": "436",
"B": "427 428",
"C": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers ____ may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"reference": "In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"options": {
"D": "437",
"A": "427 428",
"B": "429",
"C": "427 428 Limited scripted testing"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, ____ as appropriate ,when determining their assurance activities.",
"reference": "In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"options": {
"B": "438",
"A": "427 428",
"C": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This approach may apply scripted testing for high -risk features or operations and ____ unscripted testing for low - to medium -risk items as part of the same assurance effort .",
"reference": "This approach may apply scripted testing for high -risk features or operations and 431 unscripted testing for low - to medium -risk items as part of the same assurance effort .",
"options": {
"B": "431",
"A": "427 428",
"C": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '427 428 Limited scripted testing A hybrid approa...'?",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"D": "Limited",
"A": "scripted and unscripted testing",
"B": "452 software quality assurance processes",
"C": "determine"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '427 428 Limited scripted testing A hybrid approa...'?",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"B": "Limited",
"A": "scripted and unscripted testing",
"C": "452 software quality assurance processes",
"D": "determine"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"A": "427",
"B": "427 428",
"C": "429",
"D": "scripted and unscripted testing"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 427 ____ Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"B": "428",
"A": "427 428",
"C": "429",
"D": "scripted and unscripted testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that ____ is app ropriately scaled according to the risk of the computer system or automation .",
"reference": "427 428 Limited scripted testing A hybrid approach of scripted and unscripted testing that 429 is app ropriately scaled according to the risk of the computer system or automation .",
"options": {
"B": "429",
"A": "427 428",
"C": "431",
"D": "427 428 Limited scripted testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'In gener al, FDA recommends that manufacturers app...'?",
"reference": "In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"options": {
"C": "al",
"A": "427 428 Limited scripted testing",
"B": "scripted and unscripted testing",
"D": "Alabama"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In gener al, FDA recommends that manufacturers app...'?",
"reference": "In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"options": {
"D": "FDA",
"A": "Limited",
"B": "427 428 Limited scripted testing",
"C": "scripted and unscripted testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which ____ the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"reference": "In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"options": {
"D": "434",
"A": "427 428",
"B": "429",
"C": "427 428 Limited scripted testing"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are ____ consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"reference": "In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"options": {
"D": "435",
"A": "427 428",
"B": "429",
"C": "427 428 Limited scripted testing"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the ____ appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"reference": "In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"options": {
"C": "436",
"A": "427 428",
"B": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers ____ may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"reference": "In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"options": {
"D": "437",
"A": "427 428",
"B": "429",
"C": "427 428 Limited scripted testing"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, ____ as appropriate ,when determining their assurance activities.",
"reference": "In gener al, FDA recommends that manufacturers apply principles of risk -based t esting in which 434 the management, selection, prioritization, and use of testing activities and resources are 435 consciously based on corresponding types and levels of analyzed risk to determine the 436 appropriate activities.14For high-risksoftware features, functions ,and operations, manufacturers 437 may choose to consider more rigor such as the use of scripted testing or limited scripted testing, 438 as appropriate ,when determining their assurance activities.",
"options": {
"B": "438",
"A": "427 428",
"C": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What percentage is mentioned: 'For example, as part of a comprehensive assurance ...'?",
"reference": "For example, as part of a comprehensive assurance 447 approach, manufacturers can leverage the following to reduce the effort of additional assurance 448 activities : 449 450 Activities, people, and established processes that provide control in production.",
"options": {
"B": "449 450 Activities",
"A": "427 428",
"C": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, as part of a comprehensive assurance ____ approach, manufacturers can leverage the following to reduce the effort of additional assurance 448 activities : 449 450 Activities, people, and established processes that provide control in production.",
"reference": "For example, as part of a comprehensive assurance 447 approach, manufacturers can leverage the following to reduce the effort of additional assurance 448 activities : 449 450 Activities, people, and established processes that provide control in production.",
"options": {
"A": "447",
"B": "427 428",
"C": "429",
"D": "427 428 Limited scripted testing"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Firms should implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models. 3 Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product. Managements involvement 1
This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration. 2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. We update guidances periodic ally. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm . 3 See ICH guidance for industry Q9 Quality Risk Management . Contains Nonbinding Recommendations 2 in and influence on these strategies is essential in preventing and correcting conditions that can lead to data integrity problems. It is the role of management with executive responsibility to create a quality culture where employees understand that data integrity i s an organizational core value and employees are encoura ged to identify and promptly report data integrity issues. In the absence of management support of a quality culture, quality systems can break down and lead to CGMP noncompliance. In general, FDA s guidance documents do not establish legally enforceable responsibilities. Instead , guidances describe the Agency s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: ____ Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.",
"reference": "3 Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.",
"options": {
"D": "3",
"A": "industry Q9 Quality Risk Management",
"B": "the FDA Drugs guidance web page",
"C": "troika"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the absence of management support of a quality ...'?",
"reference": "In the absence of management support of a quality culture, quality systems can break down and lead to CGMP noncompliance.",
"options": {
"A": "CGMP",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the absence of management support of a quality ...'?",
"reference": "In the absence of management support of a quality culture, quality systems can break down and lead to CGMP noncompliance.",
"options": {
"B": "CGMP",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '3 See ICH guidance for industry Q9 Quality Risk Ma...'?",
"reference": "3 See ICH guidance for industry Q9 Quality Risk Management .",
"options": {
"A": "Q9 Quality Risk Management",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "the FDA Drugs guidance web page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ See ICH guidance for industry Q9 Quality Risk Management .",
"reference": "3 See ICH guidance for industry Q9 Quality Risk Management .",
"options": {
"A": "3",
"B": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "troika"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"B": "the International Council for Harmonisation (ICH",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"A": "Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"C": "2",
"A": "industry Q9 Quality Risk Management",
"B": "the FDA Drugs guidance web page",
"D": "two"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"C": "the International Council for Harmonisation (ICH",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"C": "Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"D": "FDA Drugs",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"D": "RegulatoryInformation/Guidances",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Instead , guidances describe the Agency s current ...'?",
"reference": "Instead , guidances describe the Agency s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.",
"options": {
"B": "Agency",
"A": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "government agency"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"C": "FDA Drugs",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"B": "RegulatoryInformation/Guidances",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Office of Pharmaceutical Quality",
"A": "the Office of Compliance",
"B": "the Center for Drug Evaluation and Research",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Office of Compliance",
"A": "the Office of Pharmaceutical Quality",
"B": "the Center for Drug Evaluation and Research",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Center for Drug Evaluation and Research",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Center for Biologics Evaluation and Research",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Center for Veterinary Medicine",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 5 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1. Analyze Data for Trends ............................................................................................................... 21 2. Conduct Internal Audits ................................................................................................................. 21 3. Quality Risk Management ..............................................................................................................
Corrective Action ...........................................................................................................................
22 Contains Nonbinding Recommendations 5. Preventive Actions ......................................................................................................................... 23 6. Promote Improvement ....................................................................................................................
23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................
25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any pe rson and does not operate to bind FDA or the public.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "When did this occur: 'Conduct Internal Audits .............................'?",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"B": "21 3",
"A": "21 2",
"C": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Conduct Internal Audits ................................................................................................................. ____ 3.",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"D": "21",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Conduct Internal Audits ................................................................................................................. 21 ____.",
"reference": "Conduct Internal Audits ................................................................................................................. 21 3.",
"options": {
"D": "3",
"A": "21 2",
"B": "23 6",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Analyze Data for Trends .............................'?",
"reference": "Analyze Data for Trends ............................................................................................................... 21 2.",
"options": {
"C": "Analyze Data",
"A": "Conduct Internal Audits",
"B": "Quality Risk Management",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Fill in the blank: Analyze Data for Trends ............................................................................................................... ____ 2.",
"reference": "Analyze Data for Trends ............................................................................................................... 21 2.",
"options": {
"C": "21",
"A": "21 2",
"B": "23 6",
"D": "Nonbinding Recommendations Guidance"
},
"answer": "C",
"difficulty": "hard",
"question_type": "analytical"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 45 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Implementation of quality risk management in cludes assessing the risks, selecting and implementing risk management controls commensura te with the level of risk, and evaluating the results of the risk management efforts. Since ri sk management is an ite rative process, it should be repeated if new information is developed th at changes the need for, or nature of, risk management. In a manufacturing quality system s environment, ri sk management is used as a tool in the development of product specifications and critical process parameters. Used in conjunction with process understanding, quality risk manageme nt helps manage and control change. Corrective Action Corrective action is a reactive tool for system improvement to ensure that significant problems do not recur. Both quality systems and the CGMP regulations emphasize corrective actions. Quality systems approaches call f or procedures to be developed and documented to ensure that the need for action is evaluated relevant to th e possible consequences, the root cause of the problem is investigated, possible actions are de termined, a selected action is taken within a defined timeframe, and the effectiveness of the action taken is evaluated. It is essential to document corrective actions taken (CGM P also requires this; see 211.192). It is essential to determine what actions will reduce the likelihood of a problem recurring. Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference 8. Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions 5. Preventive Actions Being proactive is an essential tool in quality systems management.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: It is essential to document corrective actions taken (CGM P also requires this; see ____).",
"reference": "It is essential to document corrective actions taken (CGM P also requires this; see 211.192).",
"options": {
"D": "211.192",
"A": "quality risk management",
"B": "quality systems management",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Both quality systems and the CGMP regulations emph...'?",
"reference": "Both quality systems and the CGMP regulations emphasize corrective actions.",
"options": {
"B": "CGMP",
"A": "Corrective Action Corrective",
"C": "Returns Complaints Internal",
"D": "quality risk management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is essential to document corrective actions taken (CGM P also requires this; see ____).",
"reference": "It is essential to document corrective actions taken (CGM P also requires this; see 211.192).",
"options": {
"C": "211.192",
"A": "quality risk management",
"B": "quality systems management",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Both quality systems and the CGMP regulations emph...'?",
"reference": "Both quality systems and the CGMP regulations emphasize corrective actions.",
"options": {
"A": "CGMP",
"B": "Corrective Action Corrective",
"C": "Returns Complaints Internal",
"D": "quality risk management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is essential to document corrective actions taken (CGM P also requires this; see ____).",
"reference": "It is essential to document corrective actions taken (CGM P also requires this; see 211.192).",
"options": {
"B": "211.192",
"A": "quality risk management",
"C": "quality systems management",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Examples of sources that can be used to ga ther su...'?",
"reference": "Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference 8.",
"options": {
"A": "ga",
"B": "Corrective Action Corrective",
"C": "CGMP",
"D": "quality risk management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Examples of sources that can be used to ga ther such information include the fo llowing: ____ See Reference 8.",
"reference": "Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference 8.",
"options": {
"D": "19",
"A": "211.192",
"B": "quality risk management",
"C": "quality systems management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference ____.",
"reference": "Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference 8.",
"options": {
"A": "8",
"B": "211.192",
"C": "quality risk management",
"D": "quality systems management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Both quality systems and the CGMP regulations emph...'?",
"reference": "Both quality systems and the CGMP regulations emphasize corrective actions.",
"options": {
"D": "CGMP",
"A": "Corrective Action Corrective",
"B": "Returns Complaints Internal",
"C": "quality risk management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Both quality systems and the CGMP regulations emph...'?",
"reference": "Both quality systems and the CGMP regulations emphasize corrective actions.",
"options": {
"D": "CGMP",
"A": "Corrective Action Corrective",
"B": "Returns Complaints Internal",
"C": "quality risk management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is essential to document corrective actions taken (CGM P also requires this; see ____).",
"reference": "It is essential to document corrective actions taken (CGM P also requires this; see 211.192).",
"options": {
"A": "211.192",
"B": "quality risk management",
"C": "quality systems management",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Both quality systems and the CGMP regulations emph...'?",
"reference": "Both quality systems and the CGMP regulations emphasize corrective actions.",
"options": {
"D": "CGMP",
"A": "Corrective Action Corrective",
"B": "Returns Complaints Internal",
"C": "quality risk management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Nonconfo...'?",
"reference": "Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions 5.",
"options": {
"D": "Returns Complaints Internal",
"A": "quality risk management",
"B": "quality systems management",
"C": "Data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Nonconfo...'?",
"reference": "Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions 5.",
"options": {
"B": "Data",
"A": "quality risk management",
"C": "quality systems management",
"D": "datum"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions ____.",
"reference": "Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions 5.",
"options": {
"D": "5",
"A": "211.192",
"B": "quality risk management",
"C": "quality systems management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is essential to document corrective actions taken (CGM P also requires this; see ____).",
"reference": "It is essential to document corrective actions taken (CGM P also requires this; see 211.192).",
"options": {
"A": "211.192",
"B": "quality risk management",
"C": "quality systems management",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Nonconfo...'?",
"reference": "Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions 5.",
"options": {
"B": "Returns Complaints Internal",
"A": "quality risk management",
"C": "quality systems management",
"D": "Data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Nonconfo...'?",
"reference": "Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions 5.",
"options": {
"C": "Data",
"A": "quality risk management",
"B": "quality systems management",
"D": "datum"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions ____.",
"reference": "Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions 5.",
"options": {
"C": "5",
"A": "211.192",
"B": "quality risk management",
"D": "quality systems management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Examples of sources that can be used to ga ther su...'?",
"reference": "Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference 8.",
"options": {
"C": "ga",
"A": "Corrective Action Corrective",
"B": "CGMP",
"D": "quality risk management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Examples of sources that can be used to ga ther such information include the fo llowing: ____ See Reference 8.",
"reference": "Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference 8.",
"options": {
"D": "19",
"A": "211.192",
"B": "quality risk management",
"C": "quality systems management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference ____.",
"reference": "Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference 8.",
"options": {
"C": "8",
"A": "211.192",
"B": "quality risk management",
"D": "quality systems management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is essential to document corrective actions taken (CGM P also requires this; see ____).",
"reference": "It is essential to document corrective actions taken (CGM P also requires this; see 211.192).",
"options": {
"D": "211.192",
"A": "quality risk management",
"B": "quality systems management",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Both quality systems and the CGMP regulations emph...'?",
"reference": "Both quality systems and the CGMP regulations emphasize corrective actions.",
"options": {
"C": "CGMP",
"A": "Corrective Action Corrective",
"B": "Returns Complaints Internal",
"D": "quality risk management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Both quality systems and the CGMP regulations emph...'?",
"reference": "Both quality systems and the CGMP regulations emphasize corrective actions.",
"options": {
"C": "CGMP",
"A": "Corrective Action Corrective",
"B": "Returns Complaints Internal",
"D": "quality risk management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Both quality systems and the CGMP regulations emph...'?",
"reference": "Both quality systems and the CGMP regulations emphasize corrective actions.",
"options": {
"A": "CGMP",
"B": "Corrective Action Corrective",
"C": "Returns Complaints Internal",
"D": "quality risk management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is essential to document corrective actions taken (CGM P also requires this; see ____).",
"reference": "It is essential to document corrective actions taken (CGM P also requires this; see 211.192).",
"options": {
"B": "211.192",
"A": "quality risk management",
"C": "quality systems management",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Examples of sources that can be used to ga ther su...'?",
"reference": "Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference 8.",
"options": {
"C": "ga",
"A": "Corrective Action Corrective",
"B": "CGMP",
"D": "quality risk management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Examples of sources that can be used to ga ther such information include the fo llowing: ____ See Reference 8.",
"reference": "Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference 8.",
"options": {
"D": "19",
"A": "211.192",
"B": "quality risk management",
"C": "quality systems management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference ____.",
"reference": "Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference 8.",
"options": {
"B": "8",
"A": "211.192",
"C": "quality risk management",
"D": "quality systems management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Examples of sources that can be used to ga ther su...'?",
"reference": "Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference 8.",
"options": {
"B": "ga",
"A": "Corrective Action Corrective",
"C": "CGMP",
"D": "quality risk management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Examples of sources that can be used to ga ther such information include the fo llowing: ____ See Reference 8.",
"reference": "Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference 8.",
"options": {
"C": "19",
"A": "211.192",
"B": "quality risk management",
"D": "quality systems management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference ____.",
"reference": "Examples of sources that can be used to ga ther such information include the fo llowing: 19 See Reference 8.",
"options": {
"B": "8",
"A": "211.192",
"C": "quality risk management",
"D": "quality systems management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is essential to document corrective actions taken (CGM P also requires this; see ____).",
"reference": "It is essential to document corrective actions taken (CGM P also requires this; see 211.192).",
"options": {
"B": "211.192",
"A": "quality risk management",
"C": "quality systems management",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is essential to document corrective actions taken (CGM P also requires this; see ____).",
"reference": "It is essential to document corrective actions taken (CGM P also requires this; see 211.192).",
"options": {
"D": "211.192",
"A": "quality risk management",
"B": "quality systems management",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is essential to document corrective actions taken (CGM P also requires this; see ____).",
"reference": "It is essential to document corrective actions taken (CGM P also requires this; see 211.192).",
"options": {
"A": "211.192",
"B": "quality risk management",
"C": "quality systems management",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Nonconfo...'?",
"reference": "Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions 5.",
"options": {
"B": "Returns Complaints Internal",
"A": "quality risk management",
"C": "quality systems management",
"D": "Data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Nonconfo...'?",
"reference": "Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions 5.",
"options": {
"A": "Data",
"B": "quality risk management",
"C": "quality systems management",
"D": "datum"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions ____.",
"reference": "Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions 5.",
"options": {
"D": "5",
"A": "211.192",
"B": "quality risk management",
"C": "quality systems management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is essential to document corrective actions taken (CGM P also requires this; see ____).",
"reference": "It is essential to document corrective actions taken (CGM P also requires this; see 211.192).",
"options": {
"D": "211.192",
"A": "quality risk management",
"B": "quality systems management",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is essential to document corrective actions taken (CGM P also requires this; see ____).",
"reference": "It is essential to document corrective actions taken (CGM P also requires this; see 211.192).",
"options": {
"D": "211.192",
"A": "quality risk management",
"B": "quality systems management",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Nonconfo...'?",
"reference": "Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions 5.",
"options": {
"B": "Returns Complaints Internal",
"A": "quality risk management",
"C": "quality systems management",
"D": "Data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Nonconfo...'?",
"reference": "Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions 5.",
"options": {
"C": "Data",
"A": "quality risk management",
"B": "quality systems management",
"D": "datum"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions ____.",
"reference": "Contains Nonbinding Recommendations Nonconformance report s and rejections Returns Complaints Internal and external audits Data and ri sk assessment related to oper ations and quality system processes Management review decisions 5.",
"options": {
"D": "5",
"A": "211.192",
"B": "quality risk management",
"C": "quality systems management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Both quality systems and the CGMP regulations emph...'?",
"reference": "Both quality systems and the CGMP regulations emphasize corrective actions.",
"options": {
"C": "CGMP",
"A": "Corrective Action Corrective",
"B": "Returns Complaints Internal",
"D": "quality risk management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 45 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination
Summary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:
Error guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "Digital",
"B": "Identify",
"C": "Independent",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "Identify",
"A": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "key"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "Independent",
"B": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "freelance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"C": "go along"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"C": "go along"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "526",
"A": "525",
"B": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate ____ 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "525",
"B": "529",
"C": "530",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 ____ 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "526",
"A": "525",
"B": "529",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 ____ 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "527",
"B": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 ____ Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "528",
"A": "525",
"B": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has ____ developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "529",
"A": "525",
"B": "530",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "Digital",
"A": "Identify",
"B": "Independent",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Identify",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"C": "key"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Independent",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"C": "freelance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"D": "go along"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"C": "go along"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "526",
"A": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate ____ 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "525",
"A": "529",
"B": "530",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 ____ 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "526",
"B": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 ____ 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "527",
"A": "525",
"B": "529",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 ____ Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "528",
"A": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has ____ developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "529",
"B": "525",
"C": "530",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "Digital",
"A": "Identify",
"B": "Independent",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Identify",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"C": "key"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "Independent",
"B": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "freelance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"C": "go along"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "go along"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "526",
"A": "525",
"B": "529",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate ____ 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "525",
"A": "529",
"B": "530",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 ____ 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "526",
"A": "525",
"B": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 ____ 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "527",
"A": "525",
"B": "529",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 ____ Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "528",
"A": "525",
"B": "529",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has ____ developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "529",
"A": "525",
"B": "530",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "Digital",
"A": "Identify",
"B": "Independent",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"C": "Identify",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"D": "key"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "Independent",
"B": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "freelance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"C": "when appropriate Unscripted Testing",
"D": "go along"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "Pass",
"A": "Exploratory Testing Establish high level test p lan objectives",
"B": "when appropriate Unscripted Testing",
"C": "go along"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "526",
"A": "525",
"B": "529",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate ____ 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "525",
"A": "529",
"B": "530",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 ____ 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"B": "526",
"A": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 ____ 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"D": "527",
"A": "525",
"B": "529",
"C": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 ____ Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "528",
"B": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has ____ developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "529",
"B": "525",
"C": "530",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data ____ stored in a controlled system for monitoring purposes.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 17Assurance ActivityTest Plan Test ResultsRecord (Including Digital) Scripted Testing: LimitedLimited test cases (step -by- step procedure) identified Expected results for the test cases Identify unscripted testing applied Independent review and approval of test plan Pass/fail for test case identified Details regarding any failures/deviations found Intended use Risk determination\nSummary description of testing performed Pass/fail test result for each test case Issues found and disposition Conclusion statement Record of who performed testing and date Established review and approval when appropriate Unscripted Testing: Ad-hoc Testing of features and functions with no test plan Details regarding any failures/deviations foundIntended use Risk determination Summary description of features and functions tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing:\nError guessing Testing of failure-modes with no test plan Details regarding any failures/ deviations foundIntended use Risk determination Summary description of fail ure-modes tested and testing performed Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate Unscripted Testing: Exploratory Testing Establish high level test p lan objectives (no step-by-step procedure is necessary)Pass/fail for each test plan objective Details regarding any failures/deviations foundIntended use Risk determination Summary description of the objectives tested and testing performed Pass/fail test result for each objective Issues found and disposition Conclusion statement Record of who performed testing and date of testing Established review and approval when appropriate 525 526 527 528 Contains Nonbinding Recommendations Draft Not for Implementation 18The following is an example of a record of assurance in a scenario where a manufacturer has 529 developed a spreadsheet with the intended use of collecting and graphing nonconformance data 530 stored in a controlled system for monitoring purposes.",
"options": {
"A": "530",
"B": "525",
"C": "529",
"D": "Exploratory Testing Establish high level test p lan objectives"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
A modern quality system approach indicates that change control is warranted when data analysis or other inform ation reveals an area fo r improveme nt. Changes to an established process must be controlled and documented to ensure that desire d attributes for the finished product will be met ( 211.100(a)). Change control with regard to pharmaceuticals is addressed in more detail in the CGMP regulations. When developing a pr ocess change, it is important to keep the process design and scientific knowledge of the product in mind. If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160). When implementing a change, its effect shoul d be determined by monitoring and evaluating those specific elements that may be affected based on an understanding of the process. This approach allows the steps taken to implement a change and the effects of the change on the process to be considered systematically. Applic ation of risk analysis may facilitate evaluating the potential effect of the change. Evaluating the e ffects of a change can en tail additional tests or examinations of subsequent batches (e.g., additional in-process testing or additional stability studies). The quality system elements identified in this guidance, if implemented and maintained, will help a manufacturer manage change and implement continual improvement in manufacturing. Under a quality systems approach, procedures should be in place to ensure the accuracy of test results. Test results that are out of specification may be due to testing problems or manufacturing problems and should be investigated. Any invalidation of a test re sult should be scientifically sound and justified.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Change control with regard to pharmaceuticals is a...'?",
"reference": "Change control with regard to pharmaceuticals is addressed in more detail in the CGMP regulations.",
"options": {
"D": "CGMP",
"A": "change control",
"B": "a pr ocess change",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Change control with regard to pharmaceuticals is a...'?",
"reference": "Change control with regard to pharmaceuticals is addressed in more detail in the CGMP regulations.",
"options": {
"C": "CGMP",
"A": "change control",
"B": "a pr ocess change",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'If major design issues are encountered through pro...'?",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"D": "experien ce",
"A": "change control",
"B": "a pr ocess change",
"C": "211.42"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( ____), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"B": "211.42",
"A": "211.100(a",
"C": "211.63",
"D": "change control"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( ____), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"D": "211.63",
"A": "211.100(a",
"B": "211.42",
"C": "change control"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( ____), or the design of laborator y controls ( 211.160).",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"D": "211.100",
"A": "211.100(a",
"B": "211.42",
"C": "change control"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( ____).",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"D": "211.160",
"A": "211.100(a",
"B": "211.42",
"C": "change control"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'If major design issues are encountered through pro...'?",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"B": "experien ce",
"A": "change control",
"C": "a pr ocess change",
"D": "211.42"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( ____), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"A": "211.42",
"B": "211.100(a",
"C": "211.63",
"D": "change control"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( ____), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"B": "211.63",
"A": "211.100(a",
"C": "211.42",
"D": "change control"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Test results that are out of specification may be due to tes...'?",
"reference": "Test results that are out of specification may be due to testing problems or manufacturing problems and should be investigated.",
"options": {
"A": "Test results that are out of specification may be due to testing problems or manufacturing problems ...",
"B": "change control",
"C": "a pr ocess change",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Applic ation of risk analysis may facilitate evalu...'?",
"reference": "Applic ation of risk analysis may facilitate evaluating the potential effect of the change.",
"options": {
"A": "Applic",
"B": "experien ce",
"C": "change control",
"D": "a pr ocess change"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'If major design issues are encountered through pro...'?",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"D": "experien ce",
"A": "change control",
"B": "a pr ocess change",
"C": "211.42"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( ____), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"B": "211.42",
"A": "211.100(a",
"C": "211.63",
"D": "change control"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( ____), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"B": "211.63",
"A": "211.100(a",
"C": "211.42",
"D": "change control"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( ____), or the design of laborator y controls ( 211.160).",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"C": "211.100",
"A": "211.100(a",
"B": "211.42",
"D": "change control"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( ____).",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"D": "211.160",
"A": "211.100(a",
"B": "211.42",
"C": "change control"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Test results that are out of specification may be due to tes...'?",
"reference": "Test results that are out of specification may be due to testing problems or manufacturing problems and should be investigated.",
"options": {
"D": "Test results that are out of specification may be due to testing problems or manufacturing problems ...",
"A": "change control",
"B": "a pr ocess change",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'If major design issues are encountered through pro...'?",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"D": "experien ce",
"A": "change control",
"B": "a pr ocess change",
"C": "211.42"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( ____), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"B": "211.42",
"A": "211.100(a",
"C": "211.63",
"D": "change control"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 5 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration. Contains Nonbinding Recommendations Draft Not for Implementation 2 numerous regulatory actio ns, including warning letters, import alerts , and consent decrees . The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ). 57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"C": "CGMP",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "records requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"C": "the Federal Food, Drug",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"A": "44",
"B": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"D": "al l",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "These data integrity -related CGMP violations"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The ____ underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"C": "42",
"A": "41 1",
"B": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 1 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Facilities and Equipment Lab facilities: 211.22(b) Staff number: 211.25(c) Under the CGMP regulations, the quality unit ( QU) has the responsibility of reviewing and approving all initial design criteria and procedures pertaining to facilities and equipment and any subsequent changes ( 211.22(c)). Under the CGMP regulations, equipment must be qualified, calibrated, cleaned, and maintained to prevent contamination a nd mix-ups ( 211.63, 211.67, 211.68). Note that the CGMP regulations require a higher standard fo r calibration and maintenance than most non- pharmaceutical quality system models. The CGMP regulations place as much emphasis on process equipment as on testing equipm ent ( 211.160, 211.63, 211.67, and 211.68) while most quality systems focus only on testing equipment.11 4. Control Outsourced Operations Outsourcing involves hiring a sec ond party under a contr act to perform the operational processes that are part of a manufacturers inherent responsibilities. For example, a manufacturer may hire another firm to package and la bel or perform CGMP regulatory training. Quality systems call for contracts (quality agreements) that clearly describe the materials or service, quality specification responsibilities, a nd communication m echanisms. Under a quality system, the manufacturer should ensure that a cont ract firm is qualified before signing a contract with that firm . The contract firms personnel should be adequately trained and monitored for performance according to their quality system, and the contract firm's and contracting manufacturers quality standards should not conflict. It is critical in a quality system to ensure that the management of the contractor be familiar with the specific requirements of the contract. However, under the CGMP requirement s, the manufacturers QU is responsible for approving or rejecting products or services provided under a contract ( 211.22(a)).
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Note that the CGMP regulations require a higher st...'?",
"reference": "Note that the CGMP regulations require a higher standard fo r calibration and maintenance than most non- pharmaceutical quality system models.",
"options": {
"B": "CGMP",
"A": "Control Outsourced Operations Outsourcing",
"C": "sec",
"D": "the contract firm's and contracting manufacturers quality standards"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 1 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555
Goal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror. 568 569 Conclusion: No errors were observed in the spreadsheet functions beyond the deviation. Incorrectly inputting text into the field is immediately visible and does not impact the risk 571 of the intended use. In addition, a validation rule was placed on the field to permit only 572 numeric data inputs. 573 Contains Nonbinding Recommendations Draft Not for Implementation 19574
When/Who: July 9, 2019, by J ane Smith 575 576
Advances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation. As a least burdensome method , FDA recommends the 579 use of electronic records, such as system logs, audit trails, and other data g enerated by the 580 software, as opposed to paper documentation and screenshots, in establishing the record 581 associated with the assurance activities. 582 583 Manufacturers have expressed confusion and concern regarding the application of Part 11, 584 Electronic Records; Electronic Signatures, to computers or automated data processing systems 585 used as part of production or the quality system.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: In addition, a validation rule was placed on the field to permit only ____ numeric data inputs.",
"reference": "In addition, a validation rule was placed on the field to permit only 572 numeric data inputs.",
"options": {
"C": "572",
"A": "550 551",
"B": "552 553",
"D": "automated data processing systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 8 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
40 41 II.Background 42 FDA envision s a future state where the medical device ecosystem is inherently focused on device 43 features and manufacturing pract ices that promote product quality and patient safety. FDA has 44 sought to identify and promote successful manufacturing practices and help device 45 manufacturers raise their manufacturing quality level. In doing so, one goal is to help 46 manufacturers produce high -quality medical devices that align with the laws and r egulations 47 implemented by FDA . Compliance with the Quality System regulation, Part 820 , is require d for 48 manufacturers of finished medical devices to the extent they engage in operations to which Part 49 820 applies . The Quality System regulation includes requ irements for medical device 50 manufacturers to develop, conduct, control, and monitor production processes to ensure that a 51 device conforms to its specifications (21 CFR 820.70, Production and Process Controls ), 52 including requirements for manufacturers to va lidate computer software used as part of 53 production or the quality system for its intended use ( see 21 CFR 820.70(i)).4Recommending 54 best practices should promote product quality and patient safety, and correlat eto higher -quality 55 outcomes. This draft guidance addresses practices relating to computers and automated data 56 processing systems used as part of production or the quality system. In recent years, advances in manufacturing technologies , including the adop tion of automation, 59 robotics, simulation, and other digital capabilities ,have allowed manufacturers to reduce sources 60 of error, optimize resources, and reduce patient risk . FDA recognizes the potential for these 61 technologies to provide significant benefit s for enhancing the quality, availability, and safety of 62 medical devices, and has undertaken several efforts to help foster the adoption and use of such 63 technologies.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "When did this occur: 'In recent years, advances in manufacturing technol...'?",
"reference": "In recent years, advances in manufacturing technologies , including the adop tion of automation, 59 robotics, simulation, and other digital capabilities ,have allowed manufacturers to reduce sources 60 of error, optimize resources, and reduce patient risk .",
"options": {
"C": "recent years",
"A": "product quality and patient safety",
"B": "their manufacturing quality level",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In recent years, advances in manufacturing technologies , including the adop tion of automation, ____ robotics, simulation, and other digital capabilities ,have allowed manufacturers to reduce sources 60 of error, optimize resources, and reduce patient risk .",
"reference": "In recent years, advances in manufacturing technologies , including the adop tion of automation, 59 robotics, simulation, and other digital capabilities ,have allowed manufacturers to reduce sources 60 of error, optimize resources, and reduce patient risk .",
"options": {
"B": "59",
"A": "one",
"C": "820",
"D": "product quality and patient safety"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In recent years, advances in manufacturing technologies , including the adop tion of automation, 59 robotics, simulation, and other digital capabilities ,have allowed manufacturers to reduce sources ____ of error, optimize resources, and reduce patient risk .",
"reference": "In recent years, advances in manufacturing technologies , including the adop tion of automation, 59 robotics, simulation, and other digital capabilities ,have allowed manufacturers to reduce sources 60 of error, optimize resources, and reduce patient risk .",
"options": {
"A": "60",
"B": "one",
"C": "820",
"D": "product quality and patient safety"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '40 41 II.Background 42 FDA envision s a future sta...'?",
"reference": "40 41 II.Background 42 FDA envision s a future state where the medical device ecosystem is inherently focused on device 43 features and manufacturing pract ices that promote product quality and patient safety.",
"options": {
"A": "FDA",
"B": "Quality System",
"C": "product quality and patient safety",
"D": "their manufacturing quality level"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 41 II.Background 42 FDA envision s a future state where the medical device ecosystem is inherently focused on device 43 features and manufacturing pract ices that promote product quality and patient safety.",
"reference": "40 41 II.Background 42 FDA envision s a future state where the medical device ecosystem is inherently focused on device 43 features and manufacturing pract ices that promote product quality and patient safety.",
"options": {
"C": "40",
"A": "one",
"B": "820",
"D": "product quality and patient safety"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 40 ____ II.Background 42 FDA envision s a future state where the medical device ecosystem is inherently focused on device 43 features and manufacturing pract ices that promote product quality and patient safety.",
"reference": "40 41 II.Background 42 FDA envision s a future state where the medical device ecosystem is inherently focused on device 43 features and manufacturing pract ices that promote product quality and patient safety.",
"options": {
"C": "41",
"A": "one",
"B": "820",
"D": "product quality and patient safety"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 40 41 II.Background ____ FDA envision s a future state where the medical device ecosystem is inherently focused on device 43 features and manufacturing pract ices that promote product quality and patient safety.",
"reference": "40 41 II.Background 42 FDA envision s a future state where the medical device ecosystem is inherently focused on device 43 features and manufacturing pract ices that promote product quality and patient safety.",
"options": {
"B": "42",
"A": "one",
"C": "820",
"D": "product quality and patient safety"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 40 41 II.Background 42 FDA envision s a future state where the medical device ecosystem is inherently focused on device ____ features and manufacturing pract ices that promote product quality and patient safety.",
"reference": "40 41 II.Background 42 FDA envision s a future state where the medical device ecosystem is inherently focused on device 43 features and manufacturing pract ices that promote product quality and patient safety.",
"options": {
"A": "43",
"B": "one",
"C": "820",
"D": "product quality and patient safety"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
71, Room 3128 Silver Spring, MD 20993- 0002
Phone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I. INTRODUCTION............................................................................................................. 1 II. BACKGROUND ............................................................................................................... 1 III. QUESTIONS AND ANSWERS ....................................................................................... Please clarify the following terms as they relate to CGMP records: .........................................
2 a. What is data integrity? ................................................................................................................
b. What is metadata? ....................................................................................................................... 3 c.
What is an audit trail? .................................................................................................................
3 d. How does FDA use the terms static and dynamic as they relate to record formats? ............. 3 e. How does FDA use the term backup in 211.68( b)?
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'BACKGROUND ..........................................'?",
"reference": "BACKGROUND ............................................................................................................... 1 III.",
"options": {
"D": "BACKGROUND",
"A": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Pharmaceutical Quality/Manufacturing Standards",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: BACKGROUND ............................................................................................................... ____ III.",
"reference": "BACKGROUND ............................................................................................................... 1 III.",
"options": {
"A": "1",
"B": "800",
"C": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '............. 3 e. How does FDA use the term backu...'?",
"reference": "............. 3 e. How does FDA use the term backup in 211.68( b)?",
"options": {
"C": "FDA",
"A": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Pharmaceutical Quality/Manufacturing Standards",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ............. ____ e. How does FDA use the term backup in 211.68( b)?",
"reference": "............. 3 e. How does FDA use the term backup in 211.68( b)?",
"options": {
"D": "3",
"A": "800",
"B": "240",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ............. 3 e. How does FDA use the term backup in ____( b)?",
"reference": "............. 3 e. How does FDA use the term backup in 211.68( b)?",
"options": {
"A": "211.68",
"B": "800",
"C": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'BACKGROUND ..........................................'?",
"reference": "BACKGROUND ............................................................................................................... 1 III.",
"options": {
"D": "BACKGROUND",
"A": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Pharmaceutical Quality/Manufacturing Standards",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: BACKGROUND ............................................................................................................... ____ III.",
"reference": "BACKGROUND ............................................................................................................... 1 III.",
"options": {
"A": "1",
"B": "800",
"C": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ....................................................................................................................... ____ c.\nWhat is an audit trail?",
"reference": "....................................................................................................................... 3 c.\nWhat is an audit trail?",
"options": {
"A": "3",
"B": "800",
"C": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '.....................................................'?",
"reference": ".................................................................................................................\n3 d. How does FDA use the terms static and dynamic as they relate to record formats?",
"options": {
"A": "FDA",
"B": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Pharmaceutical Quality/Manufacturing Standards",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .................................................................................................................\n____ d. How does FDA use the terms static and dynamic as they relate to record formats?",
"reference": ".................................................................................................................\n3 d. How does FDA use the terms static and dynamic as they relate to record formats?",
"options": {
"C": "3",
"A": "800",
"B": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: INTRODUCTION............................................................................................................. ____ II.",
"reference": "INTRODUCTION............................................................................................................. 1 II.",
"options": {
"C": "1",
"A": "800",
"B": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Please clarify the following terms as they relate ...'?",
"reference": "Please clarify the following terms as they relate to CGMP records: .........................................\n2 a.",
"options": {
"D": "CGMP",
"A": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Pharmaceutical Quality/Manufacturing Standards",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Please clarify the following terms as they relate to CGMP records: .........................................\n____ a.",
"reference": "Please clarify the following terms as they relate to CGMP records: .........................................\n2 a.",
"options": {
"A": "2",
"B": "800",
"C": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '.....................................................'?",
"reference": ".................................................................................................................\n3 d. How does FDA use the terms static and dynamic as they relate to record formats?",
"options": {
"B": "FDA",
"A": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Pharmaceutical Quality/Manufacturing Standards",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .................................................................................................................\n____ d. How does FDA use the terms static and dynamic as they relate to record formats?",
"reference": ".................................................................................................................\n3 d. How does FDA use the terms static and dynamic as they relate to record formats?",
"options": {
"D": "3",
"A": "800",
"B": "240",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'BACKGROUND ..........................................'?",
"reference": "BACKGROUND ............................................................................................................... 1 III.",
"options": {
"C": "BACKGROUND",
"A": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Pharmaceutical Quality/Manufacturing Standards",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: BACKGROUND ............................................................................................................... ____ III.",
"reference": "BACKGROUND ............................................................................................................... 1 III.",
"options": {
"B": "1",
"A": "800",
"C": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Please clarify the following terms as they relate ...'?",
"reference": "Please clarify the following terms as they relate to CGMP records: .........................................\n2 a.",
"options": {
"D": "CGMP",
"A": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Pharmaceutical Quality/Manufacturing Standards",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Please clarify the following terms as they relate to CGMP records: .........................................\n____ a.",
"reference": "Please clarify the following terms as they relate to CGMP records: .........................................\n2 a.",
"options": {
"B": "2",
"A": "800",
"C": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '.....................................................'?",
"reference": ".................................................................................................................\n3 d. How does FDA use the terms static and dynamic as they relate to record formats?",
"options": {
"B": "FDA",
"A": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Pharmaceutical Quality/Manufacturing Standards",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '.....................................................'?",
"reference": ".................................................................................................................\n3 d. How does FDA use the terms static and dynamic as they relate to record formats?",
"options": {
"B": "FDA",
"A": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Pharmaceutical Quality/Manufacturing Standards",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .................................................................................................................\n____ d. How does FDA use the terms static and dynamic as they relate to record formats?",
"reference": ".................................................................................................................\n3 d. How does FDA use the terms static and dynamic as they relate to record formats?",
"options": {
"D": "3",
"A": "800",
"B": "240",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "When did this occur: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"D": "71, Room 3128",
"A": "20993- 0002",
"B": "April 2016",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"A": "MD",
"B": "Rockville",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center",
"D": "Veterinary Medicine Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"D": "20993- 0002",
"A": "71, Room 3128",
"B": "April 2016",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"B": "Standish Place",
"A": "Recommendations Draft Not for",
"C": "metadata",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"A": "Rockville",
"B": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center",
"C": "Veterinary Medicine Food and Drug Administration",
"D": "71, Room 3128"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"D": "MD",
"A": "Rockville",
"B": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center",
"C": "Veterinary Medicine Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"B": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"A": "Pharmaceutical Quality/Manufacturing Standards",
"C": "CGMP",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"C": "April 2016",
"A": "71, Room 3128",
"B": "20993- 0002",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 6 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy. Manufacturers may decide to conduct different assurance activities for individual 190 features, functions, or op erations. 191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses. When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration . The intended use of the software, documen ting readings , only support s 198 maintaining the quality system record and poses a low process risk. As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome. Several functions of the software may, in turn, be applied together in an operation to perform practical work in a process. For the purposes of this gu idance, a function refers to a software function and is not to be confused with a device function. Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to 200 establish that the software is fit for its intended use and maintain s a validated state .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: Manufacturers may decide to conduct different assurance activities for individual ____ features, functions, or op erations.",
"reference": "Manufacturers may decide to conduct different assurance activities for individual 190 features, functions, or op erations.",
"options": {
"B": "190",
"A": "185",
"C": "186",
"D": "a software function"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When utilizing the basic input functions of the 19...'?",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"D": "COTS",
"A": "a software function",
"B": "the vendor assessment and software installation",
"C": "cot"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the ____ COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"D": "194",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature ____ readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"C": "195",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance ____ activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"B": "196",
"A": "185",
"C": "186",
"D": "a software function"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and ____ configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"D": "197",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 40 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Under a quality systems approach, ma nagers would use quality planning to identify and allocate resources and define methods to achieve the quality objectives. Quality system plans should be documented and communicated to personnel to ensure awareness of how their operational activities are aligned with st rategic and quality goals. 5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness. U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule. Such a review typically includes assessments of the pr ocess, product, and customer needs (in this section, customer is defined as the reci pient of the produc t and the product is the goods or services provided). Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)
Product characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured. Outside of scheduled reviews, the quality system should typically be included as a standing age nda item in general m anagement meetings. In addition, a periodic review performed by a qualif ied source, external to the organization, may also be useful in assessing the suitab ility and effectiveness of the system.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"B": "5",
"A": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"C": "U",
"A": "a periodic review",
"B": "the System System review",
"D": "uracil"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"B": "5",
"A": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"A": "5",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"D": "10",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"C": "tenner"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"D": "5",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"C": "Little Phoebe"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"A": "5",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"A": "U",
"B": "a periodic review",
"C": "the System System review",
"D": "uracil"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"A": "10",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "tenner"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"A": "U",
"B": "a periodic review",
"C": "the System System review",
"D": "uracil"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"B": "U",
"A": "a periodic review",
"C": "the System System review",
"D": "uracil"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"C": "5",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"B": "U",
"A": "a periodic review",
"C": "the System System review",
"D": "uracil"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"A": "10",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "tenner"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"A": "U",
"B": "a periodic review",
"C": "the System System review",
"D": "uracil"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"D": "5",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"C": "Little Phoebe"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"C": "10",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"D": "tenner"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"C": "U",
"A": "a periodic review",
"B": "the System System review",
"D": "uracil"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"D": "5",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"C": "Little Phoebe"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"D": "10",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"C": "tenner"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"B": "U",
"A": "a periodic review",
"C": "the System System review",
"D": "uracil"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"A": "10",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "tenner"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"C": "5",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"A": "5",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"A": "10",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "tenner"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"A": "5",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"C": "5",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"B": "5",
"A": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "Little Phoebe"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"A": "U",
"B": "a periodic review",
"C": "the System System review",
"D": "uracil"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"D": "U",
"A": "a periodic review",
"B": "the System System review",
"C": "uracil"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"D": "5",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"C": "Little Phoebe"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"D": "5",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"C": "Little Phoebe"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"D": "10",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"C": "tenner"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"A": "10",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "tenner"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"C": "U",
"A": "a periodic review",
"B": "the System System review",
"D": "uracil"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"D": "10",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"C": "tenner"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"A": "10",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "tenner"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
}
]
|
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