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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 40 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Whenever software is changed, a validation analysis should be conducted not just for validation of the individual change, but also to determine the extent and impact of that change on the entire software system. Based on this analysis, the software developer should then conduct an appropriate level of software regression testing to show that unchanged but vulnerable portions of the system have not been adversely affected. Design controls and appropriate regression testing provide the confidence that the software is validated after a software change. VALIDATION COVERAGE Validation coverage should be based on the softwares complexity and safety risk not on firm size or resource constraints. The selection of validation activities, tasks, and work items should be commensurate with the complexity of the software design and the risk associated with the use of the software for the specified intended use. For lower risk devices, only baseline validation activities may be conducted. As the risk increases additional validation activities should be added to cover the additional risk. Validation documentation should be sufficient to demonstrate that all software validation plans and procedures have been completed successfully. 4.9. INDEPENDENCE OF REVIEW Validation activities should be conducted using the basic quality assurance precept of independence of review. Self-validation is extremely difficult. When possible, an independent evaluation is always better, especially for higher risk applications. Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible. Another approach is to assign internal staff members that are not involved in a particular design or its implementation, but who have sufficient knowledge to evaluate the project and conduct the verification and validation activities.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Some firms contract out for a third-party independ...'?",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"D": "FDA",
"A": "INDEPENDENCE OF REVIEW Validation",
"B": "VALIDATION COVERAGE Validation coverage",
"C": "all software validation plans"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Some firms contract out for a ____-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"A": "third",
"B": "VALIDATION COVERAGE Validation coverage",
"C": "all software validation plans",
"D": "3rd"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Some firms contract out for a third-party independ...'?",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"D": "FDA",
"A": "INDEPENDENCE OF REVIEW Validation",
"B": "VALIDATION COVERAGE Validation coverage",
"C": "all software validation plans"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Some firms contract out for a ____-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"C": "third",
"A": "VALIDATION COVERAGE Validation coverage",
"B": "all software validation plans",
"D": "3rd"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Some firms contract out for a third-party independ...'?",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"A": "FDA",
"B": "INDEPENDENCE OF REVIEW Validation",
"C": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Some firms contract out for a ____-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"C": "third",
"A": "VALIDATION COVERAGE Validation coverage",
"B": "all software validation plans",
"D": "3rd"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Some firms contract out for a third-party independ...'?",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"A": "FDA",
"B": "INDEPENDENCE OF REVIEW Validation",
"C": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Some firms contract out for a ____-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"C": "third",
"A": "VALIDATION COVERAGE Validation coverage",
"B": "all software validation plans",
"D": "3rd"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Some firms contract out for a third-party independ...'?",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"C": "FDA",
"A": "INDEPENDENCE OF REVIEW Validation",
"B": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Some firms contract out for a ____-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"B": "third",
"A": "VALIDATION COVERAGE Validation coverage",
"C": "all software validation plans",
"D": "3rd"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INDEPENDENCE OF REVIEW Validation activities shoul...'?",
"reference": "INDEPENDENCE OF REVIEW Validation activities should be conducted using the basic quality assurance precept of independence of review.",
"options": {
"A": "INDEPENDENCE OF REVIEW Validation",
"B": "FDA",
"C": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Some firms contract out for a third-party independ...'?",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"D": "FDA",
"A": "INDEPENDENCE OF REVIEW Validation",
"B": "VALIDATION COVERAGE Validation coverage",
"C": "all software validation plans"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Some firms contract out for a ____-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"C": "third",
"A": "VALIDATION COVERAGE Validation coverage",
"B": "all software validation plans",
"D": "3rd"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INDEPENDENCE OF REVIEW Validation activities shoul...'?",
"reference": "INDEPENDENCE OF REVIEW Validation activities should be conducted using the basic quality assurance precept of independence of review.",
"options": {
"A": "INDEPENDENCE OF REVIEW Validation",
"B": "FDA",
"C": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INDEPENDENCE OF REVIEW Validation activities shoul...'?",
"reference": "INDEPENDENCE OF REVIEW Validation activities should be conducted using the basic quality assurance precept of independence of review.",
"options": {
"B": "INDEPENDENCE OF REVIEW Validation",
"A": "FDA",
"C": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Some firms contract out for a third-party independ...'?",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"D": "FDA",
"A": "INDEPENDENCE OF REVIEW Validation",
"B": "VALIDATION COVERAGE Validation coverage",
"C": "all software validation plans"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Some firms contract out for a ____-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"B": "third",
"A": "VALIDATION COVERAGE Validation coverage",
"C": "all software validation plans",
"D": "3rd"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INDEPENDENCE OF REVIEW Validation activities shoul...'?",
"reference": "INDEPENDENCE OF REVIEW Validation activities should be conducted using the basic quality assurance precept of independence of review.",
"options": {
"A": "INDEPENDENCE OF REVIEW Validation",
"B": "FDA",
"C": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Some firms contract out for a third-party independ...'?",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"A": "FDA",
"B": "INDEPENDENCE OF REVIEW Validation",
"C": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Some firms contract out for a ____-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"C": "third",
"A": "VALIDATION COVERAGE Validation coverage",
"B": "all software validation plans",
"D": "3rd"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Some firms contract out for a third-party independ...'?",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"C": "FDA",
"A": "INDEPENDENCE OF REVIEW Validation",
"B": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Some firms contract out for a ____-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"C": "third",
"A": "VALIDATION COVERAGE Validation coverage",
"B": "all software validation plans",
"D": "3rd"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INDEPENDENCE OF REVIEW Validation activities shoul...'?",
"reference": "INDEPENDENCE OF REVIEW Validation activities should be conducted using the basic quality assurance precept of independence of review.",
"options": {
"D": "INDEPENDENCE OF REVIEW Validation",
"A": "FDA",
"B": "VALIDATION COVERAGE Validation coverage",
"C": "all software validation plans"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INDEPENDENCE OF REVIEW Validation activities shoul...'?",
"reference": "INDEPENDENCE OF REVIEW Validation activities should be conducted using the basic quality assurance precept of independence of review.",
"options": {
"B": "INDEPENDENCE OF REVIEW Validation",
"A": "FDA",
"C": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INDEPENDENCE OF REVIEW Validation activities shoul...'?",
"reference": "INDEPENDENCE OF REVIEW Validation activities should be conducted using the basic quality assurance precept of independence of review.",
"options": {
"D": "INDEPENDENCE OF REVIEW Validation",
"A": "FDA",
"B": "VALIDATION COVERAGE Validation coverage",
"C": "all software validation plans"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Some firms contract out for a third-party independ...'?",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"A": "FDA",
"B": "INDEPENDENCE OF REVIEW Validation",
"C": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Some firms contract out for a ____-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"D": "third",
"A": "VALIDATION COVERAGE Validation coverage",
"B": "all software validation plans",
"C": "3rd"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Some firms contract out for a third-party independ...'?",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"B": "FDA",
"A": "INDEPENDENCE OF REVIEW Validation",
"C": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Some firms contract out for a ____-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"C": "third",
"A": "VALIDATION COVERAGE Validation coverage",
"B": "all software validation plans",
"D": "3rd"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 2 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Regression testing is the rerunning of test cases that a program has previously executed correctly and comparing the current result to the previous result in order to detect unintended effects of a software change. Regression analysis and regression testing should also be employed when using integration methods to build a software product to ensure that newly integrated modules do not adversely impact the operation of previously integrated modules. In order to provide a thorough and rigorous examination of a software product, development testing is typically organized into levels. As an example, a software product's testing can be organized into unit, integration, and system levels of testing. 1) Unit (module or component) level testing focuses on the early examination of sub-program functionality and ensures that functionality not visible at the system level is examined by testing. Unit testing ensures that quality software units are furnished for integration into the finished software product. 2) Integration level testing focuses on the transfer of data and control across a program's internal and external interfaces. External interfaces are those with other software (including operating system software), system hardware, and the users and can be described as communications links. 3) System level testing demonstrates that all specified functionality exists and that the software product is trustworthy. This testing verifies the as-built program's functionality and performance with respect to the requirements for the software product as exhibited on the specified operating platform(s).
[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: ____) Unit (module or component) level testing focuses on the early examination of sub-program functionality and ensures that functionality not visible at the system level is examined by testing.",
"reference": "1) Unit (module or component) level testing focuses on the early examination of sub-program functionality and ensures that functionality not visible at the system level is examined by testing.",
"options": {
"D": "1",
"A": "a software product's testing",
"B": "Integration level testing",
"C": "ace"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 5 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Even if there are no predicate rule requirements to document, for example, date, time, or 247 sequence of events in a particular instance, it may nonetheless be important to have audit trails or 248 other ph ysical, logical, or procedural security measures in place to ensure the trustworthiness and 249 Contains Nonbinding Recommendations 7 reliability of the records.6 We recommend that you base your decision on whether to apply audit 250 trails, or other appropriate measures, on the need to comply with p redicate rule requirements, a 251 justified and documented risk assessment, and a determination of the potential effect on product 252 quality and safety and record integrity. We suggest that you apply appropriate controls based on 253 such an assessment. Audit trai ls can be particularly appropriate when users are expected to 254 create, modify, or delete regulated records during normal operation. Legacy Systems7 257 258 The Agency intends to exercise enforcement discretion with respect to all part 11 requirements 259 for syste ms that otherwise were operational prior to August 20, 1997, the effective date of part 260 11, under the circumstances specified below. This means that the Agency does not intend to take enforcement action to enforce compliance 263 with any part 11 requirement s if all the following criteria are met for a specific system: 264 265 The system was operational before the effective date. The system met all applicable predicate rule requirements before the effective date. 267 The system currently meets all applicable predicate rule requirements. 268 You have documented evidence and justification that the system is fit for its intended use 269 (including having an acceptable level of record security and integrity, if applicable).
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: We suggest that you apply appropriate controls based on ____ such an assessment.",
"reference": "We suggest that you apply appropriate controls based on 253 such an assessment.",
"options": {
"B": "253",
"A": "247",
"C": "248",
"D": "all applicable predicate rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Legacy Systems7 257 258 The Agency intends to exer...'?",
"reference": "Legacy Systems7 257 258 The Agency intends to exercise enforcement discretion with respect to all part 11 requirements 259 for syste ms that otherwise were operational prior to August 20, 1997, the effective date of part 260 11, under the circumstances specified below.",
"options": {
"A": "Agency",
"B": "all applicable predicate rule requirements",
"C": "government agency",
"D": "way"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Legacy Systems7 257 258 The Agency intends to exer...'?",
"reference": "Legacy Systems7 257 258 The Agency intends to exercise enforcement discretion with respect to all part 11 requirements 259 for syste ms that otherwise were operational prior to August 20, 1997, the effective date of part 260 11, under the circumstances specified below.",
"options": {
"B": "August 20, 1997",
"A": "all applicable predicate rule requirements",
"C": "257",
"D": "Agency"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Legacy Systems7 ____ 258 The Agency intends to exercise enforcement discretion with respect to all part 11 requirements 259 for syste ms that otherwise were operational prior to August 20, 1997, the effective date of part 260 11, under the circumstances specified below.",
"reference": "Legacy Systems7 257 258 The Agency intends to exercise enforcement discretion with respect to all part 11 requirements 259 for syste ms that otherwise were operational prior to August 20, 1997, the effective date of part 260 11, under the circumstances specified below.",
"options": {
"D": "257",
"A": "247",
"B": "248",
"C": "all applicable predicate rule requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Legacy Systems7 257 ____ The Agency intends to exercise enforcement discretion with respect to all part 11 requirements 259 for syste ms that otherwise were operational prior to August 20, 1997, the effective date of part 260 11, under the circumstances specified below.",
"reference": "Legacy Systems7 257 258 The Agency intends to exercise enforcement discretion with respect to all part 11 requirements 259 for syste ms that otherwise were operational prior to August 20, 1997, the effective date of part 260 11, under the circumstances specified below.",
"options": {
"B": "258",
"A": "247",
"C": "248",
"D": "all applicable predicate rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration. Contains Nonbinding Recommendations Draft Not for Implementation 2 numerous regulatory actio ns, including warning letters, import alerts , and consent decrees . The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ). 57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'These data integrity -related CGMP violations have...'?",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"B": "the Office of Pharmaceutical Quality",
"A": "the Office of Compliance",
"C": "the Center for Drug Evaluatio",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'These data integrity -related CGMP violations have...'?",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Office of Compliance",
"A": "the Office of Pharmaceutical Quality",
"B": "the Center for Drug Evaluatio",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'These data integrity -related CGMP violations have...'?",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Center for Drug Evaluatio",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'These data integrity -related CGMP violations have...'?",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"B": "the Center for Biologics Evaluation and Research",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'These data integrity -related CGMP violations have...'?",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Center for Veterinary Medicine",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'These data integrity -related CGMP violations have...'?",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "Office of Regulatory Affairs",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'These data integrity -related CGMP violations have...'?",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Food and Drug Administration",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These data integrity -related CGMP violations have led to ____ 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "41",
"A": "41 1",
"B": "210.1",
"C": "These data integrity -related CGMP violations"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These data integrity -related CGMP violations have led to 4____ 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"B": "1",
"A": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '57 58 Electronic signature and record -keeping req...'?",
"reference": "57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"options": {
"A": "CFR",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"B": "CGMP",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "records requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"C": "the Federal Food, Drug",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"A": "44",
"B": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"A": "al l",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The ____ underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"C": "42",
"A": "41 1",
"B": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 42 underlying premise in ____ and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"D": "210.1",
"A": "41 1",
"B": "212.2",
"C": "These data integrity -related CGMP violations"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 42 underlying premise in 210.1 and ____ is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"B": "212.2",
"A": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to ____ assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"A": "43",
"B": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) ____ regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"A": "44",
"B": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data ____ integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"C": "45",
"A": "41 1",
"B": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations
Additional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm. (Tel) 800-835-4709 or 301-827-1800 or Communications Staff, HFV-12 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 (Tel) 301-827-3800 http://www.fda.gov/cvm/guidance/published.html U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMP Regulations Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION ............................................................................................................. 1 II. BACKGROUND AND PURPOSE ..................................................................................
1 A. Background ....................................................................................................................................
1 B.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: Background ....................................................................................................................................\n____ B.",
"reference": "Background ....................................................................................................................................\n1 B.",
"options": {
"A": "1",
"B": "301",
"C": "1 II",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'BACKGROUND AND PURPOSE ..............................'?",
"reference": "BACKGROUND AND PURPOSE ..................................................................................\n1 A.",
"options": {
"A": "BACKGROUND",
"B": "Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Office of Regulatory Affairs",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: BACKGROUND AND PURPOSE ..................................................................................\n____ A.",
"reference": "BACKGROUND AND PURPOSE ..................................................................................\n1 A.",
"options": {
"A": "1",
"B": "301",
"C": "1 II",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Background ....................................................................................................................................\n____ B.",
"reference": "Background ....................................................................................................................................\n1 B.",
"options": {
"A": "1",
"B": "301",
"C": "1 II",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'BACKGROUND AND PURPOSE ..............................'?",
"reference": "BACKGROUND AND PURPOSE ..................................................................................\n1 A.",
"options": {
"C": "BACKGROUND",
"A": "Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Office of Regulatory Affairs",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: BACKGROUND AND PURPOSE ..................................................................................\n____ A.",
"reference": "BACKGROUND AND PURPOSE ..................................................................................\n1 A.",
"options": {
"B": "1",
"A": "301",
"C": "1 II",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Background ....................................................................................................................................\n____ B.",
"reference": "Background ....................................................................................................................................\n1 B.",
"options": {
"D": "1",
"A": "301",
"B": "1 II",
"C": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Background ....................................................................................................................................\n____ B.",
"reference": "Background ....................................................................................................................................\n1 B.",
"options": {
"C": "1",
"A": "301",
"B": "1 II",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION ............................................................................................................. ____ II.",
"reference": "INTRODUCTION ............................................................................................................. 1 II.",
"options": {
"D": "1",
"A": "301",
"B": "1 II",
"C": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'BACKGROUND AND PURPOSE ..............................'?",
"reference": "BACKGROUND AND PURPOSE ..................................................................................\n1 A.",
"options": {
"D": "BACKGROUND",
"A": "Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Office of Regulatory Affairs",
"C": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: BACKGROUND AND PURPOSE ..................................................................................\n____ A.",
"reference": "BACKGROUND AND PURPOSE ..................................................................................\n1 A.",
"options": {
"C": "1",
"A": "301",
"B": "1 II",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Quality Systems Approach to ...'?",
"reference": "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations\nAdditional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"C": "Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"A": "Office of Regulatory Affairs",
"B": "ORA",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Quality Systems Approach to ...'?",
"reference": "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations\nAdditional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"A": "Office of Regulatory Affairs",
"B": "Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "ORA",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Quality Systems Approach to ...'?",
"reference": "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations\nAdditional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"A": "Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Office of Regulatory Affairs",
"C": "ORA",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Quality Systems Approach to ...'?",
"reference": "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations\nAdditional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"B": "Office of Regulatory Affairs",
"A": "Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "ORA",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Quality Systems Approach to ...'?",
"reference": "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations\nAdditional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"A": "ORA",
"B": "Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Office of Regulatory Affairs",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Guidance for Industry Quality Systems Approach to ...'?",
"reference": "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations\nAdditional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"D": "September 2006",
"A": "20857",
"B": "1401",
"C": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Quality Systems Approach to ...'?",
"reference": "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations\nAdditional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"A": "Office of Training and Communication Division of Drug Information",
"B": "Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Office of Regulatory Affairs",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Quality Systems Approach to ...'?",
"reference": "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations\nAdditional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"B": "HFD-240 Center for Drug Evaluation and Research Food and Drug Administration",
"A": "Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Office of Regulatory Affairs",
"D": "Veterinary Medicine Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Guidance for Industry Quality Systems Approach to ...'?",
"reference": "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations\nAdditional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"C": "Lane Rockville",
"A": "Tel",
"B": "Rockville Pike",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'Guidance for Industry Quality Systems Approach to ...'?",
"reference": "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations\nAdditional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"D": "MD",
"A": "Rockville",
"B": "Drug Evaluation and Research Food and Drug Administration",
"C": "Veterinary Medicine Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Guidance for Industry Quality Systems Approach to ...'?",
"reference": "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations\nAdditional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"B": "20857",
"A": "September 2006",
"C": "1401",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Guidance for Industry Quality Systems Approach to ...'?",
"reference": "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations\nAdditional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"D": "Tel",
"A": "Lane Rockville",
"B": "Rockville Pike",
"C": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Quality Systems Approach to ...'?",
"reference": "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations\nAdditional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"B": "Office of Communication",
"A": "Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Office of Regulatory Affairs",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Quality Systems Approach to ...'?",
"reference": "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations\nAdditional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"B": "Center for Biologics Evaluation and Research Food and Drug Administration",
"A": "Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Office of Regulatory Affairs",
"D": "Drug Evaluation and Research Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
......................................
12 Contains Nonbinding Recommendations 1 Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry1
This guidance represent s the current thinking of the Food and Drug Administration (FDA or Agency ) on this topic. It does not establish any rights for any person and is not bind ing on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for t his guidance as listed on the title page. The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212. Unless otherwise noted, the term CGMP in this guidance refers to CGMPs for drugs (including biologics) . FDAs authority for CGMP comes from section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FDC Act). Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General ; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals ; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography (PET) Drugs. All citations to part s 211 and 212 in this document pertain to finished pharmaceuticals and PET drugs , but these requirements are also consistent with Agency guidance on CGMP for active pharmaceutical ingredients with respect to data integrity . This guidance pr ovides the Agencys current thinking on the creation and handling of data in accordance with CGMP requirements. FDA expects that all data be reliable and accurate ( see the Background section ). CGMP regulations and guidance allow for flexible and risk- based strategies to prevent and detect data integrity issues.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'The purpose of this guidance is to clarify the rol...'?",
"reference": "The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.",
"options": {
"D": "CGMP",
"A": "the Food and Drug Administration",
"B": "FDA",
"C": "current good manufacturing practice"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The purpose of this guidance is to clarify the rol...'?",
"reference": "The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.",
"options": {
"A": "CFR",
"B": "the Food and Drug Administration",
"C": "FDA",
"D": "current good manufacturing practice"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in ____ CFR parts 210, 211, and 212.",
"reference": "The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.",
"options": {
"B": "21",
"A": "210",
"C": "211",
"D": "current good manufacturing practice"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts ____, 211, and 212.",
"reference": "The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.",
"options": {
"C": "210",
"A": "211",
"B": "212",
"D": "current good manufacturing practice"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, ____, and 212.",
"reference": "The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.",
"options": {
"A": "211",
"B": "210",
"C": "212",
"D": "current good manufacturing practice"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and ____.",
"reference": "The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.",
"options": {
"B": "212",
"A": "210",
"C": "211",
"D": "current good manufacturing practice"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It does not establish any rights for any person an...'?",
"reference": "It does not establish any rights for any person and is not bind ing on FDA or the public.",
"options": {
"A": "FDA",
"B": "the Food and Drug Administration",
"C": "Agency",
"D": "current good manufacturing practice"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The purpose of this guidance is to clarify the rol...'?",
"reference": "The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.",
"options": {
"B": "CGMP",
"A": "the Food and Drug Administration",
"C": "FDA",
"D": "current good manufacturing practice"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The purpose of this guidance is to clarify the rol...'?",
"reference": "The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.",
"options": {
"A": "CFR",
"B": "the Food and Drug Administration",
"C": "FDA",
"D": "current good manufacturing practice"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in ____ CFR parts 210, 211, and 212.",
"reference": "The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.",
"options": {
"D": "21",
"A": "210",
"B": "211",
"C": "current good manufacturing practice"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts ____, 211, and 212.",
"reference": "The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.",
"options": {
"D": "210",
"A": "211",
"B": "212",
"C": "current good manufacturing practice"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, ____, and 212.",
"reference": "The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.",
"options": {
"A": "211",
"B": "210",
"C": "212",
"D": "current good manufacturing practice"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Part 210 covers Current Good Manufacturing Practic...'?",
"reference": "Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General ; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals ; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography (PET) Drugs.",
"options": {
"D": "Current Good Manufacturing Practice",
"A": "Agency guidance",
"B": "Answers Guidance",
"C": "210"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Part 210 covers Current Good Manufacturing Practic...'?",
"reference": "Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General ; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals ; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography (PET) Drugs.",
"options": {
"C": "Holding of Drugs",
"A": "current good manufacturing practice",
"B": "Current Good Manufacturing Practice",
"D": "210"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Part 210 covers Current Good Manufacturing Practic...'?",
"reference": "Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General ; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals ; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography (PET) Drugs.",
"options": {
"D": "Current Good Manufacturing Practice",
"A": "Agency guidance",
"B": "Answers Guidance",
"C": "210"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Part 210 covers Current Good Manufacturing Practic...'?",
"reference": "Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General ; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals ; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography (PET) Drugs.",
"options": {
"C": "Finished Pharmaceuticals",
"A": "the Food and Drug Administration",
"B": "FDA",
"D": "current good manufacturing practice"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Part 210 covers Current Good Manufacturing Practic...'?",
"reference": "Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General ; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals ; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography (PET) Drugs.",
"options": {
"C": "Current Good Manufacturing Practice",
"A": "Agency guidance",
"B": "Answers Guidance",
"D": "210"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Part ____ covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General ; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals ; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography (PET) Drugs.",
"reference": "Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General ; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals ; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography (PET) Drugs.",
"options": {
"C": "210",
"A": "211",
"B": "212",
"D": "current good manufacturing practice"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General ; part ____ covers Current Good Manufacturing Practice for Finished Pharmaceuticals ; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography (PET) Drugs.",
"reference": "Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General ; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals ; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography (PET) Drugs.",
"options": {
"A": "211",
"B": "210",
"C": "212",
"D": "current good manufacturing practice"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General ; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals ; and part ____ covers Current Good Manufacturing Practice for Positron Emission Tomography (PET) Drugs.",
"reference": "Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General ; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals ; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography (PET) Drugs.",
"options": {
"A": "212",
"B": "210",
"C": "211",
"D": "current good manufacturing practice"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Unless otherwise noted, the term CGMP in this guid...'?",
"reference": "Unless otherwise noted, the term CGMP in this guidance refers to CGMPs for drugs (including biologics) .",
"options": {
"C": "CGMP",
"A": "the Food and Drug Administration",
"B": "FDA",
"D": "current good manufacturing practice"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The purpose of this guidance is to clarify the rol...'?",
"reference": "The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.",
"options": {
"B": "CGMP",
"A": "the Food and Drug Administration",
"C": "FDA",
"D": "current good manufacturing practice"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The purpose of this guidance is to clarify the rol...'?",
"reference": "The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.",
"options": {
"D": "CFR",
"A": "the Food and Drug Administration",
"B": "FDA",
"C": "current good manufacturing practice"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in ____ CFR parts 210, 211, and 212.",
"reference": "The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.",
"options": {
"A": "21",
"B": "210",
"C": "211",
"D": "current good manufacturing practice"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts ____, 211, and 212.",
"reference": "The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.",
"options": {
"A": "210",
"B": "211",
"C": "212",
"D": "current good manufacturing practice"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 5 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
When the same system is used to perform both CGMP and non- CGMP functions , the potential for non- CGMP functions to affect C GMP operations should be assessed and mitigated appropriate ly.10 If you validate the computer system but you do not validate it for its intended use , you cannot know if your workflow runs correctly .11
For example, qualifying the Manufacturing Execution System (MES) platform , a computer system, ensures that it meets its relevant requirements and specifications; however, it does not demonstrate that a given MPCR generated by the MES contains the correct calculations. In this example, validating the workflow ensures that the intended steps, requirements , and calculations in the MPCR are accurate and perform properly . This is similar to reviewing a paper MPCR and ensuring all supporting procedures are in place before the MPCR is implemented in production (see 211.100, 211.186, and 212.50(b) and the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP) ). For purposes of this guidance, the term quality unit is synonymous with the term quality control unit . For the definition of qual ity control unit, see 210.3(b)(15). 10 See note 8. 11
In computer science, validation refers to ensuring that software meets its requirements. However, this may not meet the definition of process validation as found in guidance for industry Process Validation: General Principles and Practices: The collection and evaluation of data which establishes scientific evidence that a process is capable of consistently delivering quality products. See also ICH guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, which defines validation as providing assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria. For purposes of this guidance, validation is being used in a manner consistent with the above guidance documents.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "When did this occur: 'For the definition of qual ity control unit, see ...'?",
"reference": "For the definition of qual ity control unit, see 210.3(b)(15).",
"options": {
"C": "210.3(b)(15",
"A": "211.100",
"B": "211.186",
"D": "industry Process Validation"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In this example, validating the workflow ensures t...'?",
"reference": "In this example, validating the workflow ensures that the intended steps, requirements , and calculations in the MPCR are accurate and perform properly .",
"options": {
"A": "MPCR",
"B": "CGMP",
"C": "industry Process Validation",
"D": "process validation"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'For the definition of qual ity control unit, see ...'?",
"reference": "For the definition of qual ity control unit, see 210.3(b)(15).",
"options": {
"A": "210.3(b)(15",
"B": "211.100",
"C": "211.186",
"D": "industry Process Validation"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'See also ICH guidance for industry Q7 Good Manufac...'?",
"reference": "See also ICH guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, which defines validation as providing assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria.",
"options": {
"D": "Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients",
"A": "CGMP",
"B": "industry Process Validation",
"C": "process validation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is which?",
"reference": "See also ICH guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, which defines validation as providing assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria.",
"options": {
"C": "validation",
"A": "ICH guidance",
"B": "the above guidance documents",
"D": "substantiation"
},
"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 2 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Wilburn, Handbook of Software Quality Assurance Techniques Applicable to the Nuclear Industry , NUREG/CR-4640, U.S. Nuclear Regulatory Commission, 1987. H. Hecht, et.al., Verification and Validation Guidelines for High Integrity Systems . Prepared for U.S. Nuclear Regulatory Commission, 1995. H. Hecht, et.al., Review Guidelines on Software Languages for Use in Nuclear Power Plant Safety Systems, Final Report . Prepared for U.S. Nuclear Regulatory Commission, 1996. J.D. Lawrence, W.L. Persons , Survey of Industry Methods for Producing Highly Reliable Software , NUREG/CR-6278, U.S. Nuclear Regulatory Commission, 1994. J.D. Lawrence, G.G. Preckshot, Design Factors for Safety-Critical Software , NUREG/CR-6294, U.S. Nuclear Regulatory Commission, 1994. Patricia B. Powell, Editor. NBS Special Publication 500-98, Planning for Software Validation, Verification, and Testing, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, November 1982. Patricia B. Powell, Editor. NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982. Delores R. Wallace, Roger U. Fujii, NIST Special Publication 500-165, Software Verification and Validation: Its Role in Computer Assurance and Its Relationship with Software Project Management Standards , National Computer Systems Laboratory, National Institute of Standards and Technology, U.S. Department of Commerce, September 1995.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'NBS Special Publication 500-93, Software Validatio...'?",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"B": "Software Validation",
"A": "the Nuclear Industry",
"C": "NUREG",
"D": "U.S. Nuclear Regulatory Commission"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-93, Software Validatio...'?",
"reference": "NBS Special Publication 500-93, Software Validation, Verification, and Testing Technique and Tool Reference Guide , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, September 1982.",
"options": {
"B": "Testing Technique",
"A": "U.S. Nuclear Regulatory Commission",
"C": "500",
"D": "Software Validation"
},
"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 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
The manufacturer documents: the intended use risk determination, summary description of the features, functions, operations tested the testing objectives and if they passed or failed any issues found and their disposition a concluding statement noting that the performance of the operation is acceptable the date testing was performed, and who performed the testing. Contains Nonbinding Recommendations Draft Not for Implementation 21Features , Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Electronic Signature Function: The electronic signature execution record is stored as part of the audit trail. The electronic signature employs two distinct identification components of a login and password. When an electronic signature is executed, the following information is part of the execution record: o
The name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed. The meaning associated with the signature (such as review, approval, responsibility, or authorship).The intended use of the electronic signature function is to capture and store an electronic signature where a signature is required and such that it meets requirements for electronic signatures. If the electronic signature function were to fail to perform as intended, then production or quality system records may not reflect appropriate approval or be sufficiently auditable, or may fail to meet other regulatory requirements. However, such a failur e would not foreseeably lead to compromised safety. As such, the manufacturer determined that this function does not pose high process risk. The manufacturer has performed an assessment of the system capability, supplier evaluation, and installation activ ities.
[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 21Features , Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Electronic Signature Function: The electronic signature execution record is stored as part of the audit trail.",
"options": {
"D": "Functions",
"A": "the appropriate record Electronic Signature Function",
"B": "The electronic signature execution record",
"C": "routine"
},
"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 21Features , Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Electronic Signature Function: The electronic signature execution record is stored as part of the audit trail.",
"options": {
"D": "Function",
"A": "The electronic signature execution record",
"B": "The electronic signature",
"C": "routine"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"B": "DD",
"A": "YYYY",
"C": "the appropriate record Electronic Signature Function",
"D": "The electronic signature execution record"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"C": "YYYY",
"A": "the appropriate record Electronic Signature Function",
"B": "The electronic signature execution record",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"A": "mm",
"B": "the appropriate record Electronic Signature Function",
"C": "The electronic signature execution record",
"D": "millimeter"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"D": "DD",
"A": "YYYY",
"B": "the appropriate record Electronic Signature Function",
"C": "The electronic signature execution record"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"C": "YYYY",
"A": "the appropriate record Electronic Signature Function",
"B": "The electronic signature execution record",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"C": "mm",
"A": "the appropriate record Electronic Signature Function",
"B": "The electronic signature execution record",
"D": "millimeter"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"D": "DD",
"A": "YYYY",
"B": "the appropriate record Electronic Signature Function",
"C": "The electronic signature execution record"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"B": "YYYY",
"A": "the appropriate record Electronic Signature Function",
"C": "The electronic signature execution record",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"C": "mm",
"A": "the appropriate record Electronic Signature Function",
"B": "The electronic signature execution record",
"D": "millimeter"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"C": "DD",
"A": "YYYY",
"B": "the appropriate record Electronic Signature Function",
"D": "The electronic signature execution record"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 21Features , Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Electronic Signature Function: The electronic signature execution record is stored as part of the audit trail.",
"options": {
"B": "Functions",
"A": "the appropriate record Electronic Signature Function",
"C": "The electronic signature execution record",
"D": "routine"
},
"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 21Features , Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Electronic Signature Function: The electronic signature execution record is stored as part of the audit trail.",
"options": {
"B": "Function",
"A": "The electronic signature execution record",
"C": "The electronic signature",
"D": "routine"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"B": "DD",
"A": "YYYY",
"C": "the appropriate record Electronic Signature Function",
"D": "The electronic signature execution record"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"A": "YYYY",
"B": "the appropriate record Electronic Signature Function",
"C": "The electronic signature execution record",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"A": "mm",
"B": "the appropriate record Electronic Signature Function",
"C": "The electronic signature execution record",
"D": "millimeter"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: The electronic signature employs ____ distinct identification components of a login and password.",
"reference": "The electronic signature employs two distinct identification components of a login and password.",
"options": {
"C": "two",
"A": "the appropriate record Electronic Signature Function",
"B": "The electronic signature execution record",
"D": "deuce"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The electronic signature employs ____ distinct identification components of a login and password.",
"reference": "The electronic signature employs two distinct identification components of a login and password.",
"options": {
"B": "two",
"A": "the appropriate record Electronic Signature Function",
"C": "The electronic signature execution record",
"D": "deuce"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The electronic signature employs ____ distinct identification components of a login and password.",
"reference": "The electronic signature employs two distinct identification components of a login and password.",
"options": {
"D": "two",
"A": "the appropriate record Electronic Signature Function",
"B": "The electronic signature execution record",
"C": "deuce"
},
"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 21Features , Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Electronic Signature Function: The electronic signature execution record is stored as part of the audit trail.",
"options": {
"C": "Functions",
"A": "the appropriate record Electronic Signature Function",
"B": "The electronic signature execution record",
"D": "routine"
},
"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 21Features , Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Electronic Signature Function: The electronic signature execution record is stored as part of the audit trail.",
"options": {
"A": "Function",
"B": "The electronic signature execution record",
"C": "The electronic signature",
"D": "routine"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The electronic signature employs ____ distinct identification components of a login and password.",
"reference": "The electronic signature employs two distinct identification components of a login and password.",
"options": {
"B": "two",
"A": "the appropriate record Electronic Signature Function",
"C": "The electronic signature execution record",
"D": "deuce"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"B": "DD",
"A": "YYYY",
"C": "the appropriate record Electronic Signature Function",
"D": "The electronic signature execution record"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"A": "YYYY",
"B": "the appropriate record Electronic Signature Function",
"C": "The electronic signature execution record",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
ISBN 0-471-01009-X. Tom Gilb, Dorothy Graham, Software Inspection , Addison-Wesley Publishing Company, 1993. ISBN 0-201-63181-4. Robert B. Grady, Practical Software Metrics for Project Management and Process Improvement , PTR Prentice-Hall Inc., 1992. ISBN 0-13-720384-5. Les Hatton, Safer C: Developing Software for High-integrity and Safety-critical Systems, McGraw-Hill Book Company, 1994. ISBN 0-07-707640-0. Janis V. Halvorsen, A Software Requirements Specification Document Model for the Medical Device Industry , Proceedings IEEE SOUTHEASTCON '93, Banking on Technology, April 4th
-7th, 1993, Charlotte, North Carolina. Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999. ISBN 0-7695-0299-7. Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988. ISBN 0-471-56567-9. Watts S. Humphrey, A Discipline for Software Engineering . Addison-Wesley Longman, 1995. ISBN 0-201-54610-8. Watts S. Humphrey, Managing the Software Process , Addison-Wesley Publishing Company, 1989. ISBN 0-201-18095-2. Capers Jones, Software Quality, Analysis and Guidelines for Success , International Thomson Computer Press, 1997. ISBN 1-85032-867-6. Page 41General Principles of Software Validation Guidance for Industry and FDA Staff J.M. Juran, Frank M. Gryna, Quality Planning and Analysis , Third Edition, , McGraw-Hill, 1993. ISBN 0-07-033183-9. Stephen H. Kan, Metrics and Models in Software Quality Engineering , Addison-Wesley Publishing Company, 1995. ISBN 0-201-63339-6. Cem Kaner, Jack Falk, Hung Quoc Nguyen, Testing Computer Software , Second Edition, Vsn Nostrand Reinhold, 1993. ISBN 0-442-01361-2. Craig Kaplan, Ralph Clark, Victor Tang, Secrets of Software Quality, 40 Innovations from IBM , McGraw-Hill, 1995. ISBN 0-07-911795-3. Edward Kit, Software Testing in the Real World , Addison-Wesley Longman, 1995. ISBN 0-201- 87756-2.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Who is mentioned in the context: 'Juran, Frank M. Gryna, Quality Planning and Analys...'?",
"reference": "Juran, Frank M. Gryna, Quality Planning and Analysis , Third Edition, , McGraw-Hill, 1993.",
"options": {
"D": "Frank M. Gryna",
"A": "X. Tom Gilb",
"B": "Dorothy Graham",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Juran, Frank M. Gryna, Quality Planning and Analys...'?",
"reference": "Juran, Frank M. Gryna, Quality Planning and Analysis , Third Edition, , McGraw-Hill, 1993.",
"options": {
"D": "Quality Planning and Analysis",
"A": "Software Inspection",
"B": "Addison-Wesley Publishing Company",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Juran, Frank M. Gryna, Quality Planning and Analys...'?",
"reference": "Juran, Frank M. Gryna, Quality Planning and Analysis , Third Edition, , McGraw-Hill, 1993.",
"options": {
"D": "McGraw-Hill",
"A": "Software Inspection",
"B": "Addison-Wesley Publishing Company",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Juran, Frank M. Gryna, Quality Planning and Analys...'?",
"reference": "Juran, Frank M. Gryna, Quality Planning and Analysis , Third Edition, , McGraw-Hill, 1993.",
"options": {
"C": "1993",
"A": "1992",
"B": "1994",
"D": "Software Quality Engineering"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Juran, Frank M. Gryna, Quality Planning and Analysis , ____ Edition, , McGraw-Hill, 1993.",
"reference": "Juran, Frank M. Gryna, Quality Planning and Analysis , Third Edition, , McGraw-Hill, 1993.",
"options": {
"B": "Third",
"A": "Software Quality Engineering",
"C": "Testing Computer Software",
"D": "3rd"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Juran, Frank M. Gryna, Quality Planning and Analysis , Third Edition, , McGraw-Hill, ____.",
"reference": "Juran, Frank M. Gryna, Quality Planning and Analysis , Third Edition, , McGraw-Hill, 1993.",
"options": {
"C": "1993",
"A": "1992",
"B": "1994",
"D": "Software Quality Engineering"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Debra S. Herrmann, Software Safety and Reliability...'?",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"A": "Debra S. Herrmann",
"B": "X. Tom Gilb",
"C": "Dorothy Graham",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Debra S. Herrmann, Software Safety and Reliability...'?",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"A": "Software Safety and Reliability: Techniques",
"B": "Software Inspection",
"C": "Addison-Wesley Publishing Company",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Debra S. Herrmann, Software Safety and Reliability...'?",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"A": "IEEE Computer Society",
"B": "Software Inspection",
"C": "Addison-Wesley Publishing Company",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Debra S. Herrmann, Software Safety and Reliability...'?",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"B": "1999",
"A": "1993",
"C": "1992",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Bill Hetzel, The Complete Guide to Software Testin...'?",
"reference": "Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"options": {
"A": "Bill Hetzel",
"B": "X. Tom Gilb",
"C": "Dorothy Graham",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Bill Hetzel, The Complete Guide to Software Testin...'?",
"reference": "Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"options": {
"A": "The Complete Guide to Software Testing",
"B": "Software Inspection",
"C": "Addison-Wesley Publishing Company",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Bill Hetzel, The Complete Guide to Software Testin...'?",
"reference": "Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"options": {
"D": "Wiley-QED Publication",
"A": "Software Inspection",
"B": "Addison-Wesley Publishing Company",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Bill Hetzel, The Complete Guide to Software Testin...'?",
"reference": "Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"options": {
"B": "John Wiley Sons",
"A": "X. Tom Gilb",
"C": "Dorothy Graham",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Bill Hetzel, The Complete Guide to Software Testin...'?",
"reference": "Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"options": {
"C": "1988",
"A": "1993",
"B": "1992",
"D": "Software Quality Engineering"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Bill Hetzel, The Complete Guide to Software Testing , ____ Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"reference": "Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"options": {
"B": "Second",
"A": "Software Quality Engineering",
"C": "Testing Computer Software",
"D": "secondly"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., ____.",
"reference": "Bill Hetzel, The Complete Guide to Software Testing , Second Edition, A Wiley-QED Publication, John Wiley Sons, Inc., 1988.",
"options": {
"A": "1988",
"B": "1993",
"C": "1992",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Debra S. Herrmann, Software Safety and Reliability...'?",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"D": "Debra S. Herrmann",
"A": "X. Tom Gilb",
"B": "Dorothy Graham",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Debra S. Herrmann, Software Safety and Reliability...'?",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"D": "Software Safety and Reliability: Techniques",
"A": "Software Inspection",
"B": "Addison-Wesley Publishing Company",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Debra S. Herrmann, Software Safety and Reliability...'?",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"A": "IEEE Computer Society",
"B": "Software Inspection",
"C": "Addison-Wesley Publishing Company",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Debra S. Herrmann, Software Safety and Reliability...'?",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"B": "Debra S. Herrmann",
"A": "X. Tom Gilb",
"C": "Dorothy Graham",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Debra S. Herrmann, Software Safety and Reliability...'?",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"A": "Software Safety and Reliability: Techniques",
"B": "Software Inspection",
"C": "Addison-Wesley Publishing Company",
"D": "Software Quality Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Debra S. Herrmann, Software Safety and Reliability...'?",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"D": "IEEE Computer Society",
"A": "Software Inspection",
"B": "Addison-Wesley Publishing Company",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Debra S. Herrmann, Software Safety and Reliability...'?",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"C": "1999",
"A": "1993",
"B": "1992",
"D": "Software Quality Engineering"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, ____.",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"D": "1999",
"A": "1993",
"B": "1992",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Debra S. Herrmann, Software Safety and Reliability...'?",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"C": "Debra S. Herrmann",
"A": "X. Tom Gilb",
"B": "Dorothy Graham",
"D": "Software Quality Engineering"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Debra S. Herrmann, Software Safety and Reliability...'?",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"B": "Software Safety and Reliability: Techniques",
"A": "Software Inspection",
"C": "Addison-Wesley Publishing Company",
"D": "Software Quality Engineering"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Debra S. Herrmann, Software Safety and Reliability...'?",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"D": "IEEE Computer Society",
"A": "Software Inspection",
"B": "Addison-Wesley Publishing Company",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Debra S. Herrmann, Software Safety and Reliability...'?",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"C": "1999",
"A": "1993",
"B": "1992",
"D": "Software Quality Engineering"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, ____.",
"reference": "Debra S. Herrmann, Software Safety and Reliability: Techniques, Approaches and Standards of Key Industrial Sectors, IEEE Computer Society, 1999.",
"options": {
"D": "1999",
"A": "1993",
"B": "1992",
"C": "Software Quality Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration. Contains Nonbinding Recommendations Draft Not for Implementation 2 numerous regulatory actio ns, including warning letters, import alerts , and consent decrees . The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ). 57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'These data integrity -related CGMP violations have...'?",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "the Center for Drug Evaluatio",
"D": "These data integrity -related CGMP violations"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'These data integrity -related CGMP violations have...'?",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"B": "the Office of Compliance",
"A": "the Office of Pharmaceutical Quality",
"C": "the Center for Drug Evaluatio",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'These data integrity -related CGMP violations have...'?",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Center for Drug Evaluatio",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "These data integrity -related CGMP violations"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'These data integrity -related CGMP violations have...'?",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Center for Biologics Evaluation and Research",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "These data integrity -related CGMP violations"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'These data integrity -related CGMP violations have...'?",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"B": "the Center for Veterinary Medicine",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'These data integrity -related CGMP violations have...'?",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"B": "Office of Regulatory Affairs",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'These data integrity -related CGMP violations have...'?",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"C": "the Food and Drug Administration",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These data integrity -related CGMP violations have led to ____ 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "41",
"A": "41 1",
"B": "210.1",
"C": "These data integrity -related CGMP violations"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These data integrity -related CGMP violations have led to 4____ 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"reference": "These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"B": "1",
"A": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 7 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
IEC 61506:1997, Industrial process measurement and control Documentation of application software. International Electrotechnical Commission, 1997. IEC 61508:1998, Functional safety of electrical/electronic/programmable electronic safety- related systems. International Electrotechnical Commission, 1998. IEEE Std 1012-1986, Software Verification and Validation Plans , Institute for Electrical and Electronics Engineers, 1986. Page 38General Principles of Software Validation Guidance for Industry and FDA Staff IEEE Standards Collection, Software Engineering , Institute of Electrical and Electronics Engineers, Inc., 1994. ISBN 1-55937-442-X. ISO 8402:1994, Quality management and quality assurance Vocabulary. International Organization for Standardization, 1994. ISO 9000-3:1997, Quality management and quality assurance standards - Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software . International Organization for Standardization, 1997. ISO 9001:1994, Quality systems Model for quality assurance in design, development, production, installation, and servicing. International Organization for Standardization, 1994. ISO 13485:1996, Quality systems Medical devices Particular requirements for the application of ISO 9001.
International Organization for Standardization, 1996. ISO/IEC 12119:1994, Information technology Software packages Quality requirements and testing, Joint Technical Committee ISO/IEC JTC 1, International Organization for Standardization and International Electrotechnical Commission, 1994. ISO/IEC 12207:1995, Information technology Software life cycle processes, Joint Technical Committee ISO/IEC JTC 1, Subcommittee SC 7, International Organization for Standardization and International Electrotechnical Commission, 1995.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'International Organization for Standardization, 19...'?",
"reference": "International Organization for Standardization, 1994.",
"options": {
"D": "International Organization for Standardization",
"A": "International Electrotechnical Commission",
"B": "IEC 61508:1998",
"C": "1994"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'International Organization for Standardization, 19...'?",
"reference": "International Organization for Standardization, 1994.",
"options": {
"C": "1994",
"A": "1997",
"B": "1998",
"D": "International Electrotechnical Commission"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: International Organization for Standardization, ____.",
"reference": "International Organization for Standardization, 1994.",
"options": {
"D": "1994",
"A": "1997",
"B": "1998",
"C": "International Electrotechnical Commission"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'International Electrotechnical Commission, 1997....'?",
"reference": "International Electrotechnical Commission, 1997.",
"options": {
"D": "International Electrotechnical Commission",
"A": "IEC 61508:1998",
"B": "IEEE Std",
"C": "International Organization"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'International Electrotechnical Commission, 1997....'?",
"reference": "International Electrotechnical Commission, 1997.",
"options": {
"B": "1997",
"A": "1998",
"C": "1012-1986",
"D": "International Electrotechnical Commission"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: International Electrotechnical Commission, ____.",
"reference": "International Electrotechnical Commission, 1997.",
"options": {
"C": "1997",
"A": "1998",
"B": "1012-1986",
"D": "International Electrotechnical Commission"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'International Organization for Standardization, 19...'?",
"reference": "International Organization for Standardization, 1994.",
"options": {
"C": "International Organization for Standardization",
"A": "International Electrotechnical Commission",
"B": "IEC 61508:1998",
"D": "1994"
},
"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]
The Quality System regulation requires installation and inspection procedures (including testing where appropriate) as well as documentation of inspection and testing to demonstrate proper installation. (See 21 CFR 820.170.) Likewise, manufacturing equipment must meet specified requirements, and automated systems must be validated for their intended use. (See 21 CFR 820.70(g) and 21 CFR 820.70(i) respectively.) Terminology regarding user site testing can be confusing. Terms such as beta test, site validation, user acceptance test, installation verification, and installation testing have all been used to describe user site testing. For purposes of this guidance, the term user site testing encompasses all of these and any other testing that takes place outside of the developers controlled environment. This testing should take place at a user's site with the actual hardware and software that will be part of the installed system configuration. The testing is accomplished through either actual or simulated use of the software being tested within the context in which it is intended to function. Guidance contained here is general in nature and is applicable to any user site testing. However, in some areas (e.g., blood establishment systems) there may be specific site validation issues that need to be considered in the planning of user site testing. Test planners should check with the FDA Center(s) with the corresponding product jurisdiction to determine whether there are any additional regulatory requirements for user site testing. User site testing should follow a pre-defined written plan with a formal summary of testing and a record of formal acceptance. Documented evidence of all testing procedures, test input data, and test results should be retained. There should be evidence that hardware and software are installed and configured as specified.
[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: (See ____ CFR 820.70(g) and 21 CFR 820.70(i) respectively.)",
"reference": "(See 21 CFR 820.70(g) and 21 CFR 820.70(i) respectively.)",
"options": {
"D": "21",
"A": "the term user site testing",
"B": "user site testing",
"C": "XXI"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (See ____ CFR 820.70(g) and 21 CFR 820.70(i) respectively.)",
"reference": "(See 21 CFR 820.70(g) and 21 CFR 820.70(i) respectively.)",
"options": {
"A": "21",
"B": "the term user site testing",
"C": "user site testing",
"D": "XXI"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Test planners should check with the FDA Center(s) ...'?",
"reference": "Test planners should check with the FDA Center(s) with the corresponding product jurisdiction to determine whether there are any additional regulatory requirements for user site testing.",
"options": {
"C": "FDA Center(s",
"A": "Quality System",
"B": "the term user site testing",
"D": "user site testing"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Test planners should check with the FDA Center(s) ...'?",
"reference": "Test planners should check with the FDA Center(s) with the corresponding product jurisdiction to determine whether there are any additional regulatory requirements for user site testing.",
"options": {
"D": "FDA Center(s",
"A": "Quality System",
"B": "the term user site testing",
"C": "user site testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The Quality System regulation requires installatio...'?",
"reference": "The Quality System regulation requires installation and inspection procedures (including testing where appropriate) as well as documentation of inspection and testing to demonstrate proper installation.",
"options": {
"A": "Quality System",
"B": "the term user site testing",
"C": "user site testing",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Test planners should check with the FDA Center(s) ...'?",
"reference": "Test planners should check with the FDA Center(s) with the corresponding product jurisdiction to determine whether there are any additional regulatory requirements for user site testing.",
"options": {
"C": "FDA Center(s",
"A": "Quality System",
"B": "the term user site testing",
"D": "user site testing"
},
"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]
However, their proper operation may be satisfactorily inferred by other means. For example, compilers are frequently certified by independent third-party testing, and commercial software products may have bug lists, system requirements and other operational information available from the vendor that can be compared to the device manufacturers intended use to help focus the black-box testing effort. Off-the-shelf operating systems need not be validated as a separate program. However, system-level validation testing of the application software should address all the operating system services used, including maximum loading conditions, file operations, handling of system error Page 34General Principles of Software Validation Guidance for Industry and FDA Staff conditions, and memory constraints that may be applicable to the intended use of the application program. For more detailed information, see the production and process software references in Appendix A. Page 35General Principles of Software Validation Guidance for Industry and FDA Staff APPENDIX A - REFERENCES Food and Drug Administration References Design Control Guidance for Medical Device Manufacturers , Center for Devices and Radiological Health, Food and Drug Administration, March 1997. Do It by Design, An Introduction to Human Factors in Medical Devices , Center for Devices and Radiological Health, Food and Drug Administration, March 1997. Electronic Records; Electronic Signatures Final Rule, 62 Federal Register 13430 (March 20, 1997). Glossary of Computerized System and Software Development Terminology , Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, Food and Drug Administration, August 1995. Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices , Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, May 1998.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'However, system-level validation testing of the ap...'?",
"reference": "However, system-level validation testing of the application software should address all the operating system services used, including maximum loading conditions, file operations, handling of system error Page 34General Principles of Software Validation Guidance for Industry and FDA Staff conditions, and memory constraints that may be applicable to the intended use of the application program.",
"options": {
"C": "Page 34General Principles of Software Validation Guidance for Industry",
"A": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"B": "Medical Devices",
"D": "FDA"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'However, system-level validation testing of the ap...'?",
"reference": "However, system-level validation testing of the application software should address all the operating system services used, including maximum loading conditions, file operations, handling of system error Page 34General Principles of Software Validation Guidance for Industry and FDA Staff conditions, and memory constraints that may be applicable to the intended use of the application program.",
"options": {
"C": "FDA",
"A": "Page 34General Principles of Software Validation Guidance for Industry",
"B": "Center for Devices and Radiological Health, Food and Drug Administration",
"D": "A - REFERENCES Food and Drug Administration References Design Control Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'Do It by Design, An Introduction to Human Factors ...'?",
"reference": "Do It by Design, An Introduction to Human Factors in Medical Devices , Center for Devices and Radiological Health, Food and Drug Administration, March 1997.",
"options": {
"B": "Medical Devices , Center for Devices and Radiological Health, Food and Drug Administration",
"A": "Page 34General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "A - REFERENCES Food and Drug Administration References Design Control Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Do It by Design, An Introduction to Human Factors ...'?",
"reference": "Do It by Design, An Introduction to Human Factors in Medical Devices , Center for Devices and Radiological Health, Food and Drug Administration, March 1997.",
"options": {
"C": "March 1997",
"A": "March 20, 1997",
"B": "August 1995",
"D": "A - REFERENCES Food and Drug Administration References Design Control Guidance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Do It by Design, An Introduction to Human Factors in Medical Devices , Center for Devices and Radiological Health, Food and Drug Administration, March ____.",
"reference": "Do It by Design, An Introduction to Human Factors in Medical Devices , Center for Devices and Radiological Health, Food and Drug Administration, March 1997.",
"options": {
"D": "1997",
"A": "March 1997",
"B": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 35General Principles of Software Validation G...'?",
"reference": "Page 35General Principles of Software Validation Guidance for Industry and FDA Staff APPENDIX A - REFERENCES Food and Drug Administration References Design Control Guidance for Medical Device Manufacturers , Center for Devices and Radiological Health, Food and Drug Administration, March 1997.",
"options": {
"A": "FDA",
"B": "Page 34General Principles of Software Validation Guidance for Industry",
"C": "Center for Devices and Radiological Health, Food and Drug Administration",
"D": "A - REFERENCES Food and Drug Administration References Design Control Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 35General Principles of Software Validation G...'?",
"reference": "Page 35General Principles of Software Validation Guidance for Industry and FDA Staff APPENDIX A - REFERENCES Food and Drug Administration References Design Control Guidance for Medical Device Manufacturers , Center for Devices and Radiological Health, Food and Drug Administration, March 1997.",
"options": {
"B": "Center for Devices and Radiological Health, Food and Drug Administration",
"A": "Page 34General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "A - REFERENCES Food and Drug Administration References Design Control Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Page 35General Principles of Software Validation G...'?",
"reference": "Page 35General Principles of Software Validation Guidance for Industry and FDA Staff APPENDIX A - REFERENCES Food and Drug Administration References Design Control Guidance for Medical Device Manufacturers , Center for Devices and Radiological Health, Food and Drug Administration, March 1997.",
"options": {
"C": "March 1997",
"A": "March 20, 1997",
"B": "August 1995",
"D": "A - REFERENCES Food and Drug Administration References Design Control Guidance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 35General Principles of Software Validation Guidance for Industry and FDA Staff APPENDIX A - REFERENCES Food and Drug Administration References Design Control Guidance for Medical Device Manufacturers , Center for Devices and Radiological Health, Food and Drug Administration, March ____.",
"reference": "Page 35General Principles of Software Validation Guidance for Industry and FDA Staff APPENDIX A - REFERENCES Food and Drug Administration References Design Control Guidance for Medical Device Manufacturers , Center for Devices and Radiological Health, Food and Drug Administration, March 1997.",
"options": {
"B": "1997",
"A": "March 1997",
"C": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"D": "Software Validation Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'For more detailed information, see the production ...'?",
"reference": "For more detailed information, see the production and process software references in Appendix A.",
"options": {
"D": "Appendix A.",
"A": "Appendix A. Page 35General Principles of",
"B": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Glossary of Computerized System and Software Devel...'?",
"reference": "Glossary of Computerized System and Software Development Terminology , Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, Food and Drug Administration, August 1995.",
"options": {
"A": "Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs",
"B": "Page 34General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "A - REFERENCES Food and Drug Administration References Design Control Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Glossary of Computerized System and Software Devel...'?",
"reference": "Glossary of Computerized System and Software Development Terminology , Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, Food and Drug Administration, August 1995.",
"options": {
"C": "Food and Drug Administration",
"A": "Page 34General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'However, system-level validation testing of the ap...'?",
"reference": "However, system-level validation testing of the application software should address all the operating system services used, including maximum loading conditions, file operations, handling of system error Page 34General Principles of Software Validation Guidance for Industry and FDA Staff conditions, and memory constraints that may be applicable to the intended use of the application program.",
"options": {
"D": "Page 34General Principles of Software Validation Guidance for Industry",
"A": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"B": "Medical Devices",
"C": "FDA"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'However, system-level validation testing of the ap...'?",
"reference": "However, system-level validation testing of the application software should address all the operating system services used, including maximum loading conditions, file operations, handling of system error Page 34General Principles of Software Validation Guidance for Industry and FDA Staff conditions, and memory constraints that may be applicable to the intended use of the application program.",
"options": {
"B": "FDA",
"A": "Page 34General Principles of Software Validation Guidance for Industry",
"C": "Center for Devices and Radiological Health, Food and Drug Administration",
"D": "A - REFERENCES Food and Drug Administration References Design Control Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: For example, compilers are frequently certified by independent ____-party testing, and commercial software products may have bug lists, system requirements and other operational information available from the vendor that can be compared to the device manufacturers intended use to help focus the black-box testing effort.",
"reference": "For example, compilers are frequently certified by independent third-party testing, and commercial software products may have bug lists, system requirements and other operational information available from the vendor that can be compared to the device manufacturers intended use to help focus the black-box testing effort.",
"options": {
"B": "third",
"A": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"C": "Software Validation Guidance",
"D": "3rd"
},
"answer": "B",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'However, system-level validation testing of the ap...'?",
"reference": "However, system-level validation testing of the application software should address all the operating system services used, including maximum loading conditions, file operations, handling of system error Page 34General Principles of Software Validation Guidance for Industry and FDA Staff conditions, and memory constraints that may be applicable to the intended use of the application program.",
"options": {
"A": "Page 34General Principles of Software Validation Guidance for Industry",
"B": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"C": "Medical Devices",
"D": "FDA"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'However, system-level validation testing of the ap...'?",
"reference": "However, system-level validation testing of the application software should address all the operating system services used, including maximum loading conditions, file operations, handling of system error Page 34General Principles of Software Validation Guidance for Industry and FDA Staff conditions, and memory constraints that may be applicable to the intended use of the application program.",
"options": {
"A": "FDA",
"B": "Page 34General Principles of Software Validation Guidance for Industry",
"C": "Center for Devices and Radiological Health, Food and Drug Administration",
"D": "A - REFERENCES Food and Drug Administration References Design Control Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'However, system-level validation testing of the ap...'?",
"reference": "However, system-level validation testing of the application software should address all the operating system services used, including maximum loading conditions, file operations, handling of system error Page 34General Principles of Software Validation Guidance for Industry and FDA Staff conditions, and memory constraints that may be applicable to the intended use of the application program.",
"options": {
"D": "Page 34General Principles of Software Validation Guidance for Industry",
"A": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"B": "Medical Devices",
"C": "FDA"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'However, system-level validation testing of the ap...'?",
"reference": "However, system-level validation testing of the application software should address all the operating system services used, including maximum loading conditions, file operations, handling of system error Page 34General Principles of Software Validation Guidance for Industry and FDA Staff conditions, and memory constraints that may be applicable to the intended use of the application program.",
"options": {
"A": "FDA",
"B": "Page 34General Principles of Software Validation Guidance for Industry",
"C": "Center for Devices and Radiological Health, Food and Drug Administration",
"D": "A - REFERENCES Food and Drug Administration References Design Control Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Who is mentioned in the context: 'For more detailed information, see the production ...'?",
"reference": "For more detailed information, see the production and process software references in Appendix A.",
"options": {
"B": "Appendix A.",
"A": "Appendix A. Page 35General Principles of",
"C": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"D": "Software Validation Guidance"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for the Content of Pre-market Submissions...'?",
"reference": "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices , Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, May 1998.",
"options": {
"D": "Submissions for Software Contained",
"A": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"B": "Software Validation Guidance",
"C": "Medical Devices , Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for the Content of Pre-market Submissions...'?",
"reference": "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices , Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, May 1998.",
"options": {
"D": "Medical Devices , Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"A": "Page 34General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"C": "A - REFERENCES Food and Drug Administration References Design Control Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Guidance for the Content of Pre-market Submissions...'?",
"reference": "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices , Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, May 1998.",
"options": {
"D": "May 1998",
"A": "March 1997",
"B": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices , Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, May ____.",
"reference": "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices , Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, May 1998.",
"options": {
"D": "1998",
"A": "March 1997",
"B": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Electronic Records; Electronic Signatures Final Ru...'?",
"reference": "Electronic Records; Electronic Signatures Final Rule, 62 Federal Register 13430 (March 20, 1997).",
"options": {
"D": "Federal Register 13430",
"A": "Page 34General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"C": "A - REFERENCES Food and Drug Administration References Design Control Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 10 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Conversely, relatively less risk (i.e., not high process risk) of compromised 382 safety and/or quality generally entail sless collection of objective evidence for the computer 383 software assurance effort . 384 385 Afeature, function, or operation that could lead to severe harm to a patient or user would 386 generally be high device risk. In contrast, a feature, function, or operation that would not 387 foreseeably lead to severe harm would likely not be high device risk. In either case, the risk of 388 the softwares failure to perform as intended is commensurate with the resulting medical device 389 risk. 390 391 If the manufacturer instead determined that the software feature, function, or operation does not 392 pose a high process risk ( i.e., it would not lead to a quality problem that foreseeably 393 compromises safety ), the manufacturer should consider the risk relative to the process , i.e., 394 production or the quality system. This is because the failure would not compromise safety, so the 395 failure would not introduce additional medical device risk. For example, a function that collects 396 and records process data for review would pose a low er process risk than a function that 397 determine sacceptability of product prior to human review.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: In contrast, a feature, function, or operation that would not ____ foreseeably lead to severe harm would likely not be high device risk.",
"reference": "In contrast, a feature, function, or operation that would not 387 foreseeably lead to severe harm would likely not be high device risk.",
"options": {
"B": "387",
"A": "382",
"C": "383",
"D": "i.e., not high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Conversely, relatively less risk (i.e., not high process risk) of compromised ____ safety and/or quality generally entail sless collection of objective evidence for the computer 383 software assurance effort .",
"reference": "Conversely, relatively less risk (i.e., not high process risk) of compromised 382 safety and/or quality generally entail sless collection of objective evidence for the computer 383 software assurance effort .",
"options": {
"D": "382",
"A": "383",
"B": "384 385",
"C": "i.e., not high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Conversely, relatively less risk (i.e., not high process risk) of compromised 382 safety and/or quality generally entail sless collection of objective evidence for the computer ____ software assurance effort .",
"reference": "Conversely, relatively less risk (i.e., not high process risk) of compromised 382 safety and/or quality generally entail sless collection of objective evidence for the computer 383 software assurance effort .",
"options": {
"A": "383",
"B": "382",
"C": "384 385",
"D": "i.e., not high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, a function that collects ____ and records process data for review would pose a low er process risk than a function that 397 determine sacceptability of product prior to human review.",
"reference": "For example, a function that collects 396 and records process data for review would pose a low er process risk than a function that 397 determine sacceptability of product prior to human review.",
"options": {
"D": "396",
"A": "382",
"B": "383",
"C": "i.e., not high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, a function that collects 396 and records process data for review would pose a low er process risk than a function that ____ determine sacceptability of product prior to human review.",
"reference": "For example, a function that collects 396 and records process data for review would pose a low er process risk than a function that 397 determine sacceptability of product prior to human review.",
"options": {
"A": "397",
"B": "382",
"C": "383",
"D": "i.e., not high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In contrast, a feature, function, or operation that would not ____ foreseeably lead to severe harm would likely not be high device risk.",
"reference": "In contrast, a feature, function, or operation that would not 387 foreseeably lead to severe harm would likely not be high device risk.",
"options": {
"A": "387",
"B": "382",
"C": "383",
"D": "i.e., not high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In contrast, a feature, function, or operation that would not ____ foreseeably lead to severe harm would likely not be high device risk.",
"reference": "In contrast, a feature, function, or operation that would not 387 foreseeably lead to severe harm would likely not be high device risk.",
"options": {
"A": "387",
"B": "382",
"C": "383",
"D": "i.e., not high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 391 If the manufacturer instead determined that the software feature, function, or operation does not 392 pose a high process risk ( i.e., it would not lead to a quality problem that foreseeably 393 compromises safety ), the manufacturer should consider the risk relative to the process , i.e., 394 production or the quality system.",
"reference": "390 391 If the manufacturer instead determined that the software feature, function, or operation does not 392 pose a high process risk ( i.e., it would not lead to a quality problem that foreseeably 393 compromises safety ), the manufacturer should consider the risk relative to the process , i.e., 394 production or the quality system.",
"options": {
"C": "390",
"A": "382",
"B": "383",
"D": "i.e., not high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 390 ____ If the manufacturer instead determined that the software feature, function, or operation does not 392 pose a high process risk ( i.e., it would not lead to a quality problem that foreseeably 393 compromises safety ), the manufacturer should consider the risk relative to the process , i.e., 394 production or the quality system.",
"reference": "390 391 If the manufacturer instead determined that the software feature, function, or operation does not 392 pose a high process risk ( i.e., it would not lead to a quality problem that foreseeably 393 compromises safety ), the manufacturer should consider the risk relative to the process , i.e., 394 production or the quality system.",
"options": {
"B": "391",
"A": "382",
"C": "383",
"D": "i.e., not high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 390 391 If the manufacturer instead determined that the software feature, function, or operation does not ____ pose a high process risk ( i.e., it would not lead to a quality problem that foreseeably 393 compromises safety ), the manufacturer should consider the risk relative to the process , i.e., 394 production or the quality system.",
"reference": "390 391 If the manufacturer instead determined that the software feature, function, or operation does not 392 pose a high process risk ( i.e., it would not lead to a quality problem that foreseeably 393 compromises safety ), the manufacturer should consider the risk relative to the process , i.e., 394 production or the quality system.",
"options": {
"A": "392",
"B": "382",
"C": "383",
"D": "i.e., not high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 7 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
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: '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": {
"D": "CGMP",
"A": "FDA",
"B": "Laboratory Information Management System",
"C": "chromatographic data"
},
"answer": "D",
"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: '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"
},
{
"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": {
"A": "Laboratory Information Management System",
"B": "CGMP",
"C": "chromatographic data",
"D": "the chromatographic data"
},
"answer": "A",
"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": {
"C": "an Electronic Batch Record",
"A": "chromatographic data",
"B": "the chromatographic data",
"D": "Laboratory Information Management System"
},
"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]
System level software testing addresses functional concerns and the following elements of a device's software that are related to the intended use(s): Performance issues (e.g., response times, reliability measurements);
Responses to stress conditions, e.g., behavior under maximum load, continuous use; Operation of internal and external security features; Effectiveness of recovery procedures, including disaster recovery; Usability; Compatibility with other software products; Behavior in each of the defined hardware configurations; and Accuracy of documentation. Control measures (e.g., a traceability analysis) should be used to ensure that the intended coverage is achieved. System level testing also exhibits the software product's behavior in the intended operating environment. The location of such testing is dependent upon the software developer's ability to produce the target operating environment(s). Depending upon the circumstances, simulation and/or testing at (potential) customer locations may be utilized. Test plans should identify the controls needed to ensure that the Page 26General Principles of Software Validation Guidance for Industry and FDA Staff intended coverage is achieved and that proper documentation is prepared when planned system level testing is conducted at sites not directly controlled by the software developer. Also, for a software product that is a medical device or a component of a medical device that is to be used on humans prior to FDA clearance, testing involving human subjects may require an Investigational Device Exemption (IDE) or Institutional Review Board (IRB) approval. Test procedures, test data, and test results should be documented in a manner permitting objective pass/fail decisions to be reached. They should also be suitable for review and objective decision making subsequent to running the test, and they should be suitable for use in any subsequent regression testing.
[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: 'Also, for a software product that is a medical dev...'?",
"reference": "Also, for a software product that is a medical device or a component of a medical device that is to be used on humans prior to FDA clearance, testing involving human subjects may require an Investigational Device Exemption (IDE) or Institutional Review Board (IRB) approval.",
"options": {
"B": "FDA",
"A": "Effectiveness",
"C": "Usability",
"D": "System level software testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Also, for a software product that is a medical dev...'?",
"reference": "Also, for a software product that is a medical device or a component of a medical device that is to be used on humans prior to FDA clearance, testing involving human subjects may require an Investigational Device Exemption (IDE) or Institutional Review Board (IRB) approval.",
"options": {
"D": "Institutional Review Board",
"A": "Effectiveness",
"B": "Usability",
"C": "System level software testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Also, for a software product that is a medical dev...'?",
"reference": "Also, for a software product that is a medical device or a component of a medical device that is to be used on humans prior to FDA clearance, testing involving human subjects may require an Investigational Device Exemption (IDE) or Institutional Review Board (IRB) approval.",
"options": {
"B": "IRB",
"A": "Effectiveness",
"C": "Usability",
"D": "System level software testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Test plans should identify the controls needed to ...'?",
"reference": "Test plans should identify the controls needed to ensure that the Page 26General Principles of Software Validation Guidance for Industry and FDA Staff intended coverage is achieved and that proper documentation is prepared when planned system level testing is conducted at sites not directly controlled by the software developer.",
"options": {
"A": "the Page 26General Principles of Software Validation Guidance for Industry",
"B": "System level software testing",
"C": "planned system level testing",
"D": "FDA"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 6 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Failure of these functions to perform as intended may result in a quality problem ( e.g., incomplete or inadequate reports) but, in this example, would not foreseeably lead to compromised safety because these functions are intende d for collection and recording data for monit oring and review pu rposes that do not have a direct impact on production or process performance . Therefore, the manufacturer determined t hat these functions do not pose high process risk. The supplier of the reporting software has validated the ability of the software to create and perform queri es, join data from various sources to perform data mining, perform statistical analysis and data summarization, create graphs and generate reports . Beyond this, the manufacturer has assessed the system capability and performed supplier evaluation and installation activities. As such, the manufacturer determined that the reporting function s of the software do not necessitate any additional assurance effort beyond these activities. The manufacturer documents: the intended use risk determination the date of assessment and who performed the assessment a concluding statemen t noting that the performance is acceptable given the intended use and risk.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "What causal relationship is described: 'Therefore, the manufacturer determined t hat these functions...'?",
"reference": "Therefore, the manufacturer determined t hat these functions do not pose high process risk.",
"options": {
"D": "Therefore, the manufacturer determined t hat these functions do not pose high process risk.",
"A": "the intended use risk determination",
"B": "performed supplier evaluation and installation activities",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Failure of these functions to perform as intended may result...'?",
"reference": "Failure of these functions to perform as intended may result in a quality problem ( e.g., incomplete or inadequate reports) but, in this example, would not foreseeably lead to compromised safety because these functions are intende d for collection and recording data for monit oring and review pu rposes that do not have a direct impact on production or process performance .",
"options": {
"C": "Failure of these functions to perform as intended may result in a quality problem ( e.g., incomplete...",
"A": "the intended use risk determination",
"B": "performed supplier evaluation and installation activities",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Therefore, the manufacturer determined t hat these functions...'?",
"reference": "Therefore, the manufacturer determined t hat these functions do not pose high process risk.",
"options": {
"D": "Therefore, the manufacturer determined t hat these functions do not pose high process risk.",
"A": "the intended use risk determination",
"B": "performed supplier evaluation and installation activities",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 7 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
It is also recommended that, when operating under a quality system, manufa cturers develop and docum ent control procedures to complete, secure, protect, and archive records, including data, wh ich provide evidence of operational and quality system activities. This approach is consiste nt with the CGMP regulations, which require manufacturers to establish and follow scientifically sound and a ppropriate written controls for specifications, plans, and procedures that direct operational and quality system activities and to ensure that these directives are accurate, appropr iately reviewed and approved, and available for use (see the CGMPs at 211.22 (c) and (d)). 4. Establish Policies, Objectives, and Plans Policies, objectives, and plans under a modern qual ity system provide the means by which senior m anagers articulate their vision of and comm itment to quality to all levels of the organization. Under a quality system, senior managem ent should incorporate a strong commitment to quality into the organizational mission. Senior managers should develop an organizational quality policy that aligns with th is mission; commit to meeting requirements a nd improving the quality system; and propose objectives to fulfill the quality policy. Under a quality system, to make the policy relevant, it must be communicated t o, and understood by, personne l and contractors (if applicable) and revised, as needed. Managers operating within a quality system shoul d define the quality obj ectives identified for implementing the quality policy. Senior m anagement should ensure that the quality objectives are created at the top level of the organizati on (and other levels as needed) through a for mal quality planning process. Objectives are typi cally aligned with the manufacturers strategic plans. A quality system seeks to ensure that managers support the objectives with necessary resources and have measurable go als that are monitored regularly.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "What is Managers?",
"reference": "Managers operating within a quality system shoul d define the quality obj ectives identified for implementing the quality policy.",
"options": {
"C": "quality",
"A": "Objectives",
"B": "objectives",
"D": "caliber"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is Managers?",
"reference": "Managers operating within a quality system shoul d define the quality obj ectives identified for implementing the quality policy.",
"options": {
"B": "quality",
"A": "Objectives",
"C": "objectives",
"D": "caliber"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is Managers?",
"reference": "Managers operating within a quality system shoul d define the quality obj ectives identified for implementing the quality policy.",
"options": {
"A": "quality",
"B": "Objectives",
"C": "objectives",
"D": "caliber"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is Managers?",
"reference": "Managers operating within a quality system shoul d define the quality obj ectives identified for implementing the quality policy.",
"options": {
"D": "quality",
"A": "Objectives",
"B": "objectives",
"C": "caliber"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This approach is consiste nt with the CGMP regulat...'?",
"reference": "This approach is consiste nt with the CGMP regulations, which require manufacturers to establish and follow scientifically sound and a ppropriate written controls for specifications, plans, and procedures that direct operational and quality system activities and to ensure that these directives are accurate, appropr iately reviewed and approved, and available for use (see the CGMPs at 211.22 (c) and (d)).",
"options": {
"D": "CGMP",
"A": "Establish Policies",
"B": "Objectives",
"C": "the quality objectives"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This approach is consiste nt with the CGMP regulations, which require manufacturers to establish and follow scientifically sound and a ppropriate written controls for specifications, plans, and procedures that direct operational and quality system activities and to ensure that these directives are accurate, appropr iately reviewed and approved, and available for use (see the CGMPs at ____ (c) and (d)).",
"reference": "This approach is consiste nt with the CGMP regulations, which require manufacturers to establish and follow scientifically sound and a ppropriate written controls for specifications, plans, and procedures that direct operational and quality system activities and to ensure that these directives are accurate, appropr iately reviewed and approved, and available for use (see the CGMPs at 211.22 (c) and (d)).",
"options": {
"D": "211.22",
"A": "the quality objectives",
"B": "an organizational quality policy",
"C": "CGMP"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Establish Policies, Objectives, and Plans Policies...'?",
"reference": "Establish Policies, Objectives, and Plans Policies, objectives, and plans under a modern qual ity system provide the means by which senior m anagers articulate their vision of and comm itment to quality to all levels of the organization.",
"options": {
"A": "Establish Policies",
"B": "CGMP",
"C": "Objectives",
"D": "the quality objectives"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
On the other hand, extensive testing may be needed for: a plant-wide electronic record and electronic signature system; an automated controller for a sterilization cycle; or automated test equipment used for inspection and acceptance of finished circuit boards in a life- sustaining / life-supporting device. Numerous commercial software applications may be used as part of the quality system (e.g., a spreadsheet or statistical package used for quality system calculations, a graphics package used for trend analysis, or a commercial database used for recording device history records or for complaint management). The extent of validation evidence needed for such software depends on the device manufacturers documented intended use of that software. For example, a device manufacturer who chooses not to use all the vendor-supplied capabilities of the software only needs to validate those functions that will be used and for which the device manufacturer is dependent upon the software results as part of production or the quality system. However, high risk applications should not be running in the same operating environment with non-validated software functions, even if those software functions are not used. Risk mitigation techniques such as memory partitioning or other approaches to resource protection may need to be considered when high risk applications and lower risk applications are to be used in the same operating environment. When software is upgraded or any changes are made to the software, the device manufacturer should consider how those changes may impact the used portions of the software and must reconfirm the validation of those portions of the software that are used. (See 21 CFR 820.70(i).) Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Page 32General Principles of Software Validation G...'?",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"A": "FDA",
"B": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"C": "6.2",
"A": "Numerous commercial software applications",
"B": "Software Validation Guidance",
"D": "FDA"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 32General Principles of Software Validation G...'?",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"C": "FDA",
"A": "Numerous commercial software applications",
"B": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"D": "6.2",
"A": "Numerous commercial software applications",
"B": "Software Validation Guidance",
"C": "FDA"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 32General Principles of Software Validation G...'?",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"A": "FDA",
"B": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"C": "6.2",
"A": "Numerous commercial software applications",
"B": "Software Validation Guidance",
"D": "FDA"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 32General Principles of Software Validation G...'?",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"A": "FDA",
"B": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"C": "6.2",
"A": "Numerous commercial software applications",
"B": "Software Validation Guidance",
"D": "FDA"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 32General Principles of Software Validation G...'?",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"C": "FDA",
"A": "Numerous commercial software applications",
"B": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"D": "6.2",
"A": "Numerous commercial software applications",
"B": "Software Validation Guidance",
"C": "FDA"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 32General Principles of Software Validation G...'?",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"C": "FDA",
"A": "Numerous commercial software applications",
"B": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"C": "6.2",
"A": "Numerous commercial software applications",
"B": "Software Validation Guidance",
"D": "FDA"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 32General Principles of Software Validation G...'?",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"A": "FDA",
"B": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"B": "6.2",
"A": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "FDA"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 32General Principles of Software Validation G...'?",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"A": "FDA",
"B": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"B": "6.2",
"A": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "FDA"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 4 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Commercial Manufacturing (3.1.3)
The goals of manufacturing activ ities include achieving product realization, es tablishing and maintaining a state of control, and facil itating continual improvement. The pharmaceutical quality system should assure that the desired pr oduct quality is routinely met, suitable process performance is achieved, the se t of controls are appropriate , improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded. 4. Product Discontinuation (3.1.4) The goal of product discontinuation activities is to manage the terminal stage of the product lifecycle effectively. For product discontinuation, a predefined approach should be used to manage activities such as retention of doc umentation and samples and continued product assessment (e.g., complaint handling and stability ) and reporting in accordance with regulatory requirements. B. Pharmaceutical Quality System Elements (3.2)
The elements described below might be requi red in part under regional GMP regulations. However, the Q10 models intent is to enhance th ese elements to promote the lifecycle approach to product quality. These four elements are: Process performance and product quality monitoring system Corrective action and preventive action (CAPA) system Change management system Management review of process performance and product quality These elements should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognizi ng the differences among the stages and the different goals of each stage. Throughout the product lifecycle, companies are encouraged to evaluate opportunities for innovative approach es to improve product quality. Each element is followed by a tabl e of example applications of th e element to the stages of the pharmaceutical lifecycle. 1.
[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: Product Discontinuation (____) The goal of product discontinuation activities is to manage the terminal stage of the product lifecycle effectively.",
"reference": "Product Discontinuation (3.1.4) The goal of product discontinuation activities is to manage the terminal stage of the product lifecycle effectively.",
"options": {
"D": "3.1.4",
"A": "3.1.3",
"B": "3.2",
"C": "product quality monitoring system Corrective action"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For product discontinuation, a predefined approach...'?",
"reference": "For product discontinuation, a predefined approach should be used to manage activities such as retention of doc umentation and samples and continued product assessment (e.g., complaint handling and stability ) and reporting in accordance with regulatory requirements.",
"options": {
"D": "doc",
"A": "Product Discontinuation",
"B": "B. Pharmaceutical Quality System Elements",
"C": "product quality monitoring system Corrective action"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Pharmaceutical Quality System Elements (____)\nThe elements described below might be requi red in part under regional GMP regulations.",
"reference": "Pharmaceutical Quality System Elements (3.2)\nThe elements described below might be requi red in part under regional GMP regulations.",
"options": {
"D": "3.2",
"A": "3.1.3",
"B": "3.1.4",
"C": "product quality monitoring system Corrective action"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'These four elements are: Process performance and ...'?",
"reference": "These four elements are: Process performance and product quality monitoring system Corrective action and preventive action (CAPA) system Change management system Management review of process performance and product quality These elements should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognizi ng the differences among the stages and the different goals of each stage.",
"options": {
"B": "Corrective",
"A": "the product lifecycle stages",
"C": "product quality",
"D": "restorative"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 2 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Conversely, relatively less risk (i.e., not high process risk) of compromised 382 safety and/or quality generally entail sless collection of objective evidence for the computer 383 software assurance effort . 384 385 Afeature, function, or operation that could lead to severe harm to a patient or user would 386 generally be high device risk. In contrast, a feature, function, or operation that would not 387 foreseeably lead to severe harm would likely not be high device risk. In either case, the risk of 388 the softwares failure to perform as intended is commensurate with the resulting medical device 389 risk. 390 391 If the manufacturer instead determined that the software feature, function, or operation does not 392 pose a high process risk ( i.e., it would not lead to a quality problem that foreseeably 393 compromises safety ), the manufacturer should consider the risk relative to the process , i.e., 394 production or the quality system. This is because the failure would not compromise safety, so the 395 failure would not introduce additional medical device risk. For example, a function that collects 396 and records process data for review would pose a low er process risk than a function that 397 determine sacceptability of product prior to human review.
[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: ____ 391 If the manufacturer instead determined that the software feature, function, or operation does not 392 pose a high process risk ( i.e., it would not lead to a quality problem that foreseeably 393 compromises safety ), the manufacturer should consider the risk relative to the process , i.e., 394 production or the quality system.",
"reference": "390 391 If the manufacturer instead determined that the software feature, function, or operation does not 392 pose a high process risk ( i.e., it would not lead to a quality problem that foreseeably 393 compromises safety ), the manufacturer should consider the risk relative to the process , i.e., 394 production or the quality system.",
"options": {
"D": "390",
"A": "382",
"B": "383",
"C": "i.e., not high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 390 ____ If the manufacturer instead determined that the software feature, function, or operation does not 392 pose a high process risk ( i.e., it would not lead to a quality problem that foreseeably 393 compromises safety ), the manufacturer should consider the risk relative to the process , i.e., 394 production or the quality system.",
"reference": "390 391 If the manufacturer instead determined that the software feature, function, or operation does not 392 pose a high process risk ( i.e., it would not lead to a quality problem that foreseeably 393 compromises safety ), the manufacturer should consider the risk relative to the process , i.e., 394 production or the quality system.",
"options": {
"D": "391",
"A": "382",
"B": "383",
"C": "i.e., not high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 6 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)
http://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443. 6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html . U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Resear ch (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharm aceutical CGMPs TABLE OF CONTENTS I.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "When did this occur: '6597 Internt'l Staff Phone: 301.827.3993 or Center...'?",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"B": "6597",
"A": "August 2003",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"D": "Health and Human Services Food and Drug Administration Center"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '6597 Internt'l Staff Phone: 301.827.3993 or Center...'?",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"B": "Center for Food Safety and Applied Nutrition",
"A": "Electronic Records",
"C": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"A": "6597",
"B": "August 2003",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"D": "Health and Human Services Food and Drug Administration Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 6597 Internt'l Staff Phone: ____ or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"D": "301.827.3993",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"B": "Health and Human Services Food and Drug Administration Center",
"C": "6597"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '6597 Internt'l Staff Phone: 301.827.3993 or Center...'?",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"C": "6597",
"A": "August 2003",
"B": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"D": "Health and Human Services Food and Drug Administration Center"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '6597 Internt'l Staff Phone: 301.827.3993 or Center...'?",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"C": "Center for Food Safety and Applied Nutrition",
"A": "Electronic Records",
"B": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"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 50 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Ken Shumate, Marilyn Keller, Software Specification and Design, A Disciplined Approach for Real-Time Systems , John Wiley Sons, 1992. ISBN 0-471-53296-7. Dennis D. Smith, Designing Maintainable Software , Springer-Verlag, 1999. ISBN 0-387-98783-5. Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989. ISBN 0-201-17568-1. Karl E. Wiegers, Creating a Software Engineering Culture , Dorset House Publishing, 1996. ISBN 0-932633-33-1. Karl E. Wiegers, Software Inspection, Improving Quality with Software Inspections , Software Development, April 1995, pages 55-64. Karl E. Wiegers, Software Requirements, Microsoft Press, 1999. ISBN 0-7356-0631-5. Page 43General Principles of Software Validation Guidance for Industry and FDA Staff APPENDIX B - DEVELOPMENT TEAM Center for Devices and Radiological Health Office of Compliance Stewart Crumpler Office of Device Evaluation James Cheng, Donna-
Bea Tillman Office of Health and Industry Programs Bryan Benesch, Dick Sawyer Office of Science and Technology John Murray Office of Surveillance and Biome trics Howard Press Center for Drug Evaluation and Research Office of Medical Policy Charles Snipes Center for Biologics Evaluation and Research Office of Compliance and Biologics Quality Alice Godziemski Office of Regulatory Affairs Office o f Regional Operations David Bergeson, Joan Loreng
[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: 'Dennis D. Smith, Designing Maintainable Software ,...'?",
"reference": "Dennis D. Smith, Designing Maintainable Software , Springer-Verlag, 1999.",
"options": {
"B": "Dennis D. Smith",
"A": "Ken Shumate",
"C": "Marilyn Keller",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Dennis D. Smith, Designing Maintainable Software ,...'?",
"reference": "Dennis D. Smith, Designing Maintainable Software , Springer-Verlag, 1999.",
"options": {
"C": "Designing Maintainable Software",
"A": "Compliance and Biologics Quality Alice Godziemski Office",
"B": "Biologics Evaluation and Research Office",
"D": "Dennis D. Smith"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Dennis D. Smith, Designing Maintainable Software ,...'?",
"reference": "Dennis D. Smith, Designing Maintainable Software , Springer-Verlag, 1999.",
"options": {
"C": "Springer-Verlag",
"A": "Compliance and Biologics Quality Alice Godziemski Office",
"B": "Biologics Evaluation and Research Office",
"D": "Dennis D. Smith"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Dennis D. Smith, Designing Maintainable Software ,...'?",
"reference": "Dennis D. Smith, Designing Maintainable Software , Springer-Verlag, 1999.",
"options": {
"C": "1999",
"A": "1992",
"B": "1989",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Dennis D. Smith, Designing Maintainable Software , Springer-Verlag, ____.",
"reference": "Dennis D. Smith, Designing Maintainable Software , Springer-Verlag, 1999.",
"options": {
"D": "1999",
"A": "1992",
"B": "1989",
"C": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"D": "Ian Sommerville",
"A": "Ken Shumate",
"B": "Marilyn Keller",
"C": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"A": "Software Engineering",
"B": "Software Specification and Design",
"C": "Designing Maintainable Software",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"A": "Third Edition",
"B": "Compliance and Biologics Quality Alice Godziemski Office",
"C": "Biologics Evaluation and Research Office",
"D": "Ian Sommerville"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"A": "Addison Wesley Publishing Co.",
"B": "Software Specification and Design",
"C": "Designing Maintainable Software",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"D": "1989",
"A": "1992",
"B": "1999",
"C": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Ian Sommerville, Software Engineering , ____ Edition, Addison Wesley Publishing Co., 1989.",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"D": "Third",
"A": "Compliance and Biologics Quality Alice Godziemski Office",
"B": "Biologics Evaluation and Research Office",
"C": "3rd"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., ____.",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"A": "1989",
"B": "1992",
"C": "1999",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"D": "Ian Sommerville",
"A": "Ken Shumate",
"B": "Marilyn Keller",
"C": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"D": "Software Engineering",
"A": "Software Specification and Design",
"B": "Designing Maintainable Software",
"C": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"A": "Third Edition",
"B": "Compliance and Biologics Quality Alice Godziemski Office",
"C": "Biologics Evaluation and Research Office",
"D": "Ian Sommerville"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"B": "Addison Wesley Publishing Co.",
"A": "Software Specification and Design",
"C": "Designing Maintainable Software",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"A": "1989",
"B": "1992",
"C": "1999",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Ian Sommerville, Software Engineering , ____ Edition, Addison Wesley Publishing Co., 1989.",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"A": "Third",
"B": "Compliance and Biologics Quality Alice Godziemski Office",
"C": "Biologics Evaluation and Research Office",
"D": "3rd"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., ____.",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"B": "1989",
"A": "1992",
"C": "1999",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"D": "Ian Sommerville",
"A": "Ken Shumate",
"B": "Marilyn Keller",
"C": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"D": "Software Engineering",
"A": "Software Specification and Design",
"B": "Designing Maintainable Software",
"C": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"B": "Third Edition",
"A": "Compliance and Biologics Quality Alice Godziemski Office",
"C": "Biologics Evaluation and Research Office",
"D": "Ian Sommerville"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"B": "Addison Wesley Publishing Co.",
"A": "Software Specification and Design",
"C": "Designing Maintainable Software",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"D": "1989",
"A": "1992",
"B": "1999",
"C": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Ian Sommerville, Software Engineering , ____ Edition, Addison Wesley Publishing Co., 1989.",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"A": "Third",
"B": "Compliance and Biologics Quality Alice Godziemski Office",
"C": "Biologics Evaluation and Research Office",
"D": "3rd"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Karl E. Wiegers, Creating a Software Engineering C...'?",
"reference": "Karl E. Wiegers, Creating a Software Engineering Culture , Dorset House Publishing, 1996.",
"options": {
"A": "Karl E. Wiegers",
"B": "Ken Shumate",
"C": "Marilyn Keller",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Karl E. Wiegers, Creating a Software Engineering C...'?",
"reference": "Karl E. Wiegers, Creating a Software Engineering Culture , Dorset House Publishing, 1996.",
"options": {
"D": "1996",
"A": "1992",
"B": "1999",
"C": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Karl E. Wiegers, Creating a Software Engineering Culture , Dorset House Publishing, ____.",
"reference": "Karl E. Wiegers, Creating a Software Engineering Culture , Dorset House Publishing, 1996.",
"options": {
"C": "1996",
"A": "1992",
"B": "1999",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Karl E. Wiegers, Creating a Software Engineering C...'?",
"reference": "Karl E. Wiegers, Creating a Software Engineering Culture , Dorset House Publishing, 1996.",
"options": {
"B": "Karl E. Wiegers",
"A": "Ken Shumate",
"C": "Marilyn Keller",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Karl E. Wiegers, Creating a Software Engineering C...'?",
"reference": "Karl E. Wiegers, Creating a Software Engineering Culture , Dorset House Publishing, 1996.",
"options": {
"A": "1996",
"B": "1992",
"C": "1999",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Karl E. Wiegers, Creating a Software Engineering Culture , Dorset House Publishing, ____.",
"reference": "Karl E. Wiegers, Creating a Software Engineering Culture , Dorset House Publishing, 1996.",
"options": {
"B": "1996",
"A": "1992",
"C": "1999",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"B": "Ian Sommerville",
"A": "Ken Shumate",
"C": "Marilyn Keller",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"A": "Software Engineering",
"B": "Software Specification and Design",
"C": "Designing Maintainable Software",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"A": "Third Edition",
"B": "Compliance and Biologics Quality Alice Godziemski Office",
"C": "Biologics Evaluation and Research Office",
"D": "Ian Sommerville"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"C": "Addison Wesley Publishing Co.",
"A": "Software Specification and Design",
"B": "Designing Maintainable Software",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"D": "1989",
"A": "1992",
"B": "1999",
"C": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Ian Sommerville, Software Engineering , ____ Edition, Addison Wesley Publishing Co., 1989.",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"C": "Third",
"A": "Compliance and Biologics Quality Alice Godziemski Office",
"B": "Biologics Evaluation and Research Office",
"D": "3rd"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., ____.",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"D": "1989",
"A": "1992",
"B": "1999",
"C": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Ken Shumate, Marilyn Keller, Software Specificatio...'?",
"reference": "Ken Shumate, Marilyn Keller, Software Specification and Design, A Disciplined Approach for Real-Time Systems , John Wiley Sons, 1992.",
"options": {
"B": "Ken Shumate",
"A": "Marilyn Keller",
"C": "John Wiley Sons",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Ken Shumate, Marilyn Keller, Software Specificatio...'?",
"reference": "Ken Shumate, Marilyn Keller, Software Specification and Design, A Disciplined Approach for Real-Time Systems , John Wiley Sons, 1992.",
"options": {
"D": "Marilyn Keller",
"A": "Ken Shumate",
"B": "John Wiley Sons",
"C": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Ken Shumate, Marilyn Keller, Software Specificatio...'?",
"reference": "Ken Shumate, Marilyn Keller, Software Specification and Design, A Disciplined Approach for Real-Time Systems , John Wiley Sons, 1992.",
"options": {
"B": "Software Specification and Design",
"A": "Designing Maintainable Software",
"C": "Software Engineering",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Ken Shumate, Marilyn Keller, Software Specificatio...'?",
"reference": "Ken Shumate, Marilyn Keller, Software Specification and Design, A Disciplined Approach for Real-Time Systems , John Wiley Sons, 1992.",
"options": {
"A": "John Wiley Sons",
"B": "Ken Shumate",
"C": "Marilyn Keller",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Ken Shumate, Marilyn Keller, Software Specificatio...'?",
"reference": "Ken Shumate, Marilyn Keller, Software Specification and Design, A Disciplined Approach for Real-Time Systems , John Wiley Sons, 1992.",
"options": {
"D": "1992",
"A": "1999",
"B": "1989",
"C": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Ken Shumate, Marilyn Keller, Software Specification and Design, A Disciplined Approach for Real-Time Systems , John Wiley Sons, ____.",
"reference": "Ken Shumate, Marilyn Keller, Software Specification and Design, A Disciplined Approach for Real-Time Systems , John Wiley Sons, 1992.",
"options": {
"A": "1992",
"B": "1999",
"C": "1989",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"A": "Ian Sommerville",
"B": "Ken Shumate",
"C": "Marilyn Keller",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"C": "Software Engineering",
"A": "Software Specification and Design",
"B": "Designing Maintainable Software",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"B": "Third Edition",
"A": "Compliance and Biologics Quality Alice Godziemski Office",
"C": "Biologics Evaluation and Research Office",
"D": "Ian Sommerville"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"A": "Addison Wesley Publishing Co.",
"B": "Software Specification and Design",
"C": "Designing Maintainable Software",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Ian Sommerville, Software Engineering , Third Edit...'?",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"A": "1989",
"B": "1992",
"C": "1999",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Ian Sommerville, Software Engineering , ____ Edition, Addison Wesley Publishing Co., 1989.",
"reference": "Ian Sommerville, Software Engineering , Third Edition, Addison Wesley Publishing Co., 1989.",
"options": {
"B": "Third",
"A": "Compliance and Biologics Quality Alice Godziemski Office",
"C": "Biologics Evaluation and Research Office",
"D": "3rd"
},
"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 45 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
II. PHARMACEUTICAL QUAL ITY MANAGEMENT SYSTEM A. Scope (1.2) This guidance applies to the systems s upporting the development and manufacture of pharmaceutical drug substances (i.e., active pharmaceutical ingredients (APIs)) and drug products, including biotechnology a nd biological products, throughout the product lifecycle. The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle st ages, recognizing the differences among, and the different goals of, each stage (see section IV (3)). For the purposes of this guidan ce, the product lifecycle includes the following technical activities for new and existing products: Pharmaceutical Development o Drug substance development o Formulation development (includi ng container/closure system)
Manufacture of investigational products o Delivery system development (where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers during deve lopment through manufacturing o Transfers within or between manufacturing and testing sites for marketed products Commercial Manufacturing o Acquisition and control of materials o Provision of facilities, utilities, and equipment o Production (including pack aging and labeling) o
Quality control and assurance o Release o Storage 2 o Distribution (excluding wholesaler activities)
Product Discontinuation o Retention of documentation o Sample retention o Continued product assessment and reporting B. Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10. To meet the objectives described below, ICH Q10 augments GMPs by describing specific quality system elements and management responsibilities.
[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: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"B": "Regional GMP Requirements",
"A": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "ISO Standards"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"C": "ISO Standards",
"A": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"B": "ICH Q10",
"D": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"B": "ICH Q7",
"A": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "Regional GMP Requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"A": "ISO",
"B": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"C": "ICH Q10",
"D": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"A": "ICH Q10",
"B": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "Regional GMP Requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (____) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"D": "1.3",
"A": "1.2",
"B": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To meet the objectives described below, ICH Q10 au...'?",
"reference": "To meet the objectives described below, ICH Q10 augments GMPs by describing specific quality system elements and management responsibilities.",
"options": {
"A": "Q10",
"B": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'PHARMACEUTICAL QUAL ITY MANAGEMENT SYSTEM A....'?",
"reference": "PHARMACEUTICAL QUAL ITY MANAGEMENT SYSTEM A.",
"options": {
"C": "QUAL ITY MANAGEMENT SYSTEM A.",
"A": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"B": "ICH Q10",
"D": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'PHARMACEUTICAL QUAL ITY MANAGEMENT SYSTEM A....'?",
"reference": "PHARMACEUTICAL QUAL ITY MANAGEMENT SYSTEM A.",
"options": {
"A": "QUAL ITY MANAGEMENT SYSTEM A.",
"B": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"C": "ICH Q10",
"D": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"C": "Regional GMP Requirements",
"A": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"B": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "ISO Standards"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"D": "ISO Standards",
"A": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"B": "ICH Q10",
"C": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'PHARMACEUTICAL QUAL ITY MANAGEMENT SYSTEM A....'?",
"reference": "PHARMACEUTICAL QUAL ITY MANAGEMENT SYSTEM A.",
"options": {
"D": "QUAL ITY MANAGEMENT SYSTEM A.",
"A": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"B": "ICH Q10",
"C": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To meet the objectives described below, ICH Q10 au...'?",
"reference": "To meet the objectives described below, ICH Q10 augments GMPs by describing specific quality system elements and management responsibilities.",
"options": {
"D": "Q10",
"A": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"B": "Pharmaceutical Development o Drug substance development o Formulation development",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The elements of ICH Q10 should be applied in a man...'?",
"reference": "The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle st ages, recognizing the differences among, and the different goals of, each stage (see section IV (3)).",
"options": {
"A": "ICH Q10",
"B": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle st ages, recognizing the differences among, and the different goals of, each stage (see section IV (____)).",
"reference": "The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle st ages, recognizing the differences among, and the different goals of, each stage (see section IV (3)).",
"options": {
"B": "3",
"A": "1.2",
"C": "1.3",
"D": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Scope (____) This guidance applies to the systems s upporting the development and manufacture of pharmaceutical drug substances (i.e., active pharmaceutical ingredients (APIs)) and drug products, including biotechnology a nd biological products, throughout the product lifecycle.",
"reference": "Scope (1.2) This guidance applies to the systems s upporting the development and manufacture of pharmaceutical drug substances (i.e., active pharmaceutical ingredients (APIs)) and drug products, including biotechnology a nd biological products, throughout the product lifecycle.",
"options": {
"A": "1.2",
"B": "1.3",
"C": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"D": "Pharmaceutical Development o Drug substance development o Formulation development"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"B": "Regional GMP Requirements",
"A": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "ISO Standards"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"B": "ISO Standards",
"A": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"C": "ICH Q10",
"D": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"A": "ICH Q7",
"B": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "Regional GMP Requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"D": "ISO",
"A": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"B": "ICH Q10",
"C": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"D": "ICH Q10",
"A": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"B": "Pharmaceutical Development o Drug substance development o Formulation development",
"C": "Regional GMP Requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (____) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"C": "1.3",
"A": "1.2",
"B": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"D": "Pharmaceutical Development o Drug substance development o Formulation development"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Scope (____) This guidance applies to the systems s upporting the development and manufacture of pharmaceutical drug substances (i.e., active pharmaceutical ingredients (APIs)) and drug products, including biotechnology a nd biological products, throughout the product lifecycle.",
"reference": "Scope (1.2) This guidance applies to the systems s upporting the development and manufacture of pharmaceutical drug substances (i.e., active pharmaceutical ingredients (APIs)) and drug products, including biotechnology a nd biological products, throughout the product lifecycle.",
"options": {
"C": "1.2",
"A": "1.3",
"B": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"D": "Pharmaceutical Development o Drug substance development o Formulation development"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"A": "Regional GMP Requirements",
"B": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "ISO Standards"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"B": "ISO Standards",
"A": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"C": "ICH Q10",
"D": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"A": "ICH Q7",
"B": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "Regional GMP Requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"A": "ISO",
"B": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"C": "ICH Q10",
"D": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"A": "ICH Q10",
"B": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "Regional GMP Requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (____) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"C": "1.3",
"A": "1.2",
"B": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"D": "Pharmaceutical Development o Drug substance development o Formulation development"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"B": "Regional GMP Requirements",
"A": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "ISO Standards"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"D": "ISO Standards",
"A": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"B": "ICH Q10",
"C": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"B": "ICH Q7",
"A": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "Regional GMP Requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"D": "ISO",
"A": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"B": "ICH Q10",
"C": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Scope (____) This guidance applies to the systems s upporting the development and manufacture of pharmaceutical drug substances (i.e., active pharmaceutical ingredients (APIs)) and drug products, including biotechnology a nd biological products, throughout the product lifecycle.",
"reference": "Scope (1.2) This guidance applies to the systems s upporting the development and manufacture of pharmaceutical drug substances (i.e., active pharmaceutical ingredients (APIs)) and drug products, including biotechnology a nd biological products, throughout the product lifecycle.",
"options": {
"A": "1.2",
"B": "1.3",
"C": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"D": "Pharmaceutical Development o Drug substance development o Formulation development"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Scope (____) This guidance applies to the systems s upporting the development and manufacture of pharmaceutical drug substances (i.e., active pharmaceutical ingredients (APIs)) and drug products, including biotechnology a nd biological products, throughout the product lifecycle.",
"reference": "Scope (1.2) This guidance applies to the systems s upporting the development and manufacture of pharmaceutical drug substances (i.e., active pharmaceutical ingredients (APIs)) and drug products, including biotechnology a nd biological products, throughout the product lifecycle.",
"options": {
"B": "1.2",
"A": "1.3",
"C": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"D": "Pharmaceutical Development o Drug substance development o Formulation development"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'PHARMACEUTICAL QUAL ITY MANAGEMENT SYSTEM A....'?",
"reference": "PHARMACEUTICAL QUAL ITY MANAGEMENT SYSTEM A.",
"options": {
"C": "QUAL ITY MANAGEMENT SYSTEM A.",
"A": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"B": "ICH Q10",
"D": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For the purposes of this guidan ce, the product li...'?",
"reference": "For the purposes of this guidan ce, the product lifecycle includes the following technical activities for new and existing products: Pharmaceutical Development o Drug substance development o Formulation development (includi ng container/closure system)\nManufacture of investigational products o Delivery system development (where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers during deve lopment through manufacturing o Transfers within or between manufacturing and testing sites for marketed products Commercial Manufacturing o Acquisition and control of materials o Provision of facilities, utilities, and equipment o Production (including pack aging and labeling) o\nQuality control and assurance o Release o Storage 2 o Distribution (excluding wholesaler activities)\nProduct Discontinuation o Retention of documentation o Sample retention o Continued product assessment and reporting B.",
"options": {
"B": "Pharmaceutical Development o Drug",
"A": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"C": "ICH Q10",
"D": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For the purposes of this guidan ce, the product li...'?",
"reference": "For the purposes of this guidan ce, the product lifecycle includes the following technical activities for new and existing products: Pharmaceutical Development o Drug substance development o Formulation development (includi ng container/closure system)\nManufacture of investigational products o Delivery system development (where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers during deve lopment through manufacturing o Transfers within or between manufacturing and testing sites for marketed products Commercial Manufacturing o Acquisition and control of materials o Provision of facilities, utilities, and equipment o Production (including pack aging and labeling) o\nQuality control and assurance o Release o Storage 2 o Distribution (excluding wholesaler activities)\nProduct Discontinuation o Retention of documentation o Sample retention o Continued product assessment and reporting B.",
"options": {
"D": "Commercial Manufacturing o Acquisition",
"A": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"B": "ICH Q10",
"C": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For the purposes of this guidan ce, the product li...'?",
"reference": "For the purposes of this guidan ce, the product lifecycle includes the following technical activities for new and existing products: Pharmaceutical Development o Drug substance development o Formulation development (includi ng container/closure system)\nManufacture of investigational products o Delivery system development (where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers during deve lopment through manufacturing o Transfers within or between manufacturing and testing sites for marketed products Commercial Manufacturing o Acquisition and control of materials o Provision of facilities, utilities, and equipment o Production (including pack aging and labeling) o\nQuality control and assurance o Release o Storage 2 o Distribution (excluding wholesaler activities)\nProduct Discontinuation o Retention of documentation o Sample retention o Continued product assessment and reporting B.",
"options": {
"D": "Release o Storage 2 o Distribution",
"A": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"B": "Pharmaceutical Development o Drug substance development o Formulation development",
"C": "Pharmaceutical Development o Drug"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For the purposes of this guidan ce, the product li...'?",
"reference": "For the purposes of this guidan ce, the product lifecycle includes the following technical activities for new and existing products: Pharmaceutical Development o Drug substance development o Formulation development (includi ng container/closure system)\nManufacture of investigational products o Delivery system development (where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers during deve lopment through manufacturing o Transfers within or between manufacturing and testing sites for marketed products Commercial Manufacturing o Acquisition and control of materials o Provision of facilities, utilities, and equipment o Production (including pack aging and labeling) o\nQuality control and assurance o Release o Storage 2 o Distribution (excluding wholesaler activities)\nProduct Discontinuation o Retention of documentation o Sample retention o Continued product assessment and reporting B.",
"options": {
"C": "Product Discontinuation o Retention",
"A": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"B": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "Pharmaceutical Development o Drug"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For the purposes of this guidan ce, the product lifecycle includes the following technical activities for new and existing products: Pharmaceutical Development o Drug substance development o Formulation development (includi ng container/closure system)\nManufacture of investigational products o Delivery system development (where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers during deve lopment through manufacturing o Transfers within or between manufacturing and testing sites for marketed products Commercial Manufacturing o Acquisition and control of materials o Provision of facilities, utilities, and equipment o Production (including pack aging and labeling) o\nQuality control and assurance o Release o Storage ____ o Distribution (excluding wholesaler activities)\nProduct Discontinuation o Retention of documentation o Sample retention o Continued product assessment and reporting B.",
"reference": "For the purposes of this guidan ce, the product lifecycle includes the following technical activities for new and existing products: Pharmaceutical Development o Drug substance development o Formulation development (includi ng container/closure system)\nManufacture of investigational products o Delivery system development (where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers during deve lopment through manufacturing o Transfers within or between manufacturing and testing sites for marketed products Commercial Manufacturing o Acquisition and control of materials o Provision of facilities, utilities, and equipment o Production (including pack aging and labeling) o\nQuality control and assurance o Release o Storage 2 o Distribution (excluding wholesaler activities)\nProduct Discontinuation o Retention of documentation o Sample retention o Continued product assessment and reporting B.",
"options": {
"D": "2",
"A": "1.2",
"B": "1.3",
"C": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"D": "Regional GMP Requirements",
"A": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"B": "Pharmaceutical Development o Drug substance development o Formulation development",
"C": "ISO Standards"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"D": "ISO Standards",
"A": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"B": "ICH Q10",
"C": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"A": "ICH Q7",
"B": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "Regional GMP Requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Relationship of ICH Q10 to Regional GMP Requiremen...'?",
"reference": "Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10.",
"options": {
"B": "ISO",
"A": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"C": "ICH Q10",
"D": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 4 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
In general, the record should include the following: 501 502 the intended use of the software feature, function , or operation; 503 the determination of risk of the software feature, function, or operation; 504 documentation of the assurance activities conducted, including: 505 description of the testing conducted based on the assurance activity ; 506 issues found (e.g., deviations , failures ) and the disposition; 507 conclusion statement declaring acceptability of the results; 508 the date of testing/assessment and the name of the person who conducted the 509 testing /assessment ; 510 established review and approval when appropriate (e.g., when necess ary, a 511 signature and date of an individual with signatory authority) 512 513 Documentation of assurance activities need not include more evidence than necessary to show 514 that the software feature, function, or operation performs as intended for the risk identified . FDA 515 recommends the record retain sufficient details of the assurance activity to serve as a baseline for 516 improvements or as a reference point if issues occur.15517 518 Table 1 provides some examples of ways to implement and develop the record when using the 519 risk-based testing approaches identified in Section V.C. above. Manufacturers may use 520 alternative approaches and provide different documentation so long as their approach satisfies 521 applicable legal documentation requirements .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'FDA 515 recommends the record retain sufficient de...'?",
"reference": "FDA 515 recommends the record retain sufficient details of the assurance activity to serve as a baseline for 516 improvements or as a reference point if issues occur.15517 518 Table 1 provides some examples of ways to implement and develop the record when using the 519 risk-based testing approaches identified in Section V.C.",
"options": {
"A": "FDA",
"B": "the software feature",
"C": "Food and Drug Administration",
"D": "515"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA ____ recommends the record retain sufficient details of the assurance activity to serve as a baseline for 516 improvements or as a reference point if issues occur.15517 518 Table 1 provides some examples of ways to implement and develop the record when using the 519 risk-based testing approaches identified in Section V.C.",
"reference": "FDA 515 recommends the record retain sufficient details of the assurance activity to serve as a baseline for 516 improvements or as a reference point if issues occur.15517 518 Table 1 provides some examples of ways to implement and develop the record when using the 519 risk-based testing approaches identified in Section V.C.",
"options": {
"B": "515",
"A": "501 502",
"C": "503",
"D": "the software feature"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA 515 recommends the record retain sufficient details of the assurance activity to serve as a baseline for ____ improvements or as a reference point if issues occur.15517 518 Table 1 provides some examples of ways to implement and develop the record when using the 519 risk-based testing approaches identified in Section V.C.",
"reference": "FDA 515 recommends the record retain sufficient details of the assurance activity to serve as a baseline for 516 improvements or as a reference point if issues occur.15517 518 Table 1 provides some examples of ways to implement and develop the record when using the 519 risk-based testing approaches identified in Section V.C.",
"options": {
"C": "516",
"A": "501 502",
"B": "503",
"D": "the software feature"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA 515 recommends the record retain sufficient details of the assurance activity to serve as a baseline for 516 improvements or as a reference point if issues occur.15517 ____ Table 1 provides some examples of ways to implement and develop the record when using the 519 risk-based testing approaches identified in Section V.C.",
"reference": "FDA 515 recommends the record retain sufficient details of the assurance activity to serve as a baseline for 516 improvements or as a reference point if issues occur.15517 518 Table 1 provides some examples of ways to implement and develop the record when using the 519 risk-based testing approaches identified in Section V.C.",
"options": {
"A": "518",
"B": "501 502",
"C": "503",
"D": "the software feature"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 1 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations
Additional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm. (Tel) 800-835-4709 or 301-827-1800 or Communications Staff, HFV-12 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 (Tel) 301-827-3800 http://www.fda.gov/cvm/guidance/published.html U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMP Regulations Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION ............................................................................................................. 1 II. BACKGROUND AND PURPOSE ..................................................................................
1 A. Background ....................................................................................................................................
1 B.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Guidance for Industry Quality Systems Approach to ...'?",
"reference": "Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Heal th and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluati on and Research (CBER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CGMPs Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations\nAdditional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"D": "Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"A": "Office of Regulatory Affairs",
"B": "ORA",
"C": "Drug Evaluation and Research Food and Drug Administration"
},
"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 1 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 guidance is intended to provide recommendation...'?",
"reference": "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.",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "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]
See the references in Appendix A for applicable FDA guidance documents for pre-market submissions. Page 5General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 3. CONTEXT FOR SOFTWARE VALIDATION
Many people have asked for specific guidance on what FDA expects them to do to ensure compliance with the Quality System regulation with regard to software validation. Information on software validation presented in this document is not new. Validation of software, using the principles and tasks listed in Sections 4 and 5, has been conducted in many segments of the software industry for well over 20 years. Due to the great variety of medical devices, processes, and manufacturing facilities, it is not possible to state in one document all of the specific validation elements that are applicable. However, a general application of several broad concepts can be used successfully as guidance for software validation. These broad concepts provide an acceptable framework for building a comprehensive approach to software validation. Additional specific information is available from many of the references listed in Appendix A. 3.1. DEFINITIONS AND TERMINOLOGY
Unless defined in the Quality System regulation, or otherwise specified below, all other terms used in this guidance are as defined in the current edition of the FDA Glossary of Computerized System and Software Development Terminology. The medical device Quality System regulation (21 CFR 820.3(k)) defines " establish " to mean "define, document, and implement." Where it appears in this guidance, the words "establish" and established should be interpreted to have this same meaning. Some definitions found in the medical device Quality System regulation can be confusing when compared to commonly used terminology in the software industry. Examples are requirements, specification, verification, and validation.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'The medical device Quality System regulation (21 C...'?",
"reference": "The medical device Quality System regulation (21 CFR 820.3(k)) defines \" establish \" to mean \"define, document, and implement.\"",
"options": {
"D": "Quality System",
"A": "Software Validation Guidance",
"B": "software validation",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The medical device Quality System regulation (____ CFR 820.3(k)) defines \" establish \" to mean \"define, document, and implement.\"",
"reference": "The medical device Quality System regulation (21 CFR 820.3(k)) defines \" establish \" to mean \"define, document, and implement.\"",
"options": {
"B": "21",
"A": "one",
"C": "Software Validation Guidance",
"D": "software validation"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 5General Principles of Software Validation Gu...'?",
"reference": "Page 5General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 3.",
"options": {
"A": "FDA",
"B": "Quality System",
"C": "DEFINITIONS",
"D": "Software Validation Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 4 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Errors detected during testing should be logged, classified, reviewed, and resolved prior to release of the software. Software error data that is collected and analyzed during a development life cycle may be used to determine the suitability of the software product for release for commercial distribution. Test reports should comply with the requirements of the corresponding test plans. Software products that perform useful functions in medical devices or their production are often complex. Software testing tools are frequently used to ensure consistency, thoroughness, and efficiency in the testing of such software products and to fulfill the requirements of the planned testing activities. These tools may include supporting software built in-house to facilitate unit (module) testing and subsequent integration testing (e.g., drivers and stubs) as well as commercial software testing tools. Such tools should have a degree of quality no less than the software product they are used to develop. Appropriate documentation providing evidence of the validation of these software tools for their intended use should be maintained (see section 6 of this guidance). Typical Tasks Testing by the Software Developer Test Planning Structural Test Case Identification Functional Test Case Identification Traceability Analysis - Testing Unit (Module) Tests to Detailed Design Integration Tests to High Level Design System Tests to Software Requirements Unit (Module) Test Execution Integration Test Execution Functional Test Execution System Test Execution Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report Page 27General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.6. User Site Testing Testing at the user site is an essential part of software validation.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Software testing tools are frequently used to ensu...'?",
"reference": "Software testing tools are frequently used to ensure consistency, thoroughness, and efficiency in the testing of such software products and to fulfill the requirements of the planned testing activities.",
"options": {
"C": "Software",
"A": "Detailed Design Integration",
"B": "Software Requirements Unit (Module",
"D": "Module) Test Execution Integration Test Execution Functional Test Execution System Test Execution Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report Page 27General Principles"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Testing by the Software Developer ...'?",
"reference": "Typical Tasks Testing by the Software Developer Test Planning Structural Test Case Identification Functional Test Case Identification Traceability Analysis - Testing Unit (Module) Tests to Detailed Design Integration Tests to High Level Design System Tests to Software Requirements Unit (Module) Test Execution Integration Test Execution Functional Test Execution System Test Execution Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report Page 27General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.6.",
"options": {
"B": "Detailed Design Integration",
"A": "the Software Developer Test Planning Structural Test Case Identification Functional Test Case Identification Traceability Analysis - Testing Unit (Module) Tests",
"C": "Module) Test Execution Integration Test Execution Functional Test Execution System Test Execution Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report Page 27General Principles",
"D": "Software Requirements Unit (Module"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Testing by the Software Developer ...'?",
"reference": "Typical Tasks Testing by the Software Developer Test Planning Structural Test Case Identification Functional Test Case Identification Traceability Analysis - Testing Unit (Module) Tests to Detailed Design Integration Tests to High Level Design System Tests to Software Requirements Unit (Module) Test Execution Integration Test Execution Functional Test Execution System Test Execution Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report Page 27General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.6.",
"options": {
"A": "Software Requirements Unit (Module",
"B": "Detailed Design Integration",
"C": "FDA",
"D": "the Software Developer Test Planning Structural Test Case Identification Functional Test Case Identification Traceability Analysis - Testing Unit (Module) Tests"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Testing by the Software Developer ...'?",
"reference": "Typical Tasks Testing by the Software Developer Test Planning Structural Test Case Identification Functional Test Case Identification Traceability Analysis - Testing Unit (Module) Tests to Detailed Design Integration Tests to High Level Design System Tests to Software Requirements Unit (Module) Test Execution Integration Test Execution Functional Test Execution System Test Execution Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report Page 27General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.6.",
"options": {
"B": "FDA",
"A": "Detailed Design Integration",
"C": "Software Requirements Unit (Module",
"D": "the Software Developer Test Planning Structural Test Case Identification Functional Test Case Identification Traceability Analysis - Testing Unit (Module) Tests"
},
"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 6 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Condition Coverage
This criteria requires sufficient test cases for each condition in a program decision to take on all possible outcomes at least once. It differs from branch coverage only when multiple conditions must be evaluated to reach a decision. Multi-Condition Coverage
This criteria requires sufficient test cases to exercise all possible combinations of conditions in a program decision. This criteria requires sufficient test cases for all program loops to be executed for zero, one, two, and many iterations covering initialization, typical running and termination (boundary) conditions. Path Coverage This criteria requires sufficient test cases for each feasible path, basis path, etc., from start to exit of a defined program segment, to be executed at least once. Because of the very large number of possible paths through a software program, path coverage is generally not achievable. The amount of path coverage is normally established based on the risk or criticality of the software under test. Data Flow Coverage This criteria requires sufficient test cases for each feasible data flow to be executed at least once. A number of data flow testing strategies are available. Definition-based or specification-based testing is also known as functional testing or "black-box" testing. It identifies test cases based on the definition of what the software product (whether it be a unit (module) or a complete program) is intended to do. These test cases challenge the intended use or functionality of a program, and the program's internal and external interfaces. Functional testing can be applied at all levels of software testing, from unit to system level testing. Page 24General Principles of Software Validation Guidance for Industry and FDA Staff
The following types of functional software testing involve generally increasing levels of effort: Normal Case Testing with usual inputs is necessary.
[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: 'Multi-Condition Coverage\nThis criteria requires su...'?",
"reference": "Multi-Condition Coverage\nThis criteria requires sufficient test cases to exercise all possible combinations of conditions in a program decision.",
"options": {
"B": "Multi-Condition Coverage",
"A": "Data Flow Coverage",
"C": "FDA",
"D": "sufficient test cases"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Multi-Condition Coverage\nThis criteria requires su...'?",
"reference": "Multi-Condition Coverage\nThis criteria requires sufficient test cases to exercise all possible combinations of conditions in a program decision.",
"options": {
"D": "Multi-Condition Coverage",
"A": "Data Flow Coverage",
"B": "FDA",
"C": "sufficient test cases"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Data Flow Coverage This criteria requires suffici...'?",
"reference": "Data Flow Coverage This criteria requires sufficient test cases for each feasible data flow to be executed at least once.",
"options": {
"B": "Data Flow Coverage",
"A": "Multi-Condition Coverage",
"C": "FDA",
"D": "sufficient test cases"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Because of the very large number of possible paths through a...'?",
"reference": "Because of the very large number of possible paths through a software program, path coverage is generally not achievable.",
"options": {
"A": "Because of the very large number of possible paths through a software program, path coverage is gene...",
"B": "sufficient test cases",
"C": "This information is not mentioned in the context",
"D": "The context does not provide this detail"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This criteria requires sufficient test cases for all program loops to be executed for ____, one, two, and many iterations covering initialization, typical running and termination (boundary) conditions.",
"reference": "This criteria requires sufficient test cases for all program loops to be executed for zero, one, two, and many iterations covering initialization, typical running and termination (boundary) conditions.",
"options": {
"C": "zero",
"A": "one",
"B": "two",
"D": "sufficient test cases"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This criteria requires sufficient test cases for all program loops to be executed for zero, ____, two, and many iterations covering initialization, typical running and termination (boundary) conditions.",
"reference": "This criteria requires sufficient test cases for all program loops to be executed for zero, one, two, and many iterations covering initialization, typical running and termination (boundary) conditions.",
"options": {
"B": "one",
"A": "zero",
"C": "two",
"D": "sufficient test cases"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 5 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Page 2General Principles of Software Validation Guidance for Industry and FDA Staff
In that case, the party with regulatory responsibility (i.e., the device manufacturer) needs to assess the adequacy of the off-the-shelf software developers activities and determine what additional efforts are needed to establish that the software is validated for the device manufacturers intended use. This guidance applies to: Software used as a component, part, or accessory of a medical device; Software that is itself a medical device (e.g., blood establishment software);
Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record). This document is based on generally recognized software validation principles and, therefore, can be applied to any software. For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy. This document does not specifically identify which software is or is not regulated. This guidance provides useful information and recommendations to the following individuals:
Persons subject to the medical device Quality System regulat ion Persons responsible for the design, development, or production of medical device software Persons responsible for the design, development, production, or procurement of automated tools used for the design, development, or manufacture of medical devices or software tools used to implement the quality system itself FDA Investigators FDA Compliance Officers FDA Scientific Reviewers 2.3. THE LEAST BURDENSOME APPROACH We believe we should consider the least burdensome approach in all areas of medical device regulation.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'For FDA purposes, this guidance applies to any sof...'?",
"reference": "For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy.",
"options": {
"D": "FDA",
"A": "Software",
"B": "medical device software Persons",
"C": "medical devices or software tools"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For FDA purposes, this guidance applies to any sof...'?",
"reference": "For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy.",
"options": {
"D": "the Federal Food, Drug",
"A": "FDA",
"B": "Software",
"C": "medical device software Persons"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For FDA purposes, this guidance applies to any sof...'?",
"reference": "For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy.",
"options": {
"A": "FDA",
"B": "Software",
"C": "medical device software Persons",
"D": "medical devices or software tools"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'THE LEAST BURDENSOME APPROACH We believe we should...'?",
"reference": "THE LEAST BURDENSOME APPROACH We believe we should consider the least burdensome approach in all areas of medical device regulation.",
"options": {
"C": "THE LEAST BURDENSOME APPROACH",
"A": "FDA",
"B": "Software",
"D": "medical device software Persons"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance applies to: Software used as a comp...'?",
"reference": "This guidance applies to: Software used as a component, part, or accessory of a medical device; Software that is itself a medical device (e.g., blood establishment software);\nSoftware used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record).",
"options": {
"C": "Software",
"A": "FDA",
"B": "a regulated medical device",
"D": "medical device regulation"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 3 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
CONTEXT FOR SOFTWARE VALIDATION ................................
...................
Definitions and Terminology ................................ ................................
.............................
5 3.1.1 Requirements and Specifications ................................ ................................
...................
5 3.1.2 Verification and Validation ................................ ................................
........................... 6 3.1.3 IQ/OQ/PQ ................................ ................................
................................ ......................
Software Development as Part of System Design ................................ ............................
Software is Different from Hardware ................................ ................................
................ 8 3.4. Benefits of Software Validation ................................
................................ .........................
9 3.5 Design Review ................................ ................................ ................................
...................
PRINCIPLES OF SOFTWARE VALIDATION ................................ Requirements ................................ ................................ ................................
................... Defect Prevention ................................
................................ ................................
............ 11 4.3. Time and Effort ................................ ................................ ................................
................ 11 4.4. Software Life Cycle ................................ ................................ ................................
Plans ................................ ................................ ................................
................................ ..12 4.6.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Defect Prevention ...................................'?",
"reference": "Defect Prevention ................................\n................................ ................................\n............ 11 4.3.",
"options": {
"A": "Defect Prevention",
"B": "Software Development as Part of System Design",
"C": "Software",
"D": "Software Validation"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Defect Prevention ................................\n................................ ................................\n............ ____ 4.3.",
"reference": "Defect Prevention ................................\n................................ ................................\n............ 11 4.3.",
"options": {
"C": "11",
"A": "6 3.1.3",
"B": "8 3.4",
"D": "Software Validation"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Defect Prevention ................................\n................................ ................................\n............ 11 ____.",
"reference": "Defect Prevention ................................\n................................ ................................\n............ 11 4.3.",
"options": {
"D": "4.3",
"A": "6 3.1.3",
"B": "8 3.4",
"C": "Software Validation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 15 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)
http://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443. 6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html . U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Resear ch (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharm aceutical CGMPs TABLE OF CONTENTS I.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "When did this occur: '6597 Internt'l Staff Phone: 301.827.3993 or Center...'?",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"A": "6597",
"B": "August 2003",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"D": "Health and Human Services Food and Drug Administration Center"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '6597 Internt'l Staff Phone: 301.827.3993 or Center...'?",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"B": "Center for Food Safety and Applied Nutrition",
"A": "Electronic Records",
"C": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"C": "6597",
"A": "August 2003",
"B": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"D": "Health and Human Services Food and Drug Administration Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 6597 Internt'l Staff Phone: ____ or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"D": "301.827.3993",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"B": "Health and Human Services Food and Drug Administration Center",
"C": "6597"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"D": "Electronic Records",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"B": "Health and Human Services Food and Drug Administration Center",
"C": "Electronic Signatures Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"D": "Electronic Signatures Scope",
"A": "Tel",
"B": "Training",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"D": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"A": "Electronic Records",
"B": "Office of Regulatory Affairs",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"C": "Office of Regulatory Affairs",
"A": "Electronic Records",
"B": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"B": "ORA",
"A": "Electronic Records",
"C": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"D": "August 2003",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"B": "Health and Human Services Food and Drug Administration Center",
"C": "Electronic Records"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"D": "Electronic Records",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"B": "Health and Human Services Food and Drug Administration Center",
"C": "Electronic Signatures Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"B": "Electronic Signatures Scope",
"A": "Tel",
"C": "Training",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"A": "HFD -240 Center for Drug Evaluation and Research",
"B": "Electronic Records",
"C": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"B": "Tel",
"A": "Electronic Signatures Scope",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"D": "Health and Human Services Food and Drug Administration Center"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"C": "http://www.fda.gov/cder/guidance/index.htm or",
"A": "Electronic Signatures Scope",
"B": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"D": "Health and Human Services Food and Drug Administration Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 3 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Quality Risk Management: A systematic process for the assessment, control, communication, and review of risks to the quali ty of the drug (medicinal) pro duct across the product lifecycle. (ICH Q9) Senior Management: Person(s) who direct and control a co mpany or site at the highest levels with the authority and responsibil ity to mobilize resources within the company or site. (ICH Q10 based in part on ISO 9000:2005) 16 State of Control: A condition in which the set of controls consisten tly provides assurance of continued process performance and product quality. 17 Annex I: Potential Opportunities To Enhance Science- and Risk-Based Regulatory Approaches Note: This annex reflects pot ential opportunities to enhance regul atory approaches. The actual regulatory process will be determined by region. Potential Opportunity 1. Comply with GMPs Compliance status quo 2. Demonstrate effective Opportunity to: pharmaceutical quality system, increase use of risk-based including effective use of quality approaches for regulatory risk management principles (e.g., inspections ICH Q9 and ICH Q10). 3. Demonstrate product and process understanding, including effective use of quality risk management principles (e.g., ICH Q8 and ICH Q9). Opportunity to: facilitate science-based pharmaceutical quality assessment enable innovative approaches to process validation establish real-time release mechanisms 4. Demonstrate effective pharmaceutical quality system and product and process understanding, including the use of quality risk management principles (e.g., ICH Q8, ICH Q9, and ICH Q10). Opportunity to: increase use of risk-based approaches for regulatory inspections; facilitate science-based pharmaceutical quality assessment; optimize science- and risk-based postapproval change processes to maximize benefits from innovation and continual improvement; enable innovative approaches to process validation; establish real-time release mechanisms.
[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: '17 Annex I: Potential Opportunities To Enhance Sci...'?",
"reference": "17 Annex I: Potential Opportunities To Enhance Science- and Risk-Based Regulatory Approaches Note: This annex reflects pot ential opportunities to enhance regul atory approaches.",
"options": {
"D": "Risk-Based Regulatory Approaches Note",
"A": "Quality Risk Management:",
"B": "ISO 9000:2005",
"C": "quality risk management principles"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Annex I: Potential Opportunities To Enhance Science- and Risk-Based Regulatory Approaches Note: This annex reflects pot ential opportunities to enhance regul atory approaches.",
"reference": "17 Annex I: Potential Opportunities To Enhance Science- and Risk-Based Regulatory Approaches Note: This annex reflects pot ential opportunities to enhance regul atory approaches.",
"options": {
"D": "17",
"A": "quality risk management principles",
"B": "XVII",
"C": "seventeen"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Opportunity to: facilitate science-based pharmaceutical quality assessment enable innovative approaches to process validation establish real-time release mechanisms ____.",
"reference": "Opportunity to: facilitate science-based pharmaceutical quality assessment enable innovative approaches to process validation establish real-time release mechanisms 4.",
"options": {
"B": "4",
"A": "quality risk management principles",
"C": "quaternity",
"D": "quadruplet"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 4 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
II. PHARMACEUTICAL QUAL ITY MANAGEMENT SYSTEM A. Scope (1.2) This guidance applies to the systems s upporting the development and manufacture of pharmaceutical drug substances (i.e., active pharmaceutical ingredients (APIs)) and drug products, including biotechnology a nd biological products, throughout the product lifecycle. The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle st ages, recognizing the differences among, and the different goals of, each stage (see section IV (3)). For the purposes of this guidan ce, the product lifecycle includes the following technical activities for new and existing products: Pharmaceutical Development o Drug substance development o Formulation development (includi ng container/closure system)
Manufacture of investigational products o Delivery system development (where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers during deve lopment through manufacturing o Transfers within or between manufacturing and testing sites for marketed products Commercial Manufacturing o Acquisition and control of materials o Provision of facilities, utilities, and equipment o Production (including pack aging and labeling) o
Quality control and assurance o Release o Storage 2 o Distribution (excluding wholesaler activities)
Product Discontinuation o Retention of documentation o Sample retention o Continued product assessment and reporting B. Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards, and ICH Q7 (1.3) Regional GMP requirements, the ICH guidance Q7 Good Manufacturing Pr actice Guidance for Active Pharmaceutical Ingredients, and ISO qua lity management system guidelines form the foundation for ICH Q10. To meet the objectives described below, ICH Q10 augments GMPs by describing specific quality system elements and management responsibilities.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'To meet the objectives described below, ICH Q10 au...'?",
"reference": "To meet the objectives described below, ICH Q10 augments GMPs by describing specific quality system elements and management responsibilities.",
"options": {
"A": "Q10",
"B": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To meet the objectives described below, ICH Q10 au...'?",
"reference": "To meet the objectives described below, ICH Q10 augments GMPs by describing specific quality system elements and management responsibilities.",
"options": {
"B": "Q10",
"A": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers",
"C": "Pharmaceutical Development o Drug substance development o Formulation development",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For the purposes of this guidan ce, the product li...'?",
"reference": "For the purposes of this guidan ce, the product lifecycle includes the following technical activities for new and existing products: Pharmaceutical Development o Drug substance development o Formulation development (includi ng container/closure system)\nManufacture of investigational products o Delivery system development (where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers during deve lopment through manufacturing o Transfers within or between manufacturing and testing sites for marketed products Commercial Manufacturing o Acquisition and control of materials o Provision of facilities, utilities, and equipment o Production (including pack aging and labeling) o\nQuality control and assurance o Release o Storage 2 o Distribution (excluding wholesaler activities)\nProduct Discontinuation o Retention of documentation o Sample retention o Continued product assessment and reporting B.",
"options": {
"A": "Pharmaceutical Development o Drug",
"B": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"C": "ICH Q10",
"D": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For the purposes of this guidan ce, the product li...'?",
"reference": "For the purposes of this guidan ce, the product lifecycle includes the following technical activities for new and existing products: Pharmaceutical Development o Drug substance development o Formulation development (includi ng container/closure system)\nManufacture of investigational products o Delivery system development (where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers during deve lopment through manufacturing o Transfers within or between manufacturing and testing sites for marketed products Commercial Manufacturing o Acquisition and control of materials o Provision of facilities, utilities, and equipment o Production (including pack aging and labeling) o\nQuality control and assurance o Release o Storage 2 o Distribution (excluding wholesaler activities)\nProduct Discontinuation o Retention of documentation o Sample retention o Continued product assessment and reporting B.",
"options": {
"A": "Commercial Manufacturing o Acquisition",
"B": "QUAL ITY MANAGEMENT SYSTEM A. Scope",
"C": "ICH Q10",
"D": "where relevant) o Manufacturing process development and scale-up o Analytical method development Technology Transfer o New product transfers"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
This applies to records generated and maintained on computerized systems, including electronic communications that support CGMP activities. For example, an email to authorize batch release is a CGMP record that FDA may review. You must allow authorized inspection, review, and copying of records , which includes copying of electronic data ( 211.180(c) and 212.110(a) and (b) ). See also the guidance for industry Circumstances that Constitut e Delaying, Denying, Limiting, or Refusing a Drug Inspection and section 704 of the FDC Act. Procedures governing the review of electronic records are described in chapter 5 of the Investigations Operations Manual (IOM) at https://www.fda.gov/iceci/inspections/iom/default.htm . How does FDA recommend data integrity problems be addressed ? FDA encourages you to demonstrate that you have effectively remedi ated your problems by investigating to determine the problem s scope and root cause s, conduc ting a scientifically sound risk assessment of its potential effects (including impact on data used to support submissions to Contains Nonbinding Recommendations 13 FDA) , and implementing a management strategy , including a global corrective action plan that addresses the root causes . This may include retaining a third -party auditor and removing individuals responsible for data integrity lapses from positions where they can influence CGMP - related or drug application data at you r firm. It also may include improvements in quality oversight, enhanced computer systems, and creation of mechanisms to prevent recurrences and address data integrity breaches (e.g., anonymous reporting system , data governance officials and guidelines ). These expectations mirror those developed for the Application Integrity Policy. For more detailed information , see Points T o Consider for Internal Reviews and Corrective Action Operating Plans at http://www.fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/ucm134744.htm .
[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: 'See also the guidance for industry Circumstances t...'?",
"reference": "See also the guidance for industry Circumstances that Constitut e Delaying, Denying, Limiting, or Refusing a Drug Inspection and section 704 of the FDC Act.",
"options": {
"C": "Refusing a Drug Inspection",
"A": "CGMP - related or drug application data",
"B": "data integrity problems",
"D": "Denying, Limiting"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: See also the guidance for industry Circumstances that Constitut e Delaying, Denying, Limiting, or Refusing a Drug Inspection and section ____ of the FDC Act.",
"reference": "See also the guidance for industry Circumstances that Constitut e Delaying, Denying, Limiting, or Refusing a Drug Inspection and section 704 of the FDC Act.",
"options": {
"D": "704",
"A": "212.110(a",
"B": "CGMP - related or drug application data",
"C": "data integrity problems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For example, an email to authorize batch release i...'?",
"reference": "For example, an email to authorize batch release is a CGMP record that FDA may review.",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "Refusing a Drug Inspection",
"D": "data integrity problems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For example, an email to authorize batch release i...'?",
"reference": "For example, an email to authorize batch release is a CGMP record that FDA may review.",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "CGMP - related or drug application data",
"C": "data integrity problems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'How does FDA recommend data integrity problems be ...'?",
"reference": "How does FDA recommend data integrity problems be addressed ?",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "When did this occur: 'Procedures governing the review of electronic reco...'?",
"reference": "Procedures governing the review of electronic records are described in chapter 5 of the Investigations Operations Manual (IOM) at https://www.fda.gov/iceci/inspections/iom/default.htm .",
"options": {
"C": "https://www.fda.gov/iceci/inspections/iom/default.htm",
"A": "CGMP - related or drug application data",
"B": "data integrity problems",
"D": "chapter 5"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Procedures governing the review of electronic records are described in chapter ____ of the Investigations Operations Manual (IOM) at https://www.fda.gov/iceci/inspections/iom/default.htm .",
"reference": "Procedures governing the review of electronic records are described in chapter 5 of the Investigations Operations Manual (IOM) at https://www.fda.gov/iceci/inspections/iom/default.htm .",
"options": {
"B": "5",
"A": "212.110(a",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'See also the guidance for industry Circumstances t...'?",
"reference": "See also the guidance for industry Circumstances that Constitut e Delaying, Denying, Limiting, or Refusing a Drug Inspection and section 704 of the FDC Act.",
"options": {
"C": "Refusing a Drug Inspection",
"A": "CGMP - related or drug application data",
"B": "data integrity problems",
"D": "Denying, Limiting"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: See also the guidance for industry Circumstances that Constitut e Delaying, Denying, Limiting, or Refusing a Drug Inspection and section ____ of the FDC Act.",
"reference": "See also the guidance for industry Circumstances that Constitut e Delaying, Denying, Limiting, or Refusing a Drug Inspection and section 704 of the FDC Act.",
"options": {
"C": "704",
"A": "212.110(a",
"B": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'See also the guidance for industry Circumstances t...'?",
"reference": "See also the guidance for industry Circumstances that Constitut e Delaying, Denying, Limiting, or Refusing a Drug Inspection and section 704 of the FDC Act.",
"options": {
"A": "Refusing a Drug Inspection",
"B": "CGMP - related or drug application data",
"C": "data integrity problems",
"D": "Denying, Limiting"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'See also the guidance for industry Circumstances t...'?",
"reference": "See also the guidance for industry Circumstances that Constitut e Delaying, Denying, Limiting, or Refusing a Drug Inspection and section 704 of the FDC Act.",
"options": {
"D": "Refusing a Drug Inspection",
"A": "CGMP - related or drug application data",
"B": "data integrity problems",
"C": "Denying, Limiting"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: See also the guidance for industry Circumstances that Constitut e Delaying, Denying, Limiting, or Refusing a Drug Inspection and section ____ of the FDC Act.",
"reference": "See also the guidance for industry Circumstances that Constitut e Delaying, Denying, Limiting, or Refusing a Drug Inspection and section 704 of the FDC Act.",
"options": {
"C": "704",
"A": "212.110(a",
"B": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Procedures governing the review of electronic reco...'?",
"reference": "Procedures governing the review of electronic records are described in chapter 5 of the Investigations Operations Manual (IOM) at https://www.fda.gov/iceci/inspections/iom/default.htm .",
"options": {
"C": "https://www.fda.gov/iceci/inspections/iom/default.htm",
"A": "CGMP - related or drug application data",
"B": "data integrity problems",
"D": "chapter 5"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Procedures governing the review of electronic records are described in chapter ____ of the Investigations Operations Manual (IOM) at https://www.fda.gov/iceci/inspections/iom/default.htm .",
"reference": "Procedures governing the review of electronic records are described in chapter 5 of the Investigations Operations Manual (IOM) at https://www.fda.gov/iceci/inspections/iom/default.htm .",
"options": {
"B": "5",
"A": "212.110(a",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'See also the guidance for industry Circumstances t...'?",
"reference": "See also the guidance for industry Circumstances that Constitut e Delaying, Denying, Limiting, or Refusing a Drug Inspection and section 704 of the FDC Act.",
"options": {
"A": "Refusing a Drug Inspection",
"B": "CGMP - related or drug application data",
"C": "data integrity problems",
"D": "Denying, Limiting"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: See also the guidance for industry Circumstances that Constitut e Delaying, Denying, Limiting, or Refusing a Drug Inspection and section ____ of the FDC Act.",
"reference": "See also the guidance for industry Circumstances that Constitut e Delaying, Denying, Limiting, or Refusing a Drug Inspection and section 704 of the FDC Act.",
"options": {
"C": "704",
"A": "212.110(a",
"B": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Procedures governing the review of electronic reco...'?",
"reference": "Procedures governing the review of electronic records are described in chapter 5 of the Investigations Operations Manual (IOM) at https://www.fda.gov/iceci/inspections/iom/default.htm .",
"options": {
"A": "https://www.fda.gov/iceci/inspections/iom/default.htm",
"B": "CGMP - related or drug application data",
"C": "data integrity problems",
"D": "chapter 5"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Procedures governing the review of electronic records are described in chapter ____ of the Investigations Operations Manual (IOM) at https://www.fda.gov/iceci/inspections/iom/default.htm .",
"reference": "Procedures governing the review of electronic records are described in chapter 5 of the Investigations Operations Manual (IOM) at https://www.fda.gov/iceci/inspections/iom/default.htm .",
"options": {
"D": "5",
"A": "212.110(a",
"B": "CGMP - related or drug application data",
"C": "data integrity problems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'How does FDA recommend data integrity problems be ...'?",
"reference": "How does FDA recommend data integrity problems be addressed ?",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "What amount is specified: 'You must allow authorized inspection, review, and ...'?",
"reference": "You must allow authorized inspection, review, and copying of records , which includes copying of electronic data ( 211.180(c) and 212.110(a) and (b) ).",
"options": {
"B": "211.180(c",
"A": "212.110(a",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA encourages you to demonstrate that you have ef...'?",
"reference": "FDA encourages you to demonstrate that you have effectively remedi ated your problems by investigating to determine the problem s scope and root cause s, conduc ting a scientifically sound risk assessment of its potential effects (including impact on data used to support submissions to Contains Nonbinding Recommendations 13 FDA) , and implementing a management strategy , including a global corrective action plan that addresses the root causes .",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA encourages you to demonstrate that you have ef...'?",
"reference": "FDA encourages you to demonstrate that you have effectively remedi ated your problems by investigating to determine the problem s scope and root cause s, conduc ting a scientifically sound risk assessment of its potential effects (including impact on data used to support submissions to Contains Nonbinding Recommendations 13 FDA) , and implementing a management strategy , including a global corrective action plan that addresses the root causes .",
"options": {
"D": "Contains Nonbinding Recommendations 13 FDA",
"A": "CGMP",
"B": "CGMP - related or drug application data",
"C": "data integrity problems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA encourages you to demonstrate that you have effectively remedi ated your problems by investigating to determine the problem s scope and root cause s, conduc ting a scientifically sound risk assessment of its potential effects (including impact on data used to support submissions to Contains Nonbinding Recommendations ____ FDA) , and implementing a management strategy , including a global corrective action plan that addresses the root causes .",
"reference": "FDA encourages you to demonstrate that you have effectively remedi ated your problems by investigating to determine the problem s scope and root cause s, conduc ting a scientifically sound risk assessment of its potential effects (including impact on data used to support submissions to Contains Nonbinding Recommendations 13 FDA) , and implementing a management strategy , including a global corrective action plan that addresses the root causes .",
"options": {
"D": "13",
"A": "212.110(a",
"B": "CGMP - related or drug application data",
"C": "data integrity problems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'FDA encourages you to demonstrate that you have effectively ...'?",
"reference": "FDA encourages you to demonstrate that you have effectively remedi ated your problems by investigating to determine the problem s scope and root cause s, conduc ting a scientifically sound risk assessment of its potential effects (including impact on data used to support submissions to Contains Nonbinding Recommendations 13 FDA) , and implementing a management strategy , including a global corrective action plan that addresses the root causes .",
"options": {
"B": "FDA encourages you to demonstrate that you have effectively remedi ated your problems by investigati...",
"A": "CGMP",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'How does FDA recommend data integrity problems be ...'?",
"reference": "How does FDA recommend data integrity problems be addressed ?",
"options": {
"C": "FDA",
"A": "CGMP",
"B": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'This applies to records generated and maintained o...'?",
"reference": "This applies to records generated and maintained on computerized systems, including electronic communications that support CGMP activities.",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "Refusing a Drug Inspection",
"D": "data integrity problems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: 'You must allow authorized inspection, review, and ...'?",
"reference": "You must allow authorized inspection, review, and copying of records , which includes copying of electronic data ( 211.180(c) and 212.110(a) and (b) ).",
"options": {
"C": "211.180(c",
"A": "212.110(a",
"B": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For example, an email to authorize batch release i...'?",
"reference": "For example, an email to authorize batch release is a CGMP record that FDA may review.",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "Refusing a Drug Inspection",
"D": "data integrity problems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For example, an email to authorize batch release i...'?",
"reference": "For example, an email to authorize batch release is a CGMP record that FDA may review.",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "CGMP - related or drug application data",
"C": "data integrity problems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'These expectations mirror those developed for the ...'?",
"reference": "These expectations mirror those developed for the Application Integrity Policy.",
"options": {
"D": "the Application Integrity Policy",
"A": "CGMP",
"B": "CGMP - related or drug application data",
"C": "data integrity problems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Record Retention 298 299
The Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( 11.10 (c) and any corre sponding requirement in 11.30). Persons must still 302 comply with all applicable predicate rule requirements for record retention and availability (e.g., 303 211.180(c),(d), 108.25(g), and 108.35(h)). 304 305 We suggest that your decision on how to maintain recor ds be based on predicate rule 306 requirements and that you base your decision on a justified and documented risk assessment and 307 a determination of the value of the records over time. 308 309 FDA does not intend to object if you decide to archive required records i n electronic format to 310 nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file 311 format (examples of such formats include, but are not limited to, PDF, XML, or SGML). 312 Persons must still comply with all predicate rule r equirements, and the records themselves and 313 any copies of the required records should preserve their content and meaning. As long as 314 predicate rule requirements are fully satisfied and the content and meaning of the records are 315 preserved and archived, you can delete the electronic version of the records. In addition, paper 316 and electronic record and signature components can co -exist (i.e., a hybrid8 situation) as long as 317 predicate rule requirements are met and the content and meaning of those records are p reserved. 318 319 8 Examples of hybrid situations include combinations of paper records (or other nonelectronic media) and electronic records, paper records and electronic signatures, or handwritten sig natures executed to electronic records. Contains Nonbinding Recommendations 9 319 IV. REFERENCES 320 321 Food and Drug Administration References 322 323 1.
[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: 'Record Retention 298 299\nThe Agency intends to exe...'?",
"reference": "Record Retention 298 299\nThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( 11.10 (c) and any corre sponding requirement in 11.30).",
"options": {
"D": "Record Retention 298",
"A": "SGML",
"B": "required records i n electronic format",
"C": "electronic records"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Record Retention 298 299\nThe Agency intends to exe...'?",
"reference": "Record Retention 298 299\nThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( 11.10 (c) and any corre sponding requirement in 11.30).",
"options": {
"D": "Agency",
"A": "required records i n electronic format",
"B": "electronic records",
"C": "government agency"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Record Retention ____ 299\nThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( 11.10 (c) and any corre sponding requirement in 11.30).",
"reference": "Record Retention 298 299\nThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( 11.10 (c) and any corre sponding requirement in 11.30).",
"options": {
"A": "298",
"B": "300",
"C": "301",
"D": "required records i n electronic format"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Record Retention 298 ____\nThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( 11.10 (c) and any corre sponding requirement in 11.30).",
"reference": "Record Retention 298 299\nThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( 11.10 (c) and any corre sponding requirement in 11.30).",
"options": {
"A": "299",
"B": "300",
"C": "301",
"D": "required records i n electronic format"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Record Retention 298 299\nThe Agency intends to exercise enforcement discretion with regard to the part ____ requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( 11.10 (c) and any corre sponding requirement in 11.30).",
"reference": "Record Retention 298 299\nThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( 11.10 (c) and any corre sponding requirement in 11.30).",
"options": {
"B": "11",
"A": "300",
"C": "301",
"D": "required records i n electronic format"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Record Retention 298 299\nThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements ____ for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( 11.10 (c) and any corre sponding requirement in 11.30).",
"reference": "Record Retention 298 299\nThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( 11.10 (c) and any corre sponding requirement in 11.30).",
"options": {
"B": "300",
"A": "301",
"C": "11.10",
"D": "required records i n electronic format"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Record Retention 298 299\nThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records ____ retention period ( 11.10 (c) and any corre sponding requirement in 11.30).",
"reference": "Record Retention 298 299\nThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( 11.10 (c) and any corre sponding requirement in 11.30).",
"options": {
"D": "301",
"A": "300",
"B": "11.10",
"C": "required records i n electronic format"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Record Retention 298 299\nThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( ____ (c) and any corre sponding requirement in 11.30).",
"reference": "Record Retention 298 299\nThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( 11.10 (c) and any corre sponding requirement in 11.30).",
"options": {
"A": "11.10",
"B": "300",
"C": "301",
"D": "required records i n electronic format"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Record Retention 298 299\nThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( 11.10 (c) and any corre sponding requirement in ____).",
"reference": "Record Retention 298 299\nThe Agency intends to exercise enforcement discretion with regard to the part 11 requirements 300 for the protection of records to enable their accurate and ready retrieval throughout the records 301 retention period ( 11.10 (c) and any corre sponding requirement in 11.30).",
"options": {
"D": "11.30",
"A": "300",
"B": "301",
"C": "required records i n electronic format"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'REFERENCES 320 321 Food and Drug Administration Re...'?",
"reference": "REFERENCES 320 321 Food and Drug Administration References 322 323 1.",
"options": {
"B": "REFERENCES",
"A": "Agency",
"C": "FDA",
"D": "required records i n electronic format"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '308 309 FDA does not intend to object if you decid...'?",
"reference": "308 309 FDA does not intend to object if you decide to archive required records i n electronic format to 310 nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file 311 format (examples of such formats include, but are not limited to, PDF, XML, or SGML).",
"options": {
"B": "FDA",
"A": "Agency",
"C": "PDF",
"D": "required records i n electronic format"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '308 309 FDA does not intend to object if you decid...'?",
"reference": "308 309 FDA does not intend to object if you decide to archive required records i n electronic format to 310 nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file 311 format (examples of such formats include, but are not limited to, PDF, XML, or SGML).",
"options": {
"A": "PDF",
"B": "Agency",
"C": "FDA",
"D": "required records i n electronic format"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '308 309 FDA does not intend to object if you decid...'?",
"reference": "308 309 FDA does not intend to object if you decide to archive required records i n electronic format to 310 nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file 311 format (examples of such formats include, but are not limited to, PDF, XML, or SGML).",
"options": {
"D": "XML",
"A": "Agency",
"B": "FDA",
"C": "required records i n electronic format"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: '308 309 FDA does not intend to object if you decid...'?",
"reference": "308 309 FDA does not intend to object if you decide to archive required records i n electronic format to 310 nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file 311 format (examples of such formats include, but are not limited to, PDF, XML, or SGML).",
"options": {
"B": "SGML",
"A": "Agency",
"C": "FDA",
"D": "required records i n electronic format"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 309 FDA does not intend to object if you decide to archive required records i n electronic format to 310 nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file 311 format (examples of such formats include, but are not limited to, PDF, XML, or SGML).",
"reference": "308 309 FDA does not intend to object if you decide to archive required records i n electronic format to 310 nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file 311 format (examples of such formats include, but are not limited to, PDF, XML, or SGML).",
"options": {
"B": "308",
"A": "300",
"C": "301",
"D": "required records i n electronic format"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 308 ____ FDA does not intend to object if you decide to archive required records i n electronic format to 310 nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file 311 format (examples of such formats include, but are not limited to, PDF, XML, or SGML).",
"reference": "308 309 FDA does not intend to object if you decide to archive required records i n electronic format to 310 nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file 311 format (examples of such formats include, but are not limited to, PDF, XML, or SGML).",
"options": {
"A": "309",
"B": "300",
"C": "301",
"D": "required records i n electronic format"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 308 309 FDA does not intend to object if you decide to archive required records i n electronic format to ____ nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file 311 format (examples of such formats include, but are not limited to, PDF, XML, or SGML).",
"reference": "308 309 FDA does not intend to object if you decide to archive required records i n electronic format to 310 nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file 311 format (examples of such formats include, but are not limited to, PDF, XML, or SGML).",
"options": {
"C": "310",
"A": "300",
"B": "301",
"D": "required records i n electronic format"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 308 309 FDA does not intend to object if you decide to archive required records i n electronic format to 310 nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file ____ format (examples of such formats include, but are not limited to, PDF, XML, or SGML).",
"reference": "308 309 FDA does not intend to object if you decide to archive required records i n electronic format to 310 nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file 311 format (examples of such formats include, but are not limited to, PDF, XML, or SGML).",
"options": {
"A": "311",
"B": "300",
"C": "301",
"D": "required records i n electronic format"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Persons must still comply with all predicate rule r equirements, and the records themselves and 313 any copies of the required records should preserve their content and meaning.",
"reference": "312 Persons must still comply with all predicate rule r equirements, and the records themselves and 313 any copies of the required records should preserve their content and meaning.",
"options": {
"D": "312",
"A": "300",
"B": "301",
"C": "required records i n electronic format"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 312 Persons must still comply with all predicate rule r equirements, and the records themselves and ____ any copies of the required records should preserve their content and meaning.",
"reference": "312 Persons must still comply with all predicate rule r equirements, and the records themselves and 313 any copies of the required records should preserve their content and meaning.",
"options": {
"A": "313",
"B": "300",
"C": "301",
"D": "required records i n electronic format"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 4 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
In this example, the manufacturer has 531 established additional process controls and inspections that ensure non -conform ing product is not 532 released. In this case, failure of the spreadsheet to perform as intended would not result in a 533 quality problem that foreseeably leads to compromised safety, so the spre adsheet would not pose 534 a high process risk. The manufacturer conducted rapid exploratory testing of specific functions 535 used in the spreadsheet to ensure that analyses can be created, read, updated, and/or deleted. During exploratory testing, all calculated fields updated correctly except for one deviation that 537 occurred during update testing. In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system. Because of this use, the spreadsheet is 542 different from similar software used for business operations such as for accounting. 543 544 Risk-Based Analysis: In this case, the software is only used to collect and display data 545 for monitoring nonconformances , and the manufacturer has established additional process 546 controls and inspections to ensure that nonconform ing product is not released. Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety. As such, the software does not pose a high 549 process risk, and the assurance activities should be commensurate with the process risk .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: In this scenario, the record would be documented as follows: ____ 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"reference": "In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"options": {
"C": "538",
"A": "531",
"B": "532",
"D": "a high 549 process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this scenario, the record would be documented as follows: 538 ____ Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"reference": "In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"options": {
"C": "539",
"A": "531",
"B": "532",
"D": "a high 549 process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing ____ nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"reference": "In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"options": {
"C": "540",
"A": "531",
"B": "532",
"D": "a high 549 process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is ____ used as part of production or the quality system.",
"reference": "In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"options": {
"C": "541",
"A": "531",
"B": "532",
"D": "a high 549 process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 4 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Quality by Design and Product Development Quality by design means designing and developing a pr oduct and associated manufacturing processes that will be used during product develo pment to ensure that the product consistently attains a predefined quality at th e end of the manufacturing process.5 Quality by design, in conjunction with a quality system, provides a sound framework for the transfer of product knowledge and process understand ing from drug development to the commercial manufacturing processes and for post-development changes and optimization. The CGMP regulations, when 5 See ICH-Q8 Pharmaceutical Development. 4 Contains Nonbinding Recommendations viewed in their entirety, inco rporate the concept of quality by design. This guidance describes how these elements fit together. C. Quality Risk Management Quality risk management is a valuable component of an effective quality systems framework.6
Quality risk management can, for example, help guide the setting of specifications and process parameters for drug manufacturing, assess and mitigate the risk of changing a process or specification, and determine the ex tent of discrepancy investiga tions and corrective actions. D. CAPA (Corrective and Preventive Action) CAPA is a well-known CGMP regulatory concept that focuses on investigating, understanding, and correcting discrepancies while attemp ting to prevent their recurrence. Quality system models discuss CAPA as three separate concepts, all of whic h are used in this guidance. Remedial corrections of an identified problem Root cause analysis with co rrective action to help understa nd the cause of the deviation and potentially prevent recu rrence of a similar problem Preventive action to avert recurrence of a similar potential pro blem E. Change Control Change control is another well-known CGMP concept that focuses on managing change to prevent unintended consequences.
[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: 'Quality by Design and Product Development Quality ...'?",
"reference": "Quality by Design and Product Development Quality by design means designing and developing a pr oduct and associated manufacturing processes that will be used during product develo pment to ensure that the product consistently attains a predefined quality at th e end of the manufacturing process.5 Quality by design, in conjunction with a quality system, provides a sound framework for the transfer of product knowledge and process understand ing from drug development to the commercial manufacturing processes and for post-development changes and optimization.",
"options": {
"C": "develo",
"A": "C. Quality Risk Management Quality risk management",
"B": "an effective quality systems framework.6\nQuality risk management",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations, when 5 See ICH-Q8 Pharmaceut...'?",
"reference": "The CGMP regulations, when 5 See ICH-Q8 Pharmaceutical Development.",
"options": {
"B": "CGMP",
"A": "C. Quality Risk Management Quality",
"C": "Preventive Action",
"D": "C. Quality Risk Management Quality risk management"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: The CGMP regulations, when ____ See ICH-Q8 Pharmaceutical Development.",
"reference": "The CGMP regulations, when 5 See ICH-Q8 Pharmaceutical Development.",
"options": {
"D": "5",
"A": "three",
"B": "C. Quality Risk Management Quality risk management",
"C": "an effective quality systems framework.6\nQuality risk management"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Remedial corrections of an identified problem Root...'?",
"reference": "Remedial corrections of an identified problem Root cause analysis with co rrective action to help understa nd the cause of the deviation and potentially prevent recu rrence of a similar problem Preventive action to avert recurrence of a similar potential pro blem E. Change Control Change control is another well-known CGMP concept that focuses on managing change to prevent unintended consequences.",
"options": {
"C": "Root",
"A": "C. Quality Risk Management Quality risk management",
"B": "an effective quality systems framework.6\nQuality risk management",
"D": "rootle"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
However, testing a software product only with expected, valid inputs does not thoroughly test that software product. By itself, normal case testing cannot provide sufficient confidence in the dependability of the software product. Output Forcing Choosing test inputs to ensure that selected (or all) software outputs are generated by testing. Robustness Software testing should demonstrate that a software product behaves correctly when given unexpected, invalid inputs. Methods for identifying a sufficient set of such test cases include Equivalence Class Partitioning, Boundary Value Analysis, and Special Case Identification (Error Guessing). While important and necessary, these techniques do not ensure that all of the most appropriate challenges to a software product have been identified for testing. Combinations of Inputs The functional testing methods identified above all emphasize individual or single test inputs. Most software products operate with multiple inputs under their conditions of use. Thorough software product testing should consider the combinations of inputs a software unit or system may encounter during operation. Error guessing can be extended to identify combinations of inputs, but it is an ad hoc technique. Cause-effect graphing is one functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases. Functional and structural software test case identification techniques provide specific inputs for testing, rather than random test inputs. One weakness of these techniques is the difficulty in linking structural and functional test completion criteria to a software product's reliability. Advanced software testing methods, such as statistical testing, can be employed to provide further assurance that a software product is dependable.
[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: Cause-effect graphing is ____ functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"reference": "Cause-effect graphing is one functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"options": {
"D": "one",
"A": "One",
"B": "Thorough software product testing",
"C": "Functional and structural software test case identification techniques"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Methods for identifying a sufficient set of such t...'?",
"reference": "Methods for identifying a sufficient set of such test cases include Equivalence Class Partitioning, Boundary Value Analysis, and Special Case Identification (Error Guessing).",
"options": {
"A": "Boundary Value Analysis",
"B": "Software",
"C": "Combinations of Inputs",
"D": "Thorough software product testing"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Methods for identifying a sufficient set of such t...'?",
"reference": "Methods for identifying a sufficient set of such test cases include Equivalence Class Partitioning, Boundary Value Analysis, and Special Case Identification (Error Guessing).",
"options": {
"D": "Boundary Value Analysis",
"A": "Software",
"B": "Combinations of Inputs",
"C": "Thorough software product testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Combinations of Inputs The functional testing met...'?",
"reference": "Combinations of Inputs The functional testing methods identified above all emphasize individual or single test inputs.",
"options": {
"D": "Combinations of Inputs The",
"A": "Software",
"B": "Boundary Value Analysis",
"C": "Thorough software product testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Combinations of Inputs The functional testing met...'?",
"reference": "Combinations of Inputs The functional testing methods identified above all emphasize individual or single test inputs.",
"options": {
"B": "Combinations of Inputs The",
"A": "Software",
"C": "Boundary Value Analysis",
"D": "Thorough software product testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ weakness of these techniques is the difficulty in linking structural and functional test completion criteria to a software product's reliability.",
"reference": "One weakness of these techniques is the difficulty in linking structural and functional test completion criteria to a software product's reliability.",
"options": {
"D": "One",
"A": "one",
"B": "Thorough software product testing",
"C": "Functional and structural software test case identification techniques"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robustness Software testing should demonstrate th...'?",
"reference": "Robustness Software testing should demonstrate that a software product behaves correctly when given unexpected, invalid inputs.",
"options": {
"B": "Software",
"A": "Boundary Value Analysis",
"C": "Combinations of Inputs",
"D": "Inputs The functional testing methods"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ weakness of these techniques is the difficulty in linking structural and functional test completion criteria to a software product's reliability.",
"reference": "One weakness of these techniques is the difficulty in linking structural and functional test completion criteria to a software product's reliability.",
"options": {
"A": "One",
"B": "one",
"C": "Thorough software product testing",
"D": "Functional and structural software test case identification techniques"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Methods for identifying a sufficient set of such t...'?",
"reference": "Methods for identifying a sufficient set of such test cases include Equivalence Class Partitioning, Boundary Value Analysis, and Special Case Identification (Error Guessing).",
"options": {
"D": "Boundary Value Analysis",
"A": "Software",
"B": "Combinations of Inputs",
"C": "Thorough software product testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
These data integrity -related CGMP violations have led to 41 1 This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluatio n and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and t he Office of Regulatory Affairs at the Food and Drug Administration. Contains Nonbinding Recommendations Draft Not for Implementation 2 numerous regulatory actio ns, including warning letters, import alerts , and consent decrees . The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ). 57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: '57 58 Electronic signature and record -keeping req...'?",
"reference": "57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"options": {
"D": "CFR",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "These data integrity -related CGMP violations"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"reference": "57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"options": {
"A": "57",
"B": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 57 ____ Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"reference": "57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"options": {
"C": "58",
"A": "41 1",
"B": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 57 58 Electronic signature and record -keeping requirements are laid out in ____ CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"reference": "57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"options": {
"A": "21",
"B": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part ____ and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"reference": "57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"options": {
"C": "11",
"A": "41 1",
"B": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to ____ certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"reference": "57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"options": {
"A": "59",
"B": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts ____ 210, 211, and 212.",
"reference": "57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"options": {
"D": "60",
"A": "41 1",
"B": "210.1",
"C": "These data integrity -related CGMP violations"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 ____, 211, and 212.",
"reference": "57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"options": {
"C": "210",
"A": "41 1",
"B": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, ____, and 212.",
"reference": "57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"options": {
"A": "211",
"B": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and ____.",
"reference": "57 58 Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to 59 certain records subject to records requirements set forth in A gency regulations, including parts 60 210, 211, and 212.",
"options": {
"B": "212",
"A": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"A": "CGMP",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "records requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"B": "the Federal Food, Drug",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"C": "44",
"A": "41 1",
"B": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"C": "al l",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The ____ underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"D": "42",
"A": "41 1",
"B": "210.1",
"C": "These data integrity -related CGMP violations"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 42 underlying premise in ____ and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"B": "210.1",
"A": "41 1",
"C": "212.2",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 42 underlying premise in 210.1 and ____ is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"D": "212.2",
"A": "41 1",
"B": "210.1",
"C": "These data integrity -related CGMP violations"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to ____ assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"C": "43",
"A": "41 1",
"B": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) ____ regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"B": "44",
"A": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data ____ integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"A": "45",
"B": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"A": "CGMP",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "records requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"B": "the Federal Food, Drug",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"A": "44",
"B": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The 42 underlying premise in 210.1 and 212.2 is t...'?",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"B": "al l",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The ____ underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"C": "42",
"A": "41 1",
"B": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 42 underlying premise in ____ and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"C": "210.1",
"A": "41 1",
"B": "212.2",
"D": "These data integrity -related CGMP violations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 42 underlying premise in 210.1 and ____ is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"A": "212.2",
"B": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to ____ assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"B": "43",
"A": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) ____ regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"B": "44",
"A": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data ____ integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"reference": "The 42 underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to 43 assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FDC Act) 44 regarding safety, identity, strength, quality, and purity.2 Requirements with respect to data 45 integrity in parts 211 and 212 include , among other things : 46 47 211.68 (requiring that backup data are exact and complete, and secure from 48 alteration, inadvertent erasures, or loss ); 49 212.110(b) (requiring that data be stored to prevent deterioration or loss ); 50 211.100 and 211.160 ( requiring that certain activities be documented at the time 51 of performance and that laboratory controls be scientifically sou nd); 52 211.180 ( requiring that records be retained as original records , true copies , or 53 other accurate reproductions of the original records) ; and 54 211.188, 211.194, and 212.60( g) (requiring complete information, complete 55 data derived from al l tests , complete record of all data, and complete records of 56 all tests performed ).",
"options": {
"A": "45",
"B": "41 1",
"C": "210.1",
"D": "These data integrity -related CGMP violations"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 5 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
On the other hand, when 166 persons use computers to generate paper printouts of electronic records, and those paper records 167 meet all the requirements of the applicable predicate rules and persons rely on the paper records 168 to perform their regulated activities, FDA would generally not co nsider persons to be "using 169 electronic records in lieu of paper records" under 11.2(a) and 11.2(b). In these instances, the 170 use of computer systems in the generation of paper records would not trigger part 11. Definition of Part 11 Records 173 174 Under this narrow interpretation, FDA considers part 11 to be applicable to the following records 175 or signatures in electronic format (part 11 records or signatures): 176 177 Records that are required to be maintained under predicate rule requirements and that are 178 maintained in electronic format in place of paper format . On the other hand, records (and 179 any associated signatures) that are not required to be retained under predicate rules, but 180 that are nonetheless maintained in electronic format, are not part 11 records . We recommend that you determine, based on the predicate rules, whether specific records 182 are part 11 records. We recommend that you document such decisions. 183 184 Records that are required to be maintained under predicate rules, that are maintained in 185 electro nic format in addition to paper format, and that are relied on to perform regulated 186 activities . In some cases, actual business practices may dictate whether you are using electronic 188 records instead of paper records under 11.2(a). For example, if a reco rd is required to 189 be maintained under a predicate rule and you use a computer to generate a paper printout 190 of the electronic records, but you nonetheless rely on the electronic record to perform 191 regulated activities, the Agency may consider you to be using the electronic record 192 instead of the paper record.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: ____ 184 Records that are required to be maintained under predicate rules, that are maintained in 185 electro nic format in addition to paper format, and that are relied on to perform regulated 186 activities .",
"reference": "183 184 Records that are required to be maintained under predicate rules, that are maintained in 185 electro nic format in addition to paper format, and that are relied on to perform regulated 186 activities .",
"options": {
"B": "183",
"A": "166",
"C": "167",
"D": "those paper records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 183 ____ Records that are required to be maintained under predicate rules, that are maintained in 185 electro nic format in addition to paper format, and that are relied on to perform regulated 186 activities .",
"reference": "183 184 Records that are required to be maintained under predicate rules, that are maintained in 185 electro nic format in addition to paper format, and that are relied on to perform regulated 186 activities .",
"options": {
"C": "184",
"A": "166",
"B": "167",
"D": "those paper records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 183 184 Records that are required to be maintained under predicate rules, that are maintained in ____ electro nic format in addition to paper format, and that are relied on to perform regulated 186 activities .",
"reference": "183 184 Records that are required to be maintained under predicate rules, that are maintained in 185 electro nic format in addition to paper format, and that are relied on to perform regulated 186 activities .",
"options": {
"A": "185",
"B": "166",
"C": "167",
"D": "those paper records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 183 184 Records that are required to be maintained under predicate rules, that are maintained in 185 electro nic format in addition to paper format, and that are relied on to perform regulated ____ activities .",
"reference": "183 184 Records that are required to be maintained under predicate rules, that are maintained in 185 electro nic format in addition to paper format, and that are relied on to perform regulated 186 activities .",
"options": {
"A": "186",
"B": "166",
"C": "167",
"D": "those paper records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: On the other hand, records (and ____ any associated signatures) that are not required to be retained under predicate rules, but 180 that are nonetheless maintained in electronic format, are not part 11 records .",
"reference": "On the other hand, records (and 179 any associated signatures) that are not required to be retained under predicate rules, but 180 that are nonetheless maintained in electronic format, are not part 11 records .",
"options": {
"C": "179",
"A": "166",
"B": "167",
"D": "those paper records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 15 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
In this example, the manufacturer has 531 established additional process controls and inspections that ensure non -conform ing product is not 532 released. In this case, failure of the spreadsheet to perform as intended would not result in a 533 quality problem that foreseeably leads to compromised safety, so the spre adsheet would not pose 534 a high process risk. The manufacturer conducted rapid exploratory testing of specific functions 535 used in the spreadsheet to ensure that analyses can be created, read, updated, and/or deleted. During exploratory testing, all calculated fields updated correctly except for one deviation that 537 occurred during update testing. In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system. Because of this use, the spreadsheet is 542 different from similar software used for business operations such as for accounting. 543 544 Risk-Based Analysis: In this case, the software is only used to collect and display data 545 for monitoring nonconformances , and the manufacturer has established additional process 546 controls and inspections to ensure that nonconform ing product is not released. Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety. As such, the software does not pose a high 549 process risk, and the assurance activities should be commensurate with the process risk .
[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: As such, the software does not pose a high ____ process risk, and the assurance activities should be commensurate with the process risk .",
"reference": "As such, the software does not pose a high 549 process risk, and the assurance activities should be commensurate with the process risk .",
"options": {
"C": "549",
"A": "531",
"B": "532",
"D": "531 established additional process controls"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Because of this use, the spreadsheet is ____ different from similar software used for business operations such as for accounting.",
"reference": "Because of this use, the spreadsheet is 542 different from similar software used for business operations such as for accounting.",
"options": {
"A": "542",
"B": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Because of this use, the spreadsheet is 542 different from s...'?",
"reference": "Because of this use, the spreadsheet is 542 different from similar software used for business operations such as for accounting.",
"options": {
"B": "Because of this use, the spreadsheet is 542 different from similar software used for business operat...",
"A": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this case, failure of the spreadsheet to perform as intended would not result in a ____ quality problem that foreseeably leads to compromised safety, so the spre adsheet would not pose 534 a high process risk.",
"reference": "In this case, failure of the spreadsheet to perform as intended would not result in a 533 quality problem that foreseeably leads to compromised safety, so the spre adsheet would not pose 534 a high process risk.",
"options": {
"B": "533",
"A": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this case, failure of the spreadsheet to perform as intended would not result in a 533 quality problem that foreseeably leads to compromised safety, so the spre adsheet would not pose ____ a high process risk.",
"reference": "In this case, failure of the spreadsheet to perform as intended would not result in a 533 quality problem that foreseeably leads to compromised safety, so the spre adsheet would not pose 534 a high process risk.",
"options": {
"B": "534",
"A": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'In this case, failure of the spreadsheet to perform as inten...'?",
"reference": "In this case, failure of the spreadsheet to perform as intended would not result in a 533 quality problem that foreseeably leads to compromised safety, so the spre adsheet would not pose 534 a high process risk.",
"options": {
"A": "In this case, failure of the spreadsheet to perform as intended would not result in a 533 quality pr...",
"B": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this scenario, the record would be documented as follows: ____ 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"reference": "In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"options": {
"C": "538",
"A": "531",
"B": "532",
"D": "a high 549 process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this scenario, the record would be documented as follows: 538 ____ Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"reference": "In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"options": {
"C": "539",
"A": "531",
"B": "532",
"D": "a high 549 process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing ____ nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"reference": "In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"options": {
"C": "540",
"A": "531",
"B": "532",
"D": "a high 549 process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is ____ used as part of production or the quality system.",
"reference": "In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"options": {
"B": "541",
"A": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Therefore, ____ failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"reference": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"options": {
"D": "547",
"A": "531",
"B": "532",
"C": "a high 549 process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem ____ that foreseeably leads to compromised safety.",
"reference": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"options": {
"B": "548",
"A": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Therefore, 547 failure of the spreadsheet to perform as inte...'?",
"reference": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"options": {
"B": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality prob...",
"A": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Because of this use, the spreadsheet is ____ different from similar software used for business operations such as for accounting.",
"reference": "Because of this use, the spreadsheet is 542 different from similar software used for business operations such as for accounting.",
"options": {
"A": "542",
"B": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Because of this use, the spreadsheet is 542 different from s...'?",
"reference": "Because of this use, the spreadsheet is 542 different from similar software used for business operations such as for accounting.",
"options": {
"B": "Because of this use, the spreadsheet is 542 different from similar software used for business operat...",
"A": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Maintenance and Software Changes ................................ ................................ .........
VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE ................................
................................ ................................
................
How Much Validation Evidence Is Needed? ................................
................................ ..31 6.2. Defined User Requirements ................................ ................................ ............................
Validation of Off-the-Shelf Software and Automated Equipment ................................
..33 APPENDIX A - REFERENCES ................................
................................
................................ . 35 Food and Drug Administration References ................................ ................................ ............
35 Other Government References ................................ ................................
...............................
36 International and National Consensus Standards ................................
................................ ..
37 Production Process Software References ................................ ................................ ...............
38 General Software Quality References ................................ ................................ ....................
39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................
................
43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation
This document is intended to provide guidance. It represents the Agencys current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: ................................\n................................ ..____ 6.2.",
"reference": "................................\n................................ ..31 6.2.",
"options": {
"C": "31",
"A": "Software Validation Guidance",
"B": "...............\n38 General Software Quality References",
"D": "xxxi"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ................................\n................................ ..31 ____.",
"reference": "................................\n................................ ..31 6.2.",
"options": {
"C": "6.2",
"A": "Software Validation Guidance",
"B": "...............\n38 General Software Quality References",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '35 Food and Drug Administration References ..........'?",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"C": "Food and Drug Administration",
"A": "Automated Equipment",
"B": "International",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '35 Food and Drug Administration References ..........'?",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"A": "International",
"B": "Software Validation Guidance",
"C": "...............\n38 General Software Quality References",
"D": "outside"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '35 Food and Drug Administration References ..........'?",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"B": "General Software Quality References",
"A": "Software Validation Guidance",
"C": "AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '35 Food and Drug Administration References ..........'?",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"C": "FDA",
"A": "Automated Equipment",
"B": "Food and Drug Administration",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"C": "35",
"A": "Software Validation Guidance",
"B": "...............\n38 General Software Quality References",
"D": "xxxv"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"B": "35",
"A": "Software Validation Guidance",
"C": "...............\n38 General Software Quality References",
"D": "xxxv"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n____ International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"B": "36",
"A": "Software Validation Guidance",
"C": "...............\n38 General Software Quality References",
"D": "xxxvi"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n____ Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"C": "37",
"A": "Software Validation Guidance",
"B": "...............\n38 General Software Quality References",
"D": "thirty-seven"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '35 Food and Drug Administration References ..........'?",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"D": "Food and Drug Administration",
"A": "Automated Equipment",
"B": "International",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '35 Food and Drug Administration References ..........'?",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"D": "International",
"A": "Software Validation Guidance",
"B": "...............\n38 General Software Quality References",
"C": "outside"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '35 Food and Drug Administration References ..........'?",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"C": "General Software Quality References",
"A": "Software Validation Guidance",
"B": "AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '35 Food and Drug Administration References ..........'?",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"A": "FDA",
"B": "Automated Equipment",
"C": "Food and Drug Administration",
"D": "Software Validation Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"C": "35",
"A": "Software Validation Guidance",
"B": "...............\n38 General Software Quality References",
"D": "xxxv"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"A": "35",
"B": "Software Validation Guidance",
"C": "...............\n38 General Software Quality References",
"D": "xxxv"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n____ International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"D": "36",
"A": "Software Validation Guidance",
"B": "...............\n38 General Software Quality References",
"C": "xxxvi"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n____ Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"C": "37",
"A": "Software Validation Guidance",
"B": "...............\n38 General Software Quality References",
"D": "thirty-seven"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n____ General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"D": "38",
"A": "Software Validation Guidance",
"B": "AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE",
"C": "xxxviii"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n____ APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"reference": "35 Food and Drug Administration References ................................ ................................ ............\n35 Other Government References ................................ ................................\n...............................\n36 International and National Consensus Standards ................................\n................................ ..\n37 Production Process Software References ................................ ................................ ...............\n38 General Software Quality References ................................ ................................ ....................\n39 APPENDIX B - DEVELOPMENT TEAM ................................ ................................\n................\n43 Page 1General Principles of Software Validation Guidance for Industry and FDA Staff General Principles of Software Validation\nThis document is intended to provide guidance.",
"options": {
"C": "39",
"A": "Software Validation Guidance",
"B": "...............\n38 General Software Quality References",
"D": "ixl"
},
"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]
Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)
http://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443. 6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html . U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Resear ch (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharm aceutical CGMPs TABLE OF CONTENTS I.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"D": "Electronic Records",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"B": "Health and Human Services Food and Drug Administration Center",
"C": "Electronic Signatures Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"D": "Electronic Signatures Scope",
"A": "Tel",
"B": "Training",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"D": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"A": "Electronic Records",
"B": "Office of Regulatory Affairs",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"D": "Office of Regulatory Affairs",
"A": "Electronic Records",
"B": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"A": "ORA",
"B": "Electronic Records",
"C": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"B": "August 2003",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"C": "Health and Human Services Food and Drug Administration Center",
"D": "Electronic Records"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"A": "Electronic Records",
"B": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"C": "Health and Human Services Food and Drug Administration Center",
"D": "Electronic Signatures Scope"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"C": "Electronic Signatures Scope",
"A": "Tel",
"B": "Training",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 8 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 Computer Software Assurance for Production and Quality System Software ______________________________________________________________________________
Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE
This draft guidance document is being distributed for comment purposes only. Document issued on September 13, 2022 . You should submit comments and suggestions regarding this draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to https://www.regulations.gov . Submit written comments to the Dockets Ma nagement Staff , Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA -305), Rockville, MD 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register . For questions about this document regarding CDRH -regulated devices , contact the Compliance and Quality Staff at 301 -796-5577 or by email at CaseforQualityfda.hhs.gov . For questions about this document regarding CBER -regulated dev ices, contact the Office of Communication, Outreach, and Development (OCOD) at 1 -800-835-4709 or 240 -402-8010, or by email at ocodfda.hhs.gov . U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Contains Nonbinding Recommendations Draft Not for Implementation Preface
Additional Copies CDRH Additional copies are available from the Internet. You may also send an email request to CDRH - Guidancefda.hhs.gov to receive a copy of the guidance. Please include the document number 17045 and complete title of the guidance in the request.
[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: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation Computer Software Assurance for Production and Quality System Software ______________________________________________________________________________\nDraft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE\nThis draft guidance document is being distributed for comment purposes only.",
"options": {
"B": "Draft Guidance for",
"A": "Fishers Lane",
"C": "-305",
"D": "This draft guidance document"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations Draft Not for ...'?",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation Computer Software Assurance for Production and Quality System Software ______________________________________________________________________________\nDraft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE\nThis draft guidance document is being distributed for comment purposes only.",
"options": {
"A": "Food and Drug Administration",
"B": "the Federal Register",
"C": "HFA",
"D": "This draft guidance document"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U.S. Department of Health and Human Services Food ...'?",
"reference": "U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Contains Nonbinding Recommendations Draft Not for Implementation Preface\nAdditional Copies CDRH Additional copies are available from the Internet.",
"options": {
"A": "U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation",
"B": "Food and Drug Administration",
"C": "the Federal Register",
"D": "This draft guidance document"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'You should submit comments and suggestions regardi...'?",
"reference": "You should submit comments and suggestions regarding this draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.",
"options": {
"D": "60 days",
"A": "September 13, 2022",
"B": "5630",
"C": "This draft guidance document"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'You should submit comments and suggestions regardi...'?",
"reference": "You should submit comments and suggestions regarding this draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.",
"options": {
"D": "the Federal Register",
"A": "Food and Drug Administration",
"B": "This draft guidance document",
"C": "Draft Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: You should submit comments and suggestions regarding this draft document within ____ days of publication in the Federal Register of the notice announcing the availability of the draft guidance.",
"reference": "You should submit comments and suggestions regarding this draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.",
"options": {
"B": "60",
"A": "301",
"C": "240",
"D": "This draft guidance document"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For questions about this document regarding CDRH -...'?",
"reference": "For questions about this document regarding CDRH -regulated devices , contact the Compliance and Quality Staff at 301 -796-5577 or by email at CaseforQualityfda.hhs.gov .",
"options": {
"B": "CDRH",
"A": "Food and Drug Administration",
"C": "the Federal Register",
"D": "This draft guidance document"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For questions about this document regarding CDRH -regulated devices , contact the Compliance and Quality Staff at ____ -796-5577 or by email at CaseforQualityfda.hhs.gov .",
"reference": "For questions about this document regarding CDRH -regulated devices , contact the Compliance and Quality Staff at 301 -796-5577 or by email at CaseforQualityfda.hhs.gov .",
"options": {
"A": "301",
"B": "240",
"C": "17045",
"D": "This draft guidance document"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 35 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance. Copies of Records 276 277 The Agency intend s to exercise enforcement discretion with regard to specific part 11 278 requirements for generating copies of records ( 11.10 (b) and any corresponding requirement in 279 11.30). You should provide an investigator with reasonable and useful access to records d uring 280 an inspection. All records held by you are subject to inspection in accordance with predicate 281 rules (e.g., 211.180(c), (d), and 108.35(c)(3)(ii)). 282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References). In this guidance document, we use the term legacy system to desc ribe systems already in operation before the effective date of part 11. Contains Nonbinding Recommendations 8
In each case, we recommend that the copying process used produces copies that preserve the 291 content and meaning of the record. If you have the ability to search, sort, or trend part 11 292 records, copies given to the Agency should provide the same capa bility if it is reasonable and 293 technically feasible. You should allow inspection, review, and copying of records in a human 294 readable form at your site using your hardware and following your established procedures and 295 techniques for accessing 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": "Which organization is referenced: 'In this guidance document, we use the term legacy ...'?",
"reference": "In this guidance document, we use the term legacy system to desc ribe systems already in operation before the effective date of part 11.",
"options": {
"B": "desc",
"A": "Agency",
"C": "PDF",
"D": "Part 11 273 records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this guidance document, we use the term legacy system to desc ribe systems already in operation before the effective date of part ____.",
"reference": "In this guidance document, we use the term legacy system to desc ribe systems already in operation before the effective date of part 11.",
"options": {
"A": "11",
"B": "270 271",
"C": "272",
"D": "electronic records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '270 271 If a system has been changed since August ...'?",
"reference": "270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"options": {
"D": "August 20, 1997",
"A": "Part 11 273 records",
"B": "electronic records",
"C": "270 271"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"reference": "270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"options": {
"B": "270",
"A": "270 271",
"C": "272",
"D": "Part 11 273 records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 270 ____ If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"reference": "270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"options": {
"B": "271",
"A": "270 271",
"C": "272",
"D": "Part 11 273 records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 270 271 If a system has been changed since August ____, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"reference": "270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"options": {
"D": "20",
"A": "270 271",
"B": "272",
"C": "Part 11 273 records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 270 271 If a system has been changed since August 20, ____, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"reference": "270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"options": {
"B": "1997",
"A": "August 20, 1997",
"C": "Part 11 273 records",
"D": "electronic records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the ____ system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"reference": "270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"options": {
"D": "272",
"A": "270 271",
"B": "11 273",
"C": "Part 11 273 records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part ____ controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"reference": "270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"options": {
"A": "11",
"B": "270 271",
"C": "272",
"D": "electronic records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part ____ controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"reference": "270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"options": {
"C": "11",
"A": "270 271",
"B": "272",
"D": "electronic records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 ____ records and signatures pursuant to the enforcement policy expressed in this guidance.",
"reference": "270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance.",
"options": {
"C": "273",
"A": "270 271",
"B": "272",
"D": "electronic records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '282 283 We recommend that you supply copies of ele...'?",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"C": "PDF",
"A": "Agency",
"B": "XML",
"D": "Part 11 273 records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '282 283 We recommend that you supply copies of ele...'?",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"A": "XML",
"B": "Agency",
"C": "PDF",
"D": "Part 11 273 records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '282 283 We recommend that you supply copies of ele...'?",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"B": "SGML",
"A": "Agency",
"C": "PDF",
"D": "Part 11 273 records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"A": "282",
"B": "270 271",
"C": "272",
"D": "Part 11 273 records"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 ____ We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"D": "283",
"A": "270 271",
"B": "272",
"C": "Part 11 273 records"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 283 We recommend that you supply copies of electronic records by: ____ 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"B": "284",
"A": "270 271",
"C": "272",
"D": "Part 11 273 records"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 283 We recommend that you supply copies of electronic records by: 284 ____ Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"B": "285",
"A": "270 271",
"C": "272",
"D": "Part 11 273 records"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are ____ maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"B": "286",
"A": "270 271",
"C": "272",
"D": "Part 11 273 records"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats ____ Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"C": "287",
"A": "270 271",
"B": "272",
"D": "Part 11 273 records"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make ____ copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"C": "288",
"A": "270 271",
"B": "272",
"D": "Part 11 273 records"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited ____ to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"B": "289",
"A": "270 271",
"C": "272",
"D": "Part 11 273 records"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) ____ 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"B": "290",
"A": "270 271",
"C": "272",
"D": "Part 11 273 records"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '282 283 We recommend that you supply copies of ele...'?",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"D": "PDF",
"A": "Agency",
"B": "XML",
"C": "Part 11 273 records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '282 283 We recommend that you supply copies of ele...'?",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"C": "XML",
"A": "Agency",
"B": "PDF",
"D": "Part 11 273 records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '282 283 We recommend that you supply copies of ele...'?",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"B": "SGML",
"A": "Agency",
"C": "PDF",
"D": "Part 11 273 records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"A": "282",
"B": "270 271",
"C": "272",
"D": "Part 11 273 records"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 ____ We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"D": "283",
"A": "270 271",
"B": "272",
"C": "Part 11 273 records"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 283 We recommend that you supply copies of electronic records by: ____ 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"D": "284",
"A": "270 271",
"B": "272",
"C": "Part 11 273 records"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 283 We recommend that you supply copies of electronic records by: 284 ____ Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"D": "285",
"A": "270 271",
"B": "272",
"C": "Part 11 273 records"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are ____ maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"C": "286",
"A": "270 271",
"B": "272",
"D": "Part 11 273 records"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats ____ Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"D": "287",
"A": "270 271",
"B": "272",
"C": "Part 11 273 records"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make ____ copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"C": "288",
"A": "270 271",
"B": "272",
"D": "Part 11 273 records"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited ____ to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"B": "289",
"A": "270 271",
"C": "272",
"D": "Part 11 273 records"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) ____ 6 Various guidance documents on information security are available (see References).",
"reference": "282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References).",
"options": {
"A": "290",
"B": "270 271",
"C": "272",
"D": "Part 11 273 records"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 50 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
If the developers are not involved, it is all the more important that the user have persons who understand the importance of careful test planning, the definition of expected test results, and the recording of all test outputs. Typical Tasks User Site Testing Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report 5.2.7. Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware. The operational maintenance of hardware and software are different because their failure/error mechanisms are different. Hardware maintenance typically includes preventive hardware maintenance actions, component replacement, and corrective changes. Software maintenance includes corrective, perfective, and adaptive maintenance but does not include preventive maintenance actions or software component replacement. Changes made to correct errors and faults in the software are corrective maintenance. Changes made to the software to improve the performance, maintainability, or other attributes of the software system are perfective maintenance. Software changes to make the software system usable in a changed environment are adaptive maintenance. When changes are made to a software system, either during initial development or during post release maintenance, sufficient regression analysis and testing should be conducted to demonstrate that portions of the software not involved in the change were not adversely impacted. This is in addition to testing that evaluates the correctness of the implemented change(s). The specific validation effort necessary for each software change is determined by the type of change, the development products affected, and the impact of those products on the operation of the software.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"C": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"C": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Typical Tasks User Site Testing Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report ____.",
"reference": "Typical Tasks User Site Testing Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report 5.2.7.",
"options": {
"D": "5.2.7",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"B": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"A": "Maintenance and Software Changes",
"C": "Software maintenance",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"A": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"B": "Maintenance and Software Changes",
"C": "Software maintenance",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"D": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"B": "same",
"A": "Maintenance and Software Changes",
"C": "Software maintenance",
"D": "Lapplander"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"B": "same",
"A": "Maintenance and Software Changes",
"C": "Software maintenance",
"D": "Lapplander"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"D": "same",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"C": "Lapplander"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Typical Tasks User Site Testing Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report ____.",
"reference": "Typical Tasks User Site Testing Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report 5.2.7.",
"options": {
"D": "5.2.7",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Typical Tasks User Site Testing Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report ____.",
"reference": "Typical Tasks User Site Testing Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report 5.2.7.",
"options": {
"D": "5.2.7",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"C": "same",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"D": "Lapplander"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"C": "same",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"D": "Lapplander"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"A": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"B": "Maintenance and Software Changes",
"C": "Software maintenance",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"A": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"B": "Maintenance and Software Changes",
"C": "Software maintenance",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"C": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"C": "same",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"D": "Lapplander"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"A": "same",
"B": "Maintenance and Software Changes",
"C": "Software maintenance",
"D": "Lapplander"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"B": "same",
"A": "Maintenance and Software Changes",
"C": "Software maintenance",
"D": "Lapplander"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"A": "same",
"B": "Maintenance and Software Changes",
"C": "Software maintenance",
"D": "Lapplander"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"C": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"D": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"A": "same",
"B": "Maintenance and Software Changes",
"C": "Software maintenance",
"D": "Lapplander"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"D": "same",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"C": "Lapplander"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"D": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Typical Tasks User Site Testing Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report ____.",
"reference": "Typical Tasks User Site Testing Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report 5.2.7.",
"options": {
"B": "5.2.7",
"A": "Maintenance and Software Changes",
"C": "Software maintenance",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"B": "same",
"A": "Maintenance and Software Changes",
"C": "Software maintenance",
"D": "Lapplander"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"A": "same",
"B": "Maintenance and Software Changes",
"C": "Software maintenance",
"D": "Lapplander"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"D": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"C": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Typical Tasks User Site Testing Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report ____.",
"reference": "Typical Tasks User Site Testing Acceptance Test Execution Test Results Evaluation Error Evaluation/Resolution Final Test Report 5.2.7.",
"options": {
"C": "5.2.7",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"C": "same",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"D": "Lapplander"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"D": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"D": "same",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"C": "Lapplander"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"C": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"C": "same",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"D": "Lapplander"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The operational maintenance of hardware and software are dif...'?",
"reference": "The operational maintenance of hardware and software are different because their failure/error mechanisms are different.",
"options": {
"D": "The operational maintenance of hardware and software are different because their failure/error mecha...",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is maintenance?",
"reference": "Maintenance and Software Changes As applied to software, the term maintenance does not mean the same as when applied to hardware.",
"options": {
"D": "same",
"A": "Maintenance and Software Changes",
"B": "Software maintenance",
"C": "Lapplander"
},
"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 1 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
CONTEXT FOR SOFTWARE VALIDATION ................................
...................
Definitions and Terminology ................................ ................................
.............................
5 3.1.1 Requirements and Specifications ................................ ................................
...................
5 3.1.2 Verification and Validation ................................ ................................
........................... 6 3.1.3 IQ/OQ/PQ ................................ ................................
................................ ......................
Software Development as Part of System Design ................................ ............................
Software is Different from Hardware ................................ ................................
................ 8 3.4. Benefits of Software Validation ................................
................................ .........................
9 3.5 Design Review ................................ ................................ ................................
...................
PRINCIPLES OF SOFTWARE VALIDATION ................................ Requirements ................................ ................................ ................................
................... Defect Prevention ................................
................................ ................................
............ 11 4.3. Time and Effort ................................ ................................ ................................
................ 11 4.4. Software Life Cycle ................................ ................................ ................................
Plans ................................ ................................ ................................
................................ ..12 4.6.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: Benefits of Software Validation ................................\n................................ .........................\n____ 3.5 Design Review ................................ ................................ ................................\n...................\nPRINCIPLES OF SOFTWARE VALIDATION ................................",
"reference": "Benefits of Software Validation ................................\n................................ .........................\n9 3.5 Design Review ................................ ................................ ................................\n...................\nPRINCIPLES OF SOFTWARE VALIDATION ................................",
"options": {
"B": "9",
"A": "6 3.1.3",
"C": "8 3.4",
"D": "Software Validation"
},
"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 6 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
82 83 FDA believes that applying a r isk-based approach to computer software used as part of 84 production or the quality system would better focus manufacturers assuranc e activities to help 85 ensure product quality while helping to fulfill the validation requirements of 21 CFR 820.70(i). For these reasons, FDA is now providing recommendations on computer software assurance for 87 computers and automated data processing systems used as part of medical device production or 88 the quality system. FDA believes that these recommendations will help foster the adoption and 89 use of innovative technologies that promote patient access to high -quality medical devices and 90 help manufacturers to keep pace with the dynamic, rapidly changing technology landscape , while 91 promot ing compliance with laws and regulations implemented by FDA . When final, this guidance is intended to provide recommendations regarding computer software 95 assurance for computers or automated data processing systems used as part of production or the 96 quality system. This guidance is not intended to provide a complete description of all software validation 99 principles. FDA has previously outlined principles for software validation, including managing 100 changes as part of the software lifecycle, in FDAs Software Validation guidance . This guidance 101 applies the risk -based approach to software validation discussed in the Software Validation 102 guidance to production or quality system software . This guidance additionally discusses specific 103 risk considerations, acceptable testing methods, and efficient generati on of objective evidence 104 for production or quality system software. 105 106 This guidance does not provide recommendations for the design verification or validation 107 requirements specified in 21 CFR 820.30 when applied to software in a medical device (SiMD) 108 or software as a medical device (SaMD).
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'FDA believes that these recommendations will help ...'?",
"reference": "FDA believes that these recommendations will help foster the adoption and 89 use of innovative technologies that promote patient access to high -quality medical devices and 90 help manufacturers to keep pace with the dynamic, rapidly changing technology landscape , while 91 promot ing compliance with laws and regulations implemented by FDA .",
"options": {
"B": "FDA",
"A": "Software Validation",
"C": "SaMD",
"D": "the Software Validation 102 guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA believes that these recommendations will help ...'?",
"reference": "FDA believes that these recommendations will help foster the adoption and 89 use of innovative technologies that promote patient access to high -quality medical devices and 90 help manufacturers to keep pace with the dynamic, rapidly changing technology landscape , while 91 promot ing compliance with laws and regulations implemented by FDA .",
"options": {
"D": "FDA",
"A": "Software Validation",
"B": "SaMD",
"C": "the Software Validation 102 guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA believes that these recommendations will help foster the adoption and ____ use of innovative technologies that promote patient access to high -quality medical devices and 90 help manufacturers to keep pace with the dynamic, rapidly changing technology landscape , while 91 promot ing compliance with laws and regulations implemented by FDA .",
"reference": "FDA believes that these recommendations will help foster the adoption and 89 use of innovative technologies that promote patient access to high -quality medical devices and 90 help manufacturers to keep pace with the dynamic, rapidly changing technology landscape , while 91 promot ing compliance with laws and regulations implemented by FDA .",
"options": {
"D": "89",
"A": "100",
"B": "101",
"C": "FDAs Software Validation guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA believes that these recommendations will help foster the adoption and 89 use of innovative technologies that promote patient access to high -quality medical devices and ____ help manufacturers to keep pace with the dynamic, rapidly changing technology landscape , while 91 promot ing compliance with laws and regulations implemented by FDA .",
"reference": "FDA believes that these recommendations will help foster the adoption and 89 use of innovative technologies that promote patient access to high -quality medical devices and 90 help manufacturers to keep pace with the dynamic, rapidly changing technology landscape , while 91 promot ing compliance with laws and regulations implemented by FDA .",
"options": {
"D": "90",
"A": "100",
"B": "101",
"C": "FDAs Software Validation guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA believes that these recommendations will help foster the adoption and 89 use of innovative technologies that promote patient access to high -quality medical devices and 90 help manufacturers to keep pace with the dynamic, rapidly changing technology landscape , while ____ promot ing compliance with laws and regulations implemented by FDA .",
"reference": "FDA believes that these recommendations will help foster the adoption and 89 use of innovative technologies that promote patient access to high -quality medical devices and 90 help manufacturers to keep pace with the dynamic, rapidly changing technology landscape , while 91 promot ing compliance with laws and regulations implemented by FDA .",
"options": {
"A": "91",
"B": "100",
"C": "101",
"D": "FDAs Software Validation guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This guidance additionally discusses specific ____ risk considerations, acceptable testing methods, and efficient generati on of objective evidence 104 for production or quality system software.",
"reference": "This guidance additionally discusses specific 103 risk considerations, acceptable testing methods, and efficient generati on of objective evidence 104 for production or quality system software.",
"options": {
"D": "103",
"A": "100",
"B": "101",
"C": "FDAs Software Validation guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
According to the United States Phar macopeia (USP), system s uitability tests should 344 include replicate injections of a standard preparation or other standard solutions to 345 determine if requirements for precision are satisfied (see USP General Chapter 621 346 Chromatography) . System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and 212.60). 350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60). All data should be included in the record that is retained 355 and subject to review unless there is documented scientific justification for its exclusion. 356 357 For more information , see also the ICH guidance for industry Q2(R1)
Validation of 358 Analytical Procedure s: Text and Methodology. Is it acceptable to only save the final results from reprocess ed laboratory 361 chromatography? Analytical methods should be capable and stable. For most lab analys es, reprocessing 364 data should not be regularly needed. If chromatography is reprocessed, written 365 procedures must be established and followed and each result retained for review (s ee 366 211.160(a) , 211.160(b) , 211.165(c) , 211.194(a)(4) , and 212.60(a) ). FDA requires 367 complete data in laboratory records, which includes raw data, graphs, charts, and spectra 368 from laboratory instruments ( 211.194(a) and 212.60(g)(3) ). Can an internal tip regarding a quality issue, such as potential data 371 falsification, be handled informally outsi de of the documented CGMP quality 372 system?
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Who is mentioned in the context: 'Is it acceptable to only save the final results fr...'?",
"reference": "Is it acceptable to only save the final results from reprocess ed laboratory 361 chromatography?",
"options": {
"B": "reprocess ed laboratory",
"A": "Q2(R1",
"C": "potential data 371 falsification",
"D": "367 complete data"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Is it acceptable to only save the final results from reprocess ed laboratory ____ chromatography?",
"reference": "Is it acceptable to only save the final results from reprocess ed laboratory 361 chromatography?",
"options": {
"D": "361",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: '350 351 If an actual sample is to be used for syst...'?",
"reference": "350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"options": {
"C": "211.160",
"A": "344",
"B": "345",
"D": "potential data 371 falsification"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"reference": "350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"options": {
"A": "350",
"B": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 350 ____ If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"reference": "350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"options": {
"D": "351",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 350 351 If an actual sample is to be used for system suitability testing, it should be a properly ____ characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"reference": "350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"options": {
"D": "352",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, ____ and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"reference": "350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"options": {
"D": "353",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( ____ 211.160, 211.165, and 212.60).",
"reference": "350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"options": {
"D": "354",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 ____, 211.165, and 212.60).",
"reference": "350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"options": {
"A": "211.160",
"B": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, ____, and 212.60).",
"reference": "350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"options": {
"B": "211.165",
"A": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and ____).",
"reference": "350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"options": {
"D": "212.60",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: '356 357 For more information , see also the ICH gu...'?",
"reference": "356 357 For more information , see also the ICH guidance for industry Q2(R1)\nValidation of 358 Analytical Procedure s: Text and Methodology.",
"options": {
"C": "Q2(R1",
"A": "reprocess ed laboratory",
"B": "potential data 371 falsification",
"D": "367 complete data"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: For most lab analys es, reprocessing ____ data should not be regularly needed.",
"reference": "For most lab analys es, reprocessing 364 data should not be regularly needed.",
"options": {
"D": "364",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'If chromatography is reprocessed, written 365 proc...'?",
"reference": "If chromatography is reprocessed, written 365 procedures must be established and followed and each result retained for review (s ee 366 211.160(a) , 211.160(b) , 211.165(c) , 211.194(a)(4) , and 212.60(a) ).",
"options": {
"D": "366 211.160(a",
"A": "potential data 371 falsification",
"B": "367 complete data",
"C": "365"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: If chromatography is reprocessed, written ____ procedures must be established and followed and each result retained for review (s ee 366 211.160(a) , 211.160(b) , 211.165(c) , 211.194(a)(4) , and 212.60(a) ).",
"reference": "If chromatography is reprocessed, written 365 procedures must be established and followed and each result retained for review (s ee 366 211.160(a) , 211.160(b) , 211.165(c) , 211.194(a)(4) , and 212.60(a) ).",
"options": {
"C": "365",
"A": "344",
"B": "345",
"D": "potential data 371 falsification"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If chromatography is reprocessed, written 365 procedures must be established and followed and each result retained for review (s ee ____ 211.160(a) , 211.160(b) , 211.165(c) , 211.194(a)(4) , and 212.60(a) ).",
"reference": "If chromatography is reprocessed, written 365 procedures must be established and followed and each result retained for review (s ee 366 211.160(a) , 211.160(b) , 211.165(c) , 211.194(a)(4) , and 212.60(a) ).",
"options": {
"D": "366",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA requires 367 complete data in laboratory recor...'?",
"reference": "FDA requires 367 complete data in laboratory records, which includes raw data, graphs, charts, and spectra 368 from laboratory instruments ( 211.194(a) and 212.60(g)(3) ).",
"options": {
"B": "FDA",
"A": "the United States Phar",
"C": "CGMP",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA requires ____ complete data in laboratory records, which includes raw data, graphs, charts, and spectra 368 from laboratory instruments ( 211.194(a) and 212.60(g)(3) ).",
"reference": "FDA requires 367 complete data in laboratory records, which includes raw data, graphs, charts, and spectra 368 from laboratory instruments ( 211.194(a) and 212.60(g)(3) ).",
"options": {
"D": "367",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA requires 367 complete data in laboratory records, which includes raw data, graphs, charts, and spectra ____ from laboratory instruments ( 211.194(a) and 212.60(g)(3) ).",
"reference": "FDA requires 367 complete data in laboratory records, which includes raw data, graphs, charts, and spectra 368 from laboratory instruments ( 211.194(a) and 212.60(g)(3) ).",
"options": {
"D": "368",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: '350 351 If an actual sample is to be used for syst...'?",
"reference": "350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"options": {
"A": "211.160",
"B": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"reference": "350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"options": {
"D": "350",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 350 ____ If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"reference": "350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"options": {
"D": "351",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 350 351 If an actual sample is to be used for system suitability testing, it should be a properly ____ characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"reference": "350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"options": {
"A": "352",
"B": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, ____ and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"reference": "350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"options": {
"B": "353",
"A": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( ____ 211.160, 211.165, and 212.60).",
"reference": "350 351 If an actual sample is to be used for system suitability testing, it should be a properly 352 characterized secondary standard , written procedures should be established and followed, 353 and the sample should be from a different batch than the sample (s) being tested ( 354 211.160, 211.165, and 212.60).",
"options": {
"C": "354",
"A": "344",
"B": "345",
"D": "potential data 371 falsification"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 45 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 5. ACTIVITIES AND TASKS Software validation is accomplished through a series of activities and tasks that are planned and executed at various stages of the software development life cycle. These tasks may be one time occurrences or may be iterated many times, depending on the life cycle model used and the scope of changes made as the software project progresses. SOFTWARE LIFE CYCLE ACTIVITIES
This guidance does not recommend the use of any specific software life cycle model. Software developers should establish a software life cycle model that is appropriate for their product and organization. The software life cycle model that is selected should cover the software from its birth to its retirement. Activities in a typical software life cycle model include the following: Quality Planning System Requirements Definition Detailed Software Requirements Specification Software Design Specification Construction or Coding Testing Installation Operation and Support Maintenance Retirement Verification, testing, and other tasks that support software validation occur during each of these activities. A life cycle model organizes these software development activities in various ways and provides a framework for monitoring and controlling the software development project. Several software life cycle models (e.g., waterfall, spiral, rapid prototyping, incremental development, etc.) are defined in FDAs Glossary of Computerized System and Software Development Terminology , dated August 1995. These and many other life cycle models are described in various references listed in Appendix A. 5.2. TYPICAL TASKS SUPPORTING VALIDATION For each of the software life cycle activities, there are certain typical tasks that support a conclusion that the software is validated.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Page 14General Principles of Software Validation G...'?",
"reference": "Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 5.",
"options": {
"C": "FDA",
"A": "TASKS Software",
"B": "Quality Planning System Requirements Definition Detailed Software",
"D": "a typical software life cycle model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION ____.",
"reference": "Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 5.",
"options": {
"B": "5",
"A": "one",
"C": "a typical software life cycle model",
"D": "SOFTWARE LIFE CYCLE ACTIVITIES"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'TYPICAL TASKS SUPPORTING VALIDATION For each of th...'?",
"reference": "TYPICAL TASKS SUPPORTING VALIDATION For each of the software life cycle activities, there are certain typical tasks that support a conclusion that the software is validated.",
"options": {
"A": "TYPICAL TASKS SUPPORTING",
"B": "FDA",
"C": "TASKS Software",
"D": "a typical software life cycle model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'TYPICAL TASKS SUPPORTING VALIDATION For each of th...'?",
"reference": "TYPICAL TASKS SUPPORTING VALIDATION For each of the software life cycle activities, there are certain typical tasks that support a conclusion that the software is validated.",
"options": {
"B": "TYPICAL TASKS SUPPORTING",
"A": "FDA",
"C": "TASKS Software",
"D": "a typical software life cycle model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These tasks may be ____ time occurrences or may be iterated many times, depending on the life cycle model used and the scope of changes made as the software project progresses.",
"reference": "These tasks may be one time occurrences or may be iterated many times, depending on the life cycle model used and the scope of changes made as the software project progresses.",
"options": {
"C": "one",
"A": "a typical software life cycle model",
"B": "SOFTWARE LIFE CYCLE ACTIVITIES",
"D": "ace"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These tasks may be ____ time occurrences or may be iterated many times, depending on the life cycle model used and the scope of changes made as the software project progresses.",
"reference": "These tasks may be one time occurrences or may be iterated many times, depending on the life cycle model used and the scope of changes made as the software project progresses.",
"options": {
"B": "one",
"A": "a typical software life cycle model",
"C": "SOFTWARE LIFE CYCLE ACTIVITIES",
"D": "ace"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ACTIVITIES AND TASKS Software validation is accomp...'?",
"reference": "ACTIVITIES AND TASKS Software validation is accomplished through a series of activities and tasks that are planned and executed at various stages of the software development life cycle.",
"options": {
"D": "TASKS Software",
"A": "FDA",
"B": "Quality Planning System Requirements Definition Detailed Software",
"C": "a typical software life cycle model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These tasks may be ____ time occurrences or may be iterated many times, depending on the life cycle model used and the scope of changes made as the software project progresses.",
"reference": "These tasks may be one time occurrences or may be iterated many times, depending on the life cycle model used and the scope of changes made as the software project progresses.",
"options": {
"D": "one",
"A": "a typical software life cycle model",
"B": "SOFTWARE LIFE CYCLE ACTIVITIES",
"C": "ace"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software developers should establish a software li...'?",
"reference": "Software developers should establish a software life cycle model that is appropriate for their product and organization.",
"options": {
"B": "Software",
"A": "FDA",
"C": "TASKS Software",
"D": "the life cycle model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software developers should establish a software li...'?",
"reference": "Software developers should establish a software life cycle model that is appropriate for their product and organization.",
"options": {
"C": "Software",
"A": "FDA",
"B": "TASKS Software",
"D": "the life cycle model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'are defined in FDAs Glossary of Computerized Syste...'?",
"reference": "are defined in FDAs Glossary of Computerized System and Software Development Terminology , dated August 1995.",
"options": {
"D": "Glossary of Computerized System",
"A": "a typical software life cycle model",
"B": "SOFTWARE LIFE CYCLE ACTIVITIES",
"C": "August 1995"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 14General Principles of Software Validation G...'?",
"reference": "Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 5.",
"options": {
"A": "FDA",
"B": "TASKS Software",
"C": "Quality Planning System Requirements Definition Detailed Software",
"D": "a typical software life cycle model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION ____.",
"reference": "Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 5.",
"options": {
"C": "5",
"A": "one",
"B": "a typical software life cycle model",
"D": "SOFTWARE LIFE CYCLE ACTIVITIES"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ACTIVITIES AND TASKS Software validation is accomp...'?",
"reference": "ACTIVITIES AND TASKS Software validation is accomplished through a series of activities and tasks that are planned and executed at various stages of the software development life cycle.",
"options": {
"D": "TASKS Software",
"A": "FDA",
"B": "Quality Planning System Requirements Definition Detailed Software",
"C": "a typical software life cycle model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ACTIVITIES AND TASKS Software validation is accomp...'?",
"reference": "ACTIVITIES AND TASKS Software validation is accomplished through a series of activities and tasks that are planned and executed at various stages of the software development life cycle.",
"options": {
"B": "TASKS Software",
"A": "FDA",
"C": "Quality Planning System Requirements Definition Detailed Software",
"D": "a typical software life cycle model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 14General Principles of Software Validation G...'?",
"reference": "Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 5.",
"options": {
"B": "FDA",
"A": "TASKS Software",
"C": "Quality Planning System Requirements Definition Detailed Software",
"D": "a typical software life cycle model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION ____.",
"reference": "Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 5.",
"options": {
"B": "5",
"A": "one",
"C": "a typical software life cycle model",
"D": "SOFTWARE LIFE CYCLE ACTIVITIES"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'are defined in FDAs Glossary of Computerized Syste...'?",
"reference": "are defined in FDAs Glossary of Computerized System and Software Development Terminology , dated August 1995.",
"options": {
"D": "Glossary of Computerized System",
"A": "a typical software life cycle model",
"B": "SOFTWARE LIFE CYCLE ACTIVITIES",
"C": "August 1995"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'are defined in FDAs Glossary of Computerized Syste...'?",
"reference": "are defined in FDAs Glossary of Computerized System and Software Development Terminology , dated August 1995.",
"options": {
"B": "August 1995",
"A": "a typical software life cycle model",
"C": "SOFTWARE LIFE CYCLE ACTIVITIES",
"D": "Glossary of Computerized System"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: are defined in FDAs Glossary of Computerized System and Software Development Terminology , dated August ____.",
"reference": "are defined in FDAs Glossary of Computerized System and Software Development Terminology , dated August 1995.",
"options": {
"A": "1995",
"B": "August 1995",
"C": "a typical software life cycle model",
"D": "SOFTWARE LIFE CYCLE ACTIVITIES"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Activities in a typical software life cycle model ...'?",
"reference": "Activities in a typical software life cycle model include the following: Quality Planning System Requirements Definition Detailed Software Requirements Specification Software Design Specification Construction or Coding Testing Installation Operation and Support Maintenance Retirement Verification, testing, and other tasks that support software validation occur during each of these activities.",
"options": {
"D": "Quality Planning System Requirements Definition Detailed Software",
"A": "FDA",
"B": "TASKS Software",
"C": "a typical software life cycle model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Activities in a typical software life cycle model ...'?",
"reference": "Activities in a typical software life cycle model include the following: Quality Planning System Requirements Definition Detailed Software Requirements Specification Software Design Specification Construction or Coding Testing Installation Operation and Support Maintenance Retirement Verification, testing, and other tasks that support software validation occur during each of these activities.",
"options": {
"A": "Specification Software Design Specification Construction",
"B": "FDA",
"C": "TASKS Software",
"D": "a typical software life cycle model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 14General Principles of Software Validation G...'?",
"reference": "Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 5.",
"options": {
"A": "FDA",
"B": "TASKS Software",
"C": "Quality Planning System Requirements Definition Detailed Software",
"D": "a typical software life cycle model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION ____.",
"reference": "Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 5.",
"options": {
"C": "5",
"A": "one",
"B": "a typical software life cycle model",
"D": "SOFTWARE LIFE CYCLE ACTIVITIES"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Activities in a typical software life cycle model ...'?",
"reference": "Activities in a typical software life cycle model include the following: Quality Planning System Requirements Definition Detailed Software Requirements Specification Software Design Specification Construction or Coding Testing Installation Operation and Support Maintenance Retirement Verification, testing, and other tasks that support software validation occur during each of these activities.",
"options": {
"C": "Quality Planning System Requirements Definition Detailed Software",
"A": "FDA",
"B": "TASKS Software",
"D": "a typical software life cycle model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Activities in a typical software life cycle model ...'?",
"reference": "Activities in a typical software life cycle model include the following: Quality Planning System Requirements Definition Detailed Software Requirements Specification Software Design Specification Construction or Coding Testing Installation Operation and Support Maintenance Retirement Verification, testing, and other tasks that support software validation occur during each of these activities.",
"options": {
"D": "Specification Software Design Specification Construction",
"A": "FDA",
"B": "TASKS Software",
"C": "a typical software life cycle model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'TYPICAL TASKS SUPPORTING VALIDATION For each of th...'?",
"reference": "TYPICAL TASKS SUPPORTING VALIDATION For each of the software life cycle activities, there are certain typical tasks that support a conclusion that the software is validated.",
"options": {
"B": "TYPICAL TASKS SUPPORTING",
"A": "FDA",
"C": "TASKS Software",
"D": "a typical software life cycle model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 14General Principles of Software Validation G...'?",
"reference": "Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 5.",
"options": {
"C": "FDA",
"A": "TASKS Software",
"B": "Quality Planning System Requirements Definition Detailed Software",
"D": "a typical software life cycle model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION ____.",
"reference": "Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 5.",
"options": {
"C": "5",
"A": "one",
"B": "a typical software life cycle model",
"D": "SOFTWARE LIFE CYCLE ACTIVITIES"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 14General Principles of Software Validation G...'?",
"reference": "Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 5.",
"options": {
"D": "FDA",
"A": "TASKS Software",
"B": "Quality Planning System Requirements Definition Detailed Software",
"C": "a typical software life cycle model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION ____.",
"reference": "Page 14General Principles of Software Validation Guidance for Industry and FDA Staff SECTION 5.",
"options": {
"A": "5",
"B": "one",
"C": "a typical software life cycle model",
"D": "SOFTWARE LIFE CYCLE ACTIVITIES"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ACTIVITIES AND TASKS Software validation is accomp...'?",
"reference": "ACTIVITIES AND TASKS Software validation is accomplished through a series of activities and tasks that are planned and executed at various stages of the software development life cycle.",
"options": {
"C": "TASKS Software",
"A": "FDA",
"B": "Quality Planning System Requirements Definition Detailed Software",
"D": "a typical software life cycle model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Activities in a typical software life cycle model ...'?",
"reference": "Activities in a typical software life cycle model include the following: Quality Planning System Requirements Definition Detailed Software Requirements Specification Software Design Specification Construction or Coding Testing Installation Operation and Support Maintenance Retirement Verification, testing, and other tasks that support software validation occur during each of these activities.",
"options": {
"B": "Quality Planning System Requirements Definition Detailed Software",
"A": "FDA",
"C": "TASKS Software",
"D": "a typical software life cycle model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software developers should establish a software li...'?",
"reference": "Software developers should establish a software life cycle model that is appropriate for their product and organization.",
"options": {
"A": "Software",
"B": "FDA",
"C": "TASKS Software",
"D": "the life cycle model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'are defined in FDAs Glossary of Computerized Syste...'?",
"reference": "are defined in FDAs Glossary of Computerized System and Software Development Terminology , dated August 1995.",
"options": {
"C": "Glossary of Computerized System",
"A": "a typical software life cycle model",
"B": "SOFTWARE LIFE CYCLE ACTIVITIES",
"D": "August 1995"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'are defined in FDAs Glossary of Computerized Syste...'?",
"reference": "are defined in FDAs Glossary of Computerized System and Software Development Terminology , dated August 1995.",
"options": {
"A": "August 1995",
"B": "a typical software life cycle model",
"C": "SOFTWARE LIFE CYCLE ACTIVITIES",
"D": "Glossary of Computerized System"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: are defined in FDAs Glossary of Computerized System and Software Development Terminology , dated August ____.",
"reference": "are defined in FDAs Glossary of Computerized System and Software Development Terminology , dated August 1995.",
"options": {
"B": "1995",
"A": "August 1995",
"C": "a typical software life cycle model",
"D": "SOFTWARE LIFE CYCLE ACTIVITIES"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Activities in a typical software life cycle model ...'?",
"reference": "Activities in a typical software life cycle model include the following: Quality Planning System Requirements Definition Detailed Software Requirements Specification Software Design Specification Construction or Coding Testing Installation Operation and Support Maintenance Retirement Verification, testing, and other tasks that support software validation occur during each of these activities.",
"options": {
"A": "Quality Planning System Requirements Definition Detailed Software",
"B": "FDA",
"C": "TASKS Software",
"D": "a typical software life cycle model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Activities in a typical software life cycle model ...'?",
"reference": "Activities in a typical software life cycle model include the following: Quality Planning System Requirements Definition Detailed Software Requirements Specification Software Design Specification Construction or Coding Testing Installation Operation and Support Maintenance Retirement Verification, testing, and other tasks that support software validation occur during each of these activities.",
"options": {
"B": "Specification Software Design Specification Construction",
"A": "FDA",
"C": "TASKS Software",
"D": "a typical software life cycle model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Activities in a typical software life cycle model ...'?",
"reference": "Activities in a typical software life cycle model include the following: Quality Planning System Requirements Definition Detailed Software Requirements Specification Software Design Specification Construction or Coding Testing Installation Operation and Support Maintenance Retirement Verification, testing, and other tasks that support software validation occur during each of these activities.",
"options": {
"A": "Quality Planning System Requirements Definition Detailed Software",
"B": "FDA",
"C": "TASKS Software",
"D": "a typical software life cycle model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Activities in a typical software life cycle model ...'?",
"reference": "Activities in a typical software life cycle model include the following: Quality Planning System Requirements Definition Detailed Software Requirements Specification Software Design Specification Construction or Coding Testing Installation Operation and Support Maintenance Retirement Verification, testing, and other tasks that support software validation occur during each of these activities.",
"options": {
"A": "Specification Software Design Specification Construction",
"B": "FDA",
"C": "TASKS Software",
"D": "a typical software life cycle model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'TYPICAL TASKS SUPPORTING VALIDATION For each of th...'?",
"reference": "TYPICAL TASKS SUPPORTING VALIDATION For each of the software life cycle activities, there are certain typical tasks that support a conclusion that the software is validated.",
"options": {
"D": "TYPICAL TASKS SUPPORTING",
"A": "FDA",
"B": "TASKS Software",
"C": "a typical software life cycle model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These tasks may be ____ time occurrences or may be iterated many times, depending on the life cycle model used and the scope of changes made as the software project progresses.",
"reference": "These tasks may be one time occurrences or may be iterated many times, depending on the life cycle model used and the scope of changes made as the software project progresses.",
"options": {
"B": "one",
"A": "a typical software life cycle model",
"C": "SOFTWARE LIFE CYCLE ACTIVITIES",
"D": "ace"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'TYPICAL TASKS SUPPORTING VALIDATION For each of th...'?",
"reference": "TYPICAL TASKS SUPPORTING VALIDATION For each of the software life cycle activities, there are certain typical tasks that support a conclusion that the software is validated.",
"options": {
"B": "TYPICAL TASKS SUPPORTING",
"A": "FDA",
"C": "TASKS Software",
"D": "a typical software life cycle model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These tasks may be ____ time occurrences or may be iterated many times, depending on the life cycle model used and the scope of changes made as the software project progresses.",
"reference": "These tasks may be one time occurrences or may be iterated many times, depending on the life cycle model used and the scope of changes made as the software project progresses.",
"options": {
"C": "one",
"A": "a typical software life cycle model",
"B": "SOFTWARE LIFE CYCLE ACTIVITIES",
"D": "ace"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider Page 3General Principles of Software Validation Guidance for Industry and FDA Staff your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman. Comprehensive information on CDRHs Ombudsman, including ways to contact him, can be found on the Internet at: http://www.fda.gov/cdrh/resolvingdisputes/ombudsman.html . 2.4. REGULATORY REQUIREMENTS FOR SOFTWARE VALIDATION
The FDAs analysis of 3140 medical device recalls conducted between 1992 and 1998 reveals that 242 of them (7.7) are attributable to software failures. Of those software related recalls, 192 (or 79) were caused by software defects that were introduced when changes were made to the software after its initial production and distribution. Software validation and other related good software engineering practices discussed in this guidance are a principal means of avoiding such defects and resultant recalls. Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997. (See Title 21 Code of Federal Regulations (CFR) Part 820, and 61 Federal Register (FR) 52602, respectively.) Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in production of the device or in implementation of the device manufacturer's quality system. Unless specifically exempted in a classification regulation, any medical device software product developed after June 1, 1997, regardless of its device class, is subject to applicable design control provisions.
[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: 'You may send your written comments to the contact ...'?",
"reference": "You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman.",
"options": {
"D": "CDRH",
"A": "Page 3General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'You may send your written comments to the contact ...'?",
"reference": "You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman.",
"options": {
"D": "CDRH",
"A": "Page 3General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation is a requirement of the Qualit...'?",
"reference": "Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997.",
"options": {
"D": "Software",
"A": "Page 3General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"C": "3140 medical device recalls"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation is a requirement of the Qualit...'?",
"reference": "Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997.",
"options": {
"C": "Quality System",
"A": "Software Validation Guidance",
"B": "any medical device software product",
"D": "Software"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation is a requirement of the Qualit...'?",
"reference": "Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997.",
"options": {
"C": "the Federal Register",
"A": "Page 3General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Software validation is a requirement of the Qualit...'?",
"reference": "Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997.",
"options": {
"C": "October 7, 1996",
"A": "3140",
"B": "between 1992 and 1998",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Software validation is a requirement of the Qualit...'?",
"reference": "Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997.",
"options": {
"B": "June 1, 1997",
"A": "3140",
"C": "between 1992 and 1998",
"D": "Software Validation Guidance"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October ____, 1996 and took effect on June 1, 1997.",
"reference": "Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997.",
"options": {
"C": "7",
"A": "2.4",
"B": "242",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, ____ and took effect on June 1, 1997.",
"reference": "Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997.",
"options": {
"D": "1996",
"A": "3140",
"B": "between 1992 and 1998",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
If these independent security ro le assignments are not practical f or small op erations or 189 facilities with few employees, such as PET or medical gas facilities , FDA recommends 190 alternate control strategies be implemented .7
For example, in the rare instance that the 191 same person is required
t o hold the system administrator role and to be responsible for 192 the content of the records, FDA suggests having a second person review settings and 193 content . If second- person review is not possible, the Agency recommend s that the person 194 recheck settings and his or her own work. 195 196 6 In computer science, validation refers to ensuring that software meets its specifications. However, t his may not meet the definition of process validation as found in guidance for industry Process Validation: General Principle s and Practices: The collection and evaluation of data which establishes scientific evidence that a process is capable of consistently delivering quality products. See also ICH guidance for industry Q7 A Good Manufacturing Practice Guide for Active Phar maceutical Ingredients, which defines validation as providing assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria. For purpose s of this guidance, validation is being used in a ma nner consistent with the above guidance documents. For further discussion of such alternate control strategies, s ee the guidance for industry PET Drugs Current Good Manufacturing Practice (CGMP). Contains Nonbinding Recommendations Draft Not for Implementation 6 5. Why is FDA concerned with the use of shared login accounts for computer 197 systems?
[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: 'If second- person review is not possible, the Agen...'?",
"reference": "If second- person review is not possible, the Agency recommend s that the person 194 recheck settings and his or her own work.",
"options": {
"D": "Agency",
"A": "industry Process Validation",
"B": "process validation",
"C": "government agency"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If second- person review is not possible, the Agency recommend s that the person ____ recheck settings and his or her own work.",
"reference": "If second- person review is not possible, the Agency recommend s that the person 194 recheck settings and his or her own work.",
"options": {
"B": "194",
"A": "189",
"C": "190",
"D": "industry Process Validation"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is which?",
"reference": "See also ICH guidance for industry Q7 A Good Manufacturing Practice Guide for Active Phar maceutical Ingredients, which defines validation as providing assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria.",
"options": {
"D": "validation",
"A": "industry PET Drugs Current Good Manufacturing Practice",
"B": "ICH guidance",
"C": "substantiation"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'If these independent security ro le assignments ar...'?",
"reference": "If these independent security ro le assignments are not practical f or small op erations or 189 facilities with few employees, such as PET or medical gas facilities , FDA recommends 190 alternate control strategies be implemented .7\nFor example, in the rare instance that the 191 same person is required\nt o hold the system administrator role and to be responsible for 192 the content of the records, FDA suggests having a second person review settings and 193 content .",
"options": {
"C": "PET",
"A": "FDA",
"B": "industry Process Validation",
"D": "process validation"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'If these independent security ro le assignments ar...'?",
"reference": "If these independent security ro le assignments are not practical f or small op erations or 189 facilities with few employees, such as PET or medical gas facilities , FDA recommends 190 alternate control strategies be implemented .7\nFor example, in the rare instance that the 191 same person is required\nt o hold the system administrator role and to be responsible for 192 the content of the records, FDA suggests having a second person review settings and 193 content .",
"options": {
"B": "FDA",
"A": "PET",
"C": "Agency",
"D": "industry Process Validation"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'If these independent security ro le assignments ar...'?",
"reference": "If these independent security ro le assignments are not practical f or small op erations or 189 facilities with few employees, such as PET or medical gas facilities , FDA recommends 190 alternate control strategies be implemented .7\nFor example, in the rare instance that the 191 same person is required\nt o hold the system administrator role and to be responsible for 192 the content of the records, FDA suggests having a second person review settings and 193 content .",
"options": {
"D": "FDA",
"A": "PET",
"B": "Agency",
"C": "industry Process Validation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If these independent security ro le assignments are not practical f or small op erations or ____ facilities with few employees, such as PET or medical gas facilities , FDA recommends 190 alternate control strategies be implemented .7\nFor example, in the rare instance that the 191 same person is required\nt o hold the system administrator role and to be responsible for 192 the content of the records, FDA suggests having a second person review settings and 193 content .",
"reference": "If these independent security ro le assignments are not practical f or small op erations or 189 facilities with few employees, such as PET or medical gas facilities , FDA recommends 190 alternate control strategies be implemented .7\nFor example, in the rare instance that the 191 same person is required\nt o hold the system administrator role and to be responsible for 192 the content of the records, FDA suggests having a second person review settings and 193 content .",
"options": {
"A": "189",
"B": "190",
"C": "191",
"D": "industry Process Validation"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If these independent security ro le assignments are not practical f or small op erations or 189 facilities with few employees, such as PET or medical gas facilities , FDA recommends ____ alternate control strategies be implemented .7\nFor example, in the rare instance that the 191 same person is required\nt o hold the system administrator role and to be responsible for 192 the content of the records, FDA suggests having a second person review settings and 193 content .",
"reference": "If these independent security ro le assignments are not practical f or small op erations or 189 facilities with few employees, such as PET or medical gas facilities , FDA recommends 190 alternate control strategies be implemented .7\nFor example, in the rare instance that the 191 same person is required\nt o hold the system administrator role and to be responsible for 192 the content of the records, FDA suggests having a second person review settings and 193 content .",
"options": {
"A": "190",
"B": "189",
"C": "191",
"D": "industry Process Validation"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If these independent security ro le assignments are not practical f or small op erations or 189 facilities with few employees, such as PET or medical gas facilities , FDA recommends 190 alternate control strategies be implemented ____\nFor example, in the rare instance that the 191 same person is required\nt o hold the system administrator role and to be responsible for 192 the content of the records, FDA suggests having a second person review settings and 193 content .",
"reference": "If these independent security ro le assignments are not practical f or small op erations or 189 facilities with few employees, such as PET or medical gas facilities , FDA recommends 190 alternate control strategies be implemented .7\nFor example, in the rare instance that the 191 same person is required\nt o hold the system administrator role and to be responsible for 192 the content of the records, FDA suggests having a second person review settings and 193 content .",
"options": {
"C": ".7",
"A": "industry Process Validation",
"B": "process validation",
"D": "189"
},
"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 15 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Succession planning, training, capturing institutiona l knowledge, and planning for personnel, policy, and process changes are preventive actions that will help en sure that potential problems and root causes are identified, possible consequences assesse d, and appropriate actions considered. The selected preventive action should be eval uated and recorded, and the system should be monitored for the effectiveness of the action. Pr oblems can be anticipate d
and their occurrence prevented by reviewing data and analyzing risks associated with operational and quality system processes, and by keeping abreast of changes in scientific developments and regulatory requirements. Promote Improvement
The effectiveness and efficiency of a quality system can be improved through the quality activities described in this guidance. Management ma y choose to use other improvement activities as appropriate. It is critical that senior management be involved in the evaluation of this improvement process (see IV.D.3.). The following table shows how the CGMP regulati ons correlate to specific elements in the quality systems model for this section. Manufacturers should always refer to the specific regulations to make sure they ar e complying with all regulations. Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data for Trends Annual Review: 211.180(e) 2. Conduct Internal Audits -- 3. RiskAssessment 4. Corrective Action Discrepancy investigation: 211.22(a), 211.192 5.Preventive Action 6. Promote Improvement 211.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211. The central goal of a quality system is the consistent production of safe and effective products and ensuring that these activit ies are sustainable.
[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: 'Succession planning, training, capturing instituti...'?",
"reference": "Succession planning, training, capturing institutiona l knowledge, and planning for personnel, policy, and process changes are preventive actions that will help en sure that potential problems and root causes are identified, possible consequences assesse d, and appropriate actions considered.",
"options": {
"D": "institutiona l knowledge",
"A": "CGMP",
"B": "Evaluation Activities Quality System Element Regulatory Citation",
"C": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Succession planning, training, capturing institutiona l know...'?",
"reference": "Succession planning, training, capturing institutiona l knowledge, and planning for personnel, policy, and process changes are preventive actions that will help en sure that potential problems and root causes are identified, possible consequences assesse d, and appropriate actions considered.",
"options": {
"C": "Succession planning, training, capturing institutiona l knowledge, and planning for personnel, polic...",
"A": "institutiona l knowledge",
"B": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data",
"D": "a comprehensive quality systems model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The following table shows how the CGMP regulati on...'?",
"reference": "The following table shows how the CGMP regulati ons correlate to specific elements in the quality systems model for this section.",
"options": {
"C": "CGMP",
"A": "Evaluation Activities Quality System Element Regulatory Citation",
"B": "Conduct Internal Audits",
"D": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations 21 CFR CGMP Re...'?",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data for Trends Annual Review: 211.180(e) 2.",
"options": {
"D": "Evaluation Activities Quality System Element Regulatory Citation",
"A": "CGMP",
"B": "Conduct Internal Audits",
"C": "a comprehensive quality systems model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ CFR CGMP Regulations Related to Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data for Trends Annual Review: 211.180(e) 2.",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data for Trends Annual Review: 211.180(e) 2.",
"options": {
"B": "21",
"A": "1.Analyze",
"C": "211.180(e",
"D": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "B",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____1 CFR CGMP Regulations Related to Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data for Trends Annual Review: 211.180(e) 2.",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data for Trends Annual Review: 211.180(e) 2.",
"options": {
"D": "2",
"A": "1.Analyze",
"B": "211.180(e",
"C": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "D",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "What percentage is mentioned: 'Promote Improvement 211.110 V. CONCLUSION Impleme...'?",
"reference": "Promote Improvement 211.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211.",
"options": {
"A": "211.110 V.",
"B": "1.Analyze",
"C": "211.180(e",
"D": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Promote Improvement 211.110 V. CONCLUSION Impleme...'?",
"reference": "Promote Improvement 211.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211.",
"options": {
"A": "CFR",
"B": "CGMP",
"C": "Evaluation Activities Quality System Element Regulatory Citation",
"D": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Promote Improvement ____ V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211.",
"reference": "Promote Improvement 211.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211.",
"options": {
"D": "211.110",
"A": "1.Analyze",
"B": "211.180(e",
"C": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Promote Improvement ____1.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211.",
"reference": "Promote Improvement 211.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211.",
"options": {
"A": "21",
"B": "1.Analyze",
"C": "211.180(e",
"D": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Promote Improvement 211.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts ____ and 211.",
"reference": "Promote Improvement 211.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211.",
"options": {
"B": "210",
"A": "1.Analyze",
"C": "211.180(e",
"D": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Promote Improvement ____.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211.",
"reference": "Promote Improvement 211.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211.",
"options": {
"C": "211",
"A": "1.Analyze",
"B": "211.180(e",
"D": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Succession planning, training, capturing instituti...'?",
"reference": "Succession planning, training, capturing institutiona l knowledge, and planning for personnel, policy, and process changes are preventive actions that will help en sure that potential problems and root causes are identified, possible consequences assesse d, and appropriate actions considered.",
"options": {
"D": "institutiona l knowledge",
"A": "CGMP",
"B": "Evaluation Activities Quality System Element Regulatory Citation",
"C": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Succession planning, training, capturing institutiona l know...'?",
"reference": "Succession planning, training, capturing institutiona l knowledge, and planning for personnel, policy, and process changes are preventive actions that will help en sure that potential problems and root causes are identified, possible consequences assesse d, and appropriate actions considered.",
"options": {
"C": "Succession planning, training, capturing institutiona l knowledge, and planning for personnel, polic...",
"A": "institutiona l knowledge",
"B": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data",
"D": "a comprehensive quality systems model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations 21 CFR CGMP Re...'?",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data for Trends Annual Review: 211.180(e) 2.",
"options": {
"A": "Evaluation Activities Quality System Element Regulatory Citation",
"B": "CGMP",
"C": "Conduct Internal Audits",
"D": "a comprehensive quality systems model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 10 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Succession planning, training, capturing institutiona l knowledge, and planning for personnel, policy, and process changes are preventive actions that will help en sure that potential problems and root causes are identified, possible consequences assesse d, and appropriate actions considered. The selected preventive action should be eval uated and recorded, and the system should be monitored for the effectiveness of the action. Pr oblems can be anticipate d
and their occurrence prevented by reviewing data and analyzing risks associated with operational and quality system processes, and by keeping abreast of changes in scientific developments and regulatory requirements. Promote Improvement
The effectiveness and efficiency of a quality system can be improved through the quality activities described in this guidance. Management ma y choose to use other improvement activities as appropriate. It is critical that senior management be involved in the evaluation of this improvement process (see IV.D.3.). The following table shows how the CGMP regulati ons correlate to specific elements in the quality systems model for this section. Manufacturers should always refer to the specific regulations to make sure they ar e complying with all regulations. Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data for Trends Annual Review: 211.180(e) 2. Conduct Internal Audits -- 3. RiskAssessment 4. Corrective Action Discrepancy investigation: 211.22(a), 211.192 5.Preventive Action 6. Promote Improvement 211.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211. The central goal of a quality system is the consistent production of safe and effective products and ensuring that these activit ies are sustainable.
[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: Corrective Action Discrepancy investigation: 211.22(a), ____ 5.Preventive Action 6.",
"reference": "Corrective Action Discrepancy investigation: 211.22(a), 211.192 5.Preventive Action 6.",
"options": {
"A": "211.192",
"B": "1.Analyze",
"C": "211.180(e",
"D": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Corrective Action Discrepancy investigation: 211.22(a), 211.192 5.Preventive Action ____.",
"reference": "Corrective Action Discrepancy investigation: 211.22(a), 211.192 5.Preventive Action 6.",
"options": {
"B": "6",
"A": "1.Analyze",
"C": "211.180(e",
"D": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Succession planning, training, capturing instituti...'?",
"reference": "Succession planning, training, capturing institutiona l knowledge, and planning for personnel, policy, and process changes are preventive actions that will help en sure that potential problems and root causes are identified, possible consequences assesse d, and appropriate actions considered.",
"options": {
"A": "institutiona l knowledge",
"B": "CGMP",
"C": "Evaluation Activities Quality System Element Regulatory Citation",
"D": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Succession planning, training, capturing institutiona l know...'?",
"reference": "Succession planning, training, capturing institutiona l knowledge, and planning for personnel, policy, and process changes are preventive actions that will help en sure that potential problems and root causes are identified, possible consequences assesse d, and appropriate actions considered.",
"options": {
"D": "Succession planning, training, capturing institutiona l knowledge, and planning for personnel, polic...",
"A": "institutiona l knowledge",
"B": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data",
"C": "a comprehensive quality systems model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Succession planning, training, capturing instituti...'?",
"reference": "Succession planning, training, capturing institutiona l knowledge, and planning for personnel, policy, and process changes are preventive actions that will help en sure that potential problems and root causes are identified, possible consequences assesse d, and appropriate actions considered.",
"options": {
"D": "institutiona l knowledge",
"A": "CGMP",
"B": "Evaluation Activities Quality System Element Regulatory Citation",
"C": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Succession planning, training, capturing institutiona l know...'?",
"reference": "Succession planning, training, capturing institutiona l knowledge, and planning for personnel, policy, and process changes are preventive actions that will help en sure that potential problems and root causes are identified, possible consequences assesse d, and appropriate actions considered.",
"options": {
"D": "Succession planning, training, capturing institutiona l knowledge, and planning for personnel, polic...",
"A": "institutiona l knowledge",
"B": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data",
"C": "a comprehensive quality systems model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What percentage is mentioned: 'Promote Improvement 211.110 V. CONCLUSION Impleme...'?",
"reference": "Promote Improvement 211.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211.",
"options": {
"B": "211.110 V.",
"A": "1.Analyze",
"C": "211.180(e",
"D": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Promote Improvement 211.110 V. CONCLUSION Impleme...'?",
"reference": "Promote Improvement 211.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211.",
"options": {
"B": "CFR",
"A": "CGMP",
"C": "Evaluation Activities Quality System Element Regulatory Citation",
"D": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Promote Improvement ____ V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211.",
"reference": "Promote Improvement 211.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211.",
"options": {
"C": "211.110",
"A": "1.Analyze",
"B": "211.180(e",
"D": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Promote Improvement ____1.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211.",
"reference": "Promote Improvement 211.110 V. CONCLUSION Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological pro ducts, will facilitate compliance with 21 CFR parts 210 and 211.",
"options": {
"D": "21",
"A": "1.Analyze",
"B": "211.180(e",
"C": "Evaluation Activities Quality System Element Regulatory Citation 1.Analyze Data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 10 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
It is similar to a strategic direction that communicates quality expectations that the organization is striving to achieve. Quality Sys tem Formalized business prac tices that define management responsibilities for organizational structure, processes, procedures , and resources needed to fulfill product/service requirements, customer satisfaction, and continual improvement Quality Unit A group organized within an organization to promote quality in general practice Risk The combination of the probab ility of occurrence of harm a nd the severity of that harm Risk Assessment A systematic process for organizing info rmation to support a risk decision that is made within a risk mana gement process. The process c onsists of the identification of hazards and the analysis and ev aluation of risks associated wi th exposure to those hazards. Risk Management T he systematic application of qua lity management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk Senior Management Top management officials in a fi rm who have the authority and responsibility to mobilize resources Stakeholder An individual or organization having an ownership or interest in the delivery, results, and metrics of the quality system framework or business process improveme nts Verification Confir mation, through th e provision of objective ev idence, that specified requirements have been fulfilled. T he ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Division, J.P. Russell, Editor)
Validation Confirmation, through the provision of objective eviden ce, that the requirements for a specific intended use or application have been fulfilled. (Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Di vision, J.P. Russell, Editor) 28
[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: 'Risk Management T he systematic application of qu...'?",
"reference": "Risk Management T he systematic application of qua lity management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk Senior Management Top management officials in a fi rm who have the authority and responsibility to mobilize resources Stakeholder An individual or organization having an ownership or interest in the delivery, results, and metrics of the quality system framework or business process improveme nts Verification Confir mation, through th e provision of objective ev idence, that specified requirements have been fulfilled.",
"options": {
"D": "Stakeholder",
"A": "Formalized",
"B": "Quality Unit A",
"C": "ASQ Quality Audit Di vision"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Risk Management T he systematic application of qu...'?",
"reference": "Risk Management T he systematic application of qua lity management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk Senior Management Top management officials in a fi rm who have the authority and responsibility to mobilize resources Stakeholder An individual or organization having an ownership or interest in the delivery, results, and metrics of the quality system framework or business process improveme nts Verification Confir mation, through th e provision of objective ev idence, that specified requirements have been fulfilled.",
"options": {
"C": "Verification Confir",
"A": "ASQ Quality Audit Di vision",
"B": "ASQ Quality Audit Division",
"D": "Stakeholder"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Risk Management T he systematic application of qu...'?",
"reference": "Risk Management T he systematic application of qua lity management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk Senior Management Top management officials in a fi rm who have the authority and responsibility to mobilize resources Stakeholder An individual or organization having an ownership or interest in the delivery, results, and metrics of the quality system framework or business process improveme nts Verification Confir mation, through th e provision of objective ev idence, that specified requirements have been fulfilled.",
"options": {
"B": "Stakeholder",
"A": "Formalized",
"C": "Quality Unit A",
"D": "ASQ Quality Audit Di vision"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Risk Management T he systematic application of qu...'?",
"reference": "Risk Management T he systematic application of qua lity management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk Senior Management Top management officials in a fi rm who have the authority and responsibility to mobilize resources Stakeholder An individual or organization having an ownership or interest in the delivery, results, and metrics of the quality system framework or business process improveme nts Verification Confir mation, through th e provision of objective ev idence, that specified requirements have been fulfilled.",
"options": {
"A": "Verification Confir",
"B": "ASQ Quality Audit Di vision",
"C": "ASQ Quality Audit Division",
"D": "Stakeholder"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(Reference: The ASQ Auditing Handbook, 3rd edition...'?",
"reference": "(Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Di vision, J.P. Russell, Editor) 28",
"options": {
"B": "ASQ Quality Audit",
"A": "Formalized",
"C": "Quality Unit A",
"D": "a risk mana gement process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: '(Reference: The ASQ Auditing Handbook, 3rd edition...'?",
"reference": "(Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Di vision, J.P. Russell, Editor) 28",
"options": {
"A": "J.P. Russell",
"B": "ASQ Quality Audit Di vision",
"C": "ASQ Quality Audit Division",
"D": "ASQ Quality Audit"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: (Reference: The ASQ Auditing Handbook, ____ edition, ASQ Quality Audit Di vision, J.P. Russell, Editor) 28",
"reference": "(Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Di vision, J.P. Russell, Editor) 28",
"options": {
"B": "3rd",
"A": "ASQ Quality Audit Di vision",
"C": "ASQ Quality Audit Division",
"D": "third"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Di vision, J.P. Russell, Editor) ____",
"reference": "(Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Di vision, J.P. Russell, Editor) 28",
"options": {
"A": "28",
"B": "ASQ Quality Audit Di vision",
"C": "ASQ Quality Audit Division",
"D": "twenty-eight"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(Reference: The ASQ Auditing Handbook, 3rd edition...'?",
"reference": "(Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Di vision, J.P. Russell, Editor) 28",
"options": {
"B": "ASQ Quality Audit",
"A": "Formalized",
"C": "Quality Unit A",
"D": "a risk mana gement process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: '(Reference: The ASQ Auditing Handbook, 3rd edition...'?",
"reference": "(Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Di vision, J.P. Russell, Editor) 28",
"options": {
"D": "J.P. Russell",
"A": "ASQ Quality Audit Di vision",
"B": "ASQ Quality Audit Division",
"C": "ASQ Quality Audit"
},
"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 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy. Manufacturers may decide to conduct different assurance activities for individual 190 features, functions, or op erations. 191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses. When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration . The intended use of the software, documen ting readings , only support s 198 maintaining the quality system record and poses a low process risk. As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome. Several functions of the software may, in turn, be applied together in an operation to perform practical work in a process. For the purposes of this gu idance, a function refers to a software function and is not to be confused with a device function. Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to 200 establish that the software is fit for its intended use and maintain s a validated state .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: Manufacturers may decide to conduct different assurance activities for individual ____ features, functions, or op erations.",
"reference": "Manufacturers may decide to conduct different assurance activities for individual 190 features, functions, or op erations.",
"options": {
"D": "190",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '191 192 For example, a commercial off -the-shelf (...'?",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"B": "COTS",
"A": "a software function",
"C": "the vendor assessment and software installation",
"D": "cot"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"D": "191",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 191 ____ For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"C": "192",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of ____ various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"C": "193",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Manufacturers may decide to conduct different assurance activities for individual ____ features, functions, or op erations.",
"reference": "Manufacturers may decide to conduct different assurance activities for individual 190 features, functions, or op erations.",
"options": {
"A": "190",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When utilizing the basic input functions of the 19...'?",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"A": "COTS",
"B": "a software function",
"C": "the vendor assessment and software installation",
"D": "cot"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the ____ COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"A": "194",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature ____ readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"D": "195",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance ____ activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"B": "196",
"A": "185",
"C": "186",
"D": "a software function"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, initial activities ____ 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"reference": "As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"options": {
"D": "199",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, initial activities 199 ____ That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"reference": "As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"options": {
"A": "5",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, initial activities ____ 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"reference": "As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"options": {
"D": "199",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, initial activities 199 ____ That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"reference": "As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"options": {
"B": "5",
"A": "185",
"C": "186",
"D": "a software function"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, initial activities ____ 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"reference": "As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"options": {
"A": "199",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, initial activities 199 ____ That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"reference": "As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"options": {
"C": "5",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, initial activities ____ 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"reference": "As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"options": {
"D": "199",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, initial activities 199 ____ That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"reference": "As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"options": {
"C": "5",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Manufacturers may decide to conduct different assurance activities for individual ____ features, functions, or op erations.",
"reference": "Manufacturers may decide to conduct different assurance activities for individual 190 features, functions, or op erations.",
"options": {
"D": "190",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When utilizing the basic input functions of the 19...'?",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"D": "COTS",
"A": "a software function",
"B": "the vendor assessment and software installation",
"C": "cot"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 7 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
An independe nt quality unit/structure with authority to fulfill certain pharmaceutical quality sy stem responsibilities is required by regional regulations. (5) Conduct management reviews of proce ss performance and product quality and of the pharmaceutical quality system. (6) Advocate continual improvement. (7) Commit appropriate resources. B. Quality Policy (2.2) (a) Senior management should establish a quality policy that describes the overall intentions and direction of th e company related to quality. (b) The quality policy should include an expecta tion to comply with applicable regulatory requirements and should facilitate continual improvement of the pharmaceutical quality system. (c) The quality policy should be communicated to and understood by personnel at all levels in the company. The quality policy should be reviewed periodically for continuing effectiveness. C. Quality Planning ( 2.3) (a) Senior management should ensure the quality objectives to implement the quality policy are defined and communicated. (b) Quality objectives should be supported by a ll relevant levels of the company. (c) Quality objectives should align with the comp anys strategies and be consistent with the quality policy. (d) Management should provide the appropriate resources and training to achieve the 6 quality objectives. (e) Performance indicators that measure progress against quality objectives should be established, monitored, communicated regular ly, and acted upon as appropriate as described in section V.A ( 4.1) of this document. D. Resource Management (2.4) (a) Management should determine and provide adequate and appropriate resources (human, financial, materials, facilities, a nd equipment) to implement and maintain the pharmaceutical quality system and continually improve its effectiveness. (b) Management should ensure that resources are appropriately app lied to a specific product, process, or site.
[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: (____) Advocate continual improvement.",
"reference": "(6) Advocate continual improvement.",
"options": {
"B": "6",
"A": "2.2",
"C": "2.3",
"D": "B. Quality Policy"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Commit appropriate resources.",
"reference": "(7) Commit appropriate resources.",
"options": {
"A": "7",
"B": "2.2",
"C": "2.3",
"D": "B. Quality Policy"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (e) Performance indicators that measure progress against quality objectives should be established, monitored, communicated regular ly, and acted upon as appropriate as described in section V.A ( ____) of this document.",
"reference": "(e) Performance indicators that measure progress against quality objectives should be established, monitored, communicated regular ly, and acted upon as appropriate as described in section V.A ( 4.1) of this document.",
"options": {
"D": "4.1",
"A": "2.2",
"B": "2.3",
"C": "B. Quality Policy"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'C. Quality Planning ( 2.3) (a) Senior management s...'?",
"reference": "C. Quality Planning ( 2.3) (a) Senior management should ensure the quality objectives to implement the quality policy are defined and communicated.",
"options": {
"B": "C. Quality Planning",
"A": "B. Quality Policy",
"C": "a quality policy",
"D": "2.3"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: C. Quality Planning ( ____) (a) Senior management should ensure the quality objectives to implement the quality policy are defined and communicated.",
"reference": "C. Quality Planning ( 2.3) (a) Senior management should ensure the quality objectives to implement the quality policy are defined and communicated.",
"options": {
"D": "2.3",
"A": "2.2",
"B": "4.1",
"C": "B. Quality Policy"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'C. Quality Planning ( 2.3) (a) Senior management s...'?",
"reference": "C. Quality Planning ( 2.3) (a) Senior management should ensure the quality objectives to implement the quality policy are defined and communicated.",
"options": {
"B": "C. Quality Planning",
"A": "B. Quality Policy",
"C": "a quality policy",
"D": "2.3"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: C. Quality Planning ( ____) (a) Senior management should ensure the quality objectives to implement the quality policy are defined and communicated.",
"reference": "C. Quality Planning ( 2.3) (a) Senior management should ensure the quality objectives to implement the quality policy are defined and communicated.",
"options": {
"A": "2.3",
"B": "2.2",
"C": "4.1",
"D": "B. Quality Policy"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 1 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Table II: Application of Corrective Action and Preventive Action System Throughout the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability is explored. CAPA methodology is useful where corrective actions and preventive actions are incorporated into the iterative design and development process. CAPA can be used as an effective system for feedback, feedforward, and continual improvement. CAPA should be used, and the effectiveness of the actions should be evaluated. CAPA should continue after the product is discontinued. The impact on product remaining on the market should be considered, as well as other products that might be affected. 3. Change Management System (3.2.3) Innovation, continual improvement, the outputs of process performance and product quality monitoring, and CAPA drive change. To eval uate, approve, and implement these changes properly, a company should have an effective change management system. There is generally a difference in formality of change management processes prior to the initial regulatory submission and after submission, where changes to the regulatory filing might be required under regional requirements. The change management system ensures continua l improvement is undertaken in a timely and effective manner. It should provide a high de gree of assurance th ere are no unintended consequences of the change. The change management system should include the following, as appropriate for the stage of the lifecycle: (a) Quality risk management should be utilized to evaluate proposed changes. The level of effort and formality of the evaluation should be commensurate with the level of risk. (b) Proposed changes should be evaluated re lative to the marketing authorization, including design space, where established, and/or current product and process understanding.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Change Management System (3.2.3) Innovation, conti...'?",
"reference": "Change Management System (3.2.3) Innovation, continual improvement, the outputs of process performance and product quality monitoring, and CAPA drive change.",
"options": {
"A": "Change Management System",
"B": "CAPA",
"C": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Product or process variability",
"D": "CAPA drive change"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
In this example, the manufacturer has 531 established additional process controls and inspections that ensure non -conform ing product is not 532 released. In this case, failure of the spreadsheet to perform as intended would not result in a 533 quality problem that foreseeably leads to compromised safety, so the spre adsheet would not pose 534 a high process risk. The manufacturer conducted rapid exploratory testing of specific functions 535 used in the spreadsheet to ensure that analyses can be created, read, updated, and/or deleted. During exploratory testing, all calculated fields updated correctly except for one deviation that 537 occurred during update testing. In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system. Because of this use, the spreadsheet is 542 different from similar software used for business operations such as for accounting. 543 544 Risk-Based Analysis: In this case, the software is only used to collect and display data 545 for monitoring nonconformances , and the manufacturer has established additional process 546 controls and inspections to ensure that nonconform ing product is not released. Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety. As such, the software does not pose a high 549 process risk, and the assurance activities should be commensurate with the process risk .
[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: Therefore, ____ failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"reference": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"options": {
"D": "547",
"A": "531",
"B": "532",
"C": "a high 549 process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem ____ that foreseeably leads to compromised safety.",
"reference": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"options": {
"D": "548",
"A": "531",
"B": "532",
"C": "a high 549 process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Therefore, 547 failure of the spreadsheet to perform as inte...'?",
"reference": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"options": {
"A": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality prob...",
"B": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Because of this use, the spreadsheet is ____ different from similar software used for business operations such as for accounting.",
"reference": "Because of this use, the spreadsheet is 542 different from similar software used for business operations such as for accounting.",
"options": {
"C": "542",
"A": "531",
"B": "532",
"D": "a high 549 process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Because of this use, the spreadsheet is 542 different from s...'?",
"reference": "Because of this use, the spreadsheet is 542 different from similar software used for business operations such as for accounting.",
"options": {
"C": "Because of this use, the spreadsheet is 542 different from similar software used for business operat...",
"A": "531",
"B": "532",
"D": "a high 549 process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this case, failure of the spreadsheet to perform as intended would not result in a ____ quality problem that foreseeably leads to compromised safety, so the spre adsheet would not pose 534 a high process risk.",
"reference": "In this case, failure of the spreadsheet to perform as intended would not result in a 533 quality problem that foreseeably leads to compromised safety, so the spre adsheet would not pose 534 a high process risk.",
"options": {
"A": "533",
"B": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this case, failure of the spreadsheet to perform as intended would not result in a 533 quality problem that foreseeably leads to compromised safety, so the spre adsheet would not pose ____ a high process risk.",
"reference": "In this case, failure of the spreadsheet to perform as intended would not result in a 533 quality problem that foreseeably leads to compromised safety, so the spre adsheet would not pose 534 a high process risk.",
"options": {
"B": "534",
"A": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'In this case, failure of the spreadsheet to perform as inten...'?",
"reference": "In this case, failure of the spreadsheet to perform as intended would not result in a 533 quality problem that foreseeably leads to compromised safety, so the spre adsheet would not pose 534 a high process risk.",
"options": {
"A": "In this case, failure of the spreadsheet to perform as intended would not result in a 533 quality pr...",
"B": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, the software does not pose a high ____ process risk, and the assurance activities should be commensurate with the process risk .",
"reference": "As such, the software does not pose a high 549 process risk, and the assurance activities should be commensurate with the process risk .",
"options": {
"D": "549",
"A": "531",
"B": "532",
"C": "531 established additional process controls"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, the software does not pose a high ____ process risk, and the assurance activities should be commensurate with the process risk .",
"reference": "As such, the software does not pose a high 549 process risk, and the assurance activities should be commensurate with the process risk .",
"options": {
"C": "549",
"A": "531",
"B": "532",
"D": "531 established additional process controls"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Because of this use, the spreadsheet is ____ different from similar software used for business operations such as for accounting.",
"reference": "Because of this use, the spreadsheet is 542 different from similar software used for business operations such as for accounting.",
"options": {
"A": "542",
"B": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Because of this use, the spreadsheet is 542 different from s...'?",
"reference": "Because of this use, the spreadsheet is 542 different from similar software used for business operations such as for accounting.",
"options": {
"A": "Because of this use, the spreadsheet is 542 different from similar software used for business operat...",
"B": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: During exploratory testing, all calculated fields updated correctly except for ____ deviation that 537 occurred during update testing.",
"reference": "During exploratory testing, all calculated fields updated correctly except for one deviation that 537 occurred during update testing.",
"options": {
"B": "one",
"A": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: During exploratory testing, all calculated fields updated correctly except for one deviation that ____ occurred during update testing.",
"reference": "During exploratory testing, all calculated fields updated correctly except for one deviation that 537 occurred during update testing.",
"options": {
"D": "537",
"A": "531",
"B": "532",
"C": "a high 549 process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Therefore, ____ failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"reference": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"options": {
"A": "547",
"B": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem ____ that foreseeably leads to compromised safety.",
"reference": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"options": {
"A": "548",
"B": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Therefore, 547 failure of the spreadsheet to perform as inte...'?",
"reference": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"options": {
"D": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality prob...",
"A": "531",
"B": "532",
"C": "a high 549 process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this scenario, the record would be documented as follows: ____ 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"reference": "In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"options": {
"B": "538",
"A": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this scenario, the record would be documented as follows: 538 ____ Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"reference": "In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"options": {
"A": "539",
"B": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing ____ nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"reference": "In this scenario, the record would be documented as follows: 538 539 Intended Use: The spreadsheet is intended for use in collecting and graphing 540 nonconformanc e data stored in a controlled system for monitoring purposes ; as such, it is 541 used as part of production or the quality system.",
"options": {
"C": "540",
"A": "531",
"B": "532",
"D": "a high 549 process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The manufacturer conducted rapid exploratory testing of specific functions ____ used in the spreadsheet to ensure that analyses can be created, read, updated, and/or deleted.",
"reference": "The manufacturer conducted rapid exploratory testing of specific functions 535 used in the spreadsheet to ensure that analyses can be created, read, updated, and/or deleted.",
"options": {
"C": "535",
"A": "531",
"B": "532",
"D": "a high 549 process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, the software does not pose a high ____ process risk, and the assurance activities should be commensurate with the process risk .",
"reference": "As such, the software does not pose a high 549 process risk, and the assurance activities should be commensurate with the process risk .",
"options": {
"C": "549",
"A": "531",
"B": "532",
"D": "531 established additional process controls"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: During exploratory testing, all calculated fields updated correctly except for ____ deviation that 537 occurred during update testing.",
"reference": "During exploratory testing, all calculated fields updated correctly except for one deviation that 537 occurred during update testing.",
"options": {
"B": "one",
"A": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: During exploratory testing, all calculated fields updated correctly except for one deviation that ____ occurred during update testing.",
"reference": "During exploratory testing, all calculated fields updated correctly except for one deviation that 537 occurred during update testing.",
"options": {
"B": "537",
"A": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The manufacturer conducted rapid exploratory testing of specific functions ____ used in the spreadsheet to ensure that analyses can be created, read, updated, and/or deleted.",
"reference": "The manufacturer conducted rapid exploratory testing of specific functions 535 used in the spreadsheet to ensure that analyses can be created, read, updated, and/or deleted.",
"options": {
"D": "535",
"A": "531",
"B": "532",
"C": "a high 549 process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Therefore, ____ failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"reference": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"options": {
"A": "547",
"B": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem ____ that foreseeably leads to compromised safety.",
"reference": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"options": {
"D": "548",
"A": "531",
"B": "532",
"C": "a high 549 process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Therefore, 547 failure of the spreadsheet to perform as inte...'?",
"reference": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality problem 548 that foreseeably leads to compromised safety.",
"options": {
"C": "Therefore, 547 failure of the spreadsheet to perform as intended should not result in a quality prob...",
"A": "531",
"B": "532",
"D": "a high 549 process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The manufacturer conducted rapid exploratory testing of specific functions ____ used in the spreadsheet to ensure that analyses can be created, read, updated, and/or deleted.",
"reference": "The manufacturer conducted rapid exploratory testing of specific functions 535 used in the spreadsheet to ensure that analyses can be created, read, updated, and/or deleted.",
"options": {
"A": "535",
"B": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 544 Risk-Based Analysis: In this case, the software is only used to collect and display data 545 for monitoring nonconformances , and the manufacturer has established additional process 546 controls and inspections to ensure that nonconform ing product is not released.",
"reference": "543 544 Risk-Based Analysis: In this case, the software is only used to collect and display data 545 for monitoring nonconformances , and the manufacturer has established additional process 546 controls and inspections to ensure that nonconform ing product is not released.",
"options": {
"A": "543",
"B": "531",
"C": "532",
"D": "a high 549 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 5 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
This process risk 249 identification step focuses only on the process , as opposed to the medical device risk posed to the 250 patient or user . Examples of software features, functions, or operations that are generally high 251 process risk are those that: 252 253 maintain process parameters (e.g., temperature, pressure, or humidity) that affect the 254 physical properties of prod uct or manufacturing processes that are identified as essential 255 to device safety or quality; 256 257 measure, inspect, analyze and/or determine acceptability of product or process with 258 limited or no additional human awareness or review; 259 260 perform process correctio ns or adjustments of process parameters based on data 261 monitoring or automated feedback from other process steps without additional human 262 awareness or review; 263 264 produce directions for use or other labeling provided to patients and users that are 265 necessary for safe operation of the medical device; and/or 266 267 automate surveillance, trending, or tracking of data that the manufacturer identifies as 268 essential to device safety and quality. In contrast, FDA considers a software feature, function, or o peration not to pose a high process 271 risk when its failure to perform as intended would not result in a quality problem that 272 foreseeably compromises safety . This includes situations where failure to perfo rm as 273 intended would not result in a quality problem, as well as situations where failure to 274 perfo rm as intended may result in a quality problem that does not foreseeably lead to 275 compromised safety .
[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: This process risk ____ identification step focuses only on the process , as opposed to the medical device risk posed to the 250 patient or user .",
"reference": "This process risk 249 identification step focuses only on the process , as opposed to the medical device risk posed to the 250 patient or user .",
"options": {
"A": "249",
"B": "250",
"C": "251",
"D": "high 251 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This process risk 249 identification step focuses only on the process , as opposed to the medical device risk posed to the ____ patient or user .",
"reference": "This process risk 249 identification step focuses only on the process , as opposed to the medical device risk posed to the 250 patient or user .",
"options": {
"A": "250",
"B": "249",
"C": "251",
"D": "high 251 process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This includes situations where failure to perfo rm as ____ intended would not result in a quality problem, as well as situations where failure to 274 perfo rm as intended may result in a quality problem that does not foreseeably lead to 275 compromised safety .",
"reference": "This includes situations where failure to perfo rm as 273 intended would not result in a quality problem, as well as situations where failure to 274 perfo rm as intended may result in a quality problem that does not foreseeably lead to 275 compromised safety .",
"options": {
"C": "273",
"A": "249",
"B": "250",
"D": "high 251 process risk"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This includes situations where failure to perfo rm as 273 intended would not result in a quality problem, as well as situations where failure to ____ perfo rm as intended may result in a quality problem that does not foreseeably lead to 275 compromised safety .",
"reference": "This includes situations where failure to perfo rm as 273 intended would not result in a quality problem, as well as situations where failure to 274 perfo rm as intended may result in a quality problem that does not foreseeably lead to 275 compromised safety .",
"options": {
"A": "274",
"B": "249",
"C": "250",
"D": "high 251 process risk"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This includes situations where failure to perfo rm as 273 intended would not result in a quality problem, as well as situations where failure to 274 perfo rm as intended may result in a quality problem that does not foreseeably lead to ____ compromised safety .",
"reference": "This includes situations where failure to perfo rm as 273 intended would not result in a quality problem, as well as situations where failure to 274 perfo rm as intended may result in a quality problem that does not foreseeably lead to 275 compromised safety .",
"options": {
"B": "275",
"A": "249",
"C": "250",
"D": "high 251 process risk"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 35 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3
The guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products. QUESTIONS AND ANSWERS 66 67 1. Please clarify the following terms as they relate to CGMP records: 68 69 a. What is data integrity ? For the purpose s of this guidance, data integrity refers to the complete ness, 72 consisten cy, and accura cy of data. Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)
.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess . 3 CDER updates guidanc es periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance W eb page at www.fda.gov/Drugs/GuidanceComplianc eRegulatoryInformation/Guidances/default.htm . For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g). Contains Nonbinding Recommendations Draft Not for Implementation 3 b. What is metadata ?
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"D": "Electronic Records",
"A": "the FDA Drugs guidance W eb page",
"B": "Complete, consistent, and accurate data",
"C": "Electronic Signatures Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"D": "Electronic Signatures Scope",
"A": "accura",
"B": "the FDA Drugs guidance W eb page",
"C": "Complete, consistent, and accurate data"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"B": "11 63",
"A": "67 1",
"C": "the FDA Drugs guidance W eb page",
"D": "Complete, consistent, and accurate data"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"A": "FDA",
"B": "Electronic Records",
"C": "Electronic Signatures Scope",
"D": "Complete, consistent, and accurate data"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part ____, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"D": "11",
"A": "68 69",
"B": "75 2",
"C": "the FDA Drugs guidance W eb page"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part 11, Electronic Records; ____ Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"C": "61",
"A": "68 69",
"B": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking ____ regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"B": "62",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part ____, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"A": "11",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part ____, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"B": "11",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 ____ as it applies to all FDA -regulated products.",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"D": "63",
"A": "68 69",
"B": "75 2",
"C": "the FDA Drugs guidance W eb page"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ CDER updates guidanc es periodically.",
"reference": "3 CDER updates guidanc es periodically.",
"options": {
"C": "3",
"A": "68 69",
"B": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For attributable, see 211.101(d), ____, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"reference": "For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"options": {
"C": "211.122",
"A": "68 69",
"B": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For attributable, see 211.101(d), 211.122, ____ , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"reference": "For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"options": {
"C": "211.186",
"A": "68 69",
"B": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see ____(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"reference": "For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"options": {
"D": "211.180",
"A": "68 69",
"B": "75 2",
"C": "the FDA Drugs guidance W eb page"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), ____, 211.188, and 212.60(g).",
"reference": "For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"options": {
"A": "211.68",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For attributable, see 211.101(d), 211.122, 211.186 , ____(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"reference": "For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"options": {
"C": "211.188",
"A": "68 69",
"B": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'For the purpose s of this guidance, data integrity...'?",
"reference": "For the purpose s of this guidance, data integrity refers to the complete ness, 72 consisten cy, and accura cy of data.",
"options": {
"A": "accura",
"B": "the FDA Drugs guidance W eb page",
"C": "guidance",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: For the purpose s of this guidance, data integrity refers to the complete ness, ____ consisten cy, and accura cy of data.",
"reference": "For the purpose s of this guidance, data integrity refers to the complete ness, 72 consisten cy, and accura cy of data.",
"options": {
"C": "72",
"A": "68 69",
"B": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation ____ b.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 3 b.",
"options": {
"B": "3",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ CDER updates guidanc es periodically.",
"reference": "3 CDER updates guidanc es periodically.",
"options": {
"B": "3",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Complete, consistent, and accurate data should 73 ...'?",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"C": "ALCOA",
"A": "Electronic Records",
"B": "Electronic Signatures Scope",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Complete, consistent, and accurate data should 73 ...'?",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"D": "CGMP",
"A": "Electronic Records",
"B": "Electronic Signatures Scope",
"C": "the FDA Drugs guidance W eb page"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Complete, consistent, and accurate data should 73 ...'?",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"B": "FD C Act section 501(a",
"A": "the FDA Drugs guidance W eb page",
"C": "Complete, consistent, and accurate data",
"D": "ALCOA"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Please clarify the following terms as they relate ...'?",
"reference": "Please clarify the following terms as they relate to CGMP records: 68 69 a.",
"options": {
"A": "CGMP",
"B": "Electronic Records",
"C": "Electronic Signatures Scope",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Please clarify the following terms as they relate to CGMP records: ____ 69 a.",
"reference": "Please clarify the following terms as they relate to CGMP records: 68 69 a.",
"options": {
"C": "68",
"A": "68 69",
"B": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Please clarify the following terms as they relate to CGMP records: 68 ____ a.",
"reference": "Please clarify the following terms as they relate to CGMP records: 68 69 a.",
"options": {
"B": "69",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Complete, consistent, and accurate data should 73 ...'?",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"D": "ALCOA",
"A": "Electronic Records",
"B": "Electronic Signatures Scope",
"C": "the FDA Drugs guidance W eb page"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Complete, consistent, and accurate data should 73 ...'?",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"C": "CGMP",
"A": "Electronic Records",
"B": "Electronic Signatures Scope",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Complete, consistent, and accurate data should 73 ...'?",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"B": "FD C Act section 501(a",
"A": "the FDA Drugs guidance W eb page",
"C": "Complete, consistent, and accurate data",
"D": "ALCOA"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should ____ be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"B": "73",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and ____ accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"A": "74",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n____ 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"D": ".4",
"A": "the FDA Drugs guidance W eb page",
"B": "Complete, consistent, and accurate data",
"C": "ALCOA"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 ____ 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"C": "75",
"A": "68 69",
"B": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 ____ FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"A": "2",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; 61 Electronic Signatures Scope and Application.3\nThe guidance outlines FDAs current thinking 62 regarding the narrow scope and application of part 11 pending FDAs reexamination of part 11 63 as it applies to all FDA -regulated products.",
"options": {
"B": "Electronic Records",
"A": "the FDA Drugs guidance W eb page",
"C": "Complete, consistent, and accurate data",
"D": "Electronic Signatures Scope"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 7 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Failure of these features, functions, or operations to perform as intended would impact the integrity of the quality system record but would not foreseeably compromise safety. As such, the manufacturer determined that the features, functions, and operatio ns do not pose high process risk. The manufacturer has performed an assessment of the system capability, supplier evaluation, and installation activities. In addition, the manufacturer supplements these activities with unscripted testing, applying error - guessing to attempt to circumvent process flow and break the system (e.g. try to d elete the audit trail).The manufacturer documents: the intended use risk determination a summary description of the failure modes tested any issues found and their disposition a concluding statement noting that the performance of the operation is accepta ble the date testing was performed, and who performed the testing. 623 624 Contains Nonbinding Recommendations Draft Not for Implementation 24Example 3: Business Intelligence Applications 625 A medical device manufacturer has decided to implement a commercial business intelligence solution for data mining, trending, and 626 reporting. The software is intended to better understand product and process performance over time, in order to provide ident ification 627 of improvement opportunities . The following features, functions, or operations were considered by the manufacturer in developing a 628 risk-based assurance strategy: 629 630 Table 4. Computer Software Assurance Example for a Business Intelligence Applicatio n 631 Features, Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Connectivity Functions:
The software allows for connecting to various databases in the organization and external data sources .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: The software is intended to better understand product and process performance over time, in order to provide ident ification ____ of improvement opportunities .",
"reference": "The software is intended to better understand product and process performance over time, in order to provide ident ification 627 of improvement opportunities .",
"options": {
"B": "627",
"A": "623 624",
"C": "626",
"D": "a Business Intelligence Applicatio n 631 Features"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The software is intended to better understand product and process performance over time, in order to provide ident ification ____ of improvement opportunities .",
"reference": "The software is intended to better understand product and process performance over time, in order to provide ident ification 627 of improvement opportunities .",
"options": {
"C": "627",
"A": "623 624",
"B": "626",
"D": "a Business Intelligence Applicatio n 631 Features"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 624 Contains Nonbinding Recommendations Draft Not for Implementation 24Example 3: Business Intelligence Applications 625 A medical device manufacturer has decided to implement a commercial business intelligence solution for data mining, trending, and 626 reporting.",
"reference": "623 624 Contains Nonbinding Recommendations Draft Not for Implementation 24Example 3: Business Intelligence Applications 625 A medical device manufacturer has decided to implement a commercial business intelligence solution for data mining, trending, and 626 reporting.",
"options": {
"A": "623",
"B": "623 624",
"C": "626",
"D": "a Business Intelligence Applicatio n 631 Features"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 623 ____ Contains Nonbinding Recommendations Draft Not for Implementation 24Example 3: Business Intelligence Applications 625 A medical device manufacturer has decided to implement a commercial business intelligence solution for data mining, trending, and 626 reporting.",
"reference": "623 624 Contains Nonbinding Recommendations Draft Not for Implementation 24Example 3: Business Intelligence Applications 625 A medical device manufacturer has decided to implement a commercial business intelligence solution for data mining, trending, and 626 reporting.",
"options": {
"B": "624",
"A": "623 624",
"C": "626",
"D": "a Business Intelligence Applicatio n 631 Features"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 62____ 624 Contains Nonbinding Recommendations Draft Not for Implementation 24Example 3: Business Intelligence Applications 625 A medical device manufacturer has decided to implement a commercial business intelligence solution for data mining, trending, and 626 reporting.",
"reference": "623 624 Contains Nonbinding Recommendations Draft Not for Implementation 24Example 3: Business Intelligence Applications 625 A medical device manufacturer has decided to implement a commercial business intelligence solution for data mining, trending, and 626 reporting.",
"options": {
"D": "3",
"A": "623 624",
"B": "626",
"C": "the appropriate record Connectivity Functions"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 623 624 Contains Nonbinding Recommendations Draft Not for Implementation 24Example 3: Business Intelligence Applications ____ A medical device manufacturer has decided to implement a commercial business intelligence solution for data mining, trending, and 626 reporting.",
"reference": "623 624 Contains Nonbinding Recommendations Draft Not for Implementation 24Example 3: Business Intelligence Applications 625 A medical device manufacturer has decided to implement a commercial business intelligence solution for data mining, trending, and 626 reporting.",
"options": {
"D": "625",
"A": "623 624",
"B": "626",
"C": "a Business Intelligence Applicatio n 631 Features"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 623 624 Contains Nonbinding Recommendations Draft Not for Implementation 24Example 3: Business Intelligence Applications 625 A medical device manufacturer has decided to implement a commercial business intelligence solution for data mining, trending, and ____ reporting.",
"reference": "623 624 Contains Nonbinding Recommendations Draft Not for Implementation 24Example 3: Business Intelligence Applications 625 A medical device manufacturer has decided to implement a commercial business intelligence solution for data mining, trending, and 626 reporting.",
"options": {
"C": "626",
"A": "623 624",
"B": "627",
"D": "a Business Intelligence Applicatio n 631 Features"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 45 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy. Manufacturers may decide to conduct different assurance activities for individual 190 features, functions, or op erations. 191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses. When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration . The intended use of the software, documen ting readings , only support s 198 maintaining the quality system record and poses a low process risk. As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome. Several functions of the software may, in turn, be applied together in an operation to perform practical work in a process. For the purposes of this gu idance, a function refers to a software function and is not to be confused with a device function. Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to 200 establish that the software is fit for its intended use and maintain s a validated state .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: As such, initial activities ____ 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"reference": "As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"options": {
"D": "199",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, initial activities 199 ____ That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"reference": "As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"options": {
"C": "5",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '191 192 For example, a commercial off -the-shelf (...'?",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"D": "COTS",
"A": "a software function",
"B": "the vendor assessment and software installation",
"C": "cot"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"B": "191",
"A": "185",
"C": "186",
"D": "a software function"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 191 ____ For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"B": "192",
"A": "185",
"C": "186",
"D": "a software function"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of ____ various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"A": "193",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to ____ establish that the software is fit for its intended use and maintain s a validated state .",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to 200 establish that the software is fit for its intended use and maintain s a validated state .",
"options": {
"C": "200",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '191 192 For example, a commercial off -the-shelf (...'?",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"B": "COTS",
"A": "a software function",
"C": "the vendor assessment and software installation",
"D": "cot"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"C": "191",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 191 ____ For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"C": "192",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of ____ various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"A": "193",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '191 192 For example, a commercial off -the-shelf (...'?",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"A": "COTS",
"B": "a software function",
"C": "the vendor assessment and software installation",
"D": "cot"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"A": "191",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 191 ____ For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"D": "192",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of ____ various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"A": "193",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to ____ establish that the software is fit for its intended use and maintain s a validated state .",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to 200 establish that the software is fit for its intended use and maintain s a validated state .",
"options": {
"C": "200",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, initial activities ____ 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"reference": "As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"options": {
"C": "199",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, initial activities 199 ____ That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"reference": "As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"options": {
"D": "5",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Manufacturers may decide to conduct different assurance activities for individual ____ features, functions, or op erations.",
"reference": "Manufacturers may decide to conduct different assurance activities for individual 190 features, functions, or op erations.",
"options": {
"A": "190",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '191 192 For example, a commercial off -the-shelf (...'?",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"A": "COTS",
"B": "a software function",
"C": "the vendor assessment and software installation",
"D": "cot"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"A": "191",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 191 ____ For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"B": "192",
"A": "185",
"C": "186",
"D": "a software function"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '191 192 For example, a commercial off -the-shelf (...'?",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"D": "COTS",
"A": "a software function",
"B": "the vendor assessment and software installation",
"C": "cot"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"D": "191",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 191 ____ For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"B": "192",
"A": "185",
"C": "186",
"D": "a software function"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of ____ various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"D": "193",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to ____ establish that the software is fit for its intended use and maintain s a validated state .",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to 200 establish that the software is fit for its intended use and maintain s a validated state .",
"options": {
"A": "200",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When utilizing the basic input functions of the 19...'?",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"D": "COTS",
"A": "a software function",
"B": "the vendor assessment and software installation",
"C": "cot"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the ____ COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"C": "194",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature ____ readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"A": "195",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance ____ activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"A": "196",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and ____ configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"A": "197",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '191 192 For example, a commercial off -the-shelf (...'?",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"C": "COTS",
"A": "a software function",
"B": "the vendor assessment and software installation",
"D": "cot"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '191 192 For example, a commercial off -the-shelf (...'?",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"C": "COTS",
"A": "a software function",
"B": "the vendor assessment and software installation",
"D": "cot"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"A": "191",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 191 ____ For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"D": "192",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of ____ various functions with different intended uses.",
"reference": "191 192 For example, a commercial off -the-shelf (COTS) spreadsheet software may be comprised of 193 various functions with different intended uses.",
"options": {
"A": "193",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to ____ establish that the software is fit for its intended use and maintain s a validated state .",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to 200 establish that the software is fit for its intended use and maintain s a validated state .",
"options": {
"C": "200",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When utilizing the basic input functions of the 19...'?",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"A": "COTS",
"B": "a software function",
"C": "the vendor assessment and software installation",
"D": "cot"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the ____ COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"D": "194",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature ____ readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"B": "195",
"A": "185",
"C": "186",
"D": "a software function"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance ____ activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"A": "196",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and ____ configuration .",
"reference": "When utilizing the basic input functions of the 194 COTS spreadsheet software for an intended use of documenting the time an d temperature 195 readings for a curing process, a manufacturer may not need to perform additional assurance 196 activities beyond those conducted by the COTS software developer and initial installation and 197 configuration .",
"options": {
"A": "197",
"B": "185",
"C": "186",
"D": "a software function"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to ____ establish that the software is fit for its intended use and maintain s a validated state .",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 9such as the vendor assessment and software installation and configuration may be sufficient to 200 establish that the software is fit for its intended use and maintain s a validated state .",
"options": {
"D": "200",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, initial activities ____ 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"reference": "As such, initial activities 199 5 That is, software is often an inte gration of features, that are used together to perform a function that provides a desired outcome.",
"options": {
"D": "199",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 3 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
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: 'William Perry, Effective Methods for Software Test...'?",
"reference": "William Perry, Effective Methods for Software Testing , John Wiley Sons, Inc. 1995.",
"options": {
"A": "William Perry",
"B": "Alan Kusinitz",
"C": "Nancy G. Leveson",
"D": "Software Systems Engineering"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'William Perry, Effective Methods for Software Test...'?",
"reference": "William Perry, Effective Methods for Software Testing , John Wiley Sons, Inc. 1995.",
"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: 'William Perry, Effective Methods for Software Test...'?",
"reference": "William Perry, Effective Methods for Software Testing , John Wiley Sons, Inc. 1995.",
"options": {
"A": "Inc. 1995",
"B": "1997",
"C": "1995",
"D": "Software Systems Engineering"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 4 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
This guidance uses the term quality unit7 (QU) to reflect modern practice while remaining consistent with the CGMP definition in 210.3(b)(15). The concept of a quality unit is also consistent with modern quality systems in ensuring that the various operati ons associated with all systems are appropriately planned, approved, conducted, and monitored. The CGMP regulations specifica lly assign the QU the authority to create, monitor, and implement a quality system. Su ch activities do not substitute for, or preclude, the daily responsibility of manuf acturing personnel to build quality in to the product. The QU should not take on the responsibilities of other units of a manufacturers organization, such as the responsibilities handled by manufacturing personnel, engineer s, and development scientists.8 Manufacturing personnel and the QU are both critical in fulfilling the manufacturers responsibility to produce quality products. Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):
Ensuring that controls are implemente d and completed satisfactorily during manufacturing operations Ensuring that developed procedures and sp ecifications are appropriate and followed, including those used by a firm unde r contract to the manufacturer Approving or rejecting incoming ma terials, in-process ma terials, and drug products Reviewing production records and investig ating any unexplained discrepancies Under a quality system, it is normally expected that the product and pro cess developm ent units, the manufacturing units, and the QU will remain inde pendent. In very limited circumstances, a single individual can perform both production and quality functions. That person is still accountable for imple menting all th e controls and reviewing the re sults of manufacture to ensure that product quality standards have been met.
[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 CGMP regulations specifica lly assign the QU t...'?",
"reference": "The CGMP regulations specifica lly assign the QU the authority to create, monitor, and implement a quality system.",
"options": {
"B": "CGMP",
"A": "scientists.8 Manufacturing",
"C": "modern quality systems",
"D": "product quality standards"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The QU should not take on the responsibilities of ...'?",
"reference": "The QU should not take on the responsibilities of other units of a manufacturers organization, such as the responsibilities handled by manufacturing personnel, engineer s, and development scientists.8 Manufacturing personnel and the QU are both critical in fulfilling the manufacturers responsibility to produce quality products.",
"options": {
"B": "scientists.8 Manufacturing",
"A": "modern quality systems",
"C": "product quality standards",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The QU should not take on the responsibilities of ...'?",
"reference": "The QU should not take on the responsibilities of other units of a manufacturers organization, such as the responsibilities handled by manufacturing personnel, engineer s, and development scientists.8 Manufacturing personnel and the QU are both critical in fulfilling the manufacturers responsibility to produce quality products.",
"options": {
"C": "scientists.8 Manufacturing",
"A": "modern quality systems",
"B": "product quality standards",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The QU should not take on the responsibilities of ...'?",
"reference": "The QU should not take on the responsibilities of other units of a manufacturers organization, such as the responsibilities handled by manufacturing personnel, engineer s, and development scientists.8 Manufacturing personnel and the QU are both critical in fulfilling the manufacturers responsibility to produce quality products.",
"options": {
"A": "scientists.8 Manufacturing",
"B": "modern quality systems",
"C": "product quality standards",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555
Goal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror. 568 569 Conclusion: No errors were observed in the spreadsheet functions beyond the deviation. Incorrectly inputting text into the field is immediately visible and does not impact the risk 571 of the intended use. In addition, a validation rule was placed on the field to permit only 572 numeric data inputs. 573 Contains Nonbinding Recommendations Draft Not for Implementation 19574
When/Who: July 9, 2019, by J ane Smith 575 576
Advances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation. As a least burdensome method , FDA recommends the 579 use of electronic records, such as system logs, audit trails, and other data g enerated by the 580 software, as opposed to paper documentation and screenshots, in establishing the record 581 associated with the assurance activities. 582 583 Manufacturers have expressed confusion and concern regarding the application of Part 11, 584 Electronic Records; Electronic Signatures, to computers or automated data processing systems 585 used as part of production or the quality system.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: In addition, a validation rule was placed on the field to permit only ____ numeric data inputs.",
"reference": "In addition, a validation rule was placed on the field to permit only 572 numeric data inputs.",
"options": {
"B": "572",
"A": "550 551",
"C": "552 553",
"D": "automated data processing systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Incorrectly inputting text into the field is immediately visible and does not impact the risk ____ of the intended use.",
"reference": "Incorrectly inputting text into the field is immediately visible and does not impact the risk 571 of the intended use.",
"options": {
"C": "571",
"A": "550 551",
"B": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Incorrectly inputting text into the field is immediately visible and does not impact the risk ____ of the intended use.",
"reference": "Incorrectly inputting text into the field is immediately visible and does not impact the risk 571 of the intended use.",
"options": {
"D": "571",
"A": "550 551",
"B": "552 553",
"C": "only 572 numeric data inputs"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 569 Conclusion: No errors were observed in the spreadsheet functions beyond the deviation.",
"reference": "568 569 Conclusion: No errors were observed in the spreadsheet functions beyond the deviation.",
"options": {
"A": "568",
"B": "550 551",
"C": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 568 ____ Conclusion: No errors were observed in the spreadsheet functions beyond the deviation.",
"reference": "568 569 Conclusion: No errors were observed in the spreadsheet functions beyond the deviation.",
"options": {
"C": "569",
"A": "550 551",
"B": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'As a least burdensome method , FDA recommends the ...'?",
"reference": "As a least burdensome method , FDA recommends the 579 use of electronic records, such as system logs, audit trails, and other data g enerated by the 580 software, as opposed to paper documentation and screenshots, in establishing the record 581 associated with the assurance activities.",
"options": {
"D": "FDA",
"A": "Delete",
"B": "Passed 563 o Verify",
"C": "only 572 numeric data inputs"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As a least burdensome method , FDA recommends the ____ use of electronic records, such as system logs, audit trails, and other data g enerated by the 580 software, as opposed to paper documentation and screenshots, in establishing the record 581 associated with the assurance activities.",
"reference": "As a least burdensome method , FDA recommends the 579 use of electronic records, such as system logs, audit trails, and other data g enerated by the 580 software, as opposed to paper documentation and screenshots, in establishing the record 581 associated with the assurance activities.",
"options": {
"C": "579",
"A": "550 551",
"B": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As a least burdensome method , FDA recommends the 579 use of electronic records, such as system logs, audit trails, and other data g enerated by the ____ software, as opposed to paper documentation and screenshots, in establishing the record 581 associated with the assurance activities.",
"reference": "As a least burdensome method , FDA recommends the 579 use of electronic records, such as system logs, audit trails, and other data g enerated by the 580 software, as opposed to paper documentation and screenshots, in establishing the record 581 associated with the assurance activities.",
"options": {
"B": "580",
"A": "550 551",
"C": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As a least burdensome method , FDA recommends the 579 use of electronic records, such as system logs, audit trails, and other data g enerated by the 580 software, as opposed to paper documentation and screenshots, in establishing the record ____ associated with the assurance activities.",
"reference": "As a least burdensome method , FDA recommends the 579 use of electronic records, such as system logs, audit trails, and other data g enerated by the 580 software, as opposed to paper documentation and screenshots, in establishing the record 581 associated with the assurance activities.",
"options": {
"C": "581",
"A": "550 551",
"B": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '573 Contains Nonbinding Recommendations Draft Not ...'?",
"reference": "573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"options": {
"D": "July 9, 2019",
"A": "only 572 numeric data inputs",
"B": "automated data processing systems",
"C": "573"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: '573 Contains Nonbinding Recommendations Draft Not ...'?",
"reference": "573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"options": {
"C": "July 9, 2019",
"A": "only 572 numeric data inputs",
"B": "automated data processing systems",
"D": "573"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"reference": "573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"options": {
"D": "573",
"A": "550 551",
"B": "552 553",
"C": "only 572 numeric data inputs"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 573 Contains Nonbinding Recommendations Draft Not for Implementation ____\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"reference": "573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"options": {
"D": "19574",
"A": "550 551",
"B": "552 553",
"C": "only 572 numeric data inputs"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 573 Contains Nonbinding Recommendations Draft Not for Implementation 1____574\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"reference": "573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"options": {
"A": "9",
"B": "550 551",
"C": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, ____, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"reference": "573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"options": {
"B": "2019",
"A": "July 9, 2019",
"C": "only 572 numeric data inputs",
"D": "automated data processing systems"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith ____ 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"reference": "573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"options": {
"B": "575",
"A": "550 551",
"C": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith 575 ____\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"reference": "573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"options": {
"D": "576",
"A": "550 551",
"B": "552 553",
"C": "only 572 numeric data inputs"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, ____ testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"reference": "573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"options": {
"A": "577",
"B": "550 551",
"C": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need ____ for manual or paper -based documentation.",
"reference": "573 Contains Nonbinding Recommendations Draft Not for Implementation 19574\nWhen/Who: July 9, 2019, by J ane Smith 575 576\nAdvances in digital technology may allow for manufacturers to leverage automated traceability, 577 testing, and the electronic capture of work performed to document the results, reducing the need 578 for manual or paper -based documentation.",
"options": {
"B": "578",
"A": "550 551",
"C": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 569 Conclusion: No errors were observed in the spreadsheet functions beyond the deviation.",
"reference": "568 569 Conclusion: No errors were observed in the spreadsheet functions beyond the deviation.",
"options": {
"C": "568",
"A": "550 551",
"B": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '550 551 Tested: Spreadsheet X, Version 1.2 552 553...'?",
"reference": "550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"options": {
"B": "Delete",
"A": "Passed 563 o Verify",
"C": "FDA",
"D": "only 572 numeric data inputs"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '550 551 Tested: Spreadsheet X, Version 1.2 552 553...'?",
"reference": "550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"options": {
"A": "Passed 563 o Verify",
"B": "550 551",
"C": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"reference": "550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"options": {
"A": "550",
"B": "550 551",
"C": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 550 ____ Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"reference": "550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"options": {
"D": "551",
"A": "550 551",
"B": "552 553",
"C": "only 572 numeric data inputs"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 550 551 Tested: Spreadsheet X, Version ____ 552 553 Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"reference": "550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"options": {
"B": "1.2",
"A": "550 551",
"C": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 550 551 Tested: Spreadsheet X, Version 1.2 ____ 553 Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"reference": "550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"options": {
"B": "552",
"A": "550 551",
"C": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 550 551 Tested: Spreadsheet X, Version 1.2 552 ____ Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"reference": "550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"options": {
"D": "553",
"A": "550 551",
"B": "552 553",
"C": "only 572 numeric data inputs"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing ____ 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"reference": "550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"options": {
"D": "554",
"A": "550 551",
"B": "552 553",
"C": "only 572 numeric data inputs"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 ____\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"reference": "550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"options": {
"D": "555",
"A": "550 551",
"B": "552 553",
"C": "only 572 numeric data inputs"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted ____ 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"reference": "550 551 Tested: Spreadsheet X, Version 1.2 552 553 Test type: Unscripted testing exploratory testing 554 555\nGoal: Ensure that analyses can be correctly created , read, updated , and deleted 556 557 Testing objectives and activities: 558 559 o Create new analysis Passed 560 o Read data from the required source Passed 561 o Update data in the analysis Failed due to input error, then passed 562 o Delete data Passed 563 o Verify through observation that all calculated fields correctly update with changes 564 Passed with noted deviation 565 566 Deviation: During update testing, when the user inadvertently input text into an 567 updatable field requiring numeric data , the associated row showed an immediate er ror.",
"options": {
"B": "556",
"A": "550 551",
"C": "552 553",
"D": "only 572 numeric data inputs"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 35 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) April 2009 ICH Guidance for Industry Q10 Pharmaceutical Quality System
Additional copies are available from: Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave.,Bldg. 51, Room 2201 Silver Spring, MD 20993-0002 (Tel) 301-796-3400 http://www.fda.gov/cder/guidance/index.htm Office of Communication, Outreach and Development, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 (Tel) 1-800-835-4709 or 301-827-1800 http://www.fda.gov/cber/guidelines.htm. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)
April 2009 ICH TABLE OF CONTENTS I. INTRODUCTION (1, 1.1) ................................................................................................
1 II. PHARMACEUTICAL QUALITY MANAGEMENT SYSTEM .................................
2 A. Scope (1.2) .......................................................................................................................................
2 B.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: INTRODUCTION (____, 1.1) ................................................................................................\n1 II.",
"reference": "INTRODUCTION (1, 1.1) ................................................................................................\n1 II.",
"options": {
"B": "1",
"A": "301",
"C": "1.1",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION (1, ____) ................................................................................................\n1 II.",
"reference": "INTRODUCTION (1, 1.1) ................................................................................................\n1 II.",
"options": {
"B": "1.1",
"A": "301",
"C": "1 II",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION (____, 1.1) ................................................................................................\n1 II.",
"reference": "INTRODUCTION (1, 1.1) ................................................................................................\n1 II.",
"options": {
"A": "1",
"B": "301",
"C": "1.1",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Scope (1.2) .........................................'?",
"reference": "Scope (1.2) .......................................................................................................................................\n2 B.",
"options": {
"C": "2 B.",
"A": "301",
"B": "1.1",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Scope (____) .......................................................................................................................................\n2 B.",
"reference": "Scope (1.2) .......................................................................................................................................\n2 B.",
"options": {
"B": "1.2",
"A": "301",
"C": "1.1",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Scope (1.____) .......................................................................................................................................\n2 B.",
"reference": "Scope (1.2) .......................................................................................................................................\n2 B.",
"options": {
"A": "2",
"B": "301",
"C": "1.1",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U.S. Department of Health and Human Services Food ...'?",
"reference": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)\nApril 2009 ICH TABLE OF CONTENTS I.",
"options": {
"D": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"A": "Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'U.S. Department of Health and Human Services Food ...'?",
"reference": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)\nApril 2009 ICH TABLE OF CONTENTS I.",
"options": {
"C": "April 2009",
"A": "10903",
"B": "20993-0002",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)\nApril ____ ICH TABLE OF CONTENTS I.",
"reference": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)\nApril 2009 ICH TABLE OF CONTENTS I.",
"options": {
"A": "2009",
"B": "April 2009",
"C": "10903",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Q10 Pharmaceutical Quality S...'?",
"reference": "Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) April 2009 ICH Guidance for Industry Q10 Pharmaceutical Quality System\nAdditional copies are available from: Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave.,Bldg.",
"options": {
"A": "Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration",
"C": "http://www.fda.gov/cder/guidance/index.htm Office of Communication",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Guidance for Industry Q10 Pharmaceutical Quality S...'?",
"reference": "Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) April 2009 ICH Guidance for Industry Q10 Pharmaceutical Quality System\nAdditional copies are available from: Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave.,Bldg.",
"options": {
"C": "April 2009",
"A": "10903",
"B": "20993-0002",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION (____, 1.1) ................................................................................................\n1 II.",
"reference": "INTRODUCTION (1, 1.1) ................................................................................................\n1 II.",
"options": {
"B": "1",
"A": "301",
"C": "1.1",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION (1, ____) ................................................................................................\n1 II.",
"reference": "INTRODUCTION (1, 1.1) ................................................................................................\n1 II.",
"options": {
"C": "1.1",
"A": "301",
"B": "1 II",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION (____, 1.1) ................................................................................................\n1 II.",
"reference": "INTRODUCTION (1, 1.1) ................................................................................................\n1 II.",
"options": {
"C": "1",
"A": "301",
"B": "1.1",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U.S. Department of Health and Human Services Food ...'?",
"reference": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)\nApril 2009 ICH TABLE OF CONTENTS I.",
"options": {
"A": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'U.S. Department of Health and Human Services Food ...'?",
"reference": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)\nApril 2009 ICH TABLE OF CONTENTS I.",
"options": {
"C": "April 2009",
"A": "10903",
"B": "20993-0002",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)\nApril ____ ICH TABLE OF CONTENTS I.",
"reference": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)\nApril 2009 ICH TABLE OF CONTENTS I.",
"options": {
"D": "2009",
"A": "April 2009",
"B": "10903",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: '51, Room 2201 Silver Spring, MD 20993-0002 (Tel) 3...'?",
"reference": "51, Room 2201 Silver Spring, MD 20993-0002 (Tel) 301-796-3400 http://www.fda.gov/cder/guidance/index.htm Office of Communication, Outreach and Development, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 (Tel) 1-800-835-4709 or 301-827-1800 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"A": "MD",
"B": "Rockville",
"C": "http://www.fda.gov/cber/guidelines.htm",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '51, Room 2201 Silver Spring, MD 20993-0002 (Tel) 3...'?",
"reference": "51, Room 2201 Silver Spring, MD 20993-0002 (Tel) 301-796-3400 http://www.fda.gov/cder/guidance/index.htm Office of Communication, Outreach and Development, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 (Tel) 1-800-835-4709 or 301-827-1800 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"D": "20993-0002",
"A": "April 2009",
"B": "10903",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: '51, Room 2201 Silver Spring, MD 20993-0002 (Tel) 3...'?",
"reference": "51, Room 2201 Silver Spring, MD 20993-0002 (Tel) 301-796-3400 http://www.fda.gov/cder/guidance/index.htm Office of Communication, Outreach and Development, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 (Tel) 1-800-835-4709 or 301-827-1800 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"A": "Tel",
"B": "Rockville Pike",
"C": "2 A. Scope",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '51, Room 2201 Silver Spring, MD 20993-0002 (Tel) 3...'?",
"reference": "51, Room 2201 Silver Spring, MD 20993-0002 (Tel) 301-796-3400 http://www.fda.gov/cder/guidance/index.htm Office of Communication, Outreach and Development, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 (Tel) 1-800-835-4709 or 301-827-1800 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"A": "http://www.fda.gov/cder/guidance/index.htm Office of Communication",
"B": "Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '51, Room 2201 Silver Spring, MD 20993-0002 (Tel) 3...'?",
"reference": "51, Room 2201 Silver Spring, MD 20993-0002 (Tel) 301-796-3400 http://www.fda.gov/cder/guidance/index.htm Office of Communication, Outreach and Development, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 (Tel) 1-800-835-4709 or 301-827-1800 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"D": "Center for Biologics Evaluation and Research Food and Drug Administration",
"A": "Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '51, Room 2201 Silver Spring, MD 20993-0002 (Tel) 3...'?",
"reference": "51, Room 2201 Silver Spring, MD 20993-0002 (Tel) 301-796-3400 http://www.fda.gov/cder/guidance/index.htm Office of Communication, Outreach and Development, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 (Tel) 1-800-835-4709 or 301-827-1800 http://www.fda.gov/cber/guidelines.htm.",
"options": {
"A": "1401",
"B": "April 2009",
"C": "10903",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Q10 Pharmaceutical Quality S...'?",
"reference": "Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) April 2009 ICH Guidance for Industry Q10 Pharmaceutical Quality System\nAdditional copies are available from: Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave.,Bldg.",
"options": {
"B": "Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"A": "Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration",
"C": "http://www.fda.gov/cder/guidance/index.htm Office of Communication",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Guidance for Industry Q10 Pharmaceutical Quality S...'?",
"reference": "Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) April 2009 ICH Guidance for Industry Q10 Pharmaceutical Quality System\nAdditional copies are available from: Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave.,Bldg.",
"options": {
"A": "April 2009",
"B": "10903",
"C": "20993-0002",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Q10 Pharmaceutical Quality S...'?",
"reference": "Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) April 2009 ICH Guidance for Industry Q10 Pharmaceutical Quality System\nAdditional copies are available from: Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave.,Bldg.",
"options": {
"C": "Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration",
"A": "Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "http://www.fda.gov/cder/guidance/index.htm Office of Communication",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Guidance for Industry Q10 Pharmaceutical Quality S...'?",
"reference": "Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) April 2009 ICH Guidance for Industry Q10 Pharmaceutical Quality System\nAdditional copies are available from: Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave.,Bldg.",
"options": {
"B": "10903",
"A": "April 2009",
"C": "20993-0002",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) April ____ ICH Guidance for Industry Q10 Pharmaceutical Quality System\nAdditional copies are available from: Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave.,Bldg.",
"reference": "Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) April 2009 ICH Guidance for Industry Q10 Pharmaceutical Quality System\nAdditional copies are available from: Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave.,Bldg.",
"options": {
"C": "2009",
"A": "April 2009",
"B": "10903",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) April 2009 ICH Guidance for Industry Q10 Pharmaceutical Quality System\nAdditional copies are available from: Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration ____ New Hampshire Ave.,Bldg.",
"reference": "Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) April 2009 ICH Guidance for Industry Q10 Pharmaceutical Quality System\nAdditional copies are available from: Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave.,Bldg.",
"options": {
"A": "10903",
"B": "April 2009",
"C": "20993-0002",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Scope (1.2) .........................................'?",
"reference": "Scope (1.2) .......................................................................................................................................\n2 B.",
"options": {
"D": "2 B.",
"A": "301",
"B": "1.1",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Scope (____) .......................................................................................................................................\n2 B.",
"reference": "Scope (1.2) .......................................................................................................................................\n2 B.",
"options": {
"C": "1.2",
"A": "301",
"B": "1.1",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Scope (1.____) .......................................................................................................................................\n2 B.",
"reference": "Scope (1.2) .......................................................................................................................................\n2 B.",
"options": {
"D": "2",
"A": "301",
"B": "1.1",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: PHARMACEUTICAL QUALITY MANAGEMENT SYSTEM .................................\n____ A.",
"reference": "PHARMACEUTICAL QUALITY MANAGEMENT SYSTEM .................................\n2 A.",
"options": {
"D": "2",
"A": "301",
"B": "1.1",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Scope (1.2) .........................................'?",
"reference": "Scope (1.2) .......................................................................................................................................\n2 B.",
"options": {
"B": "2 B.",
"A": "301",
"C": "1.1",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Scope (____) .......................................................................................................................................\n2 B.",
"reference": "Scope (1.2) .......................................................................................................................................\n2 B.",
"options": {
"C": "1.2",
"A": "301",
"B": "1.1",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 6 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
......................................
12 Contains Nonbinding Recommendations 1 Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry1
This guidance represent s the current thinking of the Food and Drug Administration (FDA or Agency ) on this topic. It does not establish any rights for any person and is not bind ing on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for t his guidance as listed on the title page. The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212. Unless otherwise noted, the term CGMP in this guidance refers to CGMPs for drugs (including biologics) . FDAs authority for CGMP comes from section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FDC Act). Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General ; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals ; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography (PET) Drugs. All citations to part s 211 and 212 in this document pertain to finished pharmaceuticals and PET drugs , but these requirements are also consistent with Agency guidance on CGMP for active pharmaceutical ingredients with respect to data integrity . This guidance pr ovides the Agencys current thinking on the creation and handling of data in accordance with CGMP requirements. FDA expects that all data be reliable and accurate ( see the Background section ). CGMP regulations and guidance allow for flexible and risk- based strategies to prevent and detect data integrity issues.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'All citations to part s 211 and 212 in this docume...'?",
"reference": "All citations to part s 211 and 212 in this document pertain to finished pharmaceuticals and PET drugs , but these requirements are also consistent with Agency guidance on CGMP for active pharmaceutical ingredients with respect to data integrity .",
"options": {
"C": "PET",
"A": "the Food and Drug Administration",
"B": "FDA",
"D": "current good manufacturing practice"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'All citations to part s 211 and 212 in this docume...'?",
"reference": "All citations to part s 211 and 212 in this document pertain to finished pharmaceuticals and PET drugs , but these requirements are also consistent with Agency guidance on CGMP for active pharmaceutical ingredients with respect to data integrity .",
"options": {
"B": "Agency",
"A": "current good manufacturing practice",
"C": "Current Good Manufacturing Practice",
"D": "government agency"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'All citations to part s 211 and 212 in this docume...'?",
"reference": "All citations to part s 211 and 212 in this document pertain to finished pharmaceuticals and PET drugs , but these requirements are also consistent with Agency guidance on CGMP for active pharmaceutical ingredients with respect to data integrity .",
"options": {
"C": "CGMP",
"A": "the Food and Drug Administration",
"B": "FDA",
"D": "current good manufacturing practice"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: All citations to part s ____ and 212 in this document pertain to finished pharmaceuticals and PET drugs , but these requirements are also consistent with Agency guidance on CGMP for active pharmaceutical ingredients with respect to data integrity .",
"reference": "All citations to part s 211 and 212 in this document pertain to finished pharmaceuticals and PET drugs , but these requirements are also consistent with Agency guidance on CGMP for active pharmaceutical ingredients with respect to data integrity .",
"options": {
"A": "211",
"B": "210",
"C": "212",
"D": "current good manufacturing practice"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: All citations to part s 211 and ____ in this document pertain to finished pharmaceuticals and PET drugs , but these requirements are also consistent with Agency guidance on CGMP for active pharmaceutical ingredients with respect to data integrity .",
"reference": "All citations to part s 211 and 212 in this document pertain to finished pharmaceuticals and PET drugs , but these requirements are also consistent with Agency guidance on CGMP for active pharmaceutical ingredients with respect to data integrity .",
"options": {
"B": "212",
"A": "210",
"C": "211",
"D": "current good manufacturing practice"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA expects that all data be reliable and accurate...'?",
"reference": "FDA expects that all data be reliable and accurate ( see the Background section ).",
"options": {
"D": "FDA",
"A": "the Food and Drug Administration",
"B": "Agency",
"C": "current good manufacturing practice"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Suspected or known falsification or alteration of records required under parts 210, 375 211, and 212 must be fully investigated under the CGMP quality system to determine the 376 effect of the event on patient safety, product quality, and data reliability ; to determine the 377 Contains Nonbinding Recommendations Draft Not for Implementation 10 root cause ; and to ensure the necessary corrective actions are taken ( see 211.22(a), 378 211.125(c), 211.192, 211.198, 211.204, and 212.100). 379 380 FDA invites individuals to report suspected data integrit y issues that may affect the 381 safety, identity, strength, quality, or purity of drug products at DrugInfofda.hhs.gov . 382 CGMP data integrity should be included in the subject line of the email . 383 384 See also Application Integrity Policy, available at 385 http://www.fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/default.htm . Should personnel be trained in detecti ng data integrity issues as part of a 388 routine CGMP training program? Training personnel to detect data integrity issues is consistent with the personnel 391 requirements under 211.25 and 212.10, which state that personnel must have the 392 education, tra ining, and experience, or any combination thereof, to perform their assigned 393 duties . Is the FDA investigator allowed to look at my electronic records? All records required under CGMP are subject to FDA inspection. You must allow 398 authorized inspection, review, and copying of records , which includes copying of 399 electronic data ( 211.180(c) and 212.110(a) and (b) ). See also section 704 of the FDC 400 Act. How does FDA recommend data integrity problems identified during 403 inspections , in warning letters, or in other regulatory actions be addressed ?
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "What amount is specified: 'You must allow 398 authorized inspection, review, ...'?",
"reference": "You must allow 398 authorized inspection, review, and copying of records , which includes copying of 399 electronic data ( 211.180(c) and 212.110(a) and (b) ).",
"options": {
"C": "211.180(c",
"A": "210",
"B": "375",
"D": "382 CGMP data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: You must allow ____ authorized inspection, review, and copying of records , which includes copying of 399 electronic data ( 211.180(c) and 212.110(a) and (b) ).",
"reference": "You must allow 398 authorized inspection, review, and copying of records , which includes copying of 399 electronic data ( 211.180(c) and 212.110(a) and (b) ).",
"options": {
"C": "398",
"A": "210",
"B": "375",
"D": "382 CGMP data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: You must allow 398 authorized inspection, review, and copying of records , which includes copying of ____ electronic data ( 211.180(c) and 212.110(a) and (b) ).",
"reference": "You must allow 398 authorized inspection, review, and copying of records , which includes copying of 399 electronic data ( 211.180(c) and 212.110(a) and (b) ).",
"options": {
"A": "399",
"B": "210",
"C": "375",
"D": "382 CGMP data integrity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: 'You must allow 398 authorized inspection, review, ...'?",
"reference": "You must allow 398 authorized inspection, review, and copying of records , which includes copying of 399 electronic data ( 211.180(c) and 212.110(a) and (b) ).",
"options": {
"D": "211.180(c",
"A": "210",
"B": "375",
"C": "382 CGMP data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: You must allow ____ authorized inspection, review, and copying of records , which includes copying of 399 electronic data ( 211.180(c) and 212.110(a) and (b) ).",
"reference": "You must allow 398 authorized inspection, review, and copying of records , which includes copying of 399 electronic data ( 211.180(c) and 212.110(a) and (b) ).",
"options": {
"B": "398",
"A": "210",
"C": "375",
"D": "382 CGMP data integrity"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: You must allow 398 authorized inspection, review, and copying of records , which includes copying of ____ electronic data ( 211.180(c) and 212.110(a) and (b) ).",
"reference": "You must allow 398 authorized inspection, review, and copying of records , which includes copying of 399 electronic data ( 211.180(c) and 212.110(a) and (b) ).",
"options": {
"C": "399",
"A": "210",
"B": "375",
"D": "382 CGMP data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Is the FDA investigator allowed to look at my elec...'?",
"reference": "Is the FDA investigator allowed to look at my electronic records?",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "382 CGMP data integrity",
"D": "detecti ng data integrity issues"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Is the FDA investigator allowed to look at my elec...'?",
"reference": "Is the FDA investigator allowed to look at my electronic records?",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "382 CGMP data integrity",
"D": "detecti ng data integrity issues"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Is the FDA investigator allowed to look at my elec...'?",
"reference": "Is the FDA investigator allowed to look at my electronic records?",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "382 CGMP data integrity",
"C": "detecti ng data integrity issues"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 5 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
64 65 Specifically, FDA has engaged with stakeholders via the Medical Device Innovation Consortium 66 (MDIC), site visits to medical device manufacturers, and benchmarking efforts with other 67 industries (e.g., automotive, consumer electronics) to keep abreast of the latest technologies and 68 to better understand stakeholders challenges and opportunities for further advancement. As part 69 of these ongoing efforts, medical device manufacturers have expressed a desire for greater clarity 70 regarding the Agencys expectations for software validation for computers and automated data 71 processing systems used as part of production or the quality system. Given the rapidly changing 72 3 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm . This guidance discusses the intended use of computer software used as part of production or the quality system (see 21 CFR 820.70(i)), which is different from the intended use of the device itself (see 21 CFR 801.4). Contains Nonbinding Recommendations Draft Not for Implementation 6nature of software, manufacturers have also expressed a desire for a more iterative, agile 73 approach fo r validation of computer software used as part of production or the quality system. 74 75 Traditionally, software validation has often been accomplished via software testing and other 76 verification activities conducted at each stage of the software development lifecycle. However, 77 as explained in FDAs Software Validation guidance , software testing alone is often insufficient 78 to establi sh confidence that the software is fit for its intended use . Instead, the Software 79 Validation guidance recommends that software quality assurance focus on preventing the 80 introduction of defects into the software development process , and it encourages use of a risk - 81 based approach for establishing confidence that software is fit for its intended use.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: Contains Nonbinding Recommendations Draft Not for Implementation 6nature of software, manufacturers have also expressed a desire for a more iterative, agile ____ approach fo r validation of computer software used as part of production or the quality system.",
"reference": "Contains Nonbinding Recommendations Draft Not for Implementation 6nature of software, manufacturers have also expressed a desire for a more iterative, agile 73 approach fo r validation of computer software used as part of production or the quality system.",
"options": {
"A": "73",
"B": "74 75",
"C": "76 verification",
"D": "FDAs Software Validation guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What percentage is mentioned: 'Given the rapidly changing 72 3 Available at https...'?",
"reference": "Given the rapidly changing 72 3 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm .",
"options": {
"C": "72 3 Available",
"A": "64 65",
"B": "FDAs Software Validation guidance",
"D": "the Software 79 Validation guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Given the rapidly changing ____ 3 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm .",
"reference": "Given the rapidly changing 72 3 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm .",
"options": {
"A": "72",
"B": "74 75",
"C": "76 verification",
"D": "FDAs Software Validation guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Given the rapidly changing 72 ____ Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm .",
"reference": "Given the rapidly changing 72 3 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm .",
"options": {
"C": "3",
"A": "74 75",
"B": "76 verification",
"D": "FDAs Software Validation guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What percentage is mentioned: 'Given the rapidly changing 72 3 Available at https...'?",
"reference": "Given the rapidly changing 72 3 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm .",
"options": {
"B": "72 3 Available",
"A": "64 65",
"C": "FDAs Software Validation guidance",
"D": "the Software 79 Validation guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 2 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
To maintain quality, the Agency recommends th at prior to completion of manufacturing, the m anufacturer should consider stor age and shipment requirements to meet special handling needs (in th e case of pharmaceuticals, one example might be refrigeration). Under a quality system, trends should be continually identified and evaluated. One way of accomplishing this is the use of statistical process control. The information from trend analyses can be used to continually m onitor quality, id entify potential variances before they become problems, bolster data already collected for the annual review, and facilitate improvement throughout the product life cycle. Process cap ability assessment can serve as a basis for determining the need for changes that can resu lt in process improvements and efficiency (see IV.D.1.). Address Nonconformities A key component in any quality system is handling nonconformities and/or deviations. The investigation, conclusion, and follow-up must be documented ( 211.192). To ensure that a product conforms to requirements and expectations, it is important to measure the process and the product attributes (e.g., speci fied control parameters, streng th) as planned. Discrepancies may be detected during any stage of the process or during qualit y control activities. Not all discrepancies will result in product defects; how ever, it is important to document and handle 19 Contains Nonbinding Recommendations discrepancies appropriately. A di screpancy investigation process is critical when a discrepancy is found that affects product qual ity (CGMP also requires this; see 211.192). In a quality system, it is important to devel op and docum ent procedures that define who is responsible for halting and resuming operations, recording non-conformities, investigating discrepancies, and taking remedial action.
[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: 'A di screpancy investigation process is critical w...'?",
"reference": "A di screpancy investigation process is critical when a discrepancy is found that affects product qual ity (CGMP also requires this; see 211.192).",
"options": {
"B": "CGMP",
"A": "Agency",
"C": "Address Nonconformities",
"D": "A di screpancy investigation process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A di screpancy investigation process is critical when a discrepancy is found that affects product qual ity (CGMP also requires this; see ____).",
"reference": "A di screpancy investigation process is critical when a discrepancy is found that affects product qual ity (CGMP also requires this; see 211.192).",
"options": {
"B": "211.192",
"A": "one",
"C": "One",
"D": "A di screpancy investigation process"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 3 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
System s uitability tests should be performed according to the firms established written procedures which should include the identity of the preparation to be injected and the rationale for its selection and the approved application or applicable compendial monograph ( 211.160 and 212.60). If an actual sample is to be used for system suitability testing, it should be a properly characterized secondary standard , written procedures should be es tablished and followed, and the sample should be from a different batch than the sample (s) being tested ( 211.160, 211.165, and 212.60). CGMP original records must be complete (e.g., 211.68(b), 211.188, 211.194) and subject ed to adequate review ( 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)). Transparency is necessary. A ll data including obvious errors and failing, passing, and suspect datamust be in the CGMP records that are retained and subject to review and oversight. An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) . For more information , see the ICH guidance for industry Q2(R1)
Validation of Analytical Procedure s: Text and Methodology and VICH guidances for industry GL1
Validation of Analytical Procedures: Definition and Terminology and GL2 Validation of Analytical Procedures: Methodology . Is it acceptable to only save the final results from reprocess ed laboratory chromatography? Analytical methods should be accurate and precise.16
For most lab analys es, reprocessing data should not be regularly needed. If chromatography is reprocessed, writ ten procedures
must be established and followed and each result retained for review (s ee 211.160, 211.165(c) , 211.194(a)(4) , and 212.60(a) ). FDA requires complete data in laboratory records, which includes 15 VICHVeteri nary International Conference on Harmonisation.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see ____, 211.165, 211.188, and 211.192) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"D": "211.160",
"A": "212.60",
"B": "211.165",
"C": "Analytical Procedures"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, ____, 211.188, and 211.192) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"C": "211.165",
"A": "211.160",
"B": "212.60",
"D": "Analytical Procedures"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, ____, and 211.192) .",
"reference": "An investigation with documented, scientific ally sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch ( see 211.160, 211.165, 211.188, and 211.192) .",
"options": {
"B": "211.188",
"A": "211.160",
"C": "212.60",
"D": "Analytical Procedures"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 5 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
General Principles of Software Validation; Final Guidance for Industry and FDA Staff Document issued on: January 11, 2002
This document supersedes the draft document, "General Principles of Software Validation, Version 1.1, dated June 9, 1997. U.S. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Page iiGeneral Principles of Software Validation Guidance for Industry and FDA Staff Preface Public Comment Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance which involve the Center for Devices and Radiological Health (CDRH), contact John F. Murray at (301) 594-4659 or email jfmcdrh.fda.gov For questions regarding the use or interpretation of this guidance which involve the Center for Biologics Evaluation and Research (CBER) contact Jerome Davis at (301) 827-6220 or email daviscber.fda.gov . Additional Copies CDRH Additional copies are available from the Internet at: www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/UCM085281.htm. You may also send an e-mail request to dsmicafda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number (938) to identify the guidance you are requesting.
[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: 'U.S. Department Of Health and Human Services Food ...'?",
"reference": "U.S. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Page iiGeneral Principles of Software Validation Guidance for Industry and FDA Staff Preface Public Comment Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.",
"options": {
"B": "U.S. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Page iiGeneral Principles of Software Validation Guidance for Industry",
"A": "FDA",
"C": "FDA Staff Preface Public Comment Comments",
"D": "this guidance document"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U.S. Department Of Health and Human Services Food ...'?",
"reference": "U.S. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Page iiGeneral Principles of Software Validation Guidance for Industry and FDA Staff Preface Public Comment Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.",
"options": {
"D": "FDA Staff Preface Public Comment Comments",
"A": "FDA",
"B": "U.S. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Page iiGeneral Principles of Software Validation Guidance for Industry",
"C": "this guidance document"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U.S. Department Of Health and Human Services Food ...'?",
"reference": "U.S. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Page iiGeneral Principles of Software Validation Guidance for Industry and FDA Staff Preface Public Comment Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.",
"options": {
"D": "Agency",
"A": "this guidance document",
"B": "Software Validation Guidance",
"C": "government agency"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U.S. Department Of Health and Human Services Food ...'?",
"reference": "U.S. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Page iiGeneral Principles of Software Validation Guidance for Industry and FDA Staff Preface Public Comment Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.",
"options": {
"C": "Dockets Management Branch",
"A": "FDA",
"B": "U.S. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Page iiGeneral Principles of Software Validation Guidance for Industry",
"D": "this guidance document"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U.S. Department Of Health and Human Services Food ...'?",
"reference": "U.S. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Page iiGeneral Principles of Software Validation Guidance for Industry and FDA Staff Preface Public Comment Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.",
"options": {
"D": "Division of Management Systems and",
"A": "FDA",
"B": "U.S. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Page iiGeneral Principles of Software Validation Guidance for Industry",
"C": "this guidance document"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
However, testing a software product only with expected, valid inputs does not thoroughly test that software product. By itself, normal case testing cannot provide sufficient confidence in the dependability of the software product. Output Forcing Choosing test inputs to ensure that selected (or all) software outputs are generated by testing. Robustness Software testing should demonstrate that a software product behaves correctly when given unexpected, invalid inputs. Methods for identifying a sufficient set of such test cases include Equivalence Class Partitioning, Boundary Value Analysis, and Special Case Identification (Error Guessing). While important and necessary, these techniques do not ensure that all of the most appropriate challenges to a software product have been identified for testing. Combinations of Inputs The functional testing methods identified above all emphasize individual or single test inputs. Most software products operate with multiple inputs under their conditions of use. Thorough software product testing should consider the combinations of inputs a software unit or system may encounter during operation. Error guessing can be extended to identify combinations of inputs, but it is an ad hoc technique. Cause-effect graphing is one functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases. Functional and structural software test case identification techniques provide specific inputs for testing, rather than random test inputs. One weakness of these techniques is the difficulty in linking structural and functional test completion criteria to a software product's reliability. Advanced software testing methods, such as statistical testing, can be employed to provide further assurance that a software product is dependable.
[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: 'Combinations of Inputs The functional testing met...'?",
"reference": "Combinations of Inputs The functional testing methods identified above all emphasize individual or single test inputs.",
"options": {
"D": "Combinations of Inputs The",
"A": "Software",
"B": "Boundary Value Analysis",
"C": "Thorough software product testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ weakness of these techniques is the difficulty in linking structural and functional test completion criteria to a software product's reliability.",
"reference": "One weakness of these techniques is the difficulty in linking structural and functional test completion criteria to a software product's reliability.",
"options": {
"A": "One",
"B": "one",
"C": "Thorough software product testing",
"D": "Functional and structural software test case identification techniques"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Methods for identifying a sufficient set of such t...'?",
"reference": "Methods for identifying a sufficient set of such test cases include Equivalence Class Partitioning, Boundary Value Analysis, and Special Case Identification (Error Guessing).",
"options": {
"B": "Boundary Value Analysis",
"A": "Software",
"C": "Combinations of Inputs",
"D": "Thorough software product testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Methods for identifying a sufficient set of such t...'?",
"reference": "Methods for identifying a sufficient set of such test cases include Equivalence Class Partitioning, Boundary Value Analysis, and Special Case Identification (Error Guessing).",
"options": {
"B": "Boundary Value Analysis",
"A": "Software",
"C": "Combinations of Inputs",
"D": "Thorough software product testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Cause-effect graphing is ____ functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"reference": "Cause-effect graphing is one functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"options": {
"C": "one",
"A": "One",
"B": "Thorough software product testing",
"D": "Functional and structural software test case identification techniques"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Combinations of Inputs The functional testing met...'?",
"reference": "Combinations of Inputs The functional testing methods identified above all emphasize individual or single test inputs.",
"options": {
"B": "Combinations of Inputs The",
"A": "Software",
"C": "Boundary Value Analysis",
"D": "Thorough software product testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Combinations of Inputs The functional testing met...'?",
"reference": "Combinations of Inputs The functional testing methods identified above all emphasize individual or single test inputs.",
"options": {
"D": "Combinations of Inputs The",
"A": "Software",
"B": "Boundary Value Analysis",
"C": "Thorough software product testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Methods for identifying a sufficient set of such t...'?",
"reference": "Methods for identifying a sufficient set of such test cases include Equivalence Class Partitioning, Boundary Value Analysis, and Special Case Identification (Error Guessing).",
"options": {
"C": "Boundary Value Analysis",
"A": "Software",
"B": "Combinations of Inputs",
"D": "Thorough software product testing"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Cause-effect graphing is ____ functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"reference": "Cause-effect graphing is one functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"options": {
"A": "one",
"B": "One",
"C": "Thorough software product testing",
"D": "Functional and structural software test case identification techniques"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robustness Software testing should demonstrate th...'?",
"reference": "Robustness Software testing should demonstrate that a software product behaves correctly when given unexpected, invalid inputs.",
"options": {
"C": "Software",
"A": "Boundary Value Analysis",
"B": "Combinations of Inputs",
"D": "Inputs The functional testing methods"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Methods for identifying a sufficient set of such t...'?",
"reference": "Methods for identifying a sufficient set of such test cases include Equivalence Class Partitioning, Boundary Value Analysis, and Special Case Identification (Error Guessing).",
"options": {
"B": "Boundary Value Analysis",
"A": "Software",
"C": "Combinations of Inputs",
"D": "Thorough software product testing"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Combinations of Inputs The functional testing met...'?",
"reference": "Combinations of Inputs The functional testing methods identified above all emphasize individual or single test inputs.",
"options": {
"C": "Combinations of Inputs The",
"A": "Software",
"B": "Boundary Value Analysis",
"D": "Thorough software product testing"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robustness Software testing should demonstrate th...'?",
"reference": "Robustness Software testing should demonstrate that a software product behaves correctly when given unexpected, invalid inputs.",
"options": {
"B": "Software",
"A": "Boundary Value Analysis",
"C": "Combinations of Inputs",
"D": "Inputs The functional testing methods"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robustness Software testing should demonstrate th...'?",
"reference": "Robustness Software testing should demonstrate that a software product behaves correctly when given unexpected, invalid inputs.",
"options": {
"C": "Software",
"A": "Boundary Value Analysis",
"B": "Combinations of Inputs",
"D": "Inputs The functional testing methods"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robustness Software testing should demonstrate th...'?",
"reference": "Robustness Software testing should demonstrate that a software product behaves correctly when given unexpected, invalid inputs.",
"options": {
"A": "Software",
"B": "Boundary Value Analysis",
"C": "Combinations of Inputs",
"D": "Inputs The functional testing methods"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Cause-effect graphing is ____ functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"reference": "Cause-effect graphing is one functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"options": {
"C": "one",
"A": "One",
"B": "Thorough software product testing",
"D": "Functional and structural software test case identification techniques"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Combinations of Inputs The functional testing met...'?",
"reference": "Combinations of Inputs The functional testing methods identified above all emphasize individual or single test inputs.",
"options": {
"A": "Combinations of Inputs The",
"B": "Software",
"C": "Boundary Value Analysis",
"D": "Thorough software product testing"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Combinations of Inputs The functional testing met...'?",
"reference": "Combinations of Inputs The functional testing methods identified above all emphasize individual or single test inputs.",
"options": {
"D": "Combinations of Inputs The",
"A": "Software",
"B": "Boundary Value Analysis",
"C": "Thorough software product testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Cause-effect graphing is ____ functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"reference": "Cause-effect graphing is one functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"options": {
"A": "one",
"B": "One",
"C": "Thorough software product testing",
"D": "Functional and structural software test case identification techniques"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Cause-effect graphing is ____ functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"reference": "Cause-effect graphing is one functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"options": {
"B": "one",
"A": "One",
"C": "Thorough software product testing",
"D": "Functional and structural software test case identification techniques"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Cause-effect graphing is ____ functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"reference": "Cause-effect graphing is one functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"options": {
"B": "one",
"A": "One",
"C": "Thorough software product testing",
"D": "Functional and structural software test case identification techniques"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Methods for identifying a sufficient set of such t...'?",
"reference": "Methods for identifying a sufficient set of such test cases include Equivalence Class Partitioning, Boundary Value Analysis, and Special Case Identification (Error Guessing).",
"options": {
"D": "Boundary Value Analysis",
"A": "Software",
"B": "Combinations of Inputs",
"C": "Thorough software product testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Methods for identifying a sufficient set of such t...'?",
"reference": "Methods for identifying a sufficient set of such test cases include Equivalence Class Partitioning, Boundary Value Analysis, and Special Case Identification (Error Guessing).",
"options": {
"A": "Boundary Value Analysis",
"B": "Software",
"C": "Combinations of Inputs",
"D": "Thorough software product testing"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Combinations of Inputs The functional testing met...'?",
"reference": "Combinations of Inputs The functional testing methods identified above all emphasize individual or single test inputs.",
"options": {
"D": "Combinations of Inputs The",
"A": "Software",
"B": "Boundary Value Analysis",
"C": "Thorough software product testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ weakness of these techniques is the difficulty in linking structural and functional test completion criteria to a software product's reliability.",
"reference": "One weakness of these techniques is the difficulty in linking structural and functional test completion criteria to a software product's reliability.",
"options": {
"C": "One",
"A": "one",
"B": "Thorough software product testing",
"D": "Functional and structural software test case identification techniques"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Combinations of Inputs The functional testing met...'?",
"reference": "Combinations of Inputs The functional testing methods identified above all emphasize individual or single test inputs.",
"options": {
"D": "Combinations of Inputs The",
"A": "Software",
"B": "Boundary Value Analysis",
"C": "Thorough software product testing"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Cause-effect graphing is ____ functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"reference": "Cause-effect graphing is one functional software testing technique that systematically identifies combinations of inputs to a software product for inclusion in test cases.",
"options": {
"C": "one",
"A": "One",
"B": "Thorough software product testing",
"D": "Functional and structural software test case identification techniques"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Combinations of Inputs The functional testing met...'?",
"reference": "Combinations of Inputs The functional testing methods identified above all emphasize individual or single test inputs.",
"options": {
"C": "Combinations of Inputs The",
"A": "Software",
"B": "Boundary Value Analysis",
"D": "Thorough software product testing"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Combinations of Inputs The functional testing met...'?",
"reference": "Combinations of Inputs The functional testing methods identified above all emphasize individual or single test inputs.",
"options": {
"C": "Combinations of Inputs The",
"A": "Software",
"B": "Boundary Value Analysis",
"D": "Thorough software product testing"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 2 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
The manufacturer documents: the intended use risk determination, summary description of the features, functions, operations tested the testing objectives and if they passed or failed any issues found and their disposition a concluding statement noting that the performance of the operation is acceptable the date testing was performed, and who performed the testing. Contains Nonbinding Recommendations Draft Not for Implementation 21Features , Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Electronic Signature Function: The electronic signature execution record is stored as part of the audit trail. The electronic signature employs two distinct identification components of a login and password. When an electronic signature is executed, the following information is part of the execution record: o
The name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed. The meaning associated with the signature (such as review, approval, responsibility, or authorship).The intended use of the electronic signature function is to capture and store an electronic signature where a signature is required and such that it meets requirements for electronic signatures. If the electronic signature function were to fail to perform as intended, then production or quality system records may not reflect appropriate approval or be sufficiently auditable, or may fail to meet other regulatory requirements. However, such a failur e would not foreseeably lead to compromised safety. As such, the manufacturer determined that this function does not pose high process risk. The manufacturer has performed an assessment of the system capability, supplier evaluation, and installation activ ities.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: The electronic signature employs ____ distinct identification components of a login and password.",
"reference": "The electronic signature employs two distinct identification components of a login and password.",
"options": {
"A": "two",
"B": "the appropriate record Electronic Signature Function",
"C": "The electronic signature execution record",
"D": "deuce"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'When an electronic signature is executed, the foll...'?",
"reference": "When an electronic signature is executed, the following information is part of the execution record: o\nThe name of the person who signs the reco rd o The date (DD -MM- YYYY) and time (hh:mm) the signature was executed.",
"options": {
"B": "DD",
"A": "YYYY",
"C": "the appropriate record Electronic Signature Function",
"D": "The electronic signature execution record"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 35 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Measures should ensure that all system components are exercised during the testing and that the versions of these components are those specified. The testing plan should specify testing throughout the full range of operating conditions and should specify continuation for a sufficient time to allow the system to encounter a wide spectrum of conditions and events in an effort to detect any latent faults that are not apparent during more normal activities. Some of the evaluations that have been performed earlier by the software developer at the developer's site should be repeated at the site of actual use. These may include tests for a high volume of data, heavy loads or stresses, security, fault testing (avoidance, detection, tolerance, and recovery), error messages, and implementation of safety requirements. The developer may be able to furnish the user with some of the test data sets to be used for this purpose. In addition to an evaluation of the system's ability to properly perform its intended functions, there should be an evaluation of the ability of the users of the system to understand and correctly interface with it. Operators should be able to perform the intended functions and respond in an appropriate and timely manner to all alarms, warnings, and error messages. Page 28General Principles of Software Validation Guidance for Industry and FDA Staff During user site testing, records should be maintained of both proper system performance and any system failures that are encountered. The revision of the system to compensate for faults detected during this user site testing should follow the same procedures and controls as for any other software change. The developers of the software may or may not be involved in the user site testing. If the developers are involved, they may seamlessly carry over to the user's site the last portions of design-level systems testing.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Page 28General Principles of Software Validation G...'?",
"reference": "Page 28General Principles of Software Validation Guidance for Industry and FDA Staff During user site testing, records should be maintained of both proper system performance and any system failures that are encountered.",
"options": {
"A": "FDA",
"B": "user site testing",
"C": "this user site testing",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 28General Principles of Software Validation G...'?",
"reference": "Page 28General Principles of Software Validation Guidance for Industry and FDA Staff During user site testing, records should be maintained of both proper system performance and any system failures that are encountered.",
"options": {
"A": "FDA",
"B": "user site testing",
"C": "this user site testing",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 28General Principles of Software Validation G...'?",
"reference": "Page 28General Principles of Software Validation Guidance for Industry and FDA Staff During user site testing, records should be maintained of both proper system performance and any system failures that are encountered.",
"options": {
"B": "FDA",
"A": "user site testing",
"C": "this user site testing",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 28General Principles of Software Validation G...'?",
"reference": "Page 28General Principles of Software Validation Guidance for Industry and FDA Staff During user site testing, records should be maintained of both proper system performance and any system failures that are encountered.",
"options": {
"D": "FDA",
"A": "user site testing",
"B": "this user site testing",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 28General Principles of Software Validation G...'?",
"reference": "Page 28General Principles of Software Validation Guidance for Industry and FDA Staff During user site testing, records should be maintained of both proper system performance and any system failures that are encountered.",
"options": {
"A": "FDA",
"B": "user site testing",
"C": "this user site testing",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 28General Principles of Software Validation G...'?",
"reference": "Page 28General Principles of Software Validation Guidance for Industry and FDA Staff During user site testing, records should be maintained of both proper system performance and any system failures that are encountered.",
"options": {
"A": "FDA",
"B": "user site testing",
"C": "this user site testing",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 28General Principles of Software Validation G...'?",
"reference": "Page 28General Principles of Software Validation Guidance for Industry and FDA Staff During user site testing, records should be maintained of both proper system performance and any system failures that are encountered.",
"options": {
"C": "FDA",
"A": "user site testing",
"B": "this user site testing",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 28General Principles of Software Validation G...'?",
"reference": "Page 28General Principles of Software Validation Guidance for Industry and FDA Staff During user site testing, records should be maintained of both proper system performance and any system failures that are encountered.",
"options": {
"D": "FDA",
"A": "user site testing",
"B": "this user site testing",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Since software is usually part of a larger hardware system, the validation of software typically includes evidence that all software requirements have been implemented correctly and completely and are traceable to system requirements. A conclusion that software is validated is highly dependent upon comprehensive software testing, inspections, analyses, and other verification tasks performed at each stage of the software development life cycle. Testing of device software functionality in a simulated use environment, and user site testing are typically included as components of an overall design validation program for a software automated device. Software verification and validation are difficult because a developer cannot test forever, and it is hard to know how much evidence is enough. In large measure, software validation is a matter of developing a level of confidence that the device meets all requirements and user expectations for the software automated functions and features of the device. Measures such as defects found in specifications documents, estimates of defects remaining, testing coverage, and other techniques are all used to Page 7General Principles of Software Validation Guidance for Industry and FDA Staff develop an acceptable level of confidence before shipping the product. The level of confidence, and therefore the level of software validation, verification, and testing effort needed, will vary depending upon the safety risk (hazard) posed by the automated functions of the device. Additional guidance regarding safety risk management for software may be found in Section 4 of FDAs Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices, and in the international standards ISO/IEC 14971-1 and IEC 60601-1-4 referenced in Appendix A. 3.1.3 IQ/OQ/PQ
For many years, both FDA and regulated industry have attempted to understand and define software validation within the context of process validation terminology.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Software verification and validation are difficult...'?",
"reference": "Software verification and validation are difficult because a developer cannot test forever, and it is hard to know how much evidence is enough.",
"options": {
"D": "Software",
"A": "Page 7General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"C": "an overall design validation program"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Software verification and validation are difficult because a...'?",
"reference": "Software verification and validation are difficult because a developer cannot test forever, and it is hard to know how much evidence is enough.",
"options": {
"D": "Software verification and validation are difficult because a developer cannot test forever, and it i...",
"A": "Page 7General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software verification and validation are difficult...'?",
"reference": "Software verification and validation are difficult because a developer cannot test forever, and it is hard to know how much evidence is enough.",
"options": {
"A": "Software",
"B": "Page 7General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "an overall design validation program"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Software verification and validation are difficult because a...'?",
"reference": "Software verification and validation are difficult because a developer cannot test forever, and it is hard to know how much evidence is enough.",
"options": {
"A": "Software verification and validation are difficult because a developer cannot test forever, and it i...",
"B": "Page 7General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "Software Validation Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '3.1.3 IQ/OQ/PQ\nFor many years, both FDA and regula...'?",
"reference": "3.1.3 IQ/OQ/PQ\nFor many years, both FDA and regulated industry have attempted to understand and define software validation within the context of process validation terminology.",
"options": {
"A": "many years",
"B": "14971-1",
"C": "Software Validation Guidance",
"D": "a software automated device"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '3.1.3 IQ/OQ/PQ\nFor many years, both FDA and regula...'?",
"reference": "3.1.3 IQ/OQ/PQ\nFor many years, both FDA and regulated industry have attempted to understand and define software validation within the context of process validation terminology.",
"options": {
"B": "FDA",
"A": "Page 7General Principles of Software Validation Guidance for Industry",
"C": "Submissions for Software Contained",
"D": "Software Validation Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ IQ/OQ/PQ\nFor many years, both FDA and regulated industry have attempted to understand and define software validation within the context of process validation terminology.",
"reference": "3.1.3 IQ/OQ/PQ\nFor many years, both FDA and regulated industry have attempted to understand and define software validation within the context of process validation terminology.",
"options": {
"A": "3.1.3",
"B": "Software Validation Guidance",
"C": "a software automated device",
"D": "many years"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software verification and validation are difficult...'?",
"reference": "Software verification and validation are difficult because a developer cannot test forever, and it is hard to know how much evidence is enough.",
"options": {
"B": "Software",
"A": "Page 7General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "an overall design validation program"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Software verification and validation are difficult because a...'?",
"reference": "Software verification and validation are difficult because a developer cannot test forever, and it is hard to know how much evidence is enough.",
"options": {
"A": "Software verification and validation are difficult because a developer cannot test forever, and it i...",
"B": "Page 7General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "Software Validation Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '3.1.3 IQ/OQ/PQ\nFor many years, both FDA and regula...'?",
"reference": "3.1.3 IQ/OQ/PQ\nFor many years, both FDA and regulated industry have attempted to understand and define software validation within the context of process validation terminology.",
"options": {
"B": "many years",
"A": "14971-1",
"C": "Software Validation Guidance",
"D": "a software automated device"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '3.1.3 IQ/OQ/PQ\nFor many years, both FDA and regula...'?",
"reference": "3.1.3 IQ/OQ/PQ\nFor many years, both FDA and regulated industry have attempted to understand and define software validation within the context of process validation terminology.",
"options": {
"C": "FDA",
"A": "Page 7General Principles of Software Validation Guidance for Industry",
"B": "Submissions for Software Contained",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ IQ/OQ/PQ\nFor many years, both FDA and regulated industry have attempted to understand and define software validation within the context of process validation terminology.",
"reference": "3.1.3 IQ/OQ/PQ\nFor many years, both FDA and regulated industry have attempted to understand and define software validation within the context of process validation terminology.",
"options": {
"D": "3.1.3",
"A": "Software Validation Guidance",
"B": "a software automated device",
"C": "many years"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Measures such as defects found in specifications d...'?",
"reference": "Measures such as defects found in specifications documents, estimates of defects remaining, testing coverage, and other techniques are all used to Page 7General Principles of Software Validation Guidance for Industry and FDA Staff develop an acceptable level of confidence before shipping the product.",
"options": {
"C": "Page 7General Principles of Software Validation Guidance for Industry",
"A": "a software automated device",
"B": "device software functionality",
"D": "FDA"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Measures such as defects found in specifications d...'?",
"reference": "Measures such as defects found in specifications documents, estimates of defects remaining, testing coverage, and other techniques are all used to Page 7General Principles of Software Validation Guidance for Industry and FDA Staff develop an acceptable level of confidence before shipping the product.",
"options": {
"A": "FDA",
"B": "Page 7General Principles of Software Validation Guidance for Industry",
"C": "Submissions for Software Contained",
"D": "Software Validation Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The level of confidence, and therefore the level of software...'?",
"reference": "The level of confidence, and therefore the level of software validation, verification, and testing effort needed, will vary depending upon the safety risk (hazard) posed by the automated functions of the device.",
"options": {
"A": "The level of confidence, and therefore the level of software validation, verification, and testing e...",
"B": "Software Validation Guidance",
"C": "a software automated device",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software verification and validation are difficult...'?",
"reference": "Software verification and validation are difficult because a developer cannot test forever, and it is hard to know how much evidence is enough.",
"options": {
"A": "Software",
"B": "Page 7General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "an overall design validation program"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Software verification and validation are difficult because a...'?",
"reference": "Software verification and validation are difficult because a developer cannot test forever, and it is hard to know how much evidence is enough.",
"options": {
"B": "Software verification and validation are difficult because a developer cannot test forever, and it i...",
"A": "Page 7General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "Software Validation Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Measures such as defects found in specifications d...'?",
"reference": "Measures such as defects found in specifications documents, estimates of defects remaining, testing coverage, and other techniques are all used to Page 7General Principles of Software Validation Guidance for Industry and FDA Staff develop an acceptable level of confidence before shipping the product.",
"options": {
"D": "Page 7General Principles of Software Validation Guidance for Industry",
"A": "a software automated device",
"B": "device software functionality",
"C": "FDA"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Measures such as defects found in specifications d...'?",
"reference": "Measures such as defects found in specifications documents, estimates of defects remaining, testing coverage, and other techniques are all used to Page 7General Principles of Software Validation Guidance for Industry and FDA Staff develop an acceptable level of confidence before shipping the product.",
"options": {
"D": "FDA",
"A": "Page 7General Principles of Software Validation Guidance for Industry",
"B": "Submissions for Software Contained",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The level of confidence, and therefore the level of software...'?",
"reference": "The level of confidence, and therefore the level of software validation, verification, and testing effort needed, will vary depending upon the safety risk (hazard) posed by the automated functions of the device.",
"options": {
"C": "The level of confidence, and therefore the level of software validation, verification, and testing e...",
"A": "Software Validation Guidance",
"B": "a software automated device",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Additional guidance regarding safety risk manageme...'?",
"reference": "Additional guidance regarding safety risk management for software may be found in Section 4 of FDAs Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices, and in the international standards ISO/IEC 14971-1 and IEC 60601-1-4 referenced in Appendix A.",
"options": {
"A": "Submissions for Software Contained",
"B": "Software Validation Guidance",
"C": "a software automated device",
"D": "Section 4"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Additional guidance regarding safety risk manageme...'?",
"reference": "Additional guidance regarding safety risk management for software may be found in Section 4 of FDAs Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices, and in the international standards ISO/IEC 14971-1 and IEC 60601-1-4 referenced in Appendix A.",
"options": {
"C": "Medical Devices",
"A": "Page 7General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Additional guidance regarding safety risk manageme...'?",
"reference": "Additional guidance regarding safety risk management for software may be found in Section 4 of FDAs Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices, and in the international standards ISO/IEC 14971-1 and IEC 60601-1-4 referenced in Appendix A.",
"options": {
"D": "ISO/IEC",
"A": "Page 7General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Additional guidance regarding safety risk manageme...'?",
"reference": "Additional guidance regarding safety risk management for software may be found in Section 4 of FDAs Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices, and in the international standards ISO/IEC 14971-1 and IEC 60601-1-4 referenced in Appendix A.",
"options": {
"C": "14971-1",
"A": "many years",
"B": "Software Validation Guidance",
"D": "a software automated device"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Additional guidance regarding safety risk manageme...'?",
"reference": "Additional guidance regarding safety risk management for software may be found in Section 4 of FDAs Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices, and in the international standards ISO/IEC 14971-1 and IEC 60601-1-4 referenced in Appendix A.",
"options": {
"B": "Appendix A.",
"A": "Appendix A. 3.1.3 IQ/OQ/PQ",
"C": "Software Validation Guidance",
"D": "a software automated device"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 6 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
270 271 If a system has been changed since August 20, 1997, and if the changes would prevent the 272 system from meeting predicate rule requirements, Part 11 controls should be applied to Part 11 273 records and signatures pursuant to the enforcement policy expressed in this guidance. Copies of Records 276 277 The Agency intend s to exercise enforcement discretion with regard to specific part 11 278 requirements for generating copies of records ( 11.10 (b) and any corresponding requirement in 279 11.30). You should provide an investigator with reasonable and useful access to records d uring 280 an inspection. All records held by you are subject to inspection in accordance with predicate 281 rules (e.g., 211.180(c), (d), and 108.35(c)(3)(ii)). 282 283 We recommend that you supply copies of electronic records by: 284 285 Producing copies of records held i n common portable formats when records are 286 maintained in these formats 287 Using established automated conversion or export methods, where available, to make 288 copies in a more common format (examples of such formats include, but are not limited 289 to, PDF, XML, or SGML) 290 6 Various guidance documents on information security are available (see References). In this guidance document, we use the term legacy system to desc ribe systems already in operation before the effective date of part 11. Contains Nonbinding Recommendations 8
In each case, we recommend that the copying process used produces copies that preserve the 291 content and meaning of the record. If you have the ability to search, sort, or trend part 11 292 records, copies given to the Agency should provide the same capa bility if it is reasonable and 293 technically feasible. You should allow inspection, review, and copying of records in a human 294 readable form at your site using your hardware and following your established procedures and 295 techniques for accessing 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": "Which organization is referenced: 'In this guidance document, we use the term legacy ...'?",
"reference": "In this guidance document, we use the term legacy system to desc ribe systems already in operation before the effective date of part 11.",
"options": {
"A": "desc",
"B": "Agency",
"C": "PDF",
"D": "Part 11 273 records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this guidance document, we use the term legacy system to desc ribe systems already in operation before the effective date of part ____.",
"reference": "In this guidance document, we use the term legacy system to desc ribe systems already in operation before the effective date of part 11.",
"options": {
"D": "11",
"A": "270 271",
"B": "272",
"C": "electronic records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In this guidance document, we use the term legacy ...'?",
"reference": "In this guidance document, we use the term legacy system to desc ribe systems already in operation before the effective date of part 11.",
"options": {
"A": "desc",
"B": "Agency",
"C": "PDF",
"D": "Part 11 273 records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this guidance document, we use the term legacy system to desc ribe systems already in operation before the effective date of part ____.",
"reference": "In this guidance document, we use the term legacy system to desc ribe systems already in operation before the effective date of part 11.",
"options": {
"A": "11",
"B": "270 271",
"C": "272",
"D": "electronic records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: 'All records held by you are subject to inspection ...'?",
"reference": "All records held by you are subject to inspection in accordance with predicate 281 rules (e.g., 211.180(c), (d), and 108.35(c)(3)(ii)).",
"options": {
"A": "211.180(c",
"B": "270 271",
"C": "272",
"D": "Part 11 273 records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: All records held by you are subject to inspection in accordance with predicate ____ rules (e.g., 211.180(c), (d), and 108.35(c)(3)(ii)).",
"reference": "All records held by you are subject to inspection in accordance with predicate 281 rules (e.g., 211.180(c), (d), and 108.35(c)(3)(ii)).",
"options": {
"A": "281",
"B": "270 271",
"C": "272",
"D": "Part 11 273 records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Innovation: The introduction of new technolog ies or methodologies. (ICH Q10) 15 Knowledge Management: Systematic approach to acqui ring, analyzing, storing, and disseminating information related to products, manufacturing processes, and components. (ICH Q10) Outsourced Activities: Activities conducted by a contract a cceptor under a written agreement with a contract giver. (ICH Q10) Performance Indicators: Measurable values used to quantify quality objectives to reflect the performance of an organization, process, or system, also known as performance metrics in some regions. (ICH Q10) Pharmaceutical Quality System (PQS): Management system to direct and control a pharmaceutical company with regard to quality. (ICH Q10 based upon ISO 9000:2005)
Preventive Action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation. NO TE: Preventive action is taken to prevent occurrence whereas corrective action is taken to pr event recurrence. (ISO 9000:2005) Product Realization: Achievement of a product w ith the quality attributes appropriate to meet the needs of patients, health ca re professionals, and regulatory authorities (including compliance with marketing authorization) and inte rnal customers requirements. Quality: The degree to which a set of inherent propert ies of a product, system, or process fulfils requirements. (ICH Q9) Quality Manual:
Document specifying the quality management system of an organization. (ISO 9000:2005) Quality Objectives: A means to translate the quality pol icy and strategies into measurable activities. Quality Planning: Part of quality management focu sed on setting quality objectives and specifying necessary operational processes and rela ted resources to fulfill the quality objectives. (ISO 9000:2005) Quality Policy: Overall intentions and dire ction of an organization rela ted to quality as formally expressed by senior management.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: '(ICH Q10) Pharmaceutical Quality System (PQS): Man...'?",
"reference": "(ICH Q10) Pharmaceutical Quality System (PQS): Management system to direct and control a pharmaceutical company with regard to quality.",
"options": {
"D": "PQS",
"A": "ISO",
"B": "Preventive Action: Action",
"C": "quality management focu"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (ICH Q10) ____ Knowledge Management: Systematic approach to acqui ring, analyzing, storing, and disseminating information related to products, manufacturing processes, and components.",
"reference": "(ICH Q10) 15 Knowledge Management: Systematic approach to acqui ring, analyzing, storing, and disseminating information related to products, manufacturing processes, and components.",
"options": {
"D": "15",
"A": "quality management focu",
"B": "the quality management system",
"C": "This information is not provided in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q10) Pharmaceutical Quality System (PQS): Man...'?",
"reference": "(ICH Q10) Pharmaceutical Quality System (PQS): Management system to direct and control a pharmaceutical company with regard to quality.",
"options": {
"A": "PQS",
"B": "ISO",
"C": "Preventive Action: Action",
"D": "quality management focu"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q10) Pharmaceutical Quality System (PQS): Man...'?",
"reference": "(ICH Q10) Pharmaceutical Quality System (PQS): Management system to direct and control a pharmaceutical company with regard to quality.",
"options": {
"A": "PQS",
"B": "ISO",
"C": "Preventive Action: Action",
"D": "quality management focu"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q10) Pharmaceutical Quality System (PQS): Man...'?",
"reference": "(ICH Q10) Pharmaceutical Quality System (PQS): Management system to direct and control a pharmaceutical company with regard to quality.",
"options": {
"C": "PQS",
"A": "ISO",
"B": "Preventive Action: Action",
"D": "quality management focu"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '(ICH Q10 based upon ISO 9000:2005)\nPreventive Acti...'?",
"reference": "(ICH Q10 based upon ISO 9000:2005)\nPreventive Action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.",
"options": {
"A": "Q10",
"B": "quality management focu",
"C": "the quality management system",
"D": "ISO"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q10 based upon ISO 9000:2005)\nPreventive Acti...'?",
"reference": "(ICH Q10 based upon ISO 9000:2005)\nPreventive Action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.",
"options": {
"C": "ISO",
"A": "PQS",
"B": "Preventive Action: Action",
"D": "quality management focu"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q10 based upon ISO 9000:2005)\nPreventive Acti...'?",
"reference": "(ICH Q10 based upon ISO 9000:2005)\nPreventive Action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.",
"options": {
"A": "Preventive Action: Action",
"B": "quality management focu",
"C": "the quality management system",
"D": "Q10"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ISO 9000:2005) Quality Policy: Overall intentions...'?",
"reference": "(ISO 9000:2005) Quality Policy: Overall intentions and dire ction of an organization rela ted to quality as formally expressed by senior management.",
"options": {
"D": "ISO 9000:2005",
"A": "PQS",
"B": "ISO",
"C": "quality management focu"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ISO 9000:2005) Quality Policy: Overall intentions...'?",
"reference": "(ISO 9000:2005) Quality Policy: Overall intentions and dire ction of an organization rela ted to quality as formally expressed by senior management.",
"options": {
"D": "ISO 9000:2005",
"A": "PQS",
"B": "ISO",
"C": "quality management focu"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '(ICH Q10 based upon ISO 9000:2005)\nPreventive Acti...'?",
"reference": "(ICH Q10 based upon ISO 9000:2005)\nPreventive Action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.",
"options": {
"B": "Q10",
"A": "quality management focu",
"C": "the quality management system",
"D": "ISO"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q10 based upon ISO 9000:2005)\nPreventive Acti...'?",
"reference": "(ICH Q10 based upon ISO 9000:2005)\nPreventive Action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.",
"options": {
"B": "ISO",
"A": "PQS",
"C": "Preventive Action: Action",
"D": "quality management focu"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '(ICH Q10 based upon ISO 9000:2005)\nPreventive Acti...'?",
"reference": "(ICH Q10 based upon ISO 9000:2005)\nPreventive Action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.",
"options": {
"C": "Q10",
"A": "quality management focu",
"B": "the quality management system",
"D": "ISO"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q10 based upon ISO 9000:2005)\nPreventive Acti...'?",
"reference": "(ICH Q10 based upon ISO 9000:2005)\nPreventive Action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.",
"options": {
"A": "ISO",
"B": "PQS",
"C": "Preventive Action: Action",
"D": "quality management focu"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q10 based upon ISO 9000:2005)\nPreventive Acti...'?",
"reference": "(ICH Q10 based upon ISO 9000:2005)\nPreventive Action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.",
"options": {
"C": "Preventive Action: Action",
"A": "quality management focu",
"B": "the quality management system",
"D": "Q10"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ISO 9000:2005) Quality Objectives: A means to tra...'?",
"reference": "(ISO 9000:2005) Quality Objectives: A means to translate the quality pol icy and strategies into measurable activities.",
"options": {
"B": "ISO 9000:2005",
"A": "PQS",
"C": "ISO",
"D": "quality management focu"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ISO 9000:2005) Quality Objectives: A means to tra...'?",
"reference": "(ISO 9000:2005) Quality Objectives: A means to translate the quality pol icy and strategies into measurable activities.",
"options": {
"D": "ISO 9000:2005",
"A": "PQS",
"B": "ISO",
"C": "quality management focu"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (ICH Q10) ____ Knowledge Management: Systematic approach to acqui ring, analyzing, storing, and disseminating information related to products, manufacturing processes, and components.",
"reference": "(ICH Q10) 15 Knowledge Management: Systematic approach to acqui ring, analyzing, storing, and disseminating information related to products, manufacturing processes, and components.",
"options": {
"C": "15",
"A": "quality management focu",
"B": "the quality management system",
"D": "This information is not provided in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q10) Pharmaceutical Quality System (PQS): Man...'?",
"reference": "(ICH Q10) Pharmaceutical Quality System (PQS): Management system to direct and control a pharmaceutical company with regard to quality.",
"options": {
"C": "PQS",
"A": "ISO",
"B": "Preventive Action: Action",
"D": "quality management focu"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ISO 9000:2005) Product Realization: Achievement o...'?",
"reference": "(ISO 9000:2005) Product Realization: Achievement of a product w ith the quality attributes appropriate to meet the needs of patients, health ca re professionals, and regulatory authorities (including compliance with marketing authorization) and inte rnal customers requirements.",
"options": {
"C": "ISO 9000:2005",
"A": "PQS",
"B": "ISO",
"D": "quality management focu"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q10) Pharmaceutical Quality System (PQS): Man...'?",
"reference": "(ICH Q10) Pharmaceutical Quality System (PQS): Management system to direct and control a pharmaceutical company with regard to quality.",
"options": {
"B": "PQS",
"A": "ISO",
"C": "Preventive Action: Action",
"D": "quality management focu"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ISO 9000:2005) Product Realization: Achievement o...'?",
"reference": "(ISO 9000:2005) Product Realization: Achievement of a product w ith the quality attributes appropriate to meet the needs of patients, health ca re professionals, and regulatory authorities (including compliance with marketing authorization) and inte rnal customers requirements.",
"options": {
"D": "ISO 9000:2005",
"A": "PQS",
"B": "ISO",
"C": "quality management focu"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ISO 9000:2005) Quality Policy: Overall intentions...'?",
"reference": "(ISO 9000:2005) Quality Policy: Overall intentions and dire ction of an organization rela ted to quality as formally expressed by senior management.",
"options": {
"D": "ISO 9000:2005",
"A": "PQS",
"B": "ISO",
"C": "quality management focu"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ISO 9000:2005) Quality Policy: Overall intentions...'?",
"reference": "(ISO 9000:2005) Quality Policy: Overall intentions and dire ction of an organization rela ted to quality as formally expressed by senior management.",
"options": {
"C": "ISO 9000:2005",
"A": "PQS",
"B": "ISO",
"D": "quality management focu"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (ICH Q10) ____ Knowledge Management: Systematic approach to acqui ring, analyzing, storing, and disseminating information related to products, manufacturing processes, and components.",
"reference": "(ICH Q10) 15 Knowledge Management: Systematic approach to acqui ring, analyzing, storing, and disseminating information related to products, manufacturing processes, and components.",
"options": {
"D": "15",
"A": "quality management focu",
"B": "the quality management system",
"C": "This information is not provided in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 5 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Alan Kusinitz, Software Validation , Current Issues in Medical Device Quality Systems, Association for the Advancement of Medical Instrumentation, 1997. ISBN 1-57020-075-0. Nancy G. Leveson, Safeware, System Safety and Computers , Addison-Wesley Publishing Company, 1995. ISBN 0-201-11972-2. Michael R. Lyu, Editor, Handbook of Software Reliability Engineering , IEEE Computer Society Press, McGraw-Hill, 1996. ISBN 0-07-039400-8. Steven R. Mallory, Software Development and Quality Assurance for the Healthcare Manufacturing Industries , Interpharm Press,Inc., 1994. ISBN 0-935184-58-9. Brian Marick, The Craft of Software Testing , Prentice Hall PTR, 1995. ISBN 0-13-177411-5. Steve McConnell, Rapid Development , Microsoft Press, 1996. ISBN 1-55615-900-5. Glenford J. Myers, The Art of Software Testing , John Wiley Sons, 1979. ISBN 0-471-04328-1. Peter G. Neumann, Computer Related Risks , ACM Press/Addison-Wesley Publishing Co., 1995. ISBN 0-201-55805-X. Daniel Olivier, Conducting Software Audits, Auditing Software for Conformance to FDA Requirements , Computer Application Specialists, San Diego, CA, 1994. William Perry, Effective Methods for Software Testing , John Wiley Sons, Inc. 1995. ISBN 0- 471-06097-6. William E. Perry, Randall W. Rice, Surviving the Top Ten Challenges of Software Testing , Dorset Page 42General Principles of Software Validation Guidance for Industry and FDA Staff House Publishing, 1997. ISBN 0-932633-38-2. Roger S. Pressman, Software Engineering, A Practitioner's Approach , Third Edition, McGraw-Hill Inc., 1992. ISBN 0-07-050814-3. Roger S. Pressman, A Managers Guide to Software Engineering , McGraw-Hill Inc., 1993 ISBN 0-07-050820-8. A. P. Sage, J. D. Palmer , Software Systems Engineering , John Wiley Sons, 1990. Joc Sanders, Eugene Curran, Software Quality , Addison-Wesley Publishing Co., 1994. ISBN 0- 201-63198-9.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Who is mentioned in the context: 'Roger S. Pressman, A Managers Guide to Software En...'?",
"reference": "Roger S. Pressman, A Managers Guide to Software Engineering , McGraw-Hill Inc., 1993 ISBN 0-07-050820-8.",
"options": {
"D": "Roger S. Pressman",
"A": "Alan Kusinitz",
"B": "Nancy G. Leveson",
"C": "Software Systems Engineering"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Roger S. Pressman, A Managers Guide to Software En...'?",
"reference": "Roger S. Pressman, A Managers Guide to Software Engineering , McGraw-Hill Inc., 1993 ISBN 0-07-050820-8.",
"options": {
"B": "Software Engineering",
"A": "Software Validation",
"C": "the Advancement of Medical Instrumentation",
"D": "Software Systems Engineering"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Roger S. Pressman, A Managers Guide to Software En...'?",
"reference": "Roger S. Pressman, A Managers Guide to Software Engineering , McGraw-Hill Inc., 1993 ISBN 0-07-050820-8.",
"options": {
"A": "McGraw-Hill Inc.",
"B": "Software Validation",
"C": "the Advancement of Medical Instrumentation",
"D": "Software Systems Engineering"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Roger S. Pressman, A Managers Guide to Software En...'?",
"reference": "Roger S. Pressman, A Managers Guide to Software Engineering , McGraw-Hill Inc., 1993 ISBN 0-07-050820-8.",
"options": {
"A": "1993",
"B": "1997",
"C": "1995",
"D": "Software Systems Engineering"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Roger S. Pressman, A Managers Guide to Software Engineering , McGraw-Hill Inc., ____ ISBN 0-07-050820-8.",
"reference": "Roger S. Pressman, A Managers Guide to Software Engineering , McGraw-Hill Inc., 1993 ISBN 0-07-050820-8.",
"options": {
"D": "1993",
"A": "1997",
"B": "1995",
"C": "Software Systems Engineering"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 3 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
On the other hand, when 166 persons use computers to generate paper printouts of electronic records, and those paper records 167 meet all the requirements of the applicable predicate rules and persons rely on the paper records 168 to perform their regulated activities, FDA would generally not co nsider persons to be "using 169 electronic records in lieu of paper records" under 11.2(a) and 11.2(b). In these instances, the 170 use of computer systems in the generation of paper records would not trigger part 11. Definition of Part 11 Records 173 174 Under this narrow interpretation, FDA considers part 11 to be applicable to the following records 175 or signatures in electronic format (part 11 records or signatures): 176 177 Records that are required to be maintained under predicate rule requirements and that are 178 maintained in electronic format in place of paper format . On the other hand, records (and 179 any associated signatures) that are not required to be retained under predicate rules, but 180 that are nonetheless maintained in electronic format, are not part 11 records . We recommend that you determine, based on the predicate rules, whether specific records 182 are part 11 records. We recommend that you document such decisions. 183 184 Records that are required to be maintained under predicate rules, that are maintained in 185 electro nic format in addition to paper format, and that are relied on to perform regulated 186 activities . In some cases, actual business practices may dictate whether you are using electronic 188 records instead of paper records under 11.2(a). For example, if a reco rd is required to 189 be maintained under a predicate rule and you use a computer to generate a paper printout 190 of the electronic records, but you nonetheless rely on the electronic record to perform 191 regulated activities, the Agency may consider you to be using the electronic record 192 instead of the paper record.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: In these instances, the ____ use of computer systems in the generation of paper records would not trigger part 11.",
"reference": "In these instances, the 170 use of computer systems in the generation of paper records would not trigger part 11.",
"options": {
"D": "170",
"A": "166",
"B": "167",
"C": "those paper records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In these instances, the 170 use of computer systems in the generation of paper records would not trigger part ____.",
"reference": "In these instances, the 170 use of computer systems in the generation of paper records would not trigger part 11.",
"options": {
"D": "11",
"A": "166",
"B": "167",
"C": "those paper records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In some cases, actual business practices may dictate whether you are using electronic ____ records instead of paper records under 11.2(a).",
"reference": "In some cases, actual business practices may dictate whether you are using electronic 188 records instead of paper records under 11.2(a).",
"options": {
"A": "188",
"B": "166",
"C": "167",
"D": "those paper records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
The overarching philosophy articulated in both the CGMP regulations and in robust modern quality syste ms is: 2 See Reference 1. 3
See Reference 2. 2
Contains Nonbinding Recommendations Quality should be built into the product, and testing alone cannot be relied on to ensure product quality . This guidance is intended to se rve as a bridge between the 19 78 regulations and our current understanding of quality systems. In addition to being part of the FDA's CGMP initiative, this guidance is being issued for a number of reasons:
A quality system addresses the public and priv ate sectors mutual goal of providing a high- quality drug product to patients and
prescriber s. A well-built quality system should reduce the number of (or prevent) recalls, returned or salvaged products, and defective products entering the marketplace. It is important that the CGMP regulations are ha rmonized to the extent possible with other widely used quality management systems, incl uding ISO 9000, non-U.S. pharmaceutical quality management requirements, and FDAs own medical device quality system regulations. This guidance serves as a first step to highlight common elements be tween the CGMP regulations and Quality Management Systems. With the globa lization of pharmaceutical manufacturing and the increasing prevalence of drug- and biologic-de vice combination products, the convergence of quality management principles across different regions and among various product types is very desirable. The FDA has concluded that modern quality syst ems, when coupled with manufacturing process and product knowledge and the use of effective risk management practices, can handle many types of changes to facilities, equipment, and processes without the need for prior approval regulatory submissions. Manufactur ers with a robust quality system and appropriate process knowledge can implement many types of improvements .
[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 overarching philosophy articulated in both the...'?",
"reference": "The overarching philosophy articulated in both the CGMP regulations and in robust modern quality syste ms is: 2 See Reference 1.",
"options": {
"D": "CGMP",
"A": "Contains Nonbinding Recommendations Quality",
"B": "FDA",
"C": "other widely used quality management systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The overarching philosophy articulated in both the CGMP regulations and in robust modern quality syste ms is: ____ See Reference 1.",
"reference": "The overarching philosophy articulated in both the CGMP regulations and in robust modern quality syste ms is: 2 See Reference 1.",
"options": {
"C": "2",
"A": "other widely used quality management systems",
"B": "FDAs own medical device quality system regulations",
"D": "two"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The overarching philosophy articulated in both the CGMP regulations and in robust modern quality syste ms is: 2 See Reference ____.",
"reference": "The overarching philosophy articulated in both the CGMP regulations and in robust modern quality syste ms is: 2 See Reference 1.",
"options": {
"A": "1",
"B": "other widely used quality management systems",
"C": "FDAs own medical device quality system regulations",
"D": "ace"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nContains Nonbinding Recommendations Quality should be built into the product, and testing alone cannot be relied on to ensure product quality .",
"reference": "2\nContains Nonbinding Recommendations Quality should be built into the product, and testing alone cannot be relied on to ensure product quality .",
"options": {
"C": "2",
"A": "other widely used quality management systems",
"B": "FDAs own medical device quality system regulations",
"D": "two"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'With the globa lization of pharmaceutical manufact...'?",
"reference": "With the globa lization of pharmaceutical manufacturing and the increasing prevalence of drug- and biologic-de vice combination products, the convergence of quality management principles across different regions and among various product types is very desirable.",
"options": {
"D": "drug-",
"A": "CGMP",
"B": "Contains Nonbinding Recommendations Quality",
"C": "other widely used quality management systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'With the globa lization of pharmaceutical manufact...'?",
"reference": "With the globa lization of pharmaceutical manufacturing and the increasing prevalence of drug- and biologic-de vice combination products, the convergence of quality management principles across different regions and among various product types is very desirable.",
"options": {
"C": "biologic-de",
"A": "CGMP",
"B": "Contains Nonbinding Recommendations Quality",
"D": "other widely used quality management systems"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It is important that the CGMP regulations are ha r...'?",
"reference": "It is important that the CGMP regulations are ha rmonized to the extent possible with other widely used quality management systems, incl uding ISO 9000, non-U.S. pharmaceutical quality management requirements, and FDAs own medical device quality system regulations.",
"options": {
"C": "CGMP",
"A": "Contains Nonbinding Recommendations Quality",
"B": "FDA",
"D": "other widely used quality management systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is important that the CGMP regulations are ha rmonized to the extent possible with other widely used quality management systems, incl uding ISO ____, non-U.S. pharmaceutical quality management requirements, and FDAs own medical device quality system regulations.",
"reference": "It is important that the CGMP regulations are ha rmonized to the extent possible with other widely used quality management systems, incl uding ISO 9000, non-U.S. pharmaceutical quality management requirements, and FDAs own medical device quality system regulations.",
"options": {
"D": "9000",
"A": "other widely used quality management systems",
"B": "FDAs own medical device quality system regulations",
"C": "CGMP"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The overarching philosophy articulated in both the...'?",
"reference": "The overarching philosophy articulated in both the CGMP regulations and in robust modern quality syste ms is: 2 See Reference 1.",
"options": {
"D": "CGMP",
"A": "Contains Nonbinding Recommendations Quality",
"B": "FDA",
"C": "other widely used quality management systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The overarching philosophy articulated in both the CGMP regulations and in robust modern quality syste ms is: ____ See Reference 1.",
"reference": "The overarching philosophy articulated in both the CGMP regulations and in robust modern quality syste ms is: 2 See Reference 1.",
"options": {
"B": "2",
"A": "other widely used quality management systems",
"C": "FDAs own medical device quality system regulations",
"D": "two"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'Manufactur ers with a robust quality system and ap...'?",
"reference": "Manufactur ers with a robust quality system and appropriate process knowledge can implement many types of improvements .",
"options": {
"B": "Manufactur",
"A": "other widely used quality management systems",
"C": "FDAs own medical device quality system regulations",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The FDA has concluded that modern quality syst ems...'?",
"reference": "The FDA has concluded that modern quality syst ems, when coupled with manufacturing process and product knowledge and the use of effective risk management practices, can handle many types of changes to facilities, equipment, and processes without the need for prior approval regulatory submissions.",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "Contains Nonbinding Recommendations Quality",
"D": "other widely used quality management systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "inferential"
},
{
"question": "Which organization is referenced: 'This guidance serves as a first step to highlight ...'?",
"reference": "This guidance serves as a first step to highlight common elements be tween the CGMP regulations and Quality Management Systems.",
"options": {
"A": "CGMP",
"B": "Contains Nonbinding Recommendations Quality",
"C": "FDA",
"D": "other widely used quality management systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance serves as a first step to highlight ...'?",
"reference": "This guidance serves as a first step to highlight common elements be tween the CGMP regulations and Quality Management Systems.",
"options": {
"D": "Quality Management Systems",
"A": "CGMP",
"B": "Contains Nonbinding Recommendations Quality",
"C": "FDAs own medical device quality system regulations"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This guidance serves as a ____ step to highlight common elements be tween the CGMP regulations and Quality Management Systems.",
"reference": "This guidance serves as a first step to highlight common elements be tween the CGMP regulations and Quality Management Systems.",
"options": {
"A": "first",
"B": "other widely used quality management systems",
"C": "FDAs own medical device quality system regulations",
"D": "firstly"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The FDA has concluded that modern quality syst ems...'?",
"reference": "The FDA has concluded that modern quality syst ems, when coupled with manufacturing process and product knowledge and the use of effective risk management practices, can handle many types of changes to facilities, equipment, and processes without the need for prior approval regulatory submissions.",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "Contains Nonbinding Recommendations Quality",
"C": "other widely used quality management systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "inferential"
},
{
"question": "Which organization is referenced: 'With the globa lization of pharmaceutical manufact...'?",
"reference": "With the globa lization of pharmaceutical manufacturing and the increasing prevalence of drug- and biologic-de vice combination products, the convergence of quality management principles across different regions and among various product types is very desirable.",
"options": {
"A": "drug-",
"B": "CGMP",
"C": "Contains Nonbinding Recommendations Quality",
"D": "other widely used quality management systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'With the globa lization of pharmaceutical manufact...'?",
"reference": "With the globa lization of pharmaceutical manufacturing and the increasing prevalence of drug- and biologic-de vice combination products, the convergence of quality management principles across different regions and among various product types is very desirable.",
"options": {
"C": "biologic-de",
"A": "CGMP",
"B": "Contains Nonbinding Recommendations Quality",
"D": "other widely used quality management systems"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nContains Nonbinding Recommendations Quality should be built into the product, and testing alone cannot be relied on to ensure product quality .",
"reference": "2\nContains Nonbinding Recommendations Quality should be built into the product, and testing alone cannot be relied on to ensure product quality .",
"options": {
"C": "2",
"A": "other widely used quality management systems",
"B": "FDAs own medical device quality system regulations",
"D": "two"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The FDA has concluded that modern quality syst ems...'?",
"reference": "The FDA has concluded that modern quality syst ems, when coupled with manufacturing process and product knowledge and the use of effective risk management practices, can handle many types of changes to facilities, equipment, and processes without the need for prior approval regulatory submissions.",
"options": {
"C": "FDA",
"A": "CGMP",
"B": "Contains Nonbinding Recommendations Quality",
"D": "other widely used quality management systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "inferential"
},
{
"question": "Which organization is referenced: 'It is important that the CGMP regulations are ha r...'?",
"reference": "It is important that the CGMP regulations are ha rmonized to the extent possible with other widely used quality management systems, incl uding ISO 9000, non-U.S. pharmaceutical quality management requirements, and FDAs own medical device quality system regulations.",
"options": {
"A": "CGMP",
"B": "Contains Nonbinding Recommendations Quality",
"C": "FDA",
"D": "other widely used quality management systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is important that the CGMP regulations are ha rmonized to the extent possible with other widely used quality management systems, incl uding ISO ____, non-U.S. pharmaceutical quality management requirements, and FDAs own medical device quality system regulations.",
"reference": "It is important that the CGMP regulations are ha rmonized to the extent possible with other widely used quality management systems, incl uding ISO 9000, non-U.S. pharmaceutical quality management requirements, and FDAs own medical device quality system regulations.",
"options": {
"B": "9000",
"A": "other widely used quality management systems",
"C": "FDAs own medical device quality system regulations",
"D": "CGMP"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The FDA has concluded that modern quality syst ems...'?",
"reference": "The FDA has concluded that modern quality syst ems, when coupled with manufacturing process and product knowledge and the use of effective risk management practices, can handle many types of changes to facilities, equipment, and processes without the need for prior approval regulatory submissions.",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "Contains Nonbinding Recommendations Quality",
"C": "other widely used quality management systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "inferential"
},
{
"question": "Which organization is referenced: 'In addition to being part of the FDA's CGMP initia...'?",
"reference": "In addition to being part of the FDA's CGMP initiative, this guidance is being issued for a number of reasons:\nA quality system addresses the public and priv ate sectors mutual goal of providing a high- quality drug product to patients and\nprescriber s. A well-built quality system should reduce the number of (or prevent) recalls, returned or salvaged products, and defective products entering the marketplace.",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "Contains Nonbinding Recommendations Quality",
"D": "other widely used quality management systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In addition to being part of the FDA's CGMP initia...'?",
"reference": "In addition to being part of the FDA's CGMP initiative, this guidance is being issued for a number of reasons:\nA quality system addresses the public and priv ate sectors mutual goal of providing a high- quality drug product to patients and\nprescriber s. A well-built quality system should reduce the number of (or prevent) recalls, returned or salvaged products, and defective products entering the marketplace.",
"options": {
"C": "CGMP",
"A": "Contains Nonbinding Recommendations Quality",
"B": "FDA",
"D": "other widely used quality management systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It is important that the CGMP regulations are ha r...'?",
"reference": "It is important that the CGMP regulations are ha rmonized to the extent possible with other widely used quality management systems, incl uding ISO 9000, non-U.S. pharmaceutical quality management requirements, and FDAs own medical device quality system regulations.",
"options": {
"D": "CGMP",
"A": "Contains Nonbinding Recommendations Quality",
"B": "FDA",
"C": "other widely used quality management systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: It is important that the CGMP regulations are ha rmonized to the extent possible with other widely used quality management systems, incl uding ISO ____, non-U.S. pharmaceutical quality management requirements, and FDAs own medical device quality system regulations.",
"reference": "It is important that the CGMP regulations are ha rmonized to the extent possible with other widely used quality management systems, incl uding ISO 9000, non-U.S. pharmaceutical quality management requirements, and FDAs own medical device quality system regulations.",
"options": {
"B": "9000",
"A": "other widely used quality management systems",
"C": "FDAs own medical device quality system regulations",
"D": "CGMP"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In addition to being part of the FDA's CGMP initia...'?",
"reference": "In addition to being part of the FDA's CGMP initiative, this guidance is being issued for a number of reasons:\nA quality system addresses the public and priv ate sectors mutual goal of providing a high- quality drug product to patients and\nprescriber s. A well-built quality system should reduce the number of (or prevent) recalls, returned or salvaged products, and defective products entering the marketplace.",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "Contains Nonbinding Recommendations Quality",
"C": "other widely used quality management systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In addition to being part of the FDA's CGMP initia...'?",
"reference": "In addition to being part of the FDA's CGMP initiative, this guidance is being issued for a number of reasons:\nA quality system addresses the public and priv ate sectors mutual goal of providing a high- quality drug product to patients and\nprescriber s. A well-built quality system should reduce the number of (or prevent) recalls, returned or salvaged products, and defective products entering the marketplace.",
"options": {
"A": "CGMP",
"B": "Contains Nonbinding Recommendations Quality",
"C": "FDA",
"D": "other widely used quality management systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This guidance is intended to se rve as a bridge between the ____ 78 regulations and our current understanding of quality systems.",
"reference": "This guidance is intended to se rve as a bridge between the 19 78 regulations and our current understanding of quality systems.",
"options": {
"D": "19",
"A": "other widely used quality management systems",
"B": "FDAs own medical device quality system regulations",
"C": "nineteen"
},
"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 1 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Address Nonconformities ............................................................................................................... 19 D. Evaluation Activities .................................................................................................................... 21 1. Analyze Data for Trends ............................................................................................................... 21 2. Conduct Internal Audits ................................................................................................................. 21 3. Quality Risk Management ..............................................................................................................
Corrective Action ...........................................................................................................................
22 Contains Nonbinding Recommendations 5. Preventive Actions ......................................................................................................................... 23 6. Promote Improvement ....................................................................................................................
23 V. CONCLUSION ............................................................................................................... 24 USEFUL REFERENCE MATERIALS ....................................................................................
25 GLOSSARY ................................................................................................................................. 27 Contains Nonbinding Recommendations Guidance for Industry1 Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations This guidance represents the Food and Drug Administrati on's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any pe rson and does not operate to bind FDA or the public.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'It does not create or confer any rights for or on ...'?",
"reference": "It does not create or confer any rights for or on any pe rson and does not operate to bind FDA or the public.",
"options": {
"D": "FDA",
"A": "Analyze Data",
"B": "Conduct Internal Audits",
"C": "Nonbinding Recommendations Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
For example, all production and control records , which includes audit trails, must be reviewed and approved by the quality unit ( 211.192). The regulations provide flexibili ty to have some activities reviewed by a person directly supervising or checking information ( e.g., 211.188). FDA recommends a quality system approach to implementing oversight and review of CGMP records .12 8. How often should audit trails be reviewed? If the review frequency for the data is specified in CGMP regulations , adhere to that frequency for the audit trail review. For example, 211.188(b) requires review after each significant step in manufacture, processing, packing , or holding , and 211.22 requires data review before bat ch release. In these cases, you would apply the same review frequency for the audit trail. If the review frequency for the data is not specified in CGMP regulations, you should determine the review frequency for the audit tr ail using knowledge of your processes and risk assessment tools. The risk assessment should include evaluation of data criticality, control mechanisms, and impact on product quality. Your approach to audit trail review and the frequency with which you conduct it should ensure that CGMP requirements are met, appropriate controls are implemented, and the reliability of the review is proven. See the audit trail definition in 1.c. above for further information on audit trails. Can electronic copies be used as accurate reproductions of paper or electronic records? Electronic copies can be used as true copies of paper or electronic records, provided the copies preserve the content and meaning of the original record , which includes all metadata 12 See guidance for industry Quality Systems Approach to Pharmaceutical CGMP Regulations . See also guidance for industry Contract Manufacturing Arrangements for Drugs: Quality Agreements for information about auditing as it relates to contract facilities.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'FDA recommends a quality system approach to implem...'?",
"reference": "FDA recommends a quality system approach to implementing oversight and review of CGMP records .12 8.",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "the audit trail review",
"D": "the review frequency"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA recommends a quality system approach to implem...'?",
"reference": "FDA recommends a quality system approach to implementing oversight and review of CGMP records .12 8.",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "Quality Systems Approach",
"C": "the audit trail review"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA recommends a quality system approach to implementing oversight and review of CGMP records ____ 8.",
"reference": "FDA recommends a quality system approach to implementing oversight and review of CGMP records .12 8.",
"options": {
"C": ".12",
"A": "the audit trail review",
"B": "the review frequency",
"D": "FDA"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA recommends a quality system approach to implementing oversight and review of CGMP records .12 ____.",
"reference": "FDA recommends a quality system approach to implementing oversight and review of CGMP records .12 8.",
"options": {
"B": "8",
"A": "211.192",
"C": "211.188",
"D": "the audit trail review"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, all production and control records , which includes audit trails, must be reviewed and approved by the quality unit ( ____).",
"reference": "For example, all production and control records , which includes audit trails, must be reviewed and approved by the quality unit ( 211.192).",
"options": {
"D": "211.192",
"A": "211.188",
"B": "211.188(b",
"C": "the audit trail review"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Your approach to audit trail review and the freque...'?",
"reference": "Your approach to audit trail review and the frequency with which you conduct it should ensure that CGMP requirements are met, appropriate controls are implemented, and the reliability of the review is proven.",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "Quality Systems Approach",
"D": "the audit trail review"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Electronic copies can be used as true copies of pa...'?",
"reference": "Electronic copies can be used as true copies of paper or electronic records, provided the copies preserve the content and meaning of the original record , which includes all metadata 12 See guidance for industry Quality Systems Approach to Pharmaceutical CGMP Regulations .",
"options": {
"B": "Quality Systems Approach",
"A": "FDA",
"C": "CGMP",
"D": "the audit trail review"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic copies can be used as true copies of paper or electronic records, provided the copies preserve the content and meaning of the original record , which includes all metadata ____ See guidance for industry Quality Systems Approach to Pharmaceutical CGMP Regulations .",
"reference": "Electronic copies can be used as true copies of paper or electronic records, provided the copies preserve the content and meaning of the original record , which includes all metadata 12 See guidance for industry Quality Systems Approach to Pharmaceutical CGMP Regulations .",
"options": {
"C": "12",
"A": "211.192",
"B": "211.188",
"D": "the audit trail review"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Electronic copies can be used as true copies of pa...'?",
"reference": "Electronic copies can be used as true copies of paper or electronic records, provided the copies preserve the content and meaning of the original record , which includes all metadata 12 See guidance for industry Quality Systems Approach to Pharmaceutical CGMP Regulations .",
"options": {
"A": "Quality Systems Approach",
"B": "FDA",
"C": "CGMP",
"D": "the audit trail review"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 40 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Most software development models will be iterative. This is likely to result in several versions of both the software requirement specification and the software design specification. All approved versions should be archived and controlled in accordance with established configuration management procedures. Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)
Page 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4. Construction or Coding Software may be constructed either by coding (i.e., programming) or by assembling together previously coded software components (e.g., from code libraries, off-the-shelf software, etc.) for use in a new application. Coding is the software activity where the detailed design specification is implemented as source code. Coding is the lowest level of abstraction for the software development process. It is the last stage in decomposition of the software requirements where module specifications are translated into a programming language. Coding usually involves the use of a high-level programming language, but may also entail the use of assembly language (or microcode) for time-critical operations. The source code may be either compiled or interpreted for use on a target hardware platform. Decisions on the selection of programming languages and software build tools (assemblers, linkers, and compilers) should include consideration of the impact on subsequent quality evaluation tasks (e.g., availability of debugging and testing tools for the chosen language). Some compilers offer optional levels and commands for error checking to assist in debugging the code.
[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: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"B": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"C": "Page 20General Principles of Software Validation Guidance for Industry",
"D": "Coding Software"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"D": "Page 20General Principles of Software Validation Guidance for Industry",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"B": "Coding Software",
"C": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"B": "FDA",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"C": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation",
"D": "Coding Software"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"D": "5.2.4",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"B": "Coding Software",
"C": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"A": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation",
"B": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"C": "Page 20General Principles of Software Validation Guidance for Industry",
"D": "Coding Software"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"B": "Page 20General Principles of Software Validation Guidance for Industry",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"C": "Coding Software",
"D": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"D": "FDA",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"B": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation",
"C": "Coding Software"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"D": "5.2.4",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"B": "Coding Software",
"C": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"B": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"C": "Page 20General Principles of Software Validation Guidance for Industry",
"D": "Coding Software"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"B": "Page 20General Principles of Software Validation Guidance for Industry",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"C": "Coding Software",
"D": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"C": "FDA",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"B": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation",
"D": "Coding Software"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"C": "5.2.4",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"B": "Coding Software",
"D": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"B": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"C": "Page 20General Principles of Software Validation Guidance for Industry",
"D": "Coding Software"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"A": "Page 20General Principles of Software Validation Guidance for Industry",
"B": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"C": "Coding Software",
"D": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"D": "FDA",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"B": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation",
"C": "Coding Software"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"A": "5.2.4",
"B": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"C": "Coding Software",
"D": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"B": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"C": "Page 20General Principles of Software Validation Guidance for Industry",
"D": "Coding Software"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"D": "Page 20General Principles of Software Validation Guidance for Industry",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"B": "Coding Software",
"C": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"B": "FDA",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"C": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation",
"D": "Coding Software"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"D": "5.2.4",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"B": "Coding Software",
"C": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"B": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"C": "Page 20General Principles of Software Validation Guidance for Industry",
"D": "Coding Software"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Typical Tasks Design Updated Software Risk Analy...'?",
"reference": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification to Software Requirements (and vice versa) Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation (module, integration, system, and acceptance)\nPage 20General Principles of Software Validation Guidance for Industry and FDA Staff 5.2.4.",
"options": {
"B": "Page 20General Principles of Software Validation Guidance for Industry",
"A": "Typical Tasks Design Updated Software Risk Analysis Traceability Analysis - Design Specification",
"C": "Coding Software",
"D": "Software Design Evaluation Design Communication Link Analysis Module Test Plan Generation Integration Test Plan Generation Test Design Generation"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 8 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance. The device manufacturer has latitude and flexibility in defining how validation of that software will be accomplished, but validation should be a key consideration in deciding how and by whom the software will be developed or from whom it will be purchased. The software developer defines a life cycle model. Validation is typically supported by: verifications of the outputs from each stage of that software development life cycle; and checking for proper operation of the finished software in the device manufacturers intended use environment. HOW MUCH VALIDATION EVIDENCE IS NEEDED? The level of validation effort should be commensurate with the risk posed by the automated operation. In addition to risk other factors, such as the complexity of the process software and the degree to which the device manufacturer is dependent upon that automated process to produce a safe and effective device, determine the nature and extent of testing needed as part of the validation effort. Documented requirements and risk analysis of the automated process help to define the scope of the evidence needed to show that the software is validated for its intended use. For example, an automated milling machine may require very little testing if the device manufacturer can show that the output of the operation is subsequently fully verified against the specification before release.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"B": "Page 31General Principles of Software Validation Guidance for Industry",
"A": "that software development life cycle",
"C": "the process software",
"D": "FDA"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"C": "FDA",
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"B": "Software Validation Guidance",
"D": "that software development life cycle"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is developer?",
"reference": "The software developer defines a life cycle model.",
"options": {
"C": "model",
"A": "Software Validation Guidance",
"B": "that software development life cycle",
"D": "pattern"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is developer?",
"reference": "The software developer defines a life cycle model.",
"options": {
"C": "model",
"A": "Software Validation Guidance",
"B": "that software development life cycle",
"D": "pattern"
},
"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]
In a robust quality system, production and process cont rols should be designed to ensure that the finished products have the iden tity, strength, quality, and purity they purpor t or are represented to possess (see, e.g., 211.100(a)). In a modern quality system, a design concept established during product development typically matures into a commercial design after process experimentation and progressive m odification. Risk manageme nt can help identify areas of pro cess weakness or higher risk and factors that can influence critical quality attr ibutes that should receive incr eased scrutiny. The FDA recommends that scale-up studies be used to help demons trate that a fundamentally sound design has been fully realized. A sufficiently robust manuf acturing process should be in place prior to commercial production. With proper design (see IV.C .1.) and reliable mechanisms to transfer process knowledge from development to commercial production, a manufacturer should be able to validate the ma nufacturing process.14 Conformance batches provide initial proof that the design of the process produces the intended product quality. Sufficient testing data will provide essential information on performance of the new process, as well as a mechanism for continual improvement. Modern equipment with the potent ial for continual monitoring and control can further enhance this knowledge base. Although in itial commercial batches can provide evidence to support the valid ity and consistency of the process, 15 the entire product life cycle should be addressed by the establishment of continual im provement mechanisms in the quality system.16
Thus, in accordance with the quality systems approach, process validation is not a one-time event, but an activity that cont inues throughout a products life. As experience is gained in commercial pr oduction, opportunities for pr ocess improvements ma y become evident.
[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 FDA recommends that scale-up studies be used t...'?",
"reference": "The FDA recommends that scale-up studies be used to help demons trate that a fundamentally sound design has been fully realized.",
"options": {
"D": "FDA",
"A": "production and process cont rols",
"B": "A sufficiently robust manuf acturing process",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Although in itial commercial batches can provide evidence to support the valid ity and consistency of the process, ____ the entire product life cycle should be addressed by the establishment of continual im provement mechanisms in the quality system.16\nThus, in accordance with the quality systems approach, process validation is not a one-time event, but an activity that cont inues throughout a products life.",
"reference": "Although in itial commercial batches can provide evidence to support the valid ity and consistency of the process, 15 the entire product life cycle should be addressed by the establishment of continual im provement mechanisms in the quality system.16\nThus, in accordance with the quality systems approach, process validation is not a one-time event, but an activity that cont inues throughout a products life.",
"options": {
"B": "15",
"A": "211.100(a",
"C": "one",
"D": "production and process cont rols"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Although in itial commercial batches can provide evidence to support the valid ity and consistency of the process, 15 the entire product life cycle should be addressed by the establishment of continual im provement mechanisms in the quality system.16\nThus, in accordance with the quality systems approach, process validation is not a ____-time event, but an activity that cont inues throughout a products life.",
"reference": "Although in itial commercial batches can provide evidence to support the valid ity and consistency of the process, 15 the entire product life cycle should be addressed by the establishment of continual im provement mechanisms in the quality system.16\nThus, in accordance with the quality systems approach, process validation is not a one-time event, but an activity that cont inues throughout a products life.",
"options": {
"D": "one",
"A": "211.100(a",
"B": "production and process cont rols",
"C": "A sufficiently robust manuf acturing process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Whenever software is changed, a validation analysis should be conducted not just for validation of the individual change, but also to determine the extent and impact of that change on the entire software system. Based on this analysis, the software developer should then conduct an appropriate level of software regression testing to show that unchanged but vulnerable portions of the system have not been adversely affected. Design controls and appropriate regression testing provide the confidence that the software is validated after a software change. VALIDATION COVERAGE Validation coverage should be based on the softwares complexity and safety risk not on firm size or resource constraints. The selection of validation activities, tasks, and work items should be commensurate with the complexity of the software design and the risk associated with the use of the software for the specified intended use. For lower risk devices, only baseline validation activities may be conducted. As the risk increases additional validation activities should be added to cover the additional risk. Validation documentation should be sufficient to demonstrate that all software validation plans and procedures have been completed successfully. 4.9. INDEPENDENCE OF REVIEW Validation activities should be conducted using the basic quality assurance precept of independence of review. Self-validation is extremely difficult. When possible, an independent evaluation is always better, especially for higher risk applications. Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible. Another approach is to assign internal staff members that are not involved in a particular design or its implementation, but who have sufficient knowledge to evaluate the project and conduct the verification and validation activities.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'INDEPENDENCE OF REVIEW Validation activities shoul...'?",
"reference": "INDEPENDENCE OF REVIEW Validation activities should be conducted using the basic quality assurance precept of independence of review.",
"options": {
"C": "INDEPENDENCE OF REVIEW Validation",
"A": "FDA",
"B": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Some firms contract out for a third-party independ...'?",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"A": "FDA",
"B": "INDEPENDENCE OF REVIEW Validation",
"C": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Some firms contract out for a ____-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"B": "third",
"A": "VALIDATION COVERAGE Validation coverage",
"C": "all software validation plans",
"D": "3rd"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INDEPENDENCE OF REVIEW Validation activities shoul...'?",
"reference": "INDEPENDENCE OF REVIEW Validation activities should be conducted using the basic quality assurance precept of independence of review.",
"options": {
"A": "INDEPENDENCE OF REVIEW Validation",
"B": "FDA",
"C": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INDEPENDENCE OF REVIEW Validation activities shoul...'?",
"reference": "INDEPENDENCE OF REVIEW Validation activities should be conducted using the basic quality assurance precept of independence of review.",
"options": {
"B": "INDEPENDENCE OF REVIEW Validation",
"A": "FDA",
"C": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Some firms contract out for a third-party independ...'?",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"C": "FDA",
"A": "INDEPENDENCE OF REVIEW Validation",
"B": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Some firms contract out for a ____-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"A": "third",
"B": "VALIDATION COVERAGE Validation coverage",
"C": "all software validation plans",
"D": "3rd"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Some firms contract out for a third-party independ...'?",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"D": "FDA",
"A": "INDEPENDENCE OF REVIEW Validation",
"B": "VALIDATION COVERAGE Validation coverage",
"C": "all software validation plans"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Some firms contract out for a ____-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"reference": "Some firms contract out for a third-party independent Page 13General Principles of Software Validation Guidance for Industry and FDA Staff verification and validation, but this solution may not always be feasible.",
"options": {
"D": "third",
"A": "VALIDATION COVERAGE Validation coverage",
"B": "all software validation plans",
"C": "3rd"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INDEPENDENCE OF REVIEW Validation activities shoul...'?",
"reference": "INDEPENDENCE OF REVIEW Validation activities should be conducted using the basic quality assurance precept of independence of review.",
"options": {
"C": "INDEPENDENCE OF REVIEW Validation",
"A": "FDA",
"B": "VALIDATION COVERAGE Validation coverage",
"D": "all software validation plans"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
..................................................................
4 f. What are the systems in computer or related systems in 211.68? ........................................ When is it permissible to exclude CGMP data from decision making? .................................... Does each wo rkflow on our computer system need to be validated? ........................................
How should access to CGMP computer systems be restricted? ................................................
Why is FDA concerned with the use of shared login accounts for computer syst ems? ...........
How should blank forms be controlled? ......................................................................................
How often should audit trails be reviewed? .................................................................................
Who should review audit trails? ...................................................................................................
Can electronic copies be used as accurate reproductions of paper or electronic records? Is it acceptable to retain paper printouts or static records instead of original electronic records from stand -alone computerized laboratory instruments, such as an FT -IR instrument? . Can electronic signatures be used instead of handwritten signatures for master production and control records? ............................................................................................................................... 8 12. When does electronic data become a CGMP record? ................................................................
Why has the FDA cited use of actual samples during system suitability or test, prep, or equilibration runs in warning letters? .................................................................................................. 9 14. Is it acceptable to only sa ve the final results from reprocessed laboratory chromatography?
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'When is it permissible to exclude CGMP data from d...'?",
"reference": "When is it permissible to exclude CGMP data from decision making?",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "original electronic records",
"D": "computer or related systems"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: .................................................................................................. ____ 14.",
"reference": ".................................................................................................. 9 14.",
"options": {
"C": "9",
"A": "211.68",
"B": "8 12",
"D": "CGMP computer systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .................................................................................................. 9 ____.",
"reference": ".................................................................................................. 9 14.",
"options": {
"A": "14",
"B": "211.68",
"C": "8 12",
"D": "CGMP computer systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '........................................\nHow shoul...'?",
"reference": "........................................\nHow should access to CGMP computer systems be restricted?",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "original electronic records",
"C": "computer or related systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ............................................................................................................................... ____ 12.",
"reference": "............................................................................................................................... 8 12.",
"options": {
"A": "8",
"B": "211.68",
"C": "8 12",
"D": "CGMP computer systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ............................................................................................................................... 8 ____.",
"reference": "............................................................................................................................... 8 12.",
"options": {
"B": "12",
"A": "211.68",
"C": "8 12",
"D": "CGMP computer systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .................................................................................................. ____ 14.",
"reference": ".................................................................................................. 9 14.",
"options": {
"C": "9",
"A": "211.68",
"B": "8 12",
"D": "CGMP computer systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .................................................................................................. 9 ____.",
"reference": ".................................................................................................. 9 14.",
"options": {
"A": "14",
"B": "211.68",
"C": "8 12",
"D": "CGMP computer systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '........................................\nHow shoul...'?",
"reference": "........................................\nHow should access to CGMP computer systems be restricted?",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "original electronic records",
"D": "computer or related systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: '.....................................................'?",
"reference": "................................................................\nWhy has the FDA cited use of actual samples during system suitability or test, prep, or equilibration runs in warning letters?",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "CGMP computer systems",
"D": "original electronic records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '................................................\nW...'?",
"reference": "................................................\nWhy is FDA concerned with the use of shared login accounts for computer syst ems?",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "CGMP computer systems",
"D": "original electronic records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '.....................................................'?",
"reference": "................................................................\nWhy has the FDA cited use of actual samples during system suitability or test, prep, or equilibration runs in warning letters?",
"options": {
"C": "FDA",
"A": "CGMP",
"B": "CGMP computer systems",
"D": "original electronic records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '........................................\nHow shoul...'?",
"reference": "........................................\nHow should access to CGMP computer systems be restricted?",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "original electronic records",
"D": "computer or related systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'When does electronic data become a CGMP record?...'?",
"reference": "When does electronic data become a CGMP record?",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "original electronic records",
"D": "computer or related systems"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ..................................................................\n____ f. What are the systems in computer or related systems in 211.68?",
"reference": "..................................................................\n4 f. What are the systems in computer or related systems in 211.68?",
"options": {
"A": "4",
"B": "211.68",
"C": "8 12",
"D": "CGMP computer systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ..................................................................\n4 f. What are the systems in computer or related systems in ____?",
"reference": "..................................................................\n4 f. What are the systems in computer or related systems in 211.68?",
"options": {
"A": "211.68",
"B": "8 12",
"C": "CGMP computer systems",
"D": "original electronic records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ............................................................................................................................... ____ 12.",
"reference": "............................................................................................................................... 8 12.",
"options": {
"B": "8",
"A": "211.68",
"C": "8 12",
"D": "CGMP computer systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ............................................................................................................................... 8 ____.",
"reference": "............................................................................................................................... 8 12.",
"options": {
"A": "12",
"B": "211.68",
"C": "8 12",
"D": "CGMP computer systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ............................................................................................................................... ____ 12.",
"reference": "............................................................................................................................... 8 12.",
"options": {
"D": "8",
"A": "211.68",
"B": "8 12",
"C": "CGMP computer systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ............................................................................................................................... 8 ____.",
"reference": "............................................................................................................................... 8 12.",
"options": {
"A": "12",
"B": "211.68",
"C": "8 12",
"D": "CGMP computer systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When does electronic data become a CGMP record?...'?",
"reference": "When does electronic data become a CGMP record?",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "original electronic records",
"C": "computer or related systems"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: .................................................................................................. ____ 14.",
"reference": ".................................................................................................. 9 14.",
"options": {
"A": "9",
"B": "211.68",
"C": "8 12",
"D": "CGMP computer systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .................................................................................................. 9 ____.",
"reference": ".................................................................................................. 9 14.",
"options": {
"B": "14",
"A": "211.68",
"C": "8 12",
"D": "CGMP computer systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '........................................\nHow shoul...'?",
"reference": "........................................\nHow should access to CGMP computer systems be restricted?",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "original electronic records",
"D": "computer or related systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ..................................................................\n____ f. What are the systems in computer or related systems in 211.68?",
"reference": "..................................................................\n4 f. What are the systems in computer or related systems in 211.68?",
"options": {
"A": "4",
"B": "211.68",
"C": "8 12",
"D": "CGMP computer systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ..................................................................\n4 f. What are the systems in computer or related systems in ____?",
"reference": "..................................................................\n4 f. What are the systems in computer or related systems in 211.68?",
"options": {
"D": "211.68",
"A": "8 12",
"B": "CGMP computer systems",
"C": "original electronic records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '........................................\nHow shoul...'?",
"reference": "........................................\nHow should access to CGMP computer systems be restricted?",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "original electronic records",
"D": "computer or related systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'When is it permissible to exclude CGMP data from d...'?",
"reference": "When is it permissible to exclude CGMP data from decision making?",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "original electronic records",
"D": "computer or related systems"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '.....................................................'?",
"reference": "................................................................\nWhy has the FDA cited use of actual samples during system suitability or test, prep, or equilibration runs in warning letters?",
"options": {
"A": "FDA",
"B": "CGMP",
"C": "CGMP computer systems",
"D": "original electronic records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .................................................................................................. ____ 14.",
"reference": ".................................................................................................. 9 14.",
"options": {
"B": "9",
"A": "211.68",
"C": "8 12",
"D": "CGMP computer systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
The 323 manufacturer already un dertakes some of those identified assurance activities so implements 324 only the remaining identified assurance activities . 325 326 Example 3 : An ERP management system contains a feature to automate product delivery. The 327 medical device risk depends upon, among other factors, the correct product being delivered to 328 the device user. A failure of this feature to perform as intended may result in a delivery mix -up, 329 which would be a quality problem that foreseeably compromise s safety ; as such, t he 330 manufacturer identifies this as a high process risk . Since the failure would compromise safety , 331 the manufacturer will next determine the related increase in device risk and identify the 332 assurance activities that are commensurate with th e device risk . In this case, the manufacturer 333 Contains Nonbinding Recommendations Draft Not for Implementation 12has not already implemented any of the identified assurance activities so implements all of the 334 assurance activities identified in the analysis . 335 336 Example 4: An automated graphical user interface ( GUI)function in the production software is 337 used for developing test scripts based on user interactions and to automate future testing of 338 modifications to the user interface of a system used in production. A failure of this GUI function 339 to perform as intended may result in implementation disruptions and delay updates to the 340 production system, but in this case, these errors should not foreseeably lead to compromised 341 safety because the GUI function operates in a separate test environmen t.
The manufacturer 342 identifies this as a low (not high) process risk and determine sassurance activities that are 343 commensurate with the process risk . The manufacturer already undertakes some of those 344 identified assurance activities so implements only the remaining identified assurance activities .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: ____ 336 Example 4: An automated graphical user interface ( GUI)function in the production software is 337 used for developing test scripts based on user interactions and to automate future testing of 338 modifications to the user interface of a system used in production.",
"reference": "335 336 Example 4: An automated graphical user interface ( GUI)function in the production software is 337 used for developing test scripts based on user interactions and to automate future testing of 338 modifications to the user interface of a system used in production.",
"options": {
"A": "335",
"B": "323",
"C": "324",
"D": "324 only the remaining identified assurance activities"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 335 ____ Example 4: An automated graphical user interface ( GUI)function in the production software is 337 used for developing test scripts based on user interactions and to automate future testing of 338 modifications to the user interface of a system used in production.",
"reference": "335 336 Example 4: An automated graphical user interface ( GUI)function in the production software is 337 used for developing test scripts based on user interactions and to automate future testing of 338 modifications to the user interface of a system used in production.",
"options": {
"C": "336",
"A": "323",
"B": "324",
"D": "324 only the remaining identified assurance activities"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 335 336 Example ____: An automated graphical user interface ( GUI)function in the production software is 337 used for developing test scripts based on user interactions and to automate future testing of 338 modifications to the user interface of a system used in production.",
"reference": "335 336 Example 4: An automated graphical user interface ( GUI)function in the production software is 337 used for developing test scripts based on user interactions and to automate future testing of 338 modifications to the user interface of a system used in production.",
"options": {
"A": "4",
"B": "323",
"C": "324",
"D": "only the remaining identified assurance activities"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 335 336 Example 4: An automated graphical user interface ( GUI)function in the production software is ____ used for developing test scripts based on user interactions and to automate future testing of 338 modifications to the user interface of a system used in production.",
"reference": "335 336 Example 4: An automated graphical user interface ( GUI)function in the production software is 337 used for developing test scripts based on user interactions and to automate future testing of 338 modifications to the user interface of a system used in production.",
"options": {
"B": "337",
"A": "323",
"C": "324",
"D": "324 only the remaining identified assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 335 336 Example 4: An automated graphical user interface ( GUI)function in the production software is 337 used for developing test scripts based on user interactions and to automate future testing of ____ modifications to the user interface of a system used in production.",
"reference": "335 336 Example 4: An automated graphical user interface ( GUI)function in the production software is 337 used for developing test scripts based on user interactions and to automate future testing of 338 modifications to the user interface of a system used in production.",
"options": {
"D": "338",
"A": "323",
"B": "324",
"C": "324 only the remaining identified assurance activities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The manufacturer already undertakes some of those ____ identified assurance activities so implements only the remaining identified assurance activities .",
"reference": "The manufacturer already undertakes some of those 344 identified assurance activities so implements only the remaining identified assurance activities .",
"options": {
"D": "344",
"A": "323",
"B": "324",
"C": "324 only the remaining identified assurance activities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The 323 manufacturer already un dertakes some of t...'?",
"reference": "The 323 manufacturer already un dertakes some of those identified assurance activities so implements 324 only the remaining identified assurance activities .",
"options": {
"A": "un",
"B": "ERP",
"C": "GUI",
"D": "324 only the remaining identified assurance activities"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The ____ manufacturer already un dertakes some of those identified assurance activities so implements 324 only the remaining identified assurance activities .",
"reference": "The 323 manufacturer already un dertakes some of those identified assurance activities so implements 324 only the remaining identified assurance activities .",
"options": {
"B": "323",
"A": "324",
"C": "325",
"D": "324 only the remaining identified assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 323 manufacturer already un dertakes some of those identified assurance activities so implements ____ only the remaining identified assurance activities .",
"reference": "The 323 manufacturer already un dertakes some of those identified assurance activities so implements 324 only the remaining identified assurance activities .",
"options": {
"B": "324",
"A": "323",
"C": "325",
"D": "only the remaining identified assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this case, the manufacturer ____ Contains Nonbinding Recommendations Draft Not for Implementation 12has not already implemented any of the identified assurance activities so implements all of the 334 assurance activities identified in the analysis .",
"reference": "In this case, the manufacturer 333 Contains Nonbinding Recommendations Draft Not for Implementation 12has not already implemented any of the identified assurance activities so implements all of the 334 assurance activities identified in the analysis .",
"options": {
"B": "333",
"A": "323",
"C": "324",
"D": "324 only the remaining identified assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In this case, the manufacturer 333 Contains Nonbinding Recommendations Draft Not for Implementation 12has not already implemented any of the identified assurance activities so implements all of the ____ assurance activities identified in the analysis .",
"reference": "In this case, the manufacturer 333 Contains Nonbinding Recommendations Draft Not for Implementation 12has not already implemented any of the identified assurance activities so implements all of the 334 assurance activities identified in the analysis .",
"options": {
"C": "334",
"A": "323",
"B": "324",
"D": "324 only the remaining identified assurance activities"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The 323 manufacturer already un dertakes some of t...'?",
"reference": "The 323 manufacturer already un dertakes some of those identified assurance activities so implements 324 only the remaining identified assurance activities .",
"options": {
"D": "un",
"A": "ERP",
"B": "GUI",
"C": "324 only the remaining identified assurance activities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The ____ manufacturer already un dertakes some of those identified assurance activities so implements 324 only the remaining identified assurance activities .",
"reference": "The 323 manufacturer already un dertakes some of those identified assurance activities so implements 324 only the remaining identified assurance activities .",
"options": {
"A": "323",
"B": "324",
"C": "325",
"D": "324 only the remaining identified assurance activities"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The ____ medical device risk depends upon, among other factors, the correct product being delivered to 328 the device user.",
"reference": "The 327 medical device risk depends upon, among other factors, the correct product being delivered to 328 the device user.",
"options": {
"D": "327",
"A": "323",
"B": "324",
"C": "324 only the remaining identified assurance activities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 327 medical device risk depends upon, among other factors, the correct product being delivered to ____ the device user.",
"reference": "The 327 medical device risk depends upon, among other factors, the correct product being delivered to 328 the device user.",
"options": {
"B": "328",
"A": "323",
"C": "324",
"D": "324 only the remaining identified assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A failure of this feature to perform as intended may result in a delivery mix -up, ____ which would be a quality problem that foreseeably compromise s safety ; as such, t he 330 manufacturer identifies this as a high process risk .",
"reference": "A failure of this feature to perform as intended may result in a delivery mix -up, 329 which would be a quality problem that foreseeably compromise s safety ; as such, t he 330 manufacturer identifies this as a high process risk .",
"options": {
"B": "329",
"A": "323",
"C": "324",
"D": "324 only the remaining identified assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A failure of this feature to perform as intended may result in a delivery mix -up, 329 which would be a quality problem that foreseeably compromise s safety ; as such, t he ____ manufacturer identifies this as a high process risk .",
"reference": "A failure of this feature to perform as intended may result in a delivery mix -up, 329 which would be a quality problem that foreseeably compromise s safety ; as such, t he 330 manufacturer identifies this as a high process risk .",
"options": {
"B": "330",
"A": "323",
"C": "324",
"D": "324 only the remaining identified assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The manufacturer already undertakes some of those ____ identified assurance activities so implements only the remaining identified assurance activities .",
"reference": "The manufacturer already undertakes some of those 344 identified assurance activities so implements only the remaining identified assurance activities .",
"options": {
"C": "344",
"A": "323",
"B": "324",
"D": "324 only the remaining identified assurance activities"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The ____ medical device risk depends upon, among other factors, the correct product being delivered to 328 the device user.",
"reference": "The 327 medical device risk depends upon, among other factors, the correct product being delivered to 328 the device user.",
"options": {
"B": "327",
"A": "323",
"C": "324",
"D": "324 only the remaining identified assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 327 medical device risk depends upon, among other factors, the correct product being delivered to ____ the device user.",
"reference": "The 327 medical device risk depends upon, among other factors, the correct product being delivered to 328 the device user.",
"options": {
"C": "328",
"A": "323",
"B": "324",
"D": "324 only the remaining identified assurance activities"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'A failure of this GUI function 339 to perform as i...'?",
"reference": "A failure of this GUI function 339 to perform as intended may result in implementation disruptions and delay updates to the 340 production system, but in this case, these errors should not foreseeably lead to compromised 341 safety because the GUI function operates in a separate test environmen t.\nThe manufacturer 342 identifies this as a low (not high) process risk and determine sassurance activities that are 343 commensurate with the process risk .",
"options": {
"D": "GUI",
"A": "ERP",
"B": "324 only the remaining identified assurance activities",
"C": "only the remaining identified assurance activities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'A failure of this GUI function 339 to perform as i...'?",
"reference": "A failure of this GUI function 339 to perform as intended may result in implementation disruptions and delay updates to the 340 production system, but in this case, these errors should not foreseeably lead to compromised 341 safety because the GUI function operates in a separate test environmen t.\nThe manufacturer 342 identifies this as a low (not high) process risk and determine sassurance activities that are 343 commensurate with the process risk .",
"options": {
"A": "GUI",
"B": "ERP",
"C": "324 only the remaining identified assurance activities",
"D": "only the remaining identified assurance activities"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A failure of this GUI function ____ to perform as intended may result in implementation disruptions and delay updates to the 340 production system, but in this case, these errors should not foreseeably lead to compromised 341 safety because the GUI function operates in a separate test environmen t.\nThe manufacturer 342 identifies this as a low (not high) process risk and determine sassurance activities that are 343 commensurate with the process risk .",
"reference": "A failure of this GUI function 339 to perform as intended may result in implementation disruptions and delay updates to the 340 production system, but in this case, these errors should not foreseeably lead to compromised 341 safety because the GUI function operates in a separate test environmen t.\nThe manufacturer 342 identifies this as a low (not high) process risk and determine sassurance activities that are 343 commensurate with the process risk .",
"options": {
"B": "339",
"A": "323",
"C": "324",
"D": "324 only the remaining identified assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A failure of this GUI function 339 to perform as intended may result in implementation disruptions and delay updates to the ____ production system, but in this case, these errors should not foreseeably lead to compromised 341 safety because the GUI function operates in a separate test environmen t.\nThe manufacturer 342 identifies this as a low (not high) process risk and determine sassurance activities that are 343 commensurate with the process risk .",
"reference": "A failure of this GUI function 339 to perform as intended may result in implementation disruptions and delay updates to the 340 production system, but in this case, these errors should not foreseeably lead to compromised 341 safety because the GUI function operates in a separate test environmen t.\nThe manufacturer 342 identifies this as a low (not high) process risk and determine sassurance activities that are 343 commensurate with the process risk .",
"options": {
"C": "340",
"A": "323",
"B": "324",
"D": "324 only the remaining identified assurance activities"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A failure of this GUI function 339 to perform as intended may result in implementation disruptions and delay updates to the 340 production system, but in this case, these errors should not foreseeably lead to compromised ____ safety because the GUI function operates in a separate test environmen t.\nThe manufacturer 342 identifies this as a low (not high) process risk and determine sassurance activities that are 343 commensurate with the process risk .",
"reference": "A failure of this GUI function 339 to perform as intended may result in implementation disruptions and delay updates to the 340 production system, but in this case, these errors should not foreseeably lead to compromised 341 safety because the GUI function operates in a separate test environmen t.\nThe manufacturer 342 identifies this as a low (not high) process risk and determine sassurance activities that are 343 commensurate with the process risk .",
"options": {
"D": "341",
"A": "323",
"B": "324",
"C": "324 only the remaining identified assurance activities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 50 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, September 1999. Guideline on General Principles of Process Validation , Center for Drugs and Biologics, Center For Devices and Radiological Health, Food and Drug Administration, May 1987. Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation , 61 Federal Register 52602 (October 7, 1996). Reviewer Guidance for a Pre-Market Notification Submission for Blood Establishment Computer Software , Center for Biologics Evaluation and Research, Food and Drug Administration, January 1997 Student Manual 1, Course INV545, Computer System Validation , Division of Human Resource Development, Office of Regulatory Affairs, Food and Drug Administration, 1997. Technical Report, Software Development Activities, Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, Food and Drug Administration, July 1987. Page 36General Principles of Software Validation Guidance for Industry and FDA Staff Other Government References W. Richards Adrion, Martha A. Branstad, John C. Cherniavsky. NBS Special Publication 500-75, Validation, Verification, and Testing of Computer Software, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1981. Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980. J.L. Bryant, N.P.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Page 36General Principles of Software Validation G...'?",
"reference": "Page 36General Principles of Software Validation Guidance for Industry and FDA Staff Other Government References W. Richards Adrion, Martha A. Branstad, John C. Cherniavsky.",
"options": {
"A": "FDA",
"B": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"C": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Page 36General Principles of Software Validation G...'?",
"reference": "Page 36General Principles of Software Validation Guidance for Industry and FDA Staff Other Government References W. Richards Adrion, Martha A. Branstad, John C. Cherniavsky.",
"options": {
"C": "Martha A. Branstad",
"A": "Reviewer Guidance",
"B": "John C. Cherniavsky",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Page 36General Principles of Software Validation G...'?",
"reference": "Page 36General Principles of Software Validation Guidance for Industry and FDA Staff Other Government References W. Richards Adrion, Martha A. Branstad, John C. Cherniavsky.",
"options": {
"A": "John C. Cherniavsky",
"B": "Reviewer Guidance",
"C": "Martha A. Branstad",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guideline on General Principles of Process Validat...'?",
"reference": "Guideline on General Principles of Process Validation , Center for Drugs and Biologics, Center For Devices and Radiological Health, Food and Drug Administration, May 1987.",
"options": {
"C": "Center For Devices and Radiological Health, Food and Drug Administration",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Guideline on General Principles of Process Validat...'?",
"reference": "Guideline on General Principles of Process Validation , Center for Drugs and Biologics, Center For Devices and Radiological Health, Food and Drug Administration, May 1987.",
"options": {
"C": "May 1987",
"A": "September 1999",
"B": "October 7, 1996",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Guideline on General Principles of Process Validation , Center for Drugs and Biologics, Center For Devices and Radiological Health, Food and Drug Administration, May ____.",
"reference": "Guideline on General Principles of Process Validation , Center for Drugs and Biologics, Center For Devices and Radiological Health, Food and Drug Administration, May 1987.",
"options": {
"D": "1987",
"A": "September 1999",
"B": "May 1987",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Medical Devices; Current Good Manufacturing Practi...'?",
"reference": "Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation , 61 Federal Register 52602 (October 7, 1996).",
"options": {
"B": "Medical Devices",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"C": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Medical Devices; Current Good Manufacturing Practi...'?",
"reference": "Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation , 61 Federal Register 52602 (October 7, 1996).",
"options": {
"B": "Current Good Manufacturing Practice",
"A": "Food and Drug Administration",
"C": "Software Validation Guidance",
"D": "Medical Devices"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Medical Devices; Current Good Manufacturing Practi...'?",
"reference": "Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation , 61 Federal Register 52602 (October 7, 1996).",
"options": {
"A": "CGMP",
"B": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"C": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Medical Devices; Current Good Manufacturing Practi...'?",
"reference": "Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation , 61 Federal Register 52602 (October 7, 1996).",
"options": {
"A": "Quality System Regulation",
"B": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"C": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Medical Devices; Current Good Manufacturing Practi...'?",
"reference": "Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation , 61 Federal Register 52602 (October 7, 1996).",
"options": {
"D": "Federal Register",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Medical Devices; Current Good Manufacturing Practi...'?",
"reference": "Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation , 61 Federal Register 52602 (October 7, 1996).",
"options": {
"B": "October 7, 1996",
"A": "September 1999",
"C": "May 1987",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation , ____ Federal Register 52602 (October 7, 1996).",
"reference": "Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation , 61 Federal Register 52602 (October 7, 1996).",
"options": {
"C": "61",
"A": "36General",
"B": "Food and Drug Administration",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Technical Report, Software Development Activities,...'?",
"reference": "Technical Report, Software Development Activities, Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, Food and Drug Administration, July 1987.",
"options": {
"C": "Technical Report",
"A": "Food and Drug Administration",
"B": "Software Validation Guidance",
"D": "Software Development Activities"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Technical Report, Software Development Activities,...'?",
"reference": "Technical Report, Software Development Activities, Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, Food and Drug Administration, July 1987.",
"options": {
"D": "Software Development Activities",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Technical Report, Software Development Activities,...'?",
"reference": "Technical Report, Software Development Activities, Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, Food and Drug Administration, July 1987.",
"options": {
"A": "Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs",
"B": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"C": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Technical Report, Software Development Activities,...'?",
"reference": "Technical Report, Software Development Activities, Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, Food and Drug Administration, July 1987.",
"options": {
"C": "Food and Drug Administration",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Technical Report, Software Development Activities,...'?",
"reference": "Technical Report, Software Development Activities, Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, Food and Drug Administration, July 1987.",
"options": {
"C": "July 1987",
"A": "September 1999",
"B": "May 1987",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Technical Report, Software Development Activities, Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, Food and Drug Administration, July ____.",
"reference": "Technical Report, Software Development Activities, Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, Food and Drug Administration, July 1987.",
"options": {
"D": "1987",
"A": "September 1999",
"B": "May 1987",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guideline on General Principles of Process Validat...'?",
"reference": "Guideline on General Principles of Process Validation , Center for Drugs and Biologics, Center For Devices and Radiological Health, Food and Drug Administration, May 1987.",
"options": {
"D": "Center For Devices and Radiological Health, Food and Drug Administration",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Guideline on General Principles of Process Validat...'?",
"reference": "Guideline on General Principles of Process Validation , Center for Drugs and Biologics, Center For Devices and Radiological Health, Food and Drug Administration, May 1987.",
"options": {
"B": "May 1987",
"A": "September 1999",
"C": "October 7, 1996",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Guideline on General Principles of Process Validation , Center for Drugs and Biologics, Center For Devices and Radiological Health, Food and Drug Administration, May ____.",
"reference": "Guideline on General Principles of Process Validation , Center for Drugs and Biologics, Center For Devices and Radiological Health, Food and Drug Administration, May 1987.",
"options": {
"C": "1987",
"A": "September 1999",
"B": "May 1987",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Medical Devices; Current Good Manufacturing Practi...'?",
"reference": "Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation , 61 Federal Register 52602 (October 7, 1996).",
"options": {
"C": "Medical Devices",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Medical Devices; Current Good Manufacturing Practi...'?",
"reference": "Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation , 61 Federal Register 52602 (October 7, 1996).",
"options": {
"C": "Current Good Manufacturing Practice",
"A": "Food and Drug Administration",
"B": "Software Validation Guidance",
"D": "Medical Devices"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Medical Devices; Current Good Manufacturing Practi...'?",
"reference": "Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation , 61 Federal Register 52602 (October 7, 1996).",
"options": {
"C": "CGMP",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 36General Principles of Software Validation G...'?",
"reference": "Page 36General Principles of Software Validation Guidance for Industry and FDA Staff Other Government References W. Richards Adrion, Martha A. Branstad, John C. Cherniavsky.",
"options": {
"A": "FDA",
"B": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"C": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Page 36General Principles of Software Validation G...'?",
"reference": "Page 36General Principles of Software Validation Guidance for Industry and FDA Staff Other Government References W. Richards Adrion, Martha A. Branstad, John C. Cherniavsky.",
"options": {
"A": "Martha A. Branstad",
"B": "Reviewer Guidance",
"C": "John C. Cherniavsky",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Page 36General Principles of Software Validation G...'?",
"reference": "Page 36General Principles of Software Validation Guidance for Industry and FDA Staff Other Government References W. Richards Adrion, Martha A. Branstad, John C. Cherniavsky.",
"options": {
"B": "John C. Cherniavsky",
"A": "Reviewer Guidance",
"C": "Martha A. Branstad",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-75, Validation, Verifi...'?",
"reference": "NBS Special Publication 500-75, Validation, Verification, and Testing of Computer Software, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1981.",
"options": {
"A": "Validation",
"B": "Food and Drug Administration",
"C": "Blood Establishment Computer Software",
"D": "substantiation"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-75, Validation, Verifi...'?",
"reference": "NBS Special Publication 500-75, Validation, Verification, and Testing of Computer Software, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1981.",
"options": {
"D": "Testing of Computer Software",
"A": "Food and Drug Administration",
"B": "Software Validation Guidance",
"C": "Validation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-75, Validation, Verifi...'?",
"reference": "NBS Special Publication 500-75, Validation, Verification, and Testing of Computer Software, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1981.",
"options": {
"C": "Center for Programming Science and Technology",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-75, Validation, Verifi...'?",
"reference": "NBS Special Publication 500-75, Validation, Verification, and Testing of Computer Software, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1981.",
"options": {
"C": "Institute for Computer Sciences and Technology",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-75, Validation, Verifi...'?",
"reference": "NBS Special Publication 500-75, Validation, Verification, and Testing of Computer Software, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1981.",
"options": {
"C": "National Bureau of Standards",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'NBS Special Publication 500-75, Validation, Verifi...'?",
"reference": "NBS Special Publication 500-75, Validation, Verification, and Testing of Computer Software, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1981.",
"options": {
"B": "U.S. Department of Commerce",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"C": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'NBS Special Publication 500-75, Validation, Verifi...'?",
"reference": "NBS Special Publication 500-75, Validation, Verification, and Testing of Computer Software, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1981.",
"options": {
"B": "February 1981",
"A": "September 1999",
"C": "May 1987",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: NBS Special Publication ____-75, Validation, Verification, and Testing of Computer Software, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1981.",
"reference": "NBS Special Publication 500-75, Validation, Verification, and Testing of Computer Software, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1981.",
"options": {
"C": "500",
"A": "36General",
"B": "Food and Drug Administration",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: NBS Special Publication 500-____, Validation, Verification, and Testing of Computer Software, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1981.",
"reference": "NBS Special Publication 500-75, Validation, Verification, and Testing of Computer Software, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1981.",
"options": {
"D": "75",
"A": "36General",
"B": "Food and Drug Administration",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: NBS Special Publication 500-75, Validation, Verification, and Testing of Computer Software, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February ____.",
"reference": "NBS Special Publication 500-75, Validation, Verification, and Testing of Computer Software, Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1981.",
"options": {
"C": "1981",
"A": "September 1999",
"B": "May 1987",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Martha A. Branstad, John C Cherniavsky, W. Richard...'?",
"reference": "Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980.",
"options": {
"D": "Martha A. Branstad",
"A": "Reviewer Guidance",
"B": "John C. Cherniavsky",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Martha A. Branstad, John C Cherniavsky, W. Richard...'?",
"reference": "Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980.",
"options": {
"B": "John C Cherniavsky",
"A": "Reviewer Guidance",
"C": "Martha A. Branstad",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Martha A. Branstad, John C Cherniavsky, W. Richard...'?",
"reference": "Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980.",
"options": {
"B": "W. Richards Adrion",
"A": "Reviewer Guidance",
"C": "Martha A. Branstad",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Martha A. Branstad, John C Cherniavsky, W. Richard...'?",
"reference": "Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980.",
"options": {
"D": "the Individual Programmer ,",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Martha A. Branstad, John C Cherniavsky, W. Richard...'?",
"reference": "Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980.",
"options": {
"B": "Center for Programming Science and Technology",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"C": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Martha A. Branstad, John C Cherniavsky, W. Richard...'?",
"reference": "Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980.",
"options": {
"A": "Institute for Computer Sciences and Technology",
"B": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"C": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Martha A. Branstad, John C Cherniavsky, W. Richard...'?",
"reference": "Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980.",
"options": {
"D": "National Bureau of Standards",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Martha A. Branstad, John C Cherniavsky, W. Richard...'?",
"reference": "Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980.",
"options": {
"C": "U.S. Department of Commerce",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Martha A. Branstad, John C Cherniavsky, W. Richard...'?",
"reference": "Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980.",
"options": {
"A": "February 1980",
"B": "September 1999",
"C": "May 1987",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication ____-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980.",
"reference": "Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980.",
"options": {
"C": "500",
"A": "36General",
"B": "Food and Drug Administration",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-____, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980.",
"reference": "Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980.",
"options": {
"D": "56",
"A": "36General",
"B": "Food and Drug Administration",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February ____.",
"reference": "Martha A. Branstad, John C Cherniavsky, W. Richards Adrion, NBS Special Publication 500-56, Validation, Verification, and Testing for the Individual Programmer , Center for Programming Science and Technology, Institute for Computer Sciences and Technology, National Bureau of Standards, U.S. Department of Commerce, February 1980.",
"options": {
"A": "1980",
"B": "September 1999",
"C": "May 1987",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)
http://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443. 6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html . U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Resear ch (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharm aceutical CGMPs TABLE OF CONTENTS I.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "When did this occur: '6597 Internt'l Staff Phone: 301.827.3993 or Center...'?",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"A": "6597",
"B": "August 2003",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"D": "Health and Human Services Food and Drug Administration Center"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '6597 Internt'l Staff Phone: 301.827.3993 or Center...'?",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"C": "Center for Food Safety and Applied Nutrition",
"A": "Electronic Records",
"B": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"A": "6597",
"B": "August 2003",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"D": "Health and Human Services Food and Drug Administration Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 6597 Internt'l Staff Phone: ____ or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"B": "301.827.3993",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"C": "Health and Human Services Food and Drug Administration Center",
"D": "6597"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U.S. Department of Health and Human Services Food ...'?",
"reference": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Resear ch (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharm aceutical CGMPs TABLE OF CONTENTS I.",
"options": {
"B": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation",
"A": "Electronic Records",
"C": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U.S. Department of Health and Human Services Food ...'?",
"reference": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Resear ch (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharm aceutical CGMPs TABLE OF CONTENTS I.",
"options": {
"D": "Office of Regulatory Affairs",
"A": "Electronic Records",
"B": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U.S. Department of Health and Human Services Food ...'?",
"reference": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Resear ch (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharm aceutical CGMPs TABLE OF CONTENTS I.",
"options": {
"A": "ORA",
"B": "Electronic Records",
"C": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'U.S. Department of Health and Human Services Food ...'?",
"reference": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Resear ch (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharm aceutical CGMPs TABLE OF CONTENTS I.",
"options": {
"D": "August 2003",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"B": "Health and Human Services Food and Drug Administration Center",
"C": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Resear ch (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August ____ Pharm aceutical CGMPs TABLE OF CONTENTS I.",
"reference": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Resear ch (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharm aceutical CGMPs TABLE OF CONTENTS I.",
"options": {
"C": "2003",
"A": "August 2003",
"B": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"D": "Health and Human Services Food and Drug Administration Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"C": "Electronic Records",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"B": "Health and Human Services Food and Drug Administration Center",
"D": "Electronic Signatures Scope"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '6597 Internt'l Staff Phone: 301.827.3993 or Center...'?",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"A": "6597",
"B": "August 2003",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"D": "Health and Human Services Food and Drug Administration Center"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '6597 Internt'l Staff Phone: 301.827.3993 or Center...'?",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"C": "Center for Food Safety and Applied Nutrition",
"A": "Electronic Records",
"B": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"C": "6597",
"A": "August 2003",
"B": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"D": "Health and Human Services Food and Drug Administration Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 6597 Internt'l Staff Phone: ____ or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"reference": "6597 Internt'l Staff Phone: 301.827.3993 or Center for Food Safety and Applied Nutrition (CFSAN) http://www.cfsan.fda.gov/dms/guidance.html .",
"options": {
"D": "301.827.3993",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"B": "Health and Human Services Food and Drug Administration Center",
"C": "6597"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"D": "Electronic Records",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"B": "Health and Human Services Food and Drug Administration Center",
"C": "Electronic Signatures Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"A": "Electronic Signatures Scope",
"B": "Tel",
"C": "Training",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"B": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"A": "Electronic Records",
"C": "Office of Regulatory Affairs",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"C": "Office of Regulatory Affairs",
"A": "Electronic Records",
"B": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"A": "ORA",
"B": "Electronic Records",
"C": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"B": "August 2003",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"C": "Health and Human Services Food and Drug Administration Center",
"D": "Electronic Records"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"D": "Electronic Records",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"B": "Health and Human Services Food and Drug Administration Center",
"C": "Electronic Signatures Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"D": "Electronic Signatures Scope",
"A": "Tel",
"B": "Training",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"D": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"A": "Electronic Records",
"B": "Office of Regulatory Affairs",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"A": "Office of Regulatory Affairs",
"B": "Electronic Records",
"C": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"D": "ORA",
"A": "Electronic Records",
"B": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"C": "August 2003",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"B": "Health and Human Services Food and Drug Administration Center",
"D": "Electronic Records"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"C": "Electronic Records",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"B": "Health and Human Services Food and Drug Administration Center",
"D": "Electronic Signatures Scope"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"C": "Electronic Signatures Scope",
"A": "Tel",
"B": "Training",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"D": "HFD -240 Center for Drug Evaluation and Research",
"A": "Electronic Records",
"B": "Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Guidance for Industry Part 11, Electronic Records;...'?",
"reference": "Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) August 2003 Pharmaceutical CGMPs Guidance fo r Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Division of Drug Information, HFD -240 Center for Drug Evaluation and Research (CDER) (Tel) 301 -827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Commu nication, Training and Manufacturers Assistance, HFM -40 Center for Biologics Evaluation and Research (CBER)\nhttp://www.fda.gov/cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301 -827-1800 or Communications Staff (HFV -12), Center for Veterinary Medicine (CVM) (Tel) 301 -594-1755 http://www.fda.gov/cvm/guidance/guidance.html or Division of Small Manufacturers Assistance (HFZ -220) http://www.fda.gov/cdrh/ggpmain.html Manufacturers Assistance Phone Number: 800.638.2041 or 301.443.",
"options": {
"A": "Tel",
"B": "Electronic Signatures Scope",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologi cs Evaluation and Research (CBER) Center",
"D": "Health and Human Services Food and Drug Administration Center"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
The use of off-the-shelf software in automated medical devices and in automated manufacturing and quality system operations is increasing. Off-the-shelf software may have many capabilities, only a few of which are needed by the device manufacturer. Device manufacturers are responsible for the adequacy of the software used in their devices, and used to produce devices. When device manufacturers purchase "off-the-shelf'' software, they must ensure that it will perform as intended in their chosen application. For off-the-shelf software used in manufacturing or in the quality system, additional guidance is included in Section 6.3 of this document. For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices. 2.4. QUALITY SYSTEM REGULATION VS PRE-MARKET SUBMISSIONS This document addresses Quality System regulation issues that involve the implementation of software validation. It provides guidance for the management and control of the software validation process. The management and control of the software validation process should not be confused with any other validation requirements, such as process validation for an automated manufacturing process. Device manufacturers may use the same procedures and records for compliance with quality system and design control requirements, as well as for pre-market submissions to FDA. This document does not cover any specific safety or efficacy issues related to software validation. Design issues and documentation requirements for pre-market submissions of regulated software are not addressed by this document. Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"C": "Guidance for Industry",
"A": "the software validation process",
"B": "FDA Reviewers",
"D": "Compliance on Off-The-Shelf Software Use in Medical Devices"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"D": "FDA Reviewers",
"A": "Guidance for Industry",
"B": "Quality System",
"C": "the software validation process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'QUALITY SYSTEM REGULATION VS PRE-MARKET SUBMISSION...'?",
"reference": "QUALITY SYSTEM REGULATION VS PRE-MARKET SUBMISSIONS This document addresses Quality System regulation issues that involve the implementation of software validation.",
"options": {
"A": "Quality System",
"B": "the software validation process",
"C": "This information is not mentioned in the context",
"D": "The context does not provide this detail"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For off-the-shelf software used in manufacturing or in the quality system, additional guidance is included in Section ____ of this document.",
"reference": "For off-the-shelf software used in manufacturing or in the quality system, additional guidance is included in Section 6.3 of this document.",
"options": {
"B": "6.3",
"A": "2.4",
"C": "the software validation process",
"D": "Section 6.3"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For off-the-shelf software used in manufacturing or in the quality system, additional guidance is included in Section ____ of this document.",
"reference": "For off-the-shelf software used in manufacturing or in the quality system, additional guidance is included in Section 6.3 of this document.",
"options": {
"A": "6.3",
"B": "2.4",
"C": "the software validation process",
"D": "Section 6.3"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"B": "the Office of Device Evaluation",
"A": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"D": "Center for Devices and Radiological Health",
"A": "Guidance for Industry",
"B": "FDA Reviewers",
"C": "the software validation process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"A": "the Office of Blood Research and Review, Center for Biologics Evaluation and Research",
"B": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"C": "Guidance for Industry",
"A": "the software validation process",
"B": "FDA Reviewers",
"D": "Compliance on Off-The-Shelf Software Use in Medical Devices"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"B": "FDA Reviewers",
"A": "Guidance for Industry",
"C": "Quality System",
"D": "the software validation process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'QUALITY SYSTEM REGULATION VS PRE-MARKET SUBMISSION...'?",
"reference": "QUALITY SYSTEM REGULATION VS PRE-MARKET SUBMISSIONS This document addresses Quality System regulation issues that involve the implementation of software validation.",
"options": {
"D": "Quality System",
"A": "the software validation process",
"B": "This information is not mentioned in the context",
"C": "The context does not provide this detail"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'QUALITY SYSTEM REGULATION VS PRE-MARKET SUBMISSION...'?",
"reference": "QUALITY SYSTEM REGULATION VS PRE-MARKET SUBMISSIONS This document addresses Quality System regulation issues that involve the implementation of software validation.",
"options": {
"C": "Quality System",
"A": "the software validation process",
"B": "This information is not mentioned in the context",
"D": "The context does not provide this detail"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"A": "the Office of Device Evaluation",
"B": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"B": "Center for Devices and Radiological Health",
"A": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"B": "the Office of Blood Research and Review, Center for Biologics Evaluation and Research",
"A": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For off-the-shelf software used in manufacturing or in the quality system, additional guidance is included in Section ____ of this document.",
"reference": "For off-the-shelf software used in manufacturing or in the quality system, additional guidance is included in Section 6.3 of this document.",
"options": {
"D": "6.3",
"A": "2.4",
"B": "the software validation process",
"C": "Section 6.3"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"A": "Guidance for Industry",
"B": "the software validation process",
"C": "FDA Reviewers",
"D": "Compliance on Off-The-Shelf Software Use in Medical Devices"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For device software, additional useful information...'?",
"reference": "For device software, additional useful information may be found in FDAs Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.",
"options": {
"A": "FDA Reviewers",
"B": "Guidance for Industry",
"C": "Quality System",
"D": "the software validation process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"A": "the Office of Device Evaluation",
"B": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Specific issues related to safety and efficacy, an...'?",
"reference": "Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER).",
"options": {
"B": "Center for Devices and Radiological Health",
"A": "Guidance for Industry",
"C": "FDA Reviewers",
"D": "the software validation process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
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