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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-(...TRUNCATED)
| "Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Con(...TRUNCATED)
| "[\n {\n \"question\": \"Which organization is referenced: 'Software requirements specification (...TRUNCATED)
|
"You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-(...TRUNCATED)
| "Please generate exactly 3 high-quality quizzes based strictly on the context provided in [Quiz Cont(...TRUNCATED)
| "[\n {\n \"question\": \"Fill in the blank: The pharmaceutical quality system should in clude ap(...TRUNCATED)
|
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