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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 15 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Firms should implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models. 3 Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product. Managements involvement 1
This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration. 2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. We update guidances periodic ally. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm . 3 See ICH guidance for industry Q9 Quality Risk Management . Contains Nonbinding Recommendations 2 in and influence on these strategies is essential in preventing and correcting conditions that can lead to data integrity problems. It is the role of management with executive responsibility to create a quality culture where employees understand that data integrity i s an organizational core value and employees are encoura ged to identify and promptly report data integrity issues. In the absence of management support of a quality culture, quality systems can break down and lead to CGMP noncompliance. In general, FDA s guidance documents do not establish legally enforceable responsibilities. Instead , guidances describe the Agency s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Instead , guidances describe the Agency s current ...'?",
"reference": "Instead , guidances describe the Agency s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.",
"options": {
"B": "Agency",
"A": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "government agency"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.",
"reference": "3 Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.",
"options": {
"B": "3",
"A": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "troika"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"B": "the International Council for Harmonisation (ICH",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '2 See the International Council for Harmonisation ...'?",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"D": "Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"reference": "2 See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.",
"options": {
"B": "2",
"A": "industry Q9 Quality Risk Management",
"C": "the FDA Drugs guidance web page",
"D": "two"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"C": "FDA Drugs",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"A": "RegulatoryInformation/Guidances",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"D": "FDA Drugs",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"B": "RegulatoryInformation/Guidances",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"A": "FDA Drugs",
"B": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"D": "RegulatoryInformation/Guidances",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"D": "FDA Drugs",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'To make sure you have the most recent version of a...'?",
"reference": "To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/default.htm .",
"options": {
"B": "RegulatoryInformation/Guidances",
"A": "the Office of Pharmaceutical Quality",
"C": "the Office of Compliance",
"D": "industry Q9 Quality Risk Management"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the absence of management support of a quality ...'?",
"reference": "In the absence of management support of a quality culture, quality systems can break down and lead to CGMP noncompliance.",
"options": {
"D": "CGMP",
"A": "the Office of Pharmaceutical Quality",
"B": "the Office of Compliance",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Managements involvement 1\nThis guidance has been p...'?",
"reference": "Managements involvement 1\nThis guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research , the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.",
"options": {
"D": "the Office of Pharmaceutical Quality",
"A": "the Office of Compliance",
"B": "the Center for Drug Evaluation and Research",
"C": "industry Q9 Quality Risk Management"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
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]
below, assurance activities should be conduct ed for software that is 302 high process risk and not high process risk commensurate with the risk. 303 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking . This feature ensure s that the right materials are 306 ordered and delivered to appropriate production operations . However, a qualified person checks 307 the materials before their use in production. The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered . However , the delivery of the wrong materials 310 to the qualified person should result in the rejection of those materials before use in production ; 311 as such, the quality problem should not foreseeably lead to compromise d safety . The 312 manufacturer identifies this as an intermediate (not high) process risk and determine s assurance 313 activities commensurate with the process risk . The manufacturer already undertakes some of 314 those identified assurance activities so implements only the re maining identified assurance 315 activities . 316 317 Example 2 : A similar feature in an other ERP management system performs the same tasks as in 318 the previous example except that it also automates checking the material s before their use in 319 production . A qualified person does not check the material first. The manufactu rer identifies this 320 as a high process risk because the failure of the feature to perform as intended may result in a 321 quality problem that foreseeably compromise s safety . As such, the manufacturer will determine 322 assurance activities that are commensurate with the related medical device 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: A qualified person does not check the material ____.",
"reference": "A qualified person does not check the material first.",
"options": {
"C": "first",
"A": "302 high process risk",
"B": "not high process risk commensurate",
"D": "firstly"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The manufacturer already undertakes some of ____ those identified assurance activities so implements only the re maining identified assurance 315 activities .",
"reference": "The manufacturer already undertakes some of 314 those identified assurance activities so implements only the re maining identified assurance 315 activities .",
"options": {
"B": "314",
"A": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The manufacturer already undertakes some of 314 those identified assurance activities so implements only the re maining identified assurance ____ activities .",
"reference": "The manufacturer already undertakes some of 314 those identified assurance activities so implements only the re maining identified assurance 315 activities .",
"options": {
"B": "315",
"A": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This feature ensure s that the right materials are ____ ordered and delivered to appropriate production operations .",
"reference": "This feature ensure s that the right materials are 306 ordered and delivered to appropriate production operations .",
"options": {
"D": "306",
"A": "302",
"B": "303",
"C": "302 high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The failure of this feature to perform as intended ____ may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered .",
"reference": "The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered .",
"options": {
"C": "308",
"A": "302",
"B": "303",
"D": "302 high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the ____ wrong materials would be restocked and delivered .",
"reference": "The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered .",
"options": {
"A": "309",
"B": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The failure of this feature to perform as intended 308 may r...'?",
"reference": "The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered .",
"options": {
"A": "The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and del...",
"B": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This feature ensure s that the right materials are ____ ordered and delivered to appropriate production operations .",
"reference": "This feature ensure s that the right materials are 306 ordered and delivered to appropriate production operations .",
"options": {
"A": "306",
"B": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The ____ manufacturer identifies this as an intermediate (not high) process risk and determine s assurance 313 activities commensurate with the process risk .",
"reference": "The 312 manufacturer identifies this as an intermediate (not high) process risk and determine s assurance 313 activities commensurate with the process risk .",
"options": {
"D": "312",
"A": "302",
"B": "303",
"C": "302 high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 312 manufacturer identifies this as an intermediate (not high) process risk and determine s assurance ____ activities commensurate with the process risk .",
"reference": "The 312 manufacturer identifies this as an intermediate (not high) process risk and determine s assurance 313 activities commensurate with the process risk .",
"options": {
"D": "313",
"A": "302",
"B": "303",
"C": "302 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 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
ISO/IEC 14598:1999, Information technology Software product evaluation, Joint Technical Committee ISO/IEC JTC 1, Subcommittee SC 7, International Organization for Standardization and International Electrotechnical Commission, 1999. ISO 14971-1:1998 , Medical Devices Risk Management Part 1: Application of Risk Analysis. International Organization for Standardization, 1998 . Software Considerations in Airborne Systems and Equipment Certification . Special Committee 167 of RTCA. RTCA Inc., Washington, D.C.
Tel: 202-833-9339. Document No. RTCA/DO- 178B, December 1992. Production Process Software References The Application of the Principles of GLP to Computerized Systems, Environmental Monograph 116 , Organization for Economic Cooperation and Development (OECD), 1995. George J. Grigonis, Jr., Edward J. Subak, Jr., and Michael Wyrick, Validation Key Practices for Computer Systems Used in Regulated Operations , Pharmaceutical Technology , June 1997. Guide to Inspection of Computerized Systems in Drug Processing, Reference Materials and Page 39General Principles of Software Validation Guidance for Industry and FDA Staff Training Aids for Investigators , Division of Drug Quality Compliance, Associate Director for Compliance, Office of Drugs, National Center for Drugs and Biologics, Division of Field Investigations, Associate Director for Field Support, Executive Director of Regional Operations, Food and Drug Administration, February 1983. Daniel P. Olivier, Validating Process Software, FDA Investigator Course: Medical Device Process Validation , Food and Drug Administration. GAMP Guide For Validation of Automated Systems in Pharmaceutical Manufacture,Version V3.0, Good Automated Manufacturing Practice (GAMP)
Forum, March 1998:
Volume 1, Part 1: User Guide Part 2: Supplier Guide Volume 2: Best Practice for User and Suppliers. Technical Report
No. 18, Validation of Computer-Related Systems . PDA Committee on Validation of Computer-Related 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": "When did this occur: 'ISO 14971-1:1998 , Medical Devices Risk Managemen...'?",
"reference": "ISO 14971-1:1998 , Medical Devices Risk Management Part 1: Application of Risk Analysis.",
"options": {
"A": "14971-1:1998",
"B": "1999",
"C": "1998",
"D": "Software Validation Guidance"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ISO 14971-1:1998 , Medical Devices Risk Managemen...'?",
"reference": "ISO 14971-1:1998 , Medical Devices Risk Management Part 1: Application of Risk Analysis.",
"options": {
"A": "Medical Devices Risk Management Part",
"B": "ISO",
"C": "Information",
"D": "Software Validation Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ISO 14971-1:1998 , Medical Devices Risk Managemen...'?",
"reference": "ISO 14971-1:1998 , Medical Devices Risk Management Part 1: Application of Risk Analysis.",
"options": {
"D": "Application of Risk Analysis",
"A": "ISO",
"B": "Information",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ISO ____-1:1998 , Medical Devices Risk Management Part 1: Application of Risk Analysis.",
"reference": "ISO 14971-1:1998 , Medical Devices Risk Management Part 1: Application of Risk Analysis.",
"options": {
"B": "14971",
"A": "1999",
"C": "14971-1:1998",
"D": "Software Validation Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ISO ____4971-1:1998 , Medical Devices Risk Management Part 1: Application of Risk Analysis.",
"reference": "ISO 14971-1:1998 , Medical Devices Risk Management Part 1: Application of Risk Analysis.",
"options": {
"D": "1",
"A": "14598:1999",
"B": "167",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'George J. Grigonis, Jr., Edward J. Subak, Jr., and...'?",
"reference": "George J. Grigonis, Jr., Edward J. Subak, Jr., and Michael Wyrick, Validation Key Practices for Computer Systems Used in Regulated Operations , Pharmaceutical Technology , June 1997.",
"options": {
"D": "George J. Grigonis",
"A": "Edward J. Subak",
"B": "Michael Wyrick",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'George J. Grigonis, Jr., Edward J. Subak, Jr., and...'?",
"reference": "George J. Grigonis, Jr., Edward J. Subak, Jr., and Michael Wyrick, Validation Key Practices for Computer Systems Used in Regulated Operations , Pharmaceutical Technology , June 1997.",
"options": {
"B": "Edward J. Subak",
"A": "George J. Grigonis",
"C": "Michael Wyrick",
"D": "Software Validation Guidance"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'George J. Grigonis, Jr., Edward J. Subak, Jr., and...'?",
"reference": "George J. Grigonis, Jr., Edward J. Subak, Jr., and Michael Wyrick, Validation Key Practices for Computer Systems Used in Regulated Operations , Pharmaceutical Technology , June 1997.",
"options": {
"A": "Michael Wyrick",
"B": "George J. Grigonis",
"C": "Edward J. Subak",
"D": "Software Validation Guidance"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'George J. Grigonis, Jr., Edward J. Subak, Jr., and...'?",
"reference": "George J. Grigonis, Jr., Edward J. Subak, Jr., and Michael Wyrick, Validation Key Practices for Computer Systems Used in Regulated Operations , Pharmaceutical Technology , June 1997.",
"options": {
"C": "Validation Key Practices",
"A": "ISO",
"B": "Information",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 3 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Examples ................................ ................................ ................................ ................................
................ Example 1: Nonconformance Management System ................................ ................................
............................... Example 2: Learning Management System (LMS) ................................
................................ ................................ Example 3: Business Intelligence Applications ................................ ................................ ................................
24 Contains Nonbinding Recommendations Draft Not for Implementation 4Computer Software Assurance for 1 Production and Quality System 2 Software 3 ______________________________________________________________________________ 4
Draft Guidance for Industry and 5 Food and Drug Administration Staff 6 7 This draft guidance , when finalized, will represent the current thinking of the Food an d Drug 8 Administration (FDA or Agency )on this topic. It does not establish any rights for any person 9 and is not binding on FDA or the public. You can use an alternative approach if it satisfies 10 the requirements of the applicable statutes and regulations. To discuss an alternative 11 approach, contact the FDA staff or Office responsible for this guidance aslisted on the title 12 page . 13 14 I.Introduction115
FDA is issuing this draft guidance to provide recommendations on computer software assurance 16 for computers and automated data processing systems used as part of medical device production 17 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": "Which organization is referenced: '13 14 I.Introduction115\nFDA is issuing this draft ...'?",
"reference": "13 14 I.Introduction115\nFDA is issuing this draft guidance to provide recommendations on computer software assurance 16 for computers and automated data processing systems used as part of medical device production 17 or the quality system.",
"options": {
"A": "FDA",
"B": "Nonconformance Management System",
"C": "Learning Management System",
"D": "4\nDraft Guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 14 I.Introduction115\nFDA is issuing this draft guidance to provide recommendations on computer software assurance 16 for computers and automated data processing systems used as part of medical device production 17 or the quality system.",
"reference": "13 14 I.Introduction115\nFDA is issuing this draft guidance to provide recommendations on computer software assurance 16 for computers and automated data processing systems used as part of medical device production 17 or the quality system.",
"options": {
"D": "13",
"A": "4\nDraft Guidance",
"B": "This draft guidance",
"C": "XIII"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 13 ____ I.Introduction115\nFDA is issuing this draft guidance to provide recommendations on computer software assurance 16 for computers and automated data processing systems used as part of medical device production 17 or the quality system.",
"reference": "13 14 I.Introduction115\nFDA is issuing this draft guidance to provide recommendations on computer software assurance 16 for computers and automated data processing systems used as part of medical device production 17 or the quality system.",
"options": {
"A": "14",
"B": "4\nDraft Guidance",
"C": "This draft guidance",
"D": "XIV"
},
"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]
The American National Standards Institute (ANSI) define s systems as people, 139 machines, and methods organized to accomplish a set of specific functions.5 140 Computer or related systems can refer to computer hardware, software, peripheral 141 devices, networks , cloud infrastructure , operators, and associated documents ( e.g., 142 user manuals and standard operating procedures). When is it permissible to exclude CGMP data from decision making ? Any data created as part of a CGMP record must be evaluated by the quality unit as part 147 of release criteria (see 211.22 and 212.70) and maintained for CGMP purposes ( e.g., 148 211.180). Electronic data generated to fulfill CGMP requirements should include relevant 149 metadata. T o exclude data from the release criteria decision -making process, there must 150 be a valid , documented, scientific justification for its exclusion (see the guidance for 151 industry Investigating Out -of-Specification (OOS) Test Results for Pharmaceutical 152 Production, and 211.188, 211.192, and 212.71(b) ). The requirements for record 153 retention and review do not differ depe nding on the data format ; paper-based and 154 electronic data record -keeping systems are subject to the same requirements . Does each workflow on our computer system need to be validated? Yes, a workflow, such as creation of an electronic master production a nd control r ecord 159 (MPCR), is a n intended use of a c omputer system to be checked through validation (see 160 211.63, 211.68(b), and 211.110(a)) . If you validate the computer system , but you do 161 5 American National Standard for Information Systems, Dictionary for Information Systems , American National Standards Institute, 1991.
[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 requirements for record ____ retention and review do not differ depe nding on the data format ; paper-based and 154 electronic data record -keeping systems are subject to the same requirements .",
"reference": "The requirements for record 153 retention and review do not differ depe nding on the data format ; paper-based and 154 electronic data record -keeping systems are subject to the same requirements .",
"options": {
"B": "153",
"A": "139",
"C": "140",
"D": "paper-based and 154 electronic data record -keeping systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The requirements for record 153 retention and review do not differ depe nding on the data format ; paper-based and ____ electronic data record -keeping systems are subject to the same requirements .",
"reference": "The requirements for record 153 retention and review do not differ depe nding on the data format ; paper-based and 154 electronic data record -keeping systems are subject to the same requirements .",
"options": {
"C": "154",
"A": "139",
"B": "140",
"D": "specific functions.5 140 Computer or related systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Electronic data generated to fulfill CGMP requirem...'?",
"reference": "Electronic data generated to fulfill CGMP requirements should include relevant 149 metadata.",
"options": {
"A": "CGMP",
"B": "The American National Standards Institute",
"C": "ANSI",
"D": "paper-based and 154 electronic data record -keeping systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic data generated to fulfill CGMP requirements should include relevant ____ metadata.",
"reference": "Electronic data generated to fulfill CGMP requirements should include relevant 149 metadata.",
"options": {
"B": "149",
"A": "139",
"C": "140",
"D": "paper-based and 154 electronic data record -keeping systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Electronic data generated to fulfill CGMP requirem...'?",
"reference": "Electronic data generated to fulfill CGMP requirements should include relevant 149 metadata.",
"options": {
"C": "CGMP",
"A": "The American National Standards Institute",
"B": "ANSI",
"D": "paper-based and 154 electronic data record -keeping systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic data generated to fulfill CGMP requirements should include relevant ____ metadata.",
"reference": "Electronic data generated to fulfill CGMP requirements should include relevant 149 metadata.",
"options": {
"C": "149",
"A": "139",
"B": "140",
"D": "paper-based and 154 electronic data record -keeping systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Yes, a workflow, such as creation of an electronic...'?",
"reference": "Yes, a workflow, such as creation of an electronic master production a nd control r ecord 159 (MPCR), is a n intended use of a c omputer system to be checked through validation (see 160 211.63, 211.68(b), and 211.110(a)) .",
"options": {
"C": "MPCR",
"A": "The American National Standards Institute",
"B": "ANSI",
"D": "paper-based and 154 electronic data record -keeping systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 5 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Management Review of the Ph armaceutical Quality System (4.1) Management should have a formal process for reviewing the pharmaceuti cal quality system on a periodic basis. The review should include: (a) Measurement of achievement of pharmaceutical quality system objectives (b) Assessment of performance indicators that can be used to monitor the effectiveness of processes within the pharmaceuti cal quality system, such as: (1) Complaint, deviation, CAPA and change management processes (2) Feedback on outsourced activities (3) Self-assessment processes including risk assessments, trending, and audits (4) External assessments such as regulatory inspections and findings and customer audits B. Monitoring of Internal and External Factors That Can Have an Impacton the Pharmaceutical Quality System (4.2) Factors monitored by management can include: (a) Emerging regulations, guidance, and quality issues that can have an impact on the Pharmaceutical Quality System (b) Innovations that might enhance the pharmaceutical quality system (c) Changes in business environment and objectives 13 (d) Changes in product ownership C. Outcomes of Management Review and Monitoring (4.3)
The outcome of management review of the pha rmaceutical quality system and monitoring of internal and external factors can include: (a) Improvements to the pharmaceutical quality system and related processes (b) Allocation or realloca tion of resources and/ or personnel training (c) Revisions to quality policy and quality objectives (d) Documentation and timely and effective communication of the results of the management review and actions, including esca lation of appropriate issues to senior management 14 VI. GLOSSARY (5) ICH and ISO definitions are used in ICH Q10 where they exist. For the purpose of ICH Q10, where the words requirement, requirements, or necessary appear in an ISO definition, they do not necessarily reflect a regulatory requirement.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Management Review of the Ph armaceutical Quality S...'?",
"reference": "Management Review of the Ph armaceutical Quality System (4.1) Management should have a formal process for reviewing the pharmaceuti cal quality system on a periodic basis.",
"options": {
"C": "Management Review of the Ph armaceutical Quality System",
"A": "CAPA",
"B": "B. Monitoring of Internal and External Factors",
"D": "the management review"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Management Review of the Ph armaceutical Quality System (____) Management should have a formal process for reviewing the pharmaceuti cal quality system on a periodic basis.",
"reference": "Management Review of the Ph armaceutical Quality System (4.1) Management should have a formal process for reviewing the pharmaceuti cal quality system on a periodic basis.",
"options": {
"B": "4.1",
"A": "4.2",
"C": "4.3",
"D": "Management Review"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For the purpose of ICH Q10, where the words requir...'?",
"reference": "For the purpose of ICH Q10, where the words requirement, requirements, or necessary appear in an ISO definition, they do not necessarily reflect a regulatory requirement.",
"options": {
"A": "ICH Q10",
"B": "Management Review",
"C": "ISO",
"D": "This information is not provided in the context"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For the purpose of ICH Q10, where the words requir...'?",
"reference": "For the purpose of ICH Q10, where the words requirement, requirements, or necessary appear in an ISO definition, they do not necessarily reflect a regulatory requirement.",
"options": {
"D": "ISO",
"A": "Management Review of the Ph armaceutical Quality System",
"B": "CAPA",
"C": "Management Review"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Management Review of the Ph armaceutical Quality S...'?",
"reference": "Management Review of the Ph armaceutical Quality System (4.1) Management should have a formal process for reviewing the pharmaceuti cal quality system on a periodic basis.",
"options": {
"C": "Management Review of the Ph armaceutical Quality System",
"A": "CAPA",
"B": "B. Monitoring of Internal and External Factors",
"D": "the management review"
},
"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]
Examples ................................ ................................ ................................ ................................
................ Example 1: Nonconformance Management System ................................ ................................
............................... Example 2: Learning Management System (LMS) ................................
................................ ................................ Example 3: Business Intelligence Applications ................................ ................................ ................................
24 Contains Nonbinding Recommendations Draft Not for Implementation 4Computer Software Assurance for 1 Production and Quality System 2 Software 3 ______________________________________________________________________________ 4
Draft Guidance for Industry and 5 Food and Drug Administration Staff 6 7 This draft guidance , when finalized, will represent the current thinking of the Food an d Drug 8 Administration (FDA or Agency )on this topic. It does not establish any rights for any person 9 and is not binding on FDA or the public. You can use an alternative approach if it satisfies 10 the requirements of the applicable statutes and regulations. To discuss an alternative 11 approach, contact the FDA staff or Office responsible for this guidance aslisted on the title 12 page . 13 14 I.Introduction115
FDA is issuing this draft guidance to provide recommendations on computer software assurance 16 for computers and automated data processing systems used as part of medical device production 17 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": "Which organization is referenced: 'Example 3: Business Intelligence Applications .......'?",
"reference": "Example 3: Business Intelligence Applications ................................ ................................ ................................\n24 Contains Nonbinding Recommendations Draft Not for Implementation 4Computer Software Assurance for 1 Production and Quality System 2 Software 3 ______________________________________________________________________________ 4\nDraft Guidance for Industry and 5 Food and Drug Administration Staff 6 7 This draft guidance , when finalized, will represent the current thinking of the Food an d Drug 8 Administration (FDA or Agency )on this topic.",
"options": {
"B": "Food and Drug Administration",
"A": "Nonconformance Management System",
"C": "Learning Management System",
"D": "4\nDraft Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Example 3: Business Intelligence Applications .......'?",
"reference": "Example 3: Business Intelligence Applications ................................ ................................ ................................\n24 Contains Nonbinding Recommendations Draft Not for Implementation 4Computer Software Assurance for 1 Production and Quality System 2 Software 3 ______________________________________________________________________________ 4\nDraft Guidance for Industry and 5 Food and Drug Administration Staff 6 7 This draft guidance , when finalized, will represent the current thinking of the Food an d Drug 8 Administration (FDA or Agency )on this topic.",
"options": {
"C": "6 7",
"A": "4\nDraft Guidance",
"B": "This draft guidance",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Example 3: Business Intelligence Applications .......'?",
"reference": "Example 3: Business Intelligence Applications ................................ ................................ ................................\n24 Contains Nonbinding Recommendations Draft Not for Implementation 4Computer Software Assurance for 1 Production and Quality System 2 Software 3 ______________________________________________________________________________ 4\nDraft Guidance for Industry and 5 Food and Drug Administration Staff 6 7 This draft guidance , when finalized, will represent the current thinking of the Food an d Drug 8 Administration (FDA or Agency )on this topic.",
"options": {
"B": "the Food an d Drug 8 Administration",
"A": "Nonconformance Management System",
"C": "Learning Management System",
"D": "4\nDraft Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Example 3: Business Intelligence Applications .......'?",
"reference": "Example 3: Business Intelligence Applications ................................ ................................ ................................\n24 Contains Nonbinding Recommendations Draft Not for Implementation 4Computer Software Assurance for 1 Production and Quality System 2 Software 3 ______________________________________________________________________________ 4\nDraft Guidance for Industry and 5 Food and Drug Administration Staff 6 7 This draft guidance , when finalized, will represent the current thinking of the Food an d Drug 8 Administration (FDA or Agency )on this topic.",
"options": {
"C": "FDA",
"A": "Nonconformance Management System",
"B": "Learning Management System",
"D": "4\nDraft Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Example 3: Business Intelligence Applications .......'?",
"reference": "Example 3: Business Intelligence Applications ................................ ................................ ................................\n24 Contains Nonbinding Recommendations Draft Not for Implementation 4Computer Software Assurance for 1 Production and Quality System 2 Software 3 ______________________________________________________________________________ 4\nDraft Guidance for Industry and 5 Food and Drug Administration Staff 6 7 This draft guidance , when finalized, will represent the current thinking of the Food an d Drug 8 Administration (FDA or Agency )on this topic.",
"options": {
"C": "Agency",
"A": "4\nDraft Guidance",
"B": "This draft guidance",
"D": "government agency"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Example ____: Business Intelligence Applications ................................ ................................ ................................\n24 Contains Nonbinding Recommendations Draft Not for Implementation 4Computer Software Assurance for 1 Production and Quality System 2 Software 3 ______________________________________________________________________________ 4\nDraft Guidance for Industry and 5 Food and Drug Administration Staff 6 7 This draft guidance , when finalized, will represent the current thinking of the Food an d Drug 8 Administration (FDA or Agency )on this topic.",
"reference": "Example 3: Business Intelligence Applications ................................ ................................ ................................\n24 Contains Nonbinding Recommendations Draft Not for Implementation 4Computer Software Assurance for 1 Production and Quality System 2 Software 3 ______________________________________________________________________________ 4\nDraft Guidance for Industry and 5 Food and Drug Administration Staff 6 7 This draft guidance , when finalized, will represent the current thinking of the Food an d Drug 8 Administration (FDA or Agency )on this topic.",
"options": {
"B": "3",
"A": "4\nDraft Guidance",
"C": "This draft guidance",
"D": "troika"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Example 3: Business Intelligence Applications ................................ ................................ ................................\n____ Contains Nonbinding Recommendations Draft Not for Implementation 4Computer Software Assurance for 1 Production and Quality System 2 Software 3 ______________________________________________________________________________ 4\nDraft Guidance for Industry and 5 Food and Drug Administration Staff 6 7 This draft guidance , when finalized, will represent the current thinking of the Food an d Drug 8 Administration (FDA or Agency )on this topic.",
"reference": "Example 3: Business Intelligence Applications ................................ ................................ ................................\n24 Contains Nonbinding Recommendations Draft Not for Implementation 4Computer Software Assurance for 1 Production and Quality System 2 Software 3 ______________________________________________________________________________ 4\nDraft Guidance for Industry and 5 Food and Drug Administration Staff 6 7 This draft guidance , when finalized, will represent the current thinking of the Food an d Drug 8 Administration (FDA or Agency )on this topic.",
"options": {
"D": "24",
"A": "4\nDraft Guidance",
"B": "This draft guidance",
"C": "XXIV"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Example 3: Business Intelligence Applications ................................ ................................ ................................\n24 Contains Nonbinding Recommendations Draft Not for Implementation 4Computer Software Assurance for ____ Production and Quality System 2 Software 3 ______________________________________________________________________________ 4\nDraft Guidance for Industry and 5 Food and Drug Administration Staff 6 7 This draft guidance , when finalized, will represent the current thinking of the Food an d Drug 8 Administration (FDA or Agency )on this topic.",
"reference": "Example 3: Business Intelligence Applications ................................ ................................ ................................\n24 Contains Nonbinding Recommendations Draft Not for Implementation 4Computer Software Assurance for 1 Production and Quality System 2 Software 3 ______________________________________________________________________________ 4\nDraft Guidance for Industry and 5 Food and Drug Administration Staff 6 7 This draft guidance , when finalized, will represent the current thinking of the Food an d Drug 8 Administration (FDA or Agency )on this topic.",
"options": {
"C": "1",
"A": "4\nDraft Guidance",
"B": "This draft guidance",
"D": "ace"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Example 3: Business Intelligence Applications ................................ ................................ ................................\n____4 Contains Nonbinding Recommendations Draft Not for Implementation 4Computer Software Assurance for 1 Production and Quality System 2 Software 3 ______________________________________________________________________________ 4\nDraft Guidance for Industry and 5 Food and Drug Administration Staff 6 7 This draft guidance , when finalized, will represent the current thinking of the Food an d Drug 8 Administration (FDA or Agency )on this topic.",
"reference": "Example 3: Business Intelligence Applications ................................ ................................ ................................\n24 Contains Nonbinding Recommendations Draft Not for Implementation 4Computer Software Assurance for 1 Production and Quality System 2 Software 3 ______________________________________________________________________________ 4\nDraft Guidance for Industry and 5 Food and Drug Administration Staff 6 7 This draft guidance , when finalized, will represent the current thinking of the Food an d Drug 8 Administration (FDA or Agency )on this topic.",
"options": {
"C": "2",
"A": "4\nDraft Guidance",
"B": "This draft guidance",
"D": "two"
},
"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]
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": "Which organization is referenced: 'In contrast, FDA considers a software feature, fun...'?",
"reference": "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 .",
"options": {
"D": "FDA",
"A": "high 251 process risk",
"B": "a high process 271 risk",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In contrast, FDA considers a software feature, function, or o peration not to pose a high process ____ risk when its failure to perform as intended would not result in a quality problem that 272 foreseeably compromises safety .",
"reference": "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 .",
"options": {
"D": "271",
"A": "249",
"B": "250",
"C": "high 251 process risk"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 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 ____ foreseeably compromises safety .",
"reference": "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 .",
"options": {
"B": "272",
"A": "249",
"C": "250",
"D": "high 251 process risk"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Examples of software features, functions, or operations that are generally high ____ 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.",
"reference": "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.",
"options": {
"D": "251",
"A": "249",
"B": "250",
"C": "a high process 271 risk"
},
"answer": "D",
"difficulty": "hard",
"question_type": "analytical"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 15 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": "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": {
"A": "72",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Complete, consistent, and accurate data should 73 ...'?",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"C": "ALCOA",
"A": "Electronic Records",
"B": "Electronic Signatures Scope",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Complete, consistent, and accurate data should 73 ...'?",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"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": "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": "FD C Act section 501(a",
"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 ____ 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": {
"A": "73",
"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 ____ 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": "74",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n____ 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"C": ".4",
"A": "the FDA Drugs guidance W eb page",
"B": "Complete, consistent, and accurate data",
"D": "ALCOA"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 ____ 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"B": "75",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 ____ FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"reference": "Complete, consistent, and accurate data should 73 be attributable , legible , contemporaneous ly recorded, original or a true copy, and 74 accurate (ALCOA)\n.4 75 2 FDAs authority for CGMP comes from FD C Act section 501(a )(2)(B), which states that a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess .",
"options": {
"A": "2",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For attributable, see 211.101(d), ____, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"reference": "For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"options": {
"A": "211.122",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For attributable, see 211.101(d), 211.122, ____ , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"reference": "For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"options": {
"A": "211.186",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see ____(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"reference": "For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 211.180(e) and 212.110(b) ; for contemporaneous ly recorded (at the time of performance) see 211.100(b) and 211.160(a) ; for original or a true copy see 211.180 and 211.194(a) ; and for accurate see 211.22(a), 211.68, 211.188, and 212.60(g).",
"options": {
"A": "211.180",
"B": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For attributable, see 211.101(d), 211.122, 211.186 , 211.188(b)(11), and 212.50(c)(10) ; for legible see 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": {
"B": "211.68",
"A": "68 69",
"C": "75 2",
"D": "the FDA Drugs guidance W eb page"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For attributable, see 211.101(d), 211.122, 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": {
"D": "211.188",
"A": "68 69",
"B": "75 2",
"C": "the FDA Drugs guidance W eb page"
},
"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 35 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: 'When elements of the qual ity systems model correl...'?",
"reference": "When elements of the qual ity systems model correlate with specific CGMP regulations, this corre lation is noted.",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA re gulatory and inspectional coverage will rem...'?",
"reference": "FDA re gulatory and inspectional coverage will remain focused on the specific CGMP regulations.",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "a robust quality systems model",
"D": "the quality systems model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA re gulatory and inspectional coverage will rem...'?",
"reference": "FDA re gulatory and inspectional coverage will remain focused on the specific CGMP regulations.",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'As already explained, many of the quality systems ...'?",
"reference": "As already explained, many of the quality systems elements correlate closely with the CGMP regulations.",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"C": "a robust quality systems model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"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": {
"B": "CGMP",
"A": "FDA",
"C": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When elements of the qual ity systems model correl...'?",
"reference": "When elements of the qual ity systems model correlate with specific CGMP regulations, this corre lation is noted.",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When elements of the qual ity systems model correl...'?",
"reference": "When elements of the qual ity systems model correlate with specific CGMP regulations, this corre lation is noted.",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'At the end of each section, a table shows how the ...'?",
"reference": "At the end of each section, a table shows how the specific CGMP regulat ions correlate to the elements in the quality systems model.",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"C": "a robust quality systems model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'FDA re gulatory and inspectional coverage will rem...'?",
"reference": "FDA re gulatory and inspectional coverage will remain focused on the specific CGMP regulations.",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "a robust quality systems model",
"C": "the quality systems model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA re gulatory and inspectional coverage will rem...'?",
"reference": "FDA re gulatory and inspectional coverage will remain focused on the specific 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"
},
{
"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": {
"D": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"C": "a robust quality systems model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA re gulatory and inspectional coverage will rem...'?",
"reference": "FDA re gulatory and inspectional coverage will remain focused on the specific CGMP regulations.",
"options": {
"A": "FDA",
"B": "CGMP",
"C": "a robust quality systems model",
"D": "the quality systems model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'As already explained, many of the quality systems ...'?",
"reference": "As already explained, many of the quality systems elements correlate closely with the CGMP regulations.",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When elements of the qual ity systems model correl...'?",
"reference": "When elements of the qual ity systems model correlate with specific CGMP regulations, this corre lation is noted.",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"C": "a robust quality systems model"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The model is described according to four major fac...'?",
"reference": "The model is described according to four major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"options": {
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"A": "CGMP",
"C": "a robust quality systems model",
"D": "the quality systems model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The model is described according to ____ major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"reference": "The model is described according to four major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"options": {
"A": "four",
"B": "a robust quality systems model",
"C": "the quality systems model",
"D": "quaternity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'At the end of each section, a table shows how the ...'?",
"reference": "At the end of each section, a table shows how the specific CGMP regulat ions correlate to the elements in the quality systems model.",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'When elements of the qual ity systems model correl...'?",
"reference": "When elements of the qual ity systems model correlate with specific CGMP regulations, this corre lation is noted.",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'At the end of each section, a table shows how the ...'?",
"reference": "At the end of each section, a table shows how the specific CGMP regulat ions correlate to the elements in the quality systems model.",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'As already explained, many of the quality systems ...'?",
"reference": "As already explained, many of the quality systems elements correlate closely with the CGMP regulations.",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'As already explained, many of the quality systems ...'?",
"reference": "As already explained, many of the quality systems elements correlate closely with the CGMP regulations.",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When elements of the qual ity systems model correl...'?",
"reference": "When elements of the qual ity systems model correlate with specific CGMP regulations, this corre lation is noted.",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"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": {
"D": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"C": "a robust quality systems model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"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": {
"C": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The model is described according to four major fac...'?",
"reference": "The model is described according to four major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"options": {
"D": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"A": "CGMP",
"B": "a robust quality systems model",
"C": "the quality systems model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The model is described according to ____ major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"reference": "The model is described according to four major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"options": {
"B": "four",
"A": "a robust quality systems model",
"C": "the quality systems model",
"D": "quaternity"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA re gulatory and inspectional coverage will rem...'?",
"reference": "FDA re gulatory and inspectional coverage will remain focused on the specific CGMP regulations.",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "a robust quality systems model",
"C": "the quality systems model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA re gulatory and inspectional coverage will rem...'?",
"reference": "FDA re gulatory and inspectional coverage will remain focused on the specific CGMP regulations.",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"C": "a robust quality systems model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"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"
},
{
"question": "Which organization is referenced: 'The model is described according to four major fac...'?",
"reference": "The model is described according to four major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"options": {
"D": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"A": "CGMP",
"B": "a robust quality systems model",
"C": "the quality systems model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The model is described according to ____ major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"reference": "The model is described according to four major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"options": {
"D": "four",
"A": "a robust quality systems model",
"B": "the quality systems model",
"C": "quaternity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"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": {
"C": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The model is described according to four major fac...'?",
"reference": "The model is described according to four major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"options": {
"A": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"B": "CGMP",
"C": "a robust quality systems model",
"D": "the quality systems model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The model is described according to ____ major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"reference": "The model is described according to four major factors: Management Responsibilities Resources Manufacturing Operations Evaluation Activities In each of the sections that follow, the specific elements of a robust m odern quality system s model are described.",
"options": {
"C": "four",
"A": "a robust quality systems model",
"B": "the quality systems model",
"D": "quaternity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'At the end of each section, a table shows how the ...'?",
"reference": "At the end of each section, a table shows how the specific CGMP regulat ions correlate to the elements in the quality systems model.",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "a robust quality systems model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 6 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance. The device manufacturer has latitude and flexibility in defining how validation of that software will be accomplished, but validation should be a key consideration in deciding how and by whom the software will be developed or from whom it will be purchased. The software developer defines a life cycle model. Validation is typically supported by: verifications of the outputs from each stage of that software development life cycle; and checking for proper operation of the finished software in the device manufacturers intended use environment. HOW MUCH VALIDATION EVIDENCE IS NEEDED? The level of validation effort should be commensurate with the risk posed by the automated operation. In addition to risk other factors, such as the complexity of the process software and the degree to which the device manufacturer is dependent upon that automated process to produce a safe and effective device, determine the nature and extent of testing needed as part of the validation effort. Documented requirements and risk analysis of the automated process help to define the scope of the evidence needed to show that the software is validated for its intended use. For example, an automated milling machine may require very little testing if the device manufacturer can show that the output of the operation is subsequently fully verified against the specification before release.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "What is developer?",
"reference": "The software developer defines a life cycle model.",
"options": {
"B": "model",
"A": "Software Validation Guidance",
"C": "that software development life cycle",
"D": "pattern"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"D": "Page 31General Principles of Software Validation Guidance for Industry",
"A": "that software development life cycle",
"B": "the process software",
"C": "FDA"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"D": "FDA",
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"B": "Software Validation Guidance",
"C": "that software development life cycle"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"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 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Careful and complete documentation of the design structure and interrelationships of various modules, interfaces, etc., can limit the validation effort needed when a change is made. The level of effort needed Page 29General Principles of Software Validation Guidance for Industry and FDA Staff to fully validate a change is also dependent upon the degree to which validation of the original software was documented and archived. For example, test documentation, test cases, and results of previous verification and validation testing need to be archived if they are to be available for performing subsequent regression testing. Failure to archive this information for later use can significantly increase the level of effort and expense of revalidating the software after a change is made. In addition to software verification and validation tasks that are part of the standard software development process, the following additional maintenance tasks should be addressed:
Software Validation Plan Revision - For software that was previously validated, the existing software validation plan should be revised to support the validation of the revised software. If no previous software validation plan exists, such a plan should be established to support the validation of the revised software. Anomaly Evaluation Software organizations frequently maintain documentation, such as software problem reports that describe software anomalies discovered and the specific corrective action taken to fix each anomaly. Too often, however, mistakes are repeated because software developers do not take the next step to determine the root causes of problems and make the process and procedural changes needed to avoid recurrence of the problem. Software anomalies should be evaluated in terms of their severity and their effects on system operation and safety, but they should also be treated as symptoms of process deficiencies in 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": "Which organization is referenced: 'Software anomalies should be evaluated in terms of...'?",
"reference": "Software anomalies should be evaluated in terms of their severity and their effects on system operation and safety, but they should also be treated as symptoms of process deficiencies in the quality system.",
"options": {
"C": "Software",
"A": "Page 29General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"D": "the validation effort"
},
"answer": "C",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Software anomalies should be evaluated in terms of...'?",
"reference": "Software anomalies should be evaluated in terms of their severity and their effects on system operation and safety, but they should also be treated as symptoms of process deficiencies in the quality system.",
"options": {
"C": "Software",
"A": "Page 29General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"D": "the validation effort"
},
"answer": "C",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Software anomalies should be evaluated in terms of...'?",
"reference": "Software anomalies should be evaluated in terms of their severity and their effects on system operation and safety, but they should also be treated as symptoms of process deficiencies in the quality system.",
"options": {
"A": "Software",
"B": "Page 29General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "the validation effort"
},
"answer": "A",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Anomaly Evaluation Software organizations frequen...'?",
"reference": "Anomaly Evaluation Software organizations frequently maintain documentation, such as software problem reports that describe software anomalies discovered and the specific corrective action taken to fix each anomaly.",
"options": {
"B": "Anomaly Evaluation Software",
"A": "Page 29General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "no previous software validation plan"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software anomalies should be evaluated in terms of...'?",
"reference": "Software anomalies should be evaluated in terms of their severity and their effects on system operation and safety, but they should also be treated as symptoms of process deficiencies in the quality system.",
"options": {
"D": "Software",
"A": "Page 29General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"C": "the validation effort"
},
"answer": "D",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Software anomalies should be evaluated in terms of...'?",
"reference": "Software anomalies should be evaluated in terms of their severity and their effects on system operation and safety, but they should also be treated as symptoms of process deficiencies in the quality system.",
"options": {
"A": "Software",
"B": "Page 29General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "the validation effort"
},
"answer": "A",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Anomaly Evaluation Software organizations frequen...'?",
"reference": "Anomaly Evaluation Software organizations frequently maintain documentation, such as software problem reports that describe software anomalies discovered and the specific corrective action taken to fix each anomaly.",
"options": {
"B": "Anomaly Evaluation Software",
"A": "Page 29General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "no previous software validation plan"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The level of effort needed Page 29General Principl...'?",
"reference": "The level of effort needed Page 29General Principles of Software Validation Guidance for Industry and FDA Staff to fully validate a change is also dependent upon the degree to which validation of the original software was documented and archived.",
"options": {
"A": "Page 29General Principles of Software Validation Guidance for Industry",
"B": "no previous software validation plan",
"C": "Software Validation Plan Revision",
"D": "FDA"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The level of effort needed Page 29General Principl...'?",
"reference": "The level of effort needed Page 29General Principles of Software Validation Guidance for Industry and FDA Staff to fully validate a change is also dependent upon the degree to which validation of the original software was documented and archived.",
"options": {
"C": "FDA",
"A": "Page 29General Principles of Software Validation Guidance for Industry",
"B": "Anomaly Evaluation Software",
"D": "no previous software validation plan"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Anomaly Evaluation Software organizations frequen...'?",
"reference": "Anomaly Evaluation Software organizations frequently maintain documentation, such as software problem reports that describe software anomalies discovered and the specific corrective action taken to fix each anomaly.",
"options": {
"B": "Anomaly Evaluation Software",
"A": "Page 29General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "no previous software validation plan"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The level of effort needed Page 29General Principl...'?",
"reference": "The level of effort needed Page 29General Principles of Software Validation Guidance for Industry and FDA Staff to fully validate a change is also dependent upon the degree to which validation of the original software was documented and archived.",
"options": {
"B": "Page 29General Principles of Software Validation Guidance for Industry",
"A": "no previous software validation plan",
"C": "Software Validation Plan Revision",
"D": "FDA"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The level of effort needed Page 29General Principl...'?",
"reference": "The level of effort needed Page 29General Principles of Software Validation Guidance for Industry and FDA Staff to fully validate a change is also dependent upon the degree to which validation of the original software was documented and archived.",
"options": {
"A": "FDA",
"B": "Page 29General Principles of Software Validation Guidance for Industry",
"C": "Anomaly Evaluation Software",
"D": "no previous software validation plan"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Too often, however, mistakes are repeated because software d...'?",
"reference": "Too often, however, mistakes are repeated because software developers do not take the next step to determine the root causes of problems and make the process and procedural changes needed to avoid recurrence of the problem.",
"options": {
"B": "Too often, however, mistakes are repeated because software developers do not take the next step to d...",
"A": "no previous software validation plan",
"C": "Software Validation Plan Revision",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Anomaly Evaluation Software organizations frequen...'?",
"reference": "Anomaly Evaluation Software organizations frequently maintain documentation, such as software problem reports that describe software anomalies discovered and the specific corrective action taken to fix each anomaly.",
"options": {
"D": "Anomaly Evaluation Software",
"A": "Page 29General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"C": "no previous software validation plan"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The level of effort needed Page 29General Principl...'?",
"reference": "The level of effort needed Page 29General Principles of Software Validation Guidance for Industry and FDA Staff to fully validate a change is also dependent upon the degree to which validation of the original software was documented and archived.",
"options": {
"A": "Page 29General Principles of Software Validation Guidance for Industry",
"B": "no previous software validation plan",
"C": "Software Validation Plan Revision",
"D": "FDA"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The level of effort needed Page 29General Principl...'?",
"reference": "The level of effort needed Page 29General Principles of Software Validation Guidance for Industry and FDA Staff to fully validate a change is also dependent upon the degree to which validation of the original software was documented and archived.",
"options": {
"A": "FDA",
"B": "Page 29General Principles of Software Validation Guidance for Industry",
"C": "Anomaly Evaluation Software",
"D": "no previous software validation plan"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Anomaly Evaluation Software organizations frequen...'?",
"reference": "Anomaly Evaluation Software organizations frequently maintain documentation, such as software problem reports that describe software anomalies discovered and the specific corrective action taken to fix each anomaly.",
"options": {
"A": "Anomaly Evaluation Software",
"B": "Page 29General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "no previous software validation plan"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software anomalies should be evaluated in terms of...'?",
"reference": "Software anomalies should be evaluated in terms of their severity and their effects on system operation and safety, but they should also be treated as symptoms of process deficiencies in the quality system.",
"options": {
"B": "Software",
"A": "Page 29General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "the validation effort"
},
"answer": "B",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Software anomalies should be evaluated in terms of...'?",
"reference": "Software anomalies should be evaluated in terms of their severity and their effects on system operation and safety, but they should also be treated as symptoms of process deficiencies in the quality system.",
"options": {
"D": "Software",
"A": "Page 29General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"C": "the validation effort"
},
"answer": "D",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Anomaly Evaluation Software organizations frequen...'?",
"reference": "Anomaly Evaluation Software organizations frequently maintain documentation, such as software problem reports that describe software anomalies discovered and the specific corrective action taken to fix each anomaly.",
"options": {
"B": "Anomaly Evaluation Software",
"A": "Page 29General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "no previous software validation plan"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product and is intended to be used togeth er with regional GMP requirements. The regional GMPs do not explicitly addre ss all stages of the product lifecycle (e.g., development). The quality system elements and management responsibilities described in this guidance are intended to encourage the use of sc ience- and risk-based approaches at each lifecycle stage, thereby promo ting continual improvement acro ss the entire product lifecycle. C. Relationship of ICH Q10 to Regulatory Approaches (1.4) Regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product and pro cess understanding, the results of quality risk management, and the effectiveness of the pharmaceutical quality system. When implemented, the effectiveness of the pharmaceutical quality system can normally be evaluated during a regulatory inspection at the manufacturing site. Potential opportunities to enhance science- and risk-based regulatory approaches are identified in Annex 1. Regulat ory processes will be determined by region. D. ICH Q10 Objectives (1.5) Implementation of the Q10 model should result in achievement of three main objectives that complement or enhance regional GMP requirements. Achieve Product Realization (1.5.1) To establish, implement, and maintain a system that allows the deliver y of products with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities (including compliance with approve d regulatory filings) a nd other internal and external customers. Establish and Maintain a State of Control (1.5.2) 3
To develop and use effective monitoring and control systems for process performance and product quality, thereby providing assura nce of continued suitability and capability of processes.
[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: Achieve Product Realization (____) To establish, implement, and maintain a system that allows the deliver y of products with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities (including compliance with approve d regulatory filings) a nd other internal and external customers.",
"reference": "Achieve Product Realization (1.5.1) To establish, implement, and maintain a system that allows the deliver y of products with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities (including compliance with approve d regulatory filings) a nd other internal and external customers.",
"options": {
"D": "1.5.1",
"A": "1.4",
"B": "1.5",
"C": "product quality"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'C. Relationship of ICH Q10 to Regulatory Approache...'?",
"reference": "C. Relationship of ICH Q10 to Regulatory Approaches (1.4) Regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product and pro cess understanding, the results of quality risk management, and the effectiveness of the pharmaceutical quality system.",
"options": {
"D": "Regulatory Approaches",
"A": "product quality",
"B": "the entire product lifecycle",
"C": "1.4"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: C. Relationship of ICH Q10 to Regulatory Approaches (____) Regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product and pro cess understanding, the results of quality risk management, and the effectiveness of the pharmaceutical quality system.",
"reference": "C. Relationship of ICH Q10 to Regulatory Approaches (1.4) Regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product and pro cess understanding, the results of quality risk management, and the effectiveness of the pharmaceutical quality system.",
"options": {
"B": "1.4",
"A": "1.5",
"C": "three",
"D": "product quality"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Achieve Product Realization (____) To establish, implement, and maintain a system that allows the deliver y of products with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities (including compliance with approve d regulatory filings) a nd other internal and external customers.",
"reference": "Achieve Product Realization (1.5.1) To establish, implement, and maintain a system that allows the deliver y of products with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities (including compliance with approve d regulatory filings) a nd other internal and external customers.",
"options": {
"A": "1.5.1",
"B": "1.4",
"C": "1.5",
"D": "product quality"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ICH Q10 provides a harmonized model for a pharmace...'?",
"reference": "ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product and is intended to be used togeth er with regional GMP requirements.",
"options": {
"B": "GMP",
"A": "D. ICH Q10 Objectives",
"C": "Q10",
"D": "product quality"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'C. Relationship of ICH Q10 to Regulatory Approache...'?",
"reference": "C. Relationship of ICH Q10 to Regulatory Approaches (1.4) Regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product and pro cess understanding, the results of quality risk management, and the effectiveness of the pharmaceutical quality system.",
"options": {
"A": "Regulatory Approaches",
"B": "product quality",
"C": "the entire product lifecycle",
"D": "1.4"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: C. Relationship of ICH Q10 to Regulatory Approaches (____) Regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product and pro cess understanding, the results of quality risk management, and the effectiveness of the pharmaceutical quality system.",
"reference": "C. Relationship of ICH Q10 to Regulatory Approaches (1.4) Regulatory approaches for a specific product or manufacturing facility should be commensurate with the level of product and pro cess understanding, the results of quality risk management, and the effectiveness of the pharmaceutical quality system.",
"options": {
"C": "1.4",
"A": "1.5",
"B": "three",
"D": "product quality"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Establish and Maintain a State of Control (1.5.2) ...'?",
"reference": "Establish and Maintain a State of Control (1.5.2) 3\nTo develop and use effective monitoring and control systems for process performance and product quality, thereby providing assura nce of continued suitability and capability of processes.",
"options": {
"D": "Maintain a State of Control",
"A": "product quality",
"B": "the entire product lifecycle",
"C": "1.5.2"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Establish and Maintain a State of Control (____) 3\nTo develop and use effective monitoring and control systems for process performance and product quality, thereby providing assura nce of continued suitability and capability of processes.",
"reference": "Establish and Maintain a State of Control (1.5.2) 3\nTo develop and use effective monitoring and control systems for process performance and product quality, thereby providing assura nce of continued suitability and capability of processes.",
"options": {
"D": "1.5.2",
"A": "1.4",
"B": "1.5",
"C": "product quality"
},
"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]
This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ). 26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance . This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA). 2 Available at https://www.fda.gov/regulatory -information/search -fda-guidance -documents/general -principles - software -validation . Contains Nonbinding Recommendations Draft Not for Implementation 5For
the current edition of the FDA -recognized consensus standard referenced in this document, 33 see the FDA Recognized Consensus Standards Database .334 35
In general, FDA s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 37 as recommendations, unless specific regulatory or statutory requirements are cited. T he use of 38 the word should in Agency guidances means that something is suggested or recommended, but 39 not required .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "When did this occur: '26 27 When final, this guidance will supplement FD...'?",
"reference": "26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"options": {
"B": "26 27",
"A": "the Software 30 Validation guidance",
"C": "computer software validation requirements",
"D": "General Principles of"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '26 27 When final, this guidance will supplement FD...'?",
"reference": "26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"options": {
"D": "General Principles of",
"A": "the Software 30 Validation guidance",
"B": "computer software validation requirements",
"C": "26 27"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '26 27 When final, this guidance will supplement FD...'?",
"reference": "26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"options": {
"A": "Automated Process Equipment and",
"B": "CFR",
"C": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '26 27 When final, this guidance will supplement FD...'?",
"reference": "26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"options": {
"A": "Software",
"B": "CFR",
"C": "General Principles of",
"D": "FDA s guidance documents"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"reference": "26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"options": {
"D": "26",
"A": "18 19",
"B": "820",
"C": "the Software 30 Validation guidance"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 26 ____ When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"reference": "26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"options": {
"D": "27",
"A": "18 19",
"B": "820",
"C": "the Software 30 Validation guidance"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software ____ Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"reference": "26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"options": {
"D": "28",
"A": "18 19",
"B": "820",
"C": "the Software 30 Validation guidance"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 2____ 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"reference": "26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"options": {
"C": "6",
"A": "18 19",
"B": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 ____ (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"reference": "26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"options": {
"C": "29",
"A": "18 19",
"B": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software ____ Validation guidance .",
"reference": "26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"options": {
"A": "30",
"B": "18 19",
"C": "820",
"D": "computer software validation requirements"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'T he use of 38 the word should in Agency guidances...'?",
"reference": "T he use of 38 the word should in Agency guidances means that something is suggested or recommended, but 39 not required .",
"options": {
"A": "Agency",
"B": "the Software 30 Validation guidance",
"C": "computer software validation requirements",
"D": "government agency"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: T he use of ____ the word should in Agency guidances means that something is suggested or recommended, but 39 not required .",
"reference": "T he use of 38 the word should in Agency guidances means that something is suggested or recommended, but 39 not required .",
"options": {
"C": "38",
"A": "18 19",
"B": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: T he use of 38 the word should in Agency guidances means that something is suggested or recommended, but ____ not required .",
"reference": "T he use of 38 the word should in Agency guidances means that something is suggested or recommended, but 39 not required .",
"options": {
"D": "39",
"A": "18 19",
"B": "820",
"C": "the Software 30 Validation guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'T he use of 38 the word should in Agency guidances...'?",
"reference": "T he use of 38 the word should in Agency guidances means that something is suggested or recommended, but 39 not required .",
"options": {
"C": "Agency",
"A": "the Software 30 Validation guidance",
"B": "computer software validation requirements",
"D": "government agency"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: T he use of ____ the word should in Agency guidances means that something is suggested or recommended, but 39 not required .",
"reference": "T he use of 38 the word should in Agency guidances means that something is suggested or recommended, but 39 not required .",
"options": {
"B": "38",
"A": "18 19",
"C": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: T he use of 38 the word should in Agency guidances means that something is suggested or recommended, but ____ not required .",
"reference": "T he use of 38 the word should in Agency guidances means that something is suggested or recommended, but 39 not required .",
"options": {
"A": "39",
"B": "18 19",
"C": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Available at https://www.fda.gov/regulatory -information/search -fda-guidance -documents/general -principles - software -validation .",
"reference": "2 Available at https://www.fda.gov/regulatory -information/search -fda-guidance -documents/general -principles - software -validation .",
"options": {
"C": "2",
"A": "18 19",
"B": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"A": "the Center for Devices and Radiological Health",
"B": "CFR",
"C": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"A": "CDRH",
"B": "CFR",
"C": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"B": "the Center for Biologics Evaluation and Research",
"A": "CFR",
"C": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"B": "the Center for Drug Evaluation and Research",
"A": "CFR",
"C": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"A": "Office of Combination Products",
"B": "CFR",
"C": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"B": "Office of Regulatory Affairs",
"A": "CFR",
"C": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"A": "ORA",
"B": "CFR",
"C": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'T he use of 38 the word should in Agency guidances...'?",
"reference": "T he use of 38 the word should in Agency guidances means that something is suggested or recommended, but 39 not required .",
"options": {
"B": "Agency",
"A": "the Software 30 Validation guidance",
"C": "computer software validation requirements",
"D": "government agency"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"D": "the Center for Devices and Radiological Health",
"A": "CFR",
"B": "General Principles of",
"C": "the Software 30 Validation guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"C": "CDRH",
"A": "CFR",
"B": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"A": "the Center for Biologics Evaluation and Research",
"B": "CFR",
"C": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"B": "the Center for Drug Evaluation and Research",
"A": "CFR",
"C": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"B": "Office of Combination Products",
"A": "CFR",
"C": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"A": "Office of Regulatory Affairs",
"B": "CFR",
"C": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"B": "ORA",
"A": "CFR",
"C": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Available at https://www.fda.gov/regulatory -information/search -fda-guidance -documents/general -principles - software -validation .",
"reference": "2 Available at https://www.fda.gov/regulatory -information/search -fda-guidance -documents/general -principles - software -validation .",
"options": {
"A": "2",
"B": "18 19",
"C": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"D": "the Center for Devices and Radiological Health",
"A": "CFR",
"B": "General Principles of",
"C": "the Software 30 Validation guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"B": "CDRH",
"A": "CFR",
"C": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"D": "the Center for Biologics Evaluation and Research",
"A": "CFR",
"B": "General Principles of",
"C": "the Software 30 Validation guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance has been prepared by the Center for ...'?",
"reference": "This guidance has been prepared by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) in consultation with the Center for Drug Evaluation and Research (CDER), Office of Combination Products (OCP), and Office of Regulatory Affairs (ORA).",
"options": {
"A": "the Center for Drug Evaluation and Research",
"B": "CFR",
"C": "General Principles of",
"D": "the Software 30 Validation guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This draft guidance is intended to: 18 19 Describe...'?",
"reference": "This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"options": {
"A": "CFR",
"B": "General Principles of",
"C": "Automated Process Equipment and",
"D": "the Software 30 Validation guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This draft guidance is intended to: ____ 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"reference": "This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"options": {
"C": "18",
"A": "18 19",
"B": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This draft guidance is intended to: 18 ____ Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"reference": "This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"options": {
"C": "19",
"A": "18 19",
"B": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence ____ in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"reference": "This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"options": {
"D": "20",
"A": "18 19",
"B": "820",
"C": "the Software 30 Validation guidance"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional ____ rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"reference": "This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"options": {
"D": "21",
"A": "18 19",
"B": "820",
"C": "the Software 30 Validation guidance"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and ____ 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"reference": "This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"options": {
"C": "22",
"A": "18 19",
"B": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 ____ Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"reference": "This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"options": {
"C": "23",
"A": "18 19",
"B": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer ____ softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"reference": "This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"options": {
"B": "24",
"A": "18 19",
"C": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , ____ such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"reference": "This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"options": {
"D": "25",
"A": "18 19",
"B": "820",
"C": "the Software 30 Validation guidance"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional ____ rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"reference": "This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"options": {
"A": "21",
"B": "18 19",
"C": "820",
"D": "the Software 30 Validation guidance"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part ____ (Part 820 ).",
"reference": "This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"options": {
"C": "820",
"A": "18 19",
"B": "2 Available",
"D": "the Software 30 Validation guidance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part ____ (Part 820 ).",
"reference": "This draft guidance is intended to: 18 19 Describe computer software assurance as a risk-based approach to establish confidence 20 in the automation used for production or quality systems ,and identify where additional 21 rigor may be appropriate ;and 22 23 Describe various methods and testing activities that may be applied to establish computer 24 softwa re assurance and provide objective evidence to fulfill regulatory requirements , 25 such as computer software validation requirements in 21 CFR part 820 (Part 820 ).",
"options": {
"B": "820",
"A": "18 19",
"C": "2 Available",
"D": "the Software 30 Validation guidance"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: '26 27 When final, this guidance will supplement FD...'?",
"reference": "26 27 When final, this guidance will supplement FDAs guidance, General Principles of Software 28 Validation (Software Validation guidance)2except this guidance will supersede Section 6 29 (Vali dation of Automated Process Equipment and Quality System Software) of the Software 30 Validation guidance .",
"options": {
"A": "26 27",
"B": "the Software 30 Validation guidance",
"C": "computer software validation requirements",
"D": "General Principles of"
},
"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]
Statistical testing uses randomly generated test data from defined distributions based on an operational profile (e.g., expected use, hazardous use, or malicious use of the software product). Large amounts of test data are generated and can be targeted to cover particular areas or concerns, providing an increased possibility of identifying individual and multiple rare operating conditions that were not anticipated by either the software product's designers or its testers. Statistical testing also provides high structural coverage. It does require a stable software product. Thus, structural and functional testing are prerequisites for statistical testing of a software product. Another aspect of software testing is the testing of software changes. Changes occur frequently during software development. These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements ("requirements creep"), and 3) modified designs as more effective or efficient implementations are found. Once a software product has been baselined (approved), any change to that product should have its own mini life cycle, including testing. Testing of a changed software product requires additional effort. Not only should it demonstrate that the change was implemented correctly, testing should also demonstrate that the change did not adversely impact other parts of the software product. Regression analysis and testing are employed to provide Page 25General Principles of Software Validation Guidance for Industry and FDA Staff assurance that a change has not created problems elsewhere in the software product. Regression analysis is the determination of the impact of a change based on review of the relevant documentation (e.g., software requirements specification, software design specification, source code, test plans, test cases, test scripts, etc.) in order to identify the necessary regression tests to be run.
[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: 'Regression analysis and testing are employed to pr...'?",
"reference": "Regression analysis and testing are employed to provide Page 25General Principles of Software Validation Guidance for Industry and FDA Staff assurance that a change has not created problems elsewhere in the software product.",
"options": {
"B": "FDA",
"A": "software testing",
"C": "a changed software product",
"D": "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 5 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": "Fill in the blank: For most lab analys es, reprocessing ____ data should not be regularly needed.",
"reference": "For most lab analys es, reprocessing 364 data should not be regularly needed.",
"options": {
"B": "364",
"A": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: System s uitability tests, including the identity of the preparation to be ____ injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and 212.60).",
"reference": "System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and 212.60).",
"options": {
"D": "347",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms ____ established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and 212.60).",
"reference": "System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and 212.60).",
"options": {
"A": "348",
"B": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial ____ monograph ( 211.160 and 212.60).",
"reference": "System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and 212.60).",
"options": {
"D": "349",
"A": "344",
"B": "345",
"C": "potential data 371 falsification"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( ____ and 212.60).",
"reference": "System s uitability tests, including the identity of the preparation to be 347 injected and the rational e for its selection, should be performed according to the firms 348 established written procedures and the approved application or applicable compendial 349 monograph ( 211.160 and 212.60).",
"options": {
"A": "211.160",
"B": "344",
"C": "345",
"D": "potential data 371 falsification"
},
"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 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
PDA Journal of Pharmaceutical Science and Technology, Volume 49, Number 1, January-February 1995 Supplement. Validation Compliance Annual 1995 , International Validation Forum, Inc.
General Software Quality References Boris Beizer, Black Box Testing, Techniques for Functional Testing of Software and Systems , John Wiley Sons, 1995. ISBN 0-471-12094-4. Boris Beizer, Software System Testing and Quality Assurance , International Thomson Computer Press, 1996. ISBN 1-85032-821-8. Boris Beizer, Software Testing Techniques , Second Edition, Van Nostrand Reinhold, 1990. ISBN 0- 442-20672-0. Richard Bender, Writing Testable Requirements, Version 1.0 , Bender Associates, Inc., Larkspur, CA 94777, 1996. Frederick P. Brooks, Jr., The Mythical Man-Month, Essays on Software Engineering , Addison-
Wesley Longman, Anniversary Edition, 1995. ISBN 0-201-83595-9. Silvana Castano, et.al., Database Security , ACM Press, Addison-Wesley Publishing Company, 1995. ISBN 0-201-59375-0. Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance , Drug Information Association, Maple Glen, PA, September 1988. Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982. Robert H. Dunn and Richard S. Ullman, TQM for Computer Software , Second Edition, McGraw- Hill, Inc., 1994. ISBN 0-07-018314-7. Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999. ISBN 0-201-43287-0. Robert G. Ebenau and Susan H. Strauss, Software Inspection Process , McGraw-Hill, 1994. ISBN 0-07-062166-7. Richard E. Fairley, Software Engineering Concepts , McGraw-Hill Publishing Company, 1985. ISBN 0-07-019902-7. Michael A. Friedman and Jeffrey M. Voas, Software Assessment - Reliability, Safety, Testability , Wiley-
Interscience, John Wiley Sons Inc., 1995.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"A": "Page 40General Principles of Software Validation Guidance for Industry",
"B": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"D": "FDA",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"B": "International Validation Forum",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"C": "M. S. Deutsch",
"A": "Boris Beizer",
"B": "John Wiley Sons",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"B": "Software Verification and Validation, Realistic Project Approaches",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"B": "Prentice Hall",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"C": "1982",
"A": "Number 1",
"B": "January-February 1995",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, ____.",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"D": "1982",
"A": "Number 1",
"B": "January-February 1995",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Boris Beizer, Software Testing Techniques , Second...'?",
"reference": "Boris Beizer, Software Testing Techniques , Second Edition, Van Nostrand Reinhold, 1990.",
"options": {
"D": "Boris Beizer",
"A": "John Wiley Sons",
"B": "Richard Bender",
"C": "Software Testing Techniques"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Boris Beizer, Software Testing Techniques , Second...'?",
"reference": "Boris Beizer, Software Testing Techniques , Second Edition, Van Nostrand Reinhold, 1990.",
"options": {
"C": "Software Testing Techniques",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"B": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
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]
Examine Inputs In a modern quality systems model, the term input includes any ma terial that goes into a final product, no matter whether the material is purc hased by the manufacturer or produced by the manufacturer for the purpose of processing. Materials can include item s such as components (e.g., ingredients, process water, and gas), containe rs, and closures. A robust quality system will ensure that all inputs to the manufacturing proc ess are reliable because quality controls will have been established for the receipt, produc tion, storage, and use of all inputs. The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing. In the preamble to the CGMP regulations, these requirements were explicitly interpreted.12 The preamble states that reliability can be validated by conducting tests or examinations and comparing the results to the suppliers COA. Sufficient initial tests should be done to establis h reliability and to determine a schedule for periodic reassessment. As an e ssential element of purchasing controls, it is recommended that data trends for acceptance and rejection of materials be analyzed for information on supplier performance.13
The quality systems approach also calls for periodic auditing of suppliers based on risk assessment. During the audit, a manufacturer can observe the testing or examinations conducted by the supplier to help determine the reliability of the suppliers COA. An audit shou ld also include a systematic examination of the suppliers quality system to ensure that reliability is maintained. It is recommended that a combination approach be used (i.e., verify the suppliers' COA through analysis and audits of the supplier). Under a quality systems approach, if full analytical testing is not done, the audit should cover the suppliers analysis (i.e., a specific identity test is still re quired under 211.84(d)(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": "What location is mentioned: 'An audit shou ld also include a systematic examina...'?",
"reference": "An audit shou ld also include a systematic examination of the suppliers quality system to ensure that reliability is maintained.",
"options": {
"A": "shou",
"B": "the suppliers analysis",
"C": "the suppliers quality system",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the preamble to the CGMP regulations, these req...'?",
"reference": "In the preamble to the CGMP regulations, these requirements were explicitly interpreted.12 The preamble states that reliability can be validated by conducting tests or examinations and comparing the results to the suppliers COA.",
"options": {
"B": "CGMP",
"A": "COA",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the preamble to the CGMP regulations, these req...'?",
"reference": "In the preamble to the CGMP regulations, these requirements were explicitly interpreted.12 The preamble states that reliability can be validated by conducting tests or examinations and comparing the results to the suppliers COA.",
"options": {
"C": "COA",
"A": "CGMP",
"B": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Examine Inputs In a modern quality systems model, ...'?",
"reference": "Examine Inputs In a modern quality systems model, the term input includes any ma terial that goes into a final product, no matter whether the material is purc hased by the manufacturer or produced by the manufacturer for the purpose of processing.",
"options": {
"B": "Examine Inputs",
"A": "the suppliers analysis",
"C": "the suppliers quality system",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It is recommended that a combination approach be u...'?",
"reference": "It is recommended that a combination approach be used (i.e., verify the suppliers' COA through analysis and audits of the supplier).",
"options": {
"D": "COA",
"A": "CGMP",
"B": "the suppliers analysis",
"C": "the suppliers quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'During the audit, a manufacturer can observe the t...'?",
"reference": "During the audit, a manufacturer can observe the testing or examinations conducted by the supplier to help determine the reliability of the suppliers COA.",
"options": {
"A": "COA",
"B": "CGMP",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It is recommended that a combination approach be u...'?",
"reference": "It is recommended that a combination approach be used (i.e., verify the suppliers' COA through analysis and audits of the supplier).",
"options": {
"D": "COA",
"A": "CGMP",
"B": "the suppliers analysis",
"C": "the suppliers quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the preamble to the CGMP regulations, these req...'?",
"reference": "In the preamble to the CGMP regulations, these requirements were explicitly interpreted.12 The preamble states that reliability can be validated by conducting tests or examinations and comparing the results to the suppliers COA.",
"options": {
"C": "CGMP",
"A": "COA",
"B": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the preamble to the CGMP regulations, these req...'?",
"reference": "In the preamble to the CGMP regulations, these requirements were explicitly interpreted.12 The preamble states that reliability can be validated by conducting tests or examinations and comparing the results to the suppliers COA.",
"options": {
"D": "COA",
"A": "CGMP",
"B": "the suppliers analysis",
"C": "the suppliers quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'During the audit, a manufacturer can observe the t...'?",
"reference": "During the audit, a manufacturer can observe the testing or examinations conducted by the supplier to help determine the reliability of the suppliers COA.",
"options": {
"B": "COA",
"A": "CGMP",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'During the audit, a manufacturer can observe the t...'?",
"reference": "During the audit, a manufacturer can observe the testing or examinations conducted by the supplier to help determine the reliability of the suppliers COA.",
"options": {
"A": "COA",
"B": "CGMP",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the preamble to the CGMP regulations, these req...'?",
"reference": "In the preamble to the CGMP regulations, these requirements were explicitly interpreted.12 The preamble states that reliability can be validated by conducting tests or examinations and comparing the results to the suppliers COA.",
"options": {
"B": "CGMP",
"A": "COA",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the preamble to the CGMP regulations, these req...'?",
"reference": "In the preamble to the CGMP regulations, these requirements were explicitly interpreted.12 The preamble states that reliability can be validated by conducting tests or examinations and comparing the results to the suppliers COA.",
"options": {
"C": "COA",
"A": "CGMP",
"B": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'A robust quality system will ensure that all inputs to the m...'?",
"reference": "A robust quality system will ensure that all inputs to the manufacturing proc ess are reliable because quality controls will have been established for the receipt, produc tion, storage, and use of all inputs.",
"options": {
"D": "A robust quality system will ensure that all inputs to the manufacturing proc ess are reliable becau...",
"A": "the suppliers analysis",
"B": "the suppliers quality system",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'A robust quality system will ensure that all inputs to the m...'?",
"reference": "A robust quality system will ensure that all inputs to the manufacturing proc ess are reliable because quality controls will have been established for the receipt, produc tion, storage, and use of all inputs.",
"options": {
"B": "A robust quality system will ensure that all inputs to the manufacturing proc ess are reliable becau...",
"A": "the suppliers analysis",
"C": "the suppliers quality system",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"C": "CGMP",
"A": "COA",
"B": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"B": "COA",
"A": "CGMP",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( ____) for th e release of materials for ma nufacturing.",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"C": "211.84",
"A": "under 211.84(d)(2",
"B": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the preamble to the CGMP regulations, these req...'?",
"reference": "In the preamble to the CGMP regulations, these requirements were explicitly interpreted.12 The preamble states that reliability can be validated by conducting tests or examinations and comparing the results to the suppliers COA.",
"options": {
"A": "CGMP",
"B": "COA",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the preamble to the CGMP regulations, these req...'?",
"reference": "In the preamble to the CGMP regulations, these requirements were explicitly interpreted.12 The preamble states that reliability can be validated by conducting tests or examinations and comparing the results to the suppliers COA.",
"options": {
"C": "COA",
"A": "CGMP",
"B": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'During the audit, a manufacturer can observe the t...'?",
"reference": "During the audit, a manufacturer can observe the testing or examinations conducted by the supplier to help determine the reliability of the suppliers COA.",
"options": {
"A": "COA",
"B": "CGMP",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'During the audit, a manufacturer can observe the t...'?",
"reference": "During the audit, a manufacturer can observe the testing or examinations conducted by the supplier to help determine the reliability of the suppliers COA.",
"options": {
"A": "COA",
"B": "CGMP",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'An audit shou ld also include a systematic examina...'?",
"reference": "An audit shou ld also include a systematic examination of the suppliers quality system to ensure that reliability is maintained.",
"options": {
"D": "shou",
"A": "the suppliers analysis",
"B": "the suppliers quality system",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"C": "CGMP",
"A": "COA",
"B": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"B": "COA",
"A": "CGMP",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( ____) for th e release of materials for ma nufacturing.",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"D": "211.84",
"A": "under 211.84(d)(2",
"B": "the suppliers analysis",
"C": "the suppliers quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"A": "CGMP",
"B": "COA",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"C": "COA",
"A": "CGMP",
"B": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( ____) for th e release of materials for ma nufacturing.",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"C": "211.84",
"A": "under 211.84(d)(2",
"B": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Examine Inputs In a modern quality systems model, ...'?",
"reference": "Examine Inputs In a modern quality systems model, the term input includes any ma terial that goes into a final product, no matter whether the material is purc hased by the manufacturer or produced by the manufacturer for the purpose of processing.",
"options": {
"C": "Examine Inputs",
"A": "the suppliers analysis",
"B": "the suppliers quality system",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It is recommended that a combination approach be u...'?",
"reference": "It is recommended that a combination approach be used (i.e., verify the suppliers' COA through analysis and audits of the supplier).",
"options": {
"D": "COA",
"A": "CGMP",
"B": "the suppliers analysis",
"C": "the suppliers quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"D": "CGMP",
"A": "COA",
"B": "the suppliers analysis",
"C": "the suppliers quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"D": "COA",
"A": "CGMP",
"B": "the suppliers analysis",
"C": "the suppliers quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'An audit shou ld also include a systematic examina...'?",
"reference": "An audit shou ld also include a systematic examination of the suppliers quality system to ensure that reliability is maintained.",
"options": {
"C": "shou",
"A": "the suppliers analysis",
"B": "the suppliers quality system",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'During the audit, a manufacturer can observe the t...'?",
"reference": "During the audit, a manufacturer can observe the testing or examinations conducted by the supplier to help determine the reliability of the suppliers COA.",
"options": {
"D": "COA",
"A": "CGMP",
"B": "the suppliers analysis",
"C": "the suppliers quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"D": "CGMP",
"A": "COA",
"B": "the suppliers analysis",
"C": "the suppliers quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"A": "COA",
"B": "CGMP",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( ____) for th e release of materials for ma nufacturing.",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"C": "211.84",
"A": "under 211.84(d)(2",
"B": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Examine Inputs In a modern quality systems model, ...'?",
"reference": "Examine Inputs In a modern quality systems model, the term input includes any ma terial that goes into a final product, no matter whether the material is purc hased by the manufacturer or produced by the manufacturer for the purpose of processing.",
"options": {
"B": "Examine Inputs",
"A": "the suppliers analysis",
"C": "the suppliers quality system",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It is recommended that a combination approach be u...'?",
"reference": "It is recommended that a combination approach be used (i.e., verify the suppliers' COA through analysis and audits of the supplier).",
"options": {
"C": "COA",
"A": "CGMP",
"B": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'A robust quality system will ensure that all inputs to the m...'?",
"reference": "A robust quality system will ensure that all inputs to the manufacturing proc ess are reliable because quality controls will have been established for the receipt, produc tion, storage, and use of all inputs.",
"options": {
"C": "A robust quality system will ensure that all inputs to the manufacturing proc ess are reliable becau...",
"A": "the suppliers analysis",
"B": "the suppliers quality system",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'A robust quality system will ensure that all inputs to the m...'?",
"reference": "A robust quality system will ensure that all inputs to the manufacturing proc ess are reliable because quality controls will have been established for the receipt, produc tion, storage, and use of all inputs.",
"options": {
"C": "A robust quality system will ensure that all inputs to the manufacturing proc ess are reliable becau...",
"A": "the suppliers analysis",
"B": "the suppliers quality system",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It is recommended that a combination approach be u...'?",
"reference": "It is recommended that a combination approach be used (i.e., verify the suppliers' COA through analysis and audits of the supplier).",
"options": {
"D": "COA",
"A": "CGMP",
"B": "the suppliers analysis",
"C": "the suppliers quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'An audit shou ld also include a systematic examina...'?",
"reference": "An audit shou ld also include a systematic examination of the suppliers quality system to ensure that reliability is maintained.",
"options": {
"C": "shou",
"A": "the suppliers analysis",
"B": "the suppliers quality system",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'A robust quality system will ensure that all inputs to the m...'?",
"reference": "A robust quality system will ensure that all inputs to the manufacturing proc ess are reliable because quality controls will have been established for the receipt, produc tion, storage, and use of all inputs.",
"options": {
"D": "A robust quality system will ensure that all inputs to the manufacturing proc ess are reliable becau...",
"A": "the suppliers analysis",
"B": "the suppliers quality system",
"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 8 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
They should identify the schedules, environments, resources (personnel, tools, etc. ), methodologies, cases (inputs, procedures, outputs, expected results), documentation, and reporting criteria. The magnitude of effort to be applied throughout the testing process can be linked to complexity, criticality, reliability, and/or safety issues (e.g., requiring functions or modules that produce critical outcomes to be challenged with intensive testing of their fault tolerance features). Descriptions of categories of software and software testing effort appear in the literature, for example:
NIST Special Publication 500-235, Structured Testing: A Testing Methodology Using the Cyclomatic Complexity Metric ; NUREG/CR-6293, Verification and Validation Guidelines for High Integrity Systems ; and IEEE Computer Society Press, Handbook of Software Reliability Engineering . Page 22General Principles of Software Validation Guidance for Industry and FDA Staff Software test plans should identify the particular tasks to be conducted at each stage of development and include justification of the level of effort represented by their corresponding completion criteria. Software testing has limitations that must be recognized and considered when planning the testing of a particular software product. Except for the simplest of programs, software cannot be exhaustively tested. Generally it is not feasible to test a software product with all possible inputs, nor is it possible to test all possible data processing paths that can occur during program execution. There is no one type of testing or testing methodology that can ensure a particular software product has been thoroughly tested. Testing of all program functionality does not mean all of the program has been tested. Testing of all of a program's code does not mean all necessary functionality is present in the program. Testing of all program functionality and all program code does not mean the program is 100 correct!
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Software testing has limitations that must be reco...'?",
"reference": "Software testing has limitations that must be recognized and considered when planning the testing of a particular software product.",
"options": {
"A": "Software",
"B": "the Cyclomatic Complexity Metric",
"C": "NUREG",
"D": "A Testing Methodology"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 22General Principles of Software Validation G...'?",
"reference": "Page 22General Principles of Software Validation Guidance for Industry and FDA Staff Software test plans should identify the particular tasks to be conducted at each stage of development and include justification of the level of effort represented by their corresponding completion criteria.",
"options": {
"B": "FDA",
"A": "the Cyclomatic Complexity Metric",
"C": "NUREG",
"D": "software and software testing effort"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 22General Principles of Software Validation G...'?",
"reference": "Page 22General Principles of Software Validation Guidance for Industry and FDA Staff Software test plans should identify the particular tasks to be conducted at each stage of development and include justification of the level of effort represented by their corresponding completion criteria.",
"options": {
"B": "Software",
"A": "the Cyclomatic Complexity Metric",
"C": "NUREG",
"D": "A Testing Methodology"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: There is no ____ type of testing or testing methodology that can ensure a particular software product has been thoroughly tested.",
"reference": "There is no one type of testing or testing methodology that can ensure a particular software product has been thoroughly tested.",
"options": {
"C": "one",
"A": "500",
"B": "100",
"D": "software and software testing effort"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: There is no ____ type of testing or testing methodology that can ensure a particular software product has been thoroughly tested.",
"reference": "There is no one type of testing or testing methodology that can ensure a particular software product has been thoroughly tested.",
"options": {
"B": "one",
"A": "500",
"C": "100",
"D": "software and software testing effort"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Testing of all program functionality and all program code does not mean the program is ____ correct!",
"reference": "Testing of all program functionality and all program code does not mean the program is 100 correct!",
"options": {
"C": "100",
"A": "500",
"B": "software and software testing effort",
"D": "Software testing"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 22General Principles of Software Validation G...'?",
"reference": "Page 22General Principles of Software Validation Guidance for Industry and FDA Staff Software test plans should identify the particular tasks to be conducted at each stage of development and include justification of the level of effort represented by their corresponding completion criteria.",
"options": {
"B": "FDA",
"A": "the Cyclomatic Complexity Metric",
"C": "NUREG",
"D": "software and software testing effort"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 22General Principles of Software Validation G...'?",
"reference": "Page 22General Principles of Software Validation Guidance for Industry and FDA Staff Software test plans should identify the particular tasks to be conducted at each stage of development and include justification of the level of effort represented by their corresponding completion criteria.",
"options": {
"C": "Software",
"A": "the Cyclomatic Complexity Metric",
"B": "NUREG",
"D": "A Testing Methodology"
},
"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]
Structure the Organization .............................................................................................................. Build Your Quality System to Meet Requirements ........................................................................... 9 4. Establish Policies, Objectives, and Plans ..................................................................................... 10 5.
Review the System ..........................................................................................................................
10 B. Resources ............................................................................................................................... .......
General Arrangements ................................................................................................................... 12 2. Personnel Development ................................................................................................................. 13 3. Facilities and Equipment ............................................................................................................... 13 4. Control Outsourced Operations .................................................................................................... 14 C. Manufacturing ............................................................................................................................. 15 1. Design, Develop, and Document Product and Processes .............................................................. 15 2. Examine Inputs .............................................................................................................................. 16 3. Perform and Monitor Operations ..................................................................................................
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: Build Your Quality System to Meet Requirements ........................................................................... ____ 4.",
"reference": "Build Your Quality System to Meet Requirements ........................................................................... 9 4.",
"options": {
"D": "9",
"A": "9 4",
"B": "12 2",
"C": "Control Outsourced Operations ...................................................................................................."
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Build Your Quality System to Meet Requirements ........................................................................... 9 ____.",
"reference": "Build Your Quality System to Meet Requirements ........................................................................... 9 4.",
"options": {
"A": "4",
"B": "9 4",
"C": "12 2",
"D": "Control Outsourced Operations ...................................................................................................."
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Facilities and Equipment ............................................................................................................... ____ 4.",
"reference": "Facilities and Equipment ............................................................................................................... 13 4.",
"options": {
"C": "13",
"A": "9 4",
"B": "12 2",
"D": "Control Outsourced Operations ...................................................................................................."
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Facilities and Equipment ............................................................................................................... 13 ____.",
"reference": "Facilities and Equipment ............................................................................................................... 13 4.",
"options": {
"C": "4",
"A": "9 4",
"B": "12 2",
"D": "Control Outsourced Operations ...................................................................................................."
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Build Your Quality System to Meet Requirements ........................................................................... ____ 4.",
"reference": "Build Your Quality System to Meet Requirements ........................................................................... 9 4.",
"options": {
"D": "9",
"A": "9 4",
"B": "12 2",
"C": "Control Outsourced Operations ...................................................................................................."
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Build Your Quality System to Meet Requirements ........................................................................... 9 ____.",
"reference": "Build Your Quality System to Meet Requirements ........................................................................... 9 4.",
"options": {
"B": "4",
"A": "9 4",
"C": "12 2",
"D": "Control Outsourced Operations ...................................................................................................."
},
"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]
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": "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": {
"D": "https://www.fda.gov/iceci/inspections/iom/default.htm",
"A": "CGMP - related or drug application data",
"B": "data integrity problems",
"C": "chapter 5"
},
"answer": "D",
"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: '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"
},
{
"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": {
"C": "CGMP",
"A": "FDA",
"B": "Refusing a Drug Inspection",
"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": "FDA",
"A": "CGMP",
"C": "CGMP - related or drug application data",
"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": {
"D": "211.180(c",
"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: '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"
},
{
"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": {
"A": "211.180(c",
"B": "212.110(a",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "A",
"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": {
"D": "FDA",
"A": "CGMP",
"B": "CGMP - related or drug application data",
"C": "data integrity problems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'These expectations mirror those developed for the ...'?",
"reference": "These expectations mirror those developed for the Application Integrity Policy.",
"options": {
"A": "the Application Integrity Policy",
"B": "CGMP",
"C": "CGMP - related or drug application data",
"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": {
"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: '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": {
"B": "Refusing a Drug Inspection",
"A": "CGMP - related or drug application data",
"C": "data integrity problems",
"D": "Denying, Limiting"
},
"answer": "B",
"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": {
"A": "704",
"B": "212.110(a",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This may include retaining a ____ -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.",
"reference": "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.",
"options": {
"D": "third",
"A": "CGMP - related or drug application data",
"B": "data integrity problems",
"C": "3rd"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This may include retaining a ____ -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.",
"reference": "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.",
"options": {
"D": "third",
"A": "CGMP - related or drug application data",
"B": "data integrity problems",
"C": "3rd"
},
"answer": "D",
"difficulty": "easy",
"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: '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": "Fill in the blank: This may include retaining a ____ -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.",
"reference": "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.",
"options": {
"D": "third",
"A": "CGMP - related or drug application data",
"B": "data integrity problems",
"C": "3rd"
},
"answer": "D",
"difficulty": "easy",
"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": "Which organization is referenced: 'These expectations mirror those developed for the ...'?",
"reference": "These expectations mirror those developed for the Application Integrity Policy.",
"options": {
"B": "the Application Integrity Policy",
"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: '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": {
"B": "Refusing a Drug Inspection",
"A": "CGMP - related or drug application data",
"C": "data integrity problems",
"D": "Denying, Limiting"
},
"answer": "B",
"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": {
"A": "704",
"B": "212.110(a",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "A",
"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": {
"D": "211.180(c",
"A": "212.110(a",
"B": "CGMP - related or drug application data",
"C": "data integrity problems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This may include retaining a ____ -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.",
"reference": "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.",
"options": {
"C": "third",
"A": "CGMP - related or drug application data",
"B": "data integrity problems",
"D": "3rd"
},
"answer": "C",
"difficulty": "easy",
"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": {
"A": "FDA",
"B": "CGMP",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"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": {
"B": "Refusing a Drug Inspection",
"A": "CGMP - related or drug application data",
"C": "data integrity problems",
"D": "Denying, Limiting"
},
"answer": "B",
"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": {
"A": "704",
"B": "212.110(a",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "A",
"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: '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": {
"C": "CGMP",
"A": "FDA",
"B": "Refusing a Drug Inspection",
"D": "data integrity problems"
},
"answer": "C",
"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"
},
{
"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": {
"D": "CGMP",
"A": "FDA",
"B": "Refusing a Drug Inspection",
"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": {
"A": "the Application Integrity Policy",
"B": "CGMP",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "A",
"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": {
"A": "FDA",
"B": "CGMP",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "A",
"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": {
"A": "FDA",
"B": "CGMP",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: This may include retaining a ____ -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.",
"reference": "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.",
"options": {
"B": "third",
"A": "CGMP - related or drug application data",
"C": "data integrity problems",
"D": "3rd"
},
"answer": "B",
"difficulty": "easy",
"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": "Fill in the blank: This may include retaining a ____ -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.",
"reference": "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.",
"options": {
"D": "third",
"A": "CGMP - related or drug application data",
"B": "data integrity problems",
"C": "3rd"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This may include retaining a ____ -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.",
"reference": "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.",
"options": {
"A": "third",
"B": "CGMP - related or drug application data",
"C": "data integrity problems",
"D": "3rd"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This may include retaining a ____ -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.",
"reference": "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.",
"options": {
"C": "third",
"A": "CGMP - related or drug application data",
"B": "data integrity problems",
"D": "3rd"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: This may include retaining a ____ -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.",
"reference": "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.",
"options": {
"A": "third",
"B": "CGMP - related or drug application data",
"C": "data integrity problems",
"D": "3rd"
},
"answer": "A",
"difficulty": "easy",
"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": {
"A": "the Application Integrity Policy",
"B": "CGMP",
"C": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This may include retaining a ____ -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.",
"reference": "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.",
"options": {
"B": "third",
"A": "CGMP - related or drug application data",
"C": "data integrity problems",
"D": "3rd"
},
"answer": "B",
"difficulty": "easy",
"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": {
"C": "FDA",
"A": "CGMP",
"B": "CGMP - related or drug application data",
"D": "data integrity problems"
},
"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]
130 131 Software that is fit for its i ntended use and that maintains a validated state should perform as 132 intended , helping to ensure that finished devices will be safe and effective and in compliance 133 with regulatory requirements (see 21 CFR 820.1(a)(1)). Section V below outlines a risk-based 134 framework for computer software assurance. 135 136 V. Computer Software Assurance Risk Framework 137
The following approach is intended to help manufacturers establish a risk -based framework for 138 computer software assurance throughout the softwares lifecycle . Examples of applying this risk 139 framework to various computer software assurance situations are provided in Appendix A. 140 Identifying the Intended Use 141
The regulation requires manufacturers to validate software that is used as part of production or 142 the qua lity system for its intended use ( see 21 CFR 820.70(i)). To determine whether the 143 requirement for validation applies, manufacturers must first determine whether the software is 144 intended for use as part of production or the quality system. 145 146 In general, software used as part of production or th e quality system falls into one of two 147 categories : software that is used directly as part of production or the quality system, and software 148 that support s production or the quality system. 149 150 Software with the following intended uses are considered to be use d directly as part of 151 production or the quality system: 152 153 Software intended for automating production processes, inspection, testing, or the 154 collection and processing of production data ; and 155 Software intended for automating quality system processes, collect ion and processing of 156 quality system data, or maintaining a quality record established under the Quality System 157 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": "Who is mentioned in the context: 'Examples of applying this risk 139 framework to va...'?",
"reference": "Examples of applying this risk 139 framework to various computer software assurance situations are provided in Appendix A.",
"options": {
"B": "Appendix A.",
"A": "Appendix A. 140",
"C": "135 136 V. Computer Software Assurance Risk Framework",
"D": "various computer software assurance situations"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Examples of applying this risk ____ framework to various computer software assurance situations are provided in Appendix A.",
"reference": "Examples of applying this risk 139 framework to various computer software assurance situations are provided in Appendix A.",
"options": {
"D": "139",
"A": "130 131",
"B": "132",
"C": "135 136 V. Computer Software Assurance Risk Framework"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '149 150 Software with the following intended uses ...'?",
"reference": "149 150 Software with the following intended uses are considered to be use d directly as part of 151 production or the quality system: 152 153 Software intended for automating production processes, inspection, testing, or the 154 collection and processing of production data ; and 155 Software intended for automating quality system processes, collect ion and processing of 156 quality system data, or maintaining a quality record established under the Quality System 157 regulation .",
"options": {
"B": "Software",
"A": "V. Computer Software Assurance Risk Framework 137",
"C": "Quality System",
"D": "the Quality System 157 regulation"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '149 150 Software with the following intended uses ...'?",
"reference": "149 150 Software with the following intended uses are considered to be use d directly as part of 151 production or the quality system: 152 153 Software intended for automating production processes, inspection, testing, or the 154 collection and processing of production data ; and 155 Software intended for automating quality system processes, collect ion and processing of 156 quality system data, or maintaining a quality record established under the Quality System 157 regulation .",
"options": {
"D": "Software",
"A": "V. Computer Software Assurance Risk Framework 137",
"B": "Quality System",
"C": "the Quality System 157 regulation"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 45 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
I: Application of Process Performan ce and Product Quality Monitoring System Throughout the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process and product Monitoring during A well-defined system Once manufacturing knowledge generated scale-up activities can for process ceases, monitoring and process and provide a preliminary performance and such as stability testing product monitoring indication of process product quality should continue to conducted throughout performance and the monitoring should be completion of the development can be successful integration applied to assure studies. Appropriate used to establish a into manufacturing. performance within a action on marketed control strategy for Knowledge obtained state of control and to product should manufacturing. during transfer and scale-up activities can be useful in further developing the control strategy. identify improvement areas. continue to be executed according to regional regulations. 2. Corrective Action and Preventive Action (CAPA) System (3.2.2)
The pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring. A structur ed approach to the 10 investigation process should be us ed with the objective of determining the root cause. The level of effort, formality, and documentation of the in vestigation should be co mmensurate with the level of risk, in line with IC H Q9. CAPA methodology should re sult in product and process improvements and enhanced produc t 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": "Fill in the blank: A structur ed approach to the ____ investigation process should be us ed with the objective of determining the root cause.",
"reference": "A structur ed approach to the 10 investigation process should be us ed with the objective of determining the root cause.",
"options": {
"B": "10",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"C": "process product quality",
"D": "tenner"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A structur ed approach to the ____ investigation process should be us ed with the objective of determining the root cause.",
"reference": "A structur ed approach to the 10 investigation process should be us ed with the objective of determining the root cause.",
"options": {
"D": "10",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"B": "process product quality",
"C": "tenner"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CAPA methodology should re sult in product and pro...'?",
"reference": "CAPA methodology should re sult in product and process improvements and enhanced produc t and process understanding.",
"options": {
"D": "CAPA",
"A": "Product Quality Monitoring System Throughout",
"B": "Corrective Action",
"C": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Corrective Action and Preventive Action (CAPA) Sys...'?",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"A": "Preventive Action",
"B": "Product Quality Monitoring System Throughout",
"C": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Corrective Action and Preventive Action (CAPA) Sys...'?",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"C": "CAPA",
"A": "Product Quality Monitoring System Throughout",
"B": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Corrective Action and Preventive Action (CAPA) System (____)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"C": "3.2.2",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"B": "process product quality",
"D": "Preventive Action"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CAPA methodology should re sult in product and pro...'?",
"reference": "CAPA methodology should re sult in product and process improvements and enhanced produc t and process understanding.",
"options": {
"B": "CAPA",
"A": "Product Quality Monitoring System Throughout",
"C": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A structur ed approach to the ____ investigation process should be us ed with the objective of determining the root cause.",
"reference": "A structur ed approach to the 10 investigation process should be us ed with the objective of determining the root cause.",
"options": {
"C": "10",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"B": "process product quality",
"D": "tenner"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CAPA methodology should re sult in product and pro...'?",
"reference": "CAPA methodology should re sult in product and process improvements and enhanced produc t and process understanding.",
"options": {
"A": "CAPA",
"B": "Product Quality Monitoring System Throughout",
"C": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Corrective Action and Preventive Action (CAPA) Sys...'?",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"D": "Preventive Action",
"A": "Product Quality Monitoring System Throughout",
"B": "Corrective Action",
"C": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Corrective Action and Preventive Action (CAPA) Sys...'?",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"A": "CAPA",
"B": "Product Quality Monitoring System Throughout",
"C": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Corrective Action and Preventive Action (CAPA) System (____)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"D": "3.2.2",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"B": "process product quality",
"C": "Preventive Action"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'I: Application of Process Performan ce and Product...'?",
"reference": "I: Application of Process Performan ce and Product Quality Monitoring System Throughout the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process and product Monitoring during A well-defined system Once manufacturing knowledge generated scale-up activities can for process ceases, monitoring and process and provide a preliminary performance and such as stability testing product monitoring indication of process product quality should continue to conducted throughout performance and the monitoring should be completion of the development can be successful integration applied to assure studies.",
"options": {
"A": "Product Quality Monitoring System Throughout",
"B": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"C": "process product quality",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'I: Application of Process Performan ce and Product...'?",
"reference": "I: Application of Process Performan ce and Product Quality Monitoring System Throughout the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process and product Monitoring during A well-defined system Once manufacturing knowledge generated scale-up activities can for process ceases, monitoring and process and provide a preliminary performance and such as stability testing product monitoring indication of process product quality should continue to conducted throughout performance and the monitoring should be completion of the development can be successful integration applied to assure studies.",
"options": {
"D": "Product Quality Monitoring System Throughout",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"B": "process product quality",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The level of effort, formality, and documentation ...'?",
"reference": "The level of effort, formality, and documentation of the in vestigation should be co mmensurate with the level of risk, in line with IC H Q9.",
"options": {
"B": "IC H Q9",
"A": "Product Quality Monitoring System Throughout",
"C": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A structur ed approach to the ____ investigation process should be us ed with the objective of determining the root cause.",
"reference": "A structur ed approach to the 10 investigation process should be us ed with the objective of determining the root cause.",
"options": {
"A": "10",
"B": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"C": "process product quality",
"D": "tenner"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Corrective Action and Preventive Action (CAPA) Sys...'?",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"B": "Preventive Action",
"A": "Product Quality Monitoring System Throughout",
"C": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Corrective Action and Preventive Action (CAPA) Sys...'?",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"C": "CAPA",
"A": "Product Quality Monitoring System Throughout",
"B": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Corrective Action and Preventive Action (CAPA) System (____)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"A": "3.2.2",
"B": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"C": "process product quality",
"D": "Preventive Action"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The level of effort, formality, and documentation ...'?",
"reference": "The level of effort, formality, and documentation of the in vestigation should be co mmensurate with the level of risk, in line with IC H Q9.",
"options": {
"C": "IC H Q9",
"A": "Product Quality Monitoring System Throughout",
"B": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Corrective Action and Preventive Action (CAPA) Sys...'?",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"C": "Preventive Action",
"A": "Product Quality Monitoring System Throughout",
"B": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Corrective Action and Preventive Action (CAPA) Sys...'?",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"A": "CAPA",
"B": "Product Quality Monitoring System Throughout",
"C": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Corrective Action and Preventive Action (CAPA) System (____)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"D": "3.2.2",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"B": "process product quality",
"C": "Preventive Action"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Corrective Action and Preventive Action (CAPA) Sys...'?",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"A": "Preventive Action",
"B": "Product Quality Monitoring System Throughout",
"C": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Corrective Action and Preventive Action (CAPA) Sys...'?",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"A": "CAPA",
"B": "Product Quality Monitoring System Throughout",
"C": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Corrective Action and Preventive Action (CAPA) System (____)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"B": "3.2.2",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"C": "process product quality",
"D": "Preventive Action"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A structur ed approach to the ____ investigation process should be us ed with the objective of determining the root cause.",
"reference": "A structur ed approach to the 10 investigation process should be us ed with the objective of determining the root cause.",
"options": {
"A": "10",
"B": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"C": "process product quality",
"D": "tenner"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CAPA methodology should re sult in product and pro...'?",
"reference": "CAPA methodology should re sult in product and process improvements and enhanced produc t and process understanding.",
"options": {
"C": "CAPA",
"A": "Product Quality Monitoring System Throughout",
"B": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CAPA methodology should re sult in product and pro...'?",
"reference": "CAPA methodology should re sult in product and process improvements and enhanced produc t and process understanding.",
"options": {
"D": "CAPA",
"A": "Product Quality Monitoring System Throughout",
"B": "Corrective Action",
"C": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CAPA methodology should re sult in product and pro...'?",
"reference": "CAPA methodology should re sult in product and process improvements and enhanced produc t and process understanding.",
"options": {
"D": "CAPA",
"A": "Product Quality Monitoring System Throughout",
"B": "Corrective Action",
"C": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'I: Application of Process Performan ce and Product...'?",
"reference": "I: Application of Process Performan ce and Product Quality Monitoring System Throughout the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process and product Monitoring during A well-defined system Once manufacturing knowledge generated scale-up activities can for process ceases, monitoring and process and provide a preliminary performance and such as stability testing product monitoring indication of process product quality should continue to conducted throughout performance and the monitoring should be completion of the development can be successful integration applied to assure studies.",
"options": {
"A": "Product Quality Monitoring System Throughout",
"B": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"C": "process product quality",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'performance within a action on marketed control st...'?",
"reference": "performance within a action on marketed control strategy for Knowledge obtained state of control and to product should manufacturing.",
"options": {
"B": "Knowledge",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"C": "process product quality",
"D": "cognition"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'I: Application of Process Performan ce and Product...'?",
"reference": "I: Application of Process Performan ce and Product Quality Monitoring System Throughout the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process and product Monitoring during A well-defined system Once manufacturing knowledge generated scale-up activities can for process ceases, monitoring and process and provide a preliminary performance and such as stability testing product monitoring indication of process product quality should continue to conducted throughout performance and the monitoring should be completion of the development can be successful integration applied to assure studies.",
"options": {
"B": "Product Quality Monitoring System Throughout",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"C": "process product quality",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The level of effort, formality, and documentation ...'?",
"reference": "The level of effort, formality, and documentation of the in vestigation should be co mmensurate with the level of risk, in line with IC H Q9.",
"options": {
"D": "IC H Q9",
"A": "Product Quality Monitoring System Throughout",
"B": "Corrective Action",
"C": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'I: Application of Process Performan ce and Product...'?",
"reference": "I: Application of Process Performan ce and Product Quality Monitoring System Throughout the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process and product Monitoring during A well-defined system Once manufacturing knowledge generated scale-up activities can for process ceases, monitoring and process and provide a preliminary performance and such as stability testing product monitoring indication of process product quality should continue to conducted throughout performance and the monitoring should be completion of the development can be successful integration applied to assure studies.",
"options": {
"A": "Product Quality Monitoring System Throughout",
"B": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"C": "process product quality",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The level of effort, formality, and documentation ...'?",
"reference": "The level of effort, formality, and documentation of the in vestigation should be co mmensurate with the level of risk, in line with IC H Q9.",
"options": {
"D": "IC H Q9",
"A": "Product Quality Monitoring System Throughout",
"B": "Corrective Action",
"C": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Corrective Action and Preventive Action (CAPA) Sys...'?",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"C": "Preventive Action",
"A": "Product Quality Monitoring System Throughout",
"B": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Corrective Action and Preventive Action (CAPA) Sys...'?",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"B": "CAPA",
"A": "Product Quality Monitoring System Throughout",
"C": "Corrective Action",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Corrective Action and Preventive Action (CAPA) System (____)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"reference": "Corrective Action and Preventive Action (CAPA) System (3.2.2)\nThe pharmaceutical company should have a syst em for implementing corrective actions and preventive actions resulting from the inve stigation of complain ts, product rejections, nonconformances, recalls, deviations, audits, regu latory inspections and findings, and trends from process performance and product quality monitoring.",
"options": {
"D": "3.2.2",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"B": "process product quality",
"C": "Preventive Action"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'performance within a action on marketed control st...'?",
"reference": "performance within a action on marketed control strategy for Knowledge obtained state of control and to product should manufacturing.",
"options": {
"C": "Knowledge",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"B": "process product quality",
"D": "cognition"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'I: Application of Process Performan ce and Product...'?",
"reference": "I: Application of Process Performan ce and Product Quality Monitoring System Throughout the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process and product Monitoring during A well-defined system Once manufacturing knowledge generated scale-up activities can for process ceases, monitoring and process and provide a preliminary performance and such as stability testing product monitoring indication of process product quality should continue to conducted throughout performance and the monitoring should be completion of the development can be successful integration applied to assure studies.",
"options": {
"B": "Product Quality Monitoring System Throughout",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"C": "process product quality",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'performance within a action on marketed control st...'?",
"reference": "performance within a action on marketed control strategy for Knowledge obtained state of control and to product should manufacturing.",
"options": {
"A": "Knowledge",
"B": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"C": "process product quality",
"D": "cognition"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'I: Application of Process Performan ce and Product...'?",
"reference": "I: Application of Process Performan ce and Product Quality Monitoring System Throughout the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process and product Monitoring during A well-defined system Once manufacturing knowledge generated scale-up activities can for process ceases, monitoring and process and provide a preliminary performance and such as stability testing product monitoring indication of process product quality should continue to conducted throughout performance and the monitoring should be completion of the development can be successful integration applied to assure studies.",
"options": {
"C": "Product Quality Monitoring System Throughout",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"B": "process product quality",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A structur ed approach to the ____ investigation process should be us ed with the objective of determining the root cause.",
"reference": "A structur ed approach to the 10 investigation process should be us ed with the objective of determining the root cause.",
"options": {
"C": "10",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"B": "process product quality",
"D": "tenner"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'performance within a action on marketed control st...'?",
"reference": "performance within a action on marketed control strategy for Knowledge obtained state of control and to product should manufacturing.",
"options": {
"C": "Knowledge",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Process",
"B": "process product quality",
"D": "cognition"
},
"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 7 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
40 41 II.Background 42 FDA envision s a future state where the medical device ecosystem is inherently focused on device 43 features and manufacturing pract ices that promote product quality and patient safety. FDA has 44 sought to identify and promote successful manufacturing practices and help device 45 manufacturers raise their manufacturing quality level. In doing so, one goal is to help 46 manufacturers produce high -quality medical devices that align with the laws and r egulations 47 implemented by FDA . Compliance with the Quality System regulation, Part 820 , is require d for 48 manufacturers of finished medical devices to the extent they engage in operations to which Part 49 820 applies . The Quality System regulation includes requ irements for medical device 50 manufacturers to develop, conduct, control, and monitor production processes to ensure that a 51 device conforms to its specifications (21 CFR 820.70, Production and Process Controls ), 52 including requirements for manufacturers to va lidate computer software used as part of 53 production or the quality system for its intended use ( see 21 CFR 820.70(i)).4Recommending 54 best practices should promote product quality and patient safety, and correlat eto higher -quality 55 outcomes. This draft guidance addresses practices relating to computers and automated data 56 processing systems used as part of production or the quality system. In recent years, advances in manufacturing technologies , including the adop tion of automation, 59 robotics, simulation, and other digital capabilities ,have allowed manufacturers to reduce sources 60 of error, optimize resources, and reduce patient risk . FDA recognizes the potential for these 61 technologies to provide significant benefit s for enhancing the quality, availability, and safety of 62 medical devices, and has undertaken several efforts to help foster the adoption and use of such 63 technologies.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'In doing so, one goal is to help 46 manufacturers ...'?",
"reference": "In doing so, one goal is to help 46 manufacturers produce high -quality medical devices that align with the laws and r egulations 47 implemented by FDA .",
"options": {
"D": "FDA",
"A": "Quality System",
"B": "product quality and patient safety",
"C": "their manufacturing quality level"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In doing so, ____ goal is to help 46 manufacturers produce high -quality medical devices that align with the laws and r egulations 47 implemented by FDA .",
"reference": "In doing so, one goal is to help 46 manufacturers produce high -quality medical devices that align with the laws and r egulations 47 implemented by FDA .",
"options": {
"D": "one",
"A": "820",
"B": "49 820",
"C": "product quality and patient safety"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In doing so, one goal is to help ____ manufacturers produce high -quality medical devices that align with the laws and r egulations 47 implemented by FDA .",
"reference": "In doing so, one goal is to help 46 manufacturers produce high -quality medical devices that align with the laws and r egulations 47 implemented by FDA .",
"options": {
"D": "46",
"A": "one",
"B": "820",
"C": "product quality and patient safety"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In doing so, one goal is to help 46 manufacturers produce high -quality medical devices that align with the laws and r egulations ____ implemented by FDA .",
"reference": "In doing so, one goal is to help 46 manufacturers produce high -quality medical devices that align with the laws and r egulations 47 implemented by FDA .",
"options": {
"A": "47",
"B": "one",
"C": "820",
"D": "product quality and patient safety"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In doing so, one goal is to help 46 manufacturers ...'?",
"reference": "In doing so, one goal is to help 46 manufacturers produce high -quality medical devices that align with the laws and r egulations 47 implemented by FDA .",
"options": {
"B": "FDA",
"A": "Quality System",
"C": "product quality and patient safety",
"D": "their manufacturing quality level"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In doing so, ____ goal is to help 46 manufacturers produce high -quality medical devices that align with the laws and r egulations 47 implemented by FDA .",
"reference": "In doing so, one goal is to help 46 manufacturers produce high -quality medical devices that align with the laws and r egulations 47 implemented by FDA .",
"options": {
"A": "one",
"B": "820",
"C": "49 820",
"D": "product quality and patient safety"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In doing so, one goal is to help ____ manufacturers produce high -quality medical devices that align with the laws and r egulations 47 implemented by FDA .",
"reference": "In doing so, one goal is to help 46 manufacturers produce high -quality medical devices that align with the laws and r egulations 47 implemented by FDA .",
"options": {
"A": "46",
"B": "one",
"C": "820",
"D": "product quality and patient safety"
},
"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]
Contains Nonbinding Recommendations 7 FDA recommends you implement appropriate control s to manage risks associated with each element of the system. Controls that are appropriately designed to validate a sy stem for its intended use address software, hardware, personnel, and documentation. How should access to CGMP computer systems be restricted ? You must exercise appropriate controls to as sure that changes to computerized MPCRs or other CGMP records or input of laboratory data into computerized records can be made only by authorized personnel ( 211.68(b)). Other examples of records for which control should be restricted to authorized personnel include automated visual inspection records, electronic materials management system records, and automated dispensing system weighing records. FDA recommends that you restrict the ability to alter specifications , process parameters, data, or manufacturing or testing methods by technical means where possi ble (e.g., by limiting permissions to change settings or data ). The system administrator role, including any rights to alter files and settings, should be assigned to personnel independent from those responsible for the record content. To assist in contr olling access, it is important that manufacturers establish and implement a method for documenting authorized personnels access privileges for each CGMP computer system in use ( e.g., by maintaining a list of authorized individuals) (see 211.68(b)) . Why is FDA concerned with the use of shared login accounts for computer systems? When login credentials are shared, a unique individual cannot be identified through the login and the system would not conform to the CGMP requirements in parts 211 and 212. FD A requires that system controls, including documentation controls, be designed in accordance with CGMP to assure product quality (e.g., 211.100 and 212.50).
[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 assist in contr olling access, it is important ...'?",
"reference": "To assist in contr olling access, it is important that manufacturers establish and implement a method for documenting authorized personnels access privileges for each CGMP computer system in use ( e.g., by maintaining a list of authorized individuals) (see 211.68(b)) .",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "authorized personnel",
"D": "This information is not provided in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'How should access to CGMP computer systems be rest...'?",
"reference": "How should access to CGMP computer systems be restricted ?",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "authorized personnel",
"C": "This information is not provided in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'Why is FDA concerned with the use of shared login ...'?",
"reference": "Why is FDA concerned with the use of shared login accounts for computer systems?",
"options": {
"C": "FDA",
"A": "CGMP",
"B": "other CGMP records",
"D": "CGMP computer systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'How should access to CGMP computer systems be rest...'?",
"reference": "How should access to CGMP computer systems be restricted ?",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "authorized personnel",
"D": "This information is not provided in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations 7 FDA recommen...'?",
"reference": "Contains Nonbinding Recommendations 7 FDA recommends you implement appropriate control s to manage risks associated with each element of the system.",
"options": {
"C": "FDA",
"A": "CGMP",
"B": "other CGMP records",
"D": "CGMP computer systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 35 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
479 480 The use of testing done in iterative cycles and continuously throughout the lifecycle of 481 the software used in production or as part of the quality system. For example, supporting software , as referenced in Section V.A., often carries lower risk , such 484 that the assurance effort may generally be reduced accordingly. Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary. 490 491 Manufacturers are responsible for determining the appropriate assura nce activities for ensuring 492 the software features, functions, or operations maintain a validated state . The assurance activities 493 and considerations noted above are some possible ways of providing assurance and are not 494 intended to be prescriptive or exhaust ive. Manufacturers may leverage any of the activities or a 495 combination of activities that are most appropriate for risk associated with the intended use . 496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16
Establishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .
[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: Because assurance activities ____ used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"reference": "Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"options": {
"C": "485",
"A": "479 480",
"B": "481",
"D": "such that additional assurance activities"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of ____ supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"reference": "Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"options": {
"B": "486",
"A": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be ____ sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"reference": "Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"options": {
"A": "487",
"B": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or ____ software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"reference": "Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"options": {
"D": "488",
"A": "479 480",
"B": "481",
"C": "such that additional assurance activities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted ____ testing) may be unnecessary.",
"reference": "Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"options": {
"D": "489",
"A": "479 480",
"B": "481",
"C": "such that additional assurance activities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Because assurance activities 485 used directly in production...'?",
"reference": "Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"options": {
"B": "Because assurance activities 485 used directly in production or the quality system often inherently ...",
"A": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 491 Manufacturers are responsible for determining the appropriate assura nce activities for ensuring 492 the software features, functions, or operations maintain a validated state .",
"reference": "490 491 Manufacturers are responsible for determining the appropriate assura nce activities for ensuring 492 the software features, functions, or operations maintain a validated state .",
"options": {
"C": "490",
"A": "479 480",
"B": "481",
"D": "such that additional assurance activities"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 490 ____ Manufacturers are responsible for determining the appropriate assura nce activities for ensuring 492 the software features, functions, or operations maintain a validated state .",
"reference": "490 491 Manufacturers are responsible for determining the appropriate assura nce activities for ensuring 492 the software features, functions, or operations maintain a validated state .",
"options": {
"A": "491",
"B": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 490 491 Manufacturers are responsible for determining the appropriate assura nce activities for ensuring ____ the software features, functions, or operations maintain a validated state .",
"reference": "490 491 Manufacturers are responsible for determining the appropriate assura nce activities for ensuring 492 the software features, functions, or operations maintain a validated state .",
"options": {
"B": "492",
"A": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"reference": "496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"options": {
"D": "496",
"A": "479 480",
"B": "481",
"C": "such that additional assurance activities"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 496 ____ Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"reference": "496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"options": {
"D": "497",
"A": "479 480",
"B": "481",
"C": "such that additional assurance activities"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"reference": "496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"options": {
"A": "496",
"B": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 496 ____ Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"reference": "496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"options": {
"D": "497",
"A": "479 480",
"B": "481",
"C": "such that additional assurance activities"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 496 497 Contains Nonbinding Recommendations Draft Not for Implementation ____\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"reference": "496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"options": {
"B": "16",
"A": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record ____ When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"reference": "496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"options": {
"D": "498",
"A": "479 480",
"B": "481",
"C": "such that additional assurance activities"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to ____ demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"reference": "496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"options": {
"C": "499",
"A": "479 480",
"B": "481",
"D": "such that additional assurance activities"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as ____ intended .",
"reference": "496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"options": {
"A": "500",
"B": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 491 Manufacturers are responsible for determining the appropriate assura nce activities for ensuring 492 the software features, functions, or operations maintain a validated state .",
"reference": "490 491 Manufacturers are responsible for determining the appropriate assura nce activities for ensuring 492 the software features, functions, or operations maintain a validated state .",
"options": {
"B": "490",
"A": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 490 ____ Manufacturers are responsible for determining the appropriate assura nce activities for ensuring 492 the software features, functions, or operations maintain a validated state .",
"reference": "490 491 Manufacturers are responsible for determining the appropriate assura nce activities for ensuring 492 the software features, functions, or operations maintain a validated state .",
"options": {
"C": "491",
"A": "479 480",
"B": "481",
"D": "such that additional assurance activities"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 490 491 Manufacturers are responsible for determining the appropriate assura nce activities for ensuring ____ the software features, functions, or operations maintain a validated state .",
"reference": "490 491 Manufacturers are responsible for determining the appropriate assura nce activities for ensuring 492 the software features, functions, or operations maintain a validated state .",
"options": {
"C": "492",
"A": "479 480",
"B": "481",
"D": "such that additional assurance activities"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Because assurance activities ____ used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"reference": "Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"options": {
"B": "485",
"A": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of ____ supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"reference": "Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"options": {
"D": "486",
"A": "479 480",
"B": "481",
"C": "such that additional assurance activities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be ____ sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"reference": "Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"options": {
"B": "487",
"A": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 480 The use of testing done in iterative cycles and continuously throughout the lifecycle of 481 the software used in production or as part of the quality system.",
"reference": "479 480 The use of testing done in iterative cycles and continuously throughout the lifecycle of 481 the software used in production or as part of the quality system.",
"options": {
"D": "479",
"A": "479 480",
"B": "481",
"C": "such that additional assurance activities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 479 ____ The use of testing done in iterative cycles and continuously throughout the lifecycle of 481 the software used in production or as part of the quality system.",
"reference": "479 480 The use of testing done in iterative cycles and continuously throughout the lifecycle of 481 the software used in production or as part of the quality system.",
"options": {
"B": "480",
"A": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 479 480 The use of testing done in iterative cycles and continuously throughout the lifecycle of ____ the software used in production or as part of the quality system.",
"reference": "479 480 The use of testing done in iterative cycles and continuously throughout the lifecycle of 481 the software used in production or as part of the quality system.",
"options": {
"A": "481",
"B": "479 480",
"C": "484",
"D": "such that additional assurance activities"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Manufacturers may leverage any of the activities or a ____ combination of activities that are most appropriate for risk associated with the intended use .",
"reference": "Manufacturers may leverage any of the activities or a 495 combination of activities that are most appropriate for risk associated with the intended use .",
"options": {
"B": "495",
"A": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"reference": "496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"options": {
"D": "496",
"A": "479 480",
"B": "481",
"C": "such that additional assurance activities"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 496 ____ Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"reference": "496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"options": {
"D": "497",
"A": "479 480",
"B": "481",
"C": "such that additional assurance activities"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 496 497 Contains Nonbinding Recommendations Draft Not for Implementation ____\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"reference": "496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"options": {
"D": "16",
"A": "479 480",
"B": "481",
"C": "such that additional assurance activities"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record ____ When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"reference": "496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"options": {
"A": "498",
"B": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to ____ demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"reference": "496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"options": {
"A": "499",
"B": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as ____ intended .",
"reference": "496 497 Contains Nonbinding Recommendations Draft Not for Implementation 16\nEstablishing the Appropriate Record 498 When establishing the record, the manufacturer should capture su fficient objective evidence to 499 demonstrate that the software feature, function, or operation was assessed and performs as 500 intended .",
"options": {
"B": "500",
"A": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Because assurance activities ____ used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"reference": "Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"options": {
"B": "485",
"A": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of ____ supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"reference": "Because assurance activities 485 used directly in production or the quality system often inherently cover the performance of 486 supporting software, assurance that this supporting software performs as intended may be 487 sufficiently established by lev eraging vendor validation records , software installation, or 488 software configuration , such that additional assurance activities (e.g., scripted or unscripted 489 testing) may be unnecessary.",
"options": {
"B": "486",
"A": "479 480",
"C": "481",
"D": "such that additional assurance activities"
},
"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]
For more information, see guidance for i ndustry Part 11, Electronic Records; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the scope and application of part 11 pending FDAs reexamination of part 11 as it applies to all FDA -regulated products. Contains Nonbinding Recommendations 4 III. QUESTIONS AND ANSWERS 1. Please clarify the following terms as they relate to CGMP records: a. What is data integrity ? For the purpose s of this guidance, data integrity refers to the complete ness, consistency , and accuracy of data. Complete, consistent, and accurate data should be a ttributable , legible , contemporaneous ly recorded, original or a true copy, and accurate (ALCOA) . 5 Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archiv al, retrieval, transmission, and disposition of data after the records retention period ends . 6 System design and controls should enable easy detection of errors, omissions, and aberrant results throughout the datas life cycle . What is metadata ? Metadata is the contextual information required to understand data. A data value is by itself meaningless without additional information about t he data. Metadata is often described as data about data. Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data. For example, the number 23 is meaningless without metadata, such as an in dication of the unit mg. Among other things, metadata for a particular piece of data could include a date/time stamp documenting when the data w ere acquired, a user ID of the person who conducted the test or analysis that generated the data, the instrume nt ID used to acquire the data, material status data, the material identification number, and audit trails.
[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: 'Complete, consistent, and accurate data should be ...'?",
"reference": "Complete, consistent, and accurate data should be a ttributable , legible , contemporaneous ly recorded, original or a true copy, and accurate (ALCOA) .",
"options": {
"A": "ALCOA",
"B": "Electronic Records",
"C": "FDA",
"D": "the CGMP data life cycle"
},
"answer": "A",
"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: a.",
"options": {
"C": "CGMP",
"A": "Electronic Records",
"B": "FDA",
"D": "data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Please clarify the following terms as they relate ...'?",
"reference": "Please clarify the following terms as they relate to CGMP records: a.",
"options": {
"A": "CGMP",
"B": "Electronic Records",
"C": "FDA",
"D": "data integrity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Metadata is often described as data about data....'?",
"reference": "Metadata is often described as data about data.",
"options": {
"A": "Metadata",
"B": "the CGMP data life cycle",
"C": "data integrity",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Metadata is structured information that describes,...'?",
"reference": "Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data.",
"options": {
"A": "Metadata",
"B": "the CGMP data life cycle",
"C": "data integrity",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the number ____ is meaningless without metadata, such as an in dication of the unit mg.",
"reference": "For example, the number 23 is meaningless without metadata, such as an in dication of the unit mg.",
"options": {
"C": "23",
"A": "the CGMP data life cycle",
"B": "data integrity",
"D": "XXIII"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the number ____ is meaningless without metadata, such as an in dication of the unit mg.",
"reference": "For example, the number 23 is meaningless without metadata, such as an in dication of the unit mg.",
"options": {
"A": "23",
"B": "the CGMP data life cycle",
"C": "data integrity",
"D": "XXIII"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ III.",
"reference": "Contains Nonbinding Recommendations 4 III.",
"options": {
"A": "4",
"B": "the CGMP data life cycle",
"C": "data integrity",
"D": "quaternity"
},
"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]
Under a quality system, continued training is cr itical to ensure that the employees remain proficient in their operational functions and in their understanding of CGMP regulations. Typical quality systems training should address the policies, processes, procedures, and written instructions related to operational activities, the product/se rvice, the quality system, and the desired work culture (e.g., team building, comm unication, change, behavior). Under a quality system (and the CGMP regulations), training sh ould focus on both the employees specific job functions and the related CGMP regulatory requirements. Under a quality system, managers are expected to estab lish training programs that include the following: Evaluation of training needs Provision of training to satisfy these needs Evaluation of effectiveness of training Documentation of training and/or re-training When operating in a robust quality system environm ent, it is important that managers verify that skills gained from training are im plemented in day-to-day performance. 3. Facilities and Equipment Under a quality system, the technical experts (e.g., engineers, development scientists), who have an understanding of pharmaceutical science, risk f actors, and manufacturing processes related to the product, are responsible for defining specif ic facility and equipment requirements. Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1. General Arrangements Qualifications: 211.25(a) 2. Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Develop Personnel Staff training: 211.25(a-b) Bui...'?",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"D": "Develop Personnel",
"A": "CGMP",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"C": "Typical quality systems training"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), ____ 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"A": "211.42",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 ____, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"B": "211.58",
"A": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, ____ Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"B": "211.173",
"A": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: ____ 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"A": "211.63",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 ____, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"D": "211.72",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"C": "Typical quality systems training"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, ____, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"C": "211.105",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), ____ 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"A": "211.182",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.17____ Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"C": "3",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system (and the CGMP regulations),...'?",
"reference": "Under a quality system (and the CGMP regulations), training sh ould focus on both the employees specific job functions and the related CGMP regulatory requirements.",
"options": {
"A": "CGMP",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system (and the CGMP regulations),...'?",
"reference": "Under a quality system (and the CGMP regulations), training sh ould focus on both the employees specific job functions and the related CGMP regulatory requirements.",
"options": {
"D": "CGMP",
"A": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"C": "Typical quality systems training"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: General Arrangements Qualifications: ____11.25(a) 2.",
"reference": "General Arrangements Qualifications: 211.25(a) 2.",
"options": {
"B": "2",
"A": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: General Arrangements Qualifications: ____11.25(a) 2.",
"reference": "General Arrangements Qualifications: 211.25(a) 2.",
"options": {
"A": "2",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Develop Personnel Staff training: 211.25(a-b) Bui...'?",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"C": "Develop Personnel",
"A": "CGMP",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), ____ 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"B": "211.42",
"A": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 ____, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"A": "211.58",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, ____ Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"D": "211.173",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"C": "Typical quality systems training"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: ____ 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"A": "211.63",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 ____, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"B": "211.72",
"A": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, ____, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"B": "211.105",
"A": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), ____ 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"C": "211.182",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.17____ Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"C": "3",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"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 Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"options": {
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"A": "CGMP",
"B": "Typical quality systems training",
"D": "Develop Personnel Staff training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"options": {
"B": "21",
"A": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "B",
"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 Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"options": {
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"A": "CGMP",
"B": "Typical quality systems training",
"D": "Develop Personnel Staff training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"options": {
"C": "21",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations 2____ CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"options": {
"B": "1",
"A": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system, continued training is cr i...'?",
"reference": "Under a quality system, continued training is cr itical to ensure that the employees remain proficient in their operational functions and in their understanding of CGMP regulations.",
"options": {
"C": "CGMP",
"A": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system, continued training is cr i...'?",
"reference": "Under a quality system, continued training is cr itical to ensure that the employees remain proficient in their operational functions and in their understanding of CGMP regulations.",
"options": {
"B": "CGMP",
"A": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system, continued training is cr i...'?",
"reference": "Under a quality system, continued training is cr itical to ensure that the employees remain proficient in their operational functions and in their understanding of CGMP regulations.",
"options": {
"D": "CGMP",
"A": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"C": "Typical quality systems training"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations 21 CFR CGMP Re...'?",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"options": {
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"A": "CGMP",
"C": "Typical quality systems training",
"D": "Develop Personnel Staff training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"options": {
"D": "21",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"C": "Typical quality systems training"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations 2____ CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"options": {
"D": "1",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"C": "Typical quality systems training"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations 21 CFR CGMP Re...'?",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"options": {
"A": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"B": "CGMP",
"C": "Typical quality systems training",
"D": "Develop Personnel Staff training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"options": {
"C": "21",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"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]
The source of the definition is identified in parentheses after the definition. Where no appropria te ICH or ISO definition was available, an ICH Q10 definition was developed. Capability of a Process: Ability of a process to real ize a product that will fulfill the requirements of that product. The concept of pro cess capability can also be defined in statistical terms. Change Management: A systematic approach to proposing, evaluating, approving, implementing, and reviewing changes. Continual Improvement: Recurring activity to increase the ab ility to fulfill requirements. (ISO 9000:2005) Control Strategy:
A planned set of controls, deri ved from current product and process understanding, that assures proc ess performance and product quali ty. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, fi nished product specifications, and the associated methods and frequency of monitoring and control. (ICH Q10) Corrective Action: Action to eliminate the cause of a detected nonconformity or other undesirable situation. Corrective action is taken to prevent recurrence whereas preventive action is taken to preven t occurrence. (ISO 9000:2005) Design Space: The multidimensional combination and interaction of input variables (e.g., material attributes) and process pa rameters that have been demons trated to provide assurance of quality. (ICH Q8) Enabler: A tool or process that provides the means to achieve an objective. (ICH Q10) Feedback/Feedforward: Feedback: The modification or control of a process or system by its results or effects. Feedforward: The modification or control of a pro cess using its anticipated results or effects. (Oxford Dictionary of Eng lish by Oxford University Press, 2003)
Feedback/feedforward can be applied technically in process control strate gies and conceptually in quality management.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: '(ISO 9000:2005) Design Space: The multidimensional...'?",
"reference": "(ISO 9000:2005) Design Space: The multidimensional combination and interaction of input variables (e.g., material attributes) and process pa rameters that have been demons trated to provide assurance of quality.",
"options": {
"A": "ISO 9000:2005",
"B": "ISO",
"C": "ICH Q8) Enabler",
"D": "process control strate gies"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q8) Enabler: A tool or process that provides ...'?",
"reference": "(ICH Q8) Enabler: A tool or process that provides the means to achieve an objective.",
"options": {
"C": "ICH Q8) Enabler",
"A": "ISO",
"B": "ISO 9000:2005",
"D": "process control strate gies"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(Oxford Dictionary of Eng lish by Oxford Universit...'?",
"reference": "(Oxford Dictionary of Eng lish by Oxford University Press, 2003)\nFeedback/feedforward can be applied technically in process control strate gies and conceptually in quality management.",
"options": {
"C": "Oxford Dictionary of Eng",
"A": "ISO",
"B": "ISO 9000:2005",
"D": "process control strate gies"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(Oxford Dictionary of Eng lish by Oxford Universit...'?",
"reference": "(Oxford Dictionary of Eng lish by Oxford University Press, 2003)\nFeedback/feedforward can be applied technically in process control strate gies and conceptually in quality management.",
"options": {
"B": "Oxford University Press",
"A": "ISO",
"C": "ISO 9000:2005",
"D": "process control strate gies"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '(Oxford Dictionary of Eng lish by Oxford Universit...'?",
"reference": "(Oxford Dictionary of Eng lish by Oxford University Press, 2003)\nFeedback/feedforward can be applied technically in process control strate gies and conceptually in quality management.",
"options": {
"D": "2003",
"A": "process control strate gies",
"B": "process pa rameters",
"C": "Oxford Dictionary of Eng"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: (Oxford Dictionary of Eng lish by Oxford University Press, ____)\nFeedback/feedforward can be applied technically in process control strate gies and conceptually in quality management.",
"reference": "(Oxford Dictionary of Eng lish by Oxford University Press, 2003)\nFeedback/feedforward can be applied technically in process control strate gies and conceptually in quality management.",
"options": {
"D": "2003",
"A": "process control strate gies",
"B": "process pa rameters",
"C": "Oxford Dictionary of Eng"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ISO 9000:2005) Control Strategy:\nA planned set of...'?",
"reference": "(ISO 9000:2005) Control Strategy:\nA planned set of controls, deri ved from current product and process understanding, that assures proc ess performance and product quali ty.",
"options": {
"A": "ISO 9000:2005",
"B": "ISO",
"C": "ICH Q8) Enabler",
"D": "process control strate gies"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: '(ISO 9000:2005) Control Strategy:\nA planned set of...'?",
"reference": "(ISO 9000:2005) Control Strategy:\nA planned set of controls, deri ved from current product and process understanding, that assures proc ess performance and product quali ty.",
"options": {
"A": "deri",
"B": "process control strate gies",
"C": "process pa rameters",
"D": "ISO 9000:2005"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q8) Enabler: A tool or process that provides ...'?",
"reference": "(ICH Q8) Enabler: A tool or process that provides the means to achieve an objective.",
"options": {
"D": "ICH Q8) Enabler",
"A": "ISO",
"B": "ISO 9000:2005",
"C": "process control strate gies"
},
"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]
There should be an assessment to determine whether a change to the regulatory filing is required under regional requirements. As stated in ICH Q8, working within the design space is not considered a change (from a regulatory filing perspective). However, from a pharmaceutical quality system standpoint, all changes should be evaluated by a company s change management system. (c) Proposed changes should be evaluated by e xpert teams contributing the appropriate 11 expertise and knowledge from relevant ar eas (e.g., Pharmaceutical Development, Manufacturing, Quality, Regulator y Affairs, and Medical) to ensure the change is technically justified. Prospective evaluation criteria for a proposed change should be set. (d) After implementation, an evaluation of the change should be undertaken to confirm the change objectives were achieved and that there was no deleterious impact on product quality. Application of Change Management System Throughout the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Change is an inherent part of the development process and should be documented; the formality of the change management process should be consistent with the stage of pharmaceutical development. The change management system should provide management and documentation of adjustments made to the process during technology transfer activities. A formal change management system should be in place for commercial manufacturing. Oversight by the quality unit should provide assurance of appropriate science- and risk-based assessments. Any changes after product discontinuation should go through an appropriate change management system. 4. Management Review of Process Pe rformance and Product Quality (3.2.4) Management review should provide assurance that process perf ormance and product quality are managed over the lifecycle.
[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: 'As stated in ICH Q8, working within the design spa...'?",
"reference": "As stated in ICH Q8, working within the design space is not considered a change (from a regulatory filing perspective).",
"options": {
"C": "ICH Q8",
"A": "Pharmaceutical Development, Manufacturing",
"B": "Regulator y Affairs",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Change"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(c) Proposed changes should be evaluated by e xper...'?",
"reference": "(c) Proposed changes should be evaluated by e xpert teams contributing the appropriate 11 expertise and knowledge from relevant ar eas (e.g., Pharmaceutical Development, Manufacturing, Quality, Regulator y Affairs, and Medical) to ensure the change is technically justified.",
"options": {
"C": "Pharmaceutical Development, Manufacturing",
"A": "ICH Q8",
"B": "Regulator y Affairs",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Change"
},
"answer": "C",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: '(c) Proposed changes should be evaluated by e xper...'?",
"reference": "(c) Proposed changes should be evaluated by e xpert teams contributing the appropriate 11 expertise and knowledge from relevant ar eas (e.g., Pharmaceutical Development, Manufacturing, Quality, Regulator y Affairs, and Medical) to ensure the change is technically justified.",
"options": {
"C": "Regulator y Affairs",
"A": "ICH Q8",
"B": "Pharmaceutical Development, Manufacturing",
"D": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Change"
},
"answer": "C",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Fill in the blank: (c) Proposed changes should be evaluated by e xpert teams contributing the appropriate ____ expertise and knowledge from relevant ar eas (e.g., Pharmaceutical Development, Manufacturing, Quality, Regulator y Affairs, and Medical) to ensure the change is technically justified.",
"reference": "(c) Proposed changes should be evaluated by e xpert teams contributing the appropriate 11 expertise and knowledge from relevant ar eas (e.g., Pharmaceutical Development, Manufacturing, Quality, Regulator y Affairs, and Medical) to ensure the change is technically justified.",
"options": {
"B": "11",
"A": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Change",
"C": "the change management process",
"D": "Pharmaceutical Development, Manufacturing"
},
"answer": "B",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: '(c) Proposed changes should be evaluated by e xper...'?",
"reference": "(c) Proposed changes should be evaluated by e xpert teams contributing the appropriate 11 expertise and knowledge from relevant ar eas (e.g., Pharmaceutical Development, Manufacturing, Quality, Regulator y Affairs, and Medical) to ensure the change is technically justified.",
"options": {
"D": "Pharmaceutical Development, Manufacturing",
"A": "ICH Q8",
"B": "Regulator y Affairs",
"C": "the Product Lifecycle Pharmaceutical Development Technology Transfer Commercial Manufacturing Product Discontinuation Change"
},
"answer": "D",
"difficulty": "hard",
"question_type": "analytical"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 7 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Under a quality systems approach, ma nagers would use quality planning to identify and allocate resources and define methods to achieve the quality objectives. Quality system plans should be documented and communicated to personnel to ensure awareness of how their operational activities are aligned with st rategic and quality goals. 5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness. U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule. Such a review typically includes assessments of the pr ocess, product, and customer needs (in this section, customer is defined as the reci pient of the produc t and the product is the goods or services provided). Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)
Product characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured. Outside of scheduled reviews, the quality system should typically be included as a standing age nda item in general m anagement meetings. In addition, a periodic review performed by a qualif ied source, external to the organization, may also be useful in assessing the suitab ility and effectiveness of the system.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"A": "10",
"B": "the quality systems performa nce",
"C": "a quality systems approach",
"D": "tenner"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments ____ Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"reference": "Under a quality systems a pproach, a review should consider at least the following: The appropriateness of the quality policy and objectives The results of audits and other assessments 10 Contains Nonbinding Recommendations Customer feedback, including complaints The analysis of data trending results The status of actions to prevent a potential problem or a recurrence Any follow-up actions from previous management reviews Any changes in business practices or envir onment that may affect the quality system (such as the volume or type of operations)\nProduct characteristics meeting the customers needs When developing and implementing new quality sy stems, reviews should take place more frequently than when the system has matured.",
"options": {
"C": "10",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"D": "tenner"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"B": "U",
"A": "a periodic review",
"C": "the System System review",
"D": "uracil"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"D": "U",
"A": "a periodic review",
"B": "the System System review",
"C": "uracil"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"reference": "5. Review the System System review is a key component in any r obust quality system to ensure its continuing suitability, adequacy, and effectiveness.",
"options": {
"D": "5",
"A": "the quality systems performa nce",
"B": "a quality systems approach",
"C": "Little Phoebe"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder a quality system , senior managers should c...'?",
"reference": "U nder a quality system , senior managers should conduct reviews of the quality systems performa nce according to a plan ned schedule.",
"options": {
"C": "U",
"A": "a periodic review",
"B": "the System System review",
"D": "uracil"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
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]
A modern quality system approach indicates that change control is warranted when data analysis or other inform ation reveals an area fo r improveme nt. Changes to an established process must be controlled and documented to ensure that desire d attributes for the finished product will be met ( 211.100(a)). Change control with regard to pharmaceuticals is addressed in more detail in the CGMP regulations. When developing a pr ocess change, it is important to keep the process design and scientific knowledge of the product in mind. If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160). When implementing a change, its effect shoul d be determined by monitoring and evaluating those specific elements that may be affected based on an understanding of the process. This approach allows the steps taken to implement a change and the effects of the change on the process to be considered systematically. Applic ation of risk analysis may facilitate evaluating the potential effect of the change. Evaluating the e ffects of a change can en tail additional tests or examinations of subsequent batches (e.g., additional in-process testing or additional stability studies). The quality system elements identified in this guidance, if implemented and maintained, will help a manufacturer manage change and implement continual improvement in manufacturing. Under a quality systems approach, procedures should be in place to ensure the accuracy of test results. Test results that are out of specification may be due to testing problems or manufacturing problems and should be investigated. Any invalidation of a test re sult should be scientifically sound and justified.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Who is mentioned in the context: 'If major design issues are encountered through pro...'?",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"D": "experien ce",
"A": "change control",
"B": "a pr ocess change",
"C": "211.42"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( ____), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"B": "211.42",
"A": "211.100(a",
"C": "211.63",
"D": "change control"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( ____), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"A": "211.63",
"B": "211.100(a",
"C": "211.42",
"D": "change control"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( ____), or the design of laborator y controls ( 211.160).",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"A": "211.100",
"B": "211.100(a",
"C": "211.42",
"D": "change control"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( ____).",
"reference": "If major design issues are encountered through process experien ce, a firm may want to revisit th e adequacy of the design of the manufacturing facility ( 211.42), the design of the manufacturing equipment ( 211.63), the design of the production and control procedures ( 211.100), or the design of laborator y controls ( 211.160).",
"options": {
"C": "211.160",
"A": "211.100(a",
"B": "211.42",
"D": "change control"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Applic ation of risk analysis may facilitate evalu...'?",
"reference": "Applic ation of risk analysis may facilitate evaluating the potential effect of the change.",
"options": {
"D": "Applic",
"A": "experien ce",
"B": "change control",
"C": "a pr ocess change"
},
"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 50 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
PDA Journal of Pharmaceutical Science and Technology, Volume 49, Number 1, January-February 1995 Supplement. Validation Compliance Annual 1995 , International Validation Forum, Inc.
General Software Quality References Boris Beizer, Black Box Testing, Techniques for Functional Testing of Software and Systems , John Wiley Sons, 1995. ISBN 0-471-12094-4. Boris Beizer, Software System Testing and Quality Assurance , International Thomson Computer Press, 1996. ISBN 1-85032-821-8. Boris Beizer, Software Testing Techniques , Second Edition, Van Nostrand Reinhold, 1990. ISBN 0- 442-20672-0. Richard Bender, Writing Testable Requirements, Version 1.0 , Bender Associates, Inc., Larkspur, CA 94777, 1996. Frederick P. Brooks, Jr., The Mythical Man-Month, Essays on Software Engineering , Addison-
Wesley Longman, Anniversary Edition, 1995. ISBN 0-201-83595-9. Silvana Castano, et.al., Database Security , ACM Press, Addison-Wesley Publishing Company, 1995. ISBN 0-201-59375-0. Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance , Drug Information Association, Maple Glen, PA, September 1988. Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982. Robert H. Dunn and Richard S. Ullman, TQM for Computer Software , Second Edition, McGraw- Hill, Inc., 1994. ISBN 0-07-018314-7. Elfriede Dustin, Jeff Rashka, and John Paul, Automated Software Testing Introduction, Management and Performance, Addison Wesley Longman, Inc., 1999. ISBN 0-201-43287-0. Robert G. Ebenau and Susan H. Strauss, Software Inspection Process , McGraw-Hill, 1994. ISBN 0-07-062166-7. Richard E. Fairley, Software Engineering Concepts , McGraw-Hill Publishing Company, 1985. ISBN 0-07-019902-7. Michael A. Friedman and Jeffrey M. Voas, Software Assessment - Reliability, Safety, Testability , Wiley-
Interscience, John Wiley Sons Inc., 1995.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Who is mentioned in the context: 'Robert G. Ebenau and Susan H. Strauss, Software In...'?",
"reference": "Robert G. Ebenau and Susan H. Strauss, Software Inspection Process , McGraw-Hill, 1994.",
"options": {
"B": "Robert G. Ebenau",
"A": "Boris Beizer",
"C": "John Wiley Sons",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Robert G. Ebenau and Susan H. Strauss, Software In...'?",
"reference": "Robert G. Ebenau and Susan H. Strauss, Software Inspection Process , McGraw-Hill, 1994.",
"options": {
"B": "Susan H. Strauss",
"A": "Boris Beizer",
"C": "John Wiley Sons",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robert G. Ebenau and Susan H. Strauss, Software In...'?",
"reference": "Robert G. Ebenau and Susan H. Strauss, Software Inspection Process , McGraw-Hill, 1994.",
"options": {
"D": "McGraw-Hill",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"B": "International Validation Forum",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Robert G. Ebenau and Susan H. Strauss, Software In...'?",
"reference": "Robert G. Ebenau and Susan H. Strauss, Software Inspection Process , McGraw-Hill, 1994.",
"options": {
"B": "1994",
"A": "Number 1",
"C": "January-February 1995",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Robert G. Ebenau and Susan H. Strauss, Software Inspection Process , McGraw-Hill, ____.",
"reference": "Robert G. Ebenau and Susan H. Strauss, Software Inspection Process , McGraw-Hill, 1994.",
"options": {
"B": "1994",
"A": "Number 1",
"C": "January-February 1995",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Boris Beizer, Software Testing Techniques , Second...'?",
"reference": "Boris Beizer, Software Testing Techniques , Second Edition, Van Nostrand Reinhold, 1990.",
"options": {
"D": "Boris Beizer",
"A": "John Wiley Sons",
"B": "Richard Bender",
"C": "Software Testing Techniques"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Boris Beizer, Software Testing Techniques , Second...'?",
"reference": "Boris Beizer, Software Testing Techniques , Second Edition, Van Nostrand Reinhold, 1990.",
"options": {
"D": "Software Testing Techniques",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"B": "International Validation Forum",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Boris Beizer, Software Testing Techniques , Second...'?",
"reference": "Boris Beizer, Software Testing Techniques , Second Edition, Van Nostrand Reinhold, 1990.",
"options": {
"D": "1990",
"A": "Number 1",
"B": "January-February 1995",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Boris Beizer, Software Testing Techniques , ____ Edition, Van Nostrand Reinhold, 1990.",
"reference": "Boris Beizer, Software Testing Techniques , Second Edition, Van Nostrand Reinhold, 1990.",
"options": {
"A": "Second",
"B": "Inc.\nGeneral Software Quality References Boris Beizer",
"C": "Software Testing Techniques",
"D": "secondly"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Boris Beizer, Software Testing Techniques , Second Edition, Van Nostrand Reinhold, ____.",
"reference": "Boris Beizer, Software Testing Techniques , Second Edition, Van Nostrand Reinhold, 1990.",
"options": {
"B": "1990",
"A": "Number 1",
"C": "January-February 1995",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Boris Beizer, Software Testing Techniques , Second...'?",
"reference": "Boris Beizer, Software Testing Techniques , Second Edition, Van Nostrand Reinhold, 1990.",
"options": {
"D": "Boris Beizer",
"A": "John Wiley Sons",
"B": "Richard Bender",
"C": "Software Testing Techniques"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Boris Beizer, Software Testing Techniques , Second...'?",
"reference": "Boris Beizer, Software Testing Techniques , Second Edition, Van Nostrand Reinhold, 1990.",
"options": {
"B": "Software Testing Techniques",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Robert H. Dunn and Richard S. Ullman, TQM for Comp...'?",
"reference": "Robert H. Dunn and Richard S. Ullman, TQM for Computer Software , Second Edition, McGraw- Hill, Inc., 1994.",
"options": {
"B": "Robert H. Dunn",
"A": "Boris Beizer",
"C": "John Wiley Sons",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Robert H. Dunn and Richard S. Ullman, TQM for Comp...'?",
"reference": "Robert H. Dunn and Richard S. Ullman, TQM for Computer Software , Second Edition, McGraw- Hill, Inc., 1994.",
"options": {
"D": "Richard S. Ullman",
"A": "Boris Beizer",
"B": "John Wiley Sons",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robert H. Dunn and Richard S. Ullman, TQM for Comp...'?",
"reference": "Robert H. Dunn and Richard S. Ullman, TQM for Computer Software , Second Edition, McGraw- Hill, Inc., 1994.",
"options": {
"C": "TQM",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"B": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Robert H. Dunn and Richard S. Ullman, TQM for Comp...'?",
"reference": "Robert H. Dunn and Richard S. Ullman, TQM for Computer Software , Second Edition, McGraw- Hill, Inc., 1994.",
"options": {
"C": "Hill, Inc.",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"B": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Robert H. Dunn and Richard S. Ullman, TQM for Comp...'?",
"reference": "Robert H. Dunn and Richard S. Ullman, TQM for Computer Software , Second Edition, McGraw- Hill, Inc., 1994.",
"options": {
"A": "1994",
"B": "Number 1",
"C": "January-February 1995",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Robert H. Dunn and Richard S. Ullman, TQM for Computer Software , ____ Edition, McGraw- Hill, Inc., 1994.",
"reference": "Robert H. Dunn and Richard S. Ullman, TQM for Computer Software , Second Edition, McGraw- Hill, Inc., 1994.",
"options": {
"B": "Second",
"A": "Inc.\nGeneral Software Quality References Boris Beizer",
"C": "Software Testing Techniques",
"D": "secondly"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Robert H. Dunn and Richard S. Ullman, TQM for Computer Software , Second Edition, McGraw- Hill, Inc., ____.",
"reference": "Robert H. Dunn and Richard S. Ullman, TQM for Computer Software , Second Edition, McGraw- Hill, Inc., 1994.",
"options": {
"D": "1994",
"A": "Number 1",
"B": "January-February 1995",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Richard E. Fairley, Software Engineering Concepts ...'?",
"reference": "Richard E. Fairley, Software Engineering Concepts , McGraw-Hill Publishing Company, 1985.",
"options": {
"B": "Richard E. Fairley",
"A": "Boris Beizer",
"C": "John Wiley Sons",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Richard E. Fairley, Software Engineering Concepts ...'?",
"reference": "Richard E. Fairley, Software Engineering Concepts , McGraw-Hill Publishing Company, 1985.",
"options": {
"A": "Software Engineering Concepts",
"B": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Richard E. Fairley, Software Engineering Concepts ...'?",
"reference": "Richard E. Fairley, Software Engineering Concepts , McGraw-Hill Publishing Company, 1985.",
"options": {
"A": "McGraw-Hill Publishing Company",
"B": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Richard E. Fairley, Software Engineering Concepts ...'?",
"reference": "Richard E. Fairley, Software Engineering Concepts , McGraw-Hill Publishing Company, 1985.",
"options": {
"D": "1985",
"A": "Number 1",
"B": "January-February 1995",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Richard E. Fairley, Software Engineering Concepts , McGraw-Hill Publishing Company, ____.",
"reference": "Richard E. Fairley, Software Engineering Concepts , McGraw-Hill Publishing Company, 1985.",
"options": {
"C": "1985",
"A": "Number 1",
"B": "January-February 1995",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"D": "Page 40General Principles of Software Validation Guidance for Industry",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"B": "International Validation Forum",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"D": "FDA",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"B": "International Validation Forum",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"D": "M. S. Deutsch",
"A": "Boris Beizer",
"B": "John Wiley Sons",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"C": "Software Verification and Validation, Realistic Project Approaches",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"B": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"B": "Prentice Hall",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"A": "1982",
"B": "Number 1",
"C": "January-February 1995",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, ____.",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"D": "1982",
"A": "Number 1",
"B": "January-February 1995",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'PDA Journal of Pharmaceutical Science and Technolo...'?",
"reference": "PDA Journal of Pharmaceutical Science and Technology, Volume 49, Number 1, January-February 1995 Supplement.",
"options": {
"D": "PDA Journal of Pharmaceutical Science and Technology",
"A": "International Validation Forum",
"B": "General Software Quality",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'PDA Journal of Pharmaceutical Science and Technolo...'?",
"reference": "PDA Journal of Pharmaceutical Science and Technology, Volume 49, Number 1, January-February 1995 Supplement.",
"options": {
"D": "49",
"A": "442",
"B": "Inc.\nGeneral Software Quality References Boris Beizer",
"C": "Software Testing Techniques"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'PDA Journal of Pharmaceutical Science and Technolo...'?",
"reference": "PDA Journal of Pharmaceutical Science and Technology, Volume 49, Number 1, January-February 1995 Supplement.",
"options": {
"D": "Number 1",
"A": "Inc.\nGeneral Software Quality References Boris Beizer",
"B": "Software Testing Techniques",
"C": "PDA Journal of Pharmaceutical Science and Technology"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'PDA Journal of Pharmaceutical Science and Technolo...'?",
"reference": "PDA Journal of Pharmaceutical Science and Technology, Volume 49, Number 1, January-February 1995 Supplement.",
"options": {
"A": "January-February 1995 Supplement",
"B": "Number 1",
"C": "January-February 1995",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: PDA Journal of Pharmaceutical Science and Technology, Volume ____, Number 1, January-February 1995 Supplement.",
"reference": "PDA Journal of Pharmaceutical Science and Technology, Volume 49, Number 1, January-February 1995 Supplement.",
"options": {
"D": "49",
"A": "442",
"B": "Inc.\nGeneral Software Quality References Boris Beizer",
"C": "Software Testing Techniques"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: PDA Journal of Pharmaceutical Science and Technology, Volume 49, Number ____, January-February 1995 Supplement.",
"reference": "PDA Journal of Pharmaceutical Science and Technology, Volume 49, Number 1, January-February 1995 Supplement.",
"options": {
"B": "1",
"A": "442",
"C": "Inc.\nGeneral Software Quality References Boris Beizer",
"D": "Software Testing Techniques"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Computerized Data Systems for Nonclinical Safety A...'?",
"reference": "Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance , Drug Information Association, Maple Glen, PA, September 1988.",
"options": {
"A": "Computerized Data Systems",
"B": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Computerized Data Systems for Nonclinical Safety A...'?",
"reference": "Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance , Drug Information Association, Maple Glen, PA, September 1988.",
"options": {
"A": "Quality Assurance , Drug Information Association",
"B": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Computerized Data Systems for Nonclinical Safety A...'?",
"reference": "Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance , Drug Information Association, Maple Glen, PA, September 1988.",
"options": {
"A": "Maple Glen",
"B": "Boris Beizer",
"C": "John Wiley Sons",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Computerized Data Systems for Nonclinical Safety A...'?",
"reference": "Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance , Drug Information Association, Maple Glen, PA, September 1988.",
"options": {
"D": "September 1988",
"A": "Number 1",
"B": "January-February 1995",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance , Drug Information Association, Maple Glen, PA, September ____.",
"reference": "Computerized Data Systems for Nonclinical Safety Assessment, Current Concepts and Quality Assurance , Drug Information Association, Maple Glen, PA, September 1988.",
"options": {
"B": "1988",
"A": "Number 1",
"C": "January-February 1995",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"A": "Page 40General Principles of Software Validation Guidance for Industry",
"B": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"C": "FDA",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"B": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"D": "M. S. Deutsch",
"A": "Boris Beizer",
"B": "John Wiley Sons",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"A": "Software Verification and Validation, Realistic Project Approaches",
"B": "PDA Journal of Pharmaceutical Science and Technology",
"C": "International Validation Forum",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"D": "Prentice Hall",
"A": "PDA Journal of Pharmaceutical Science and Technology",
"B": "International Validation Forum",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Page 40General Principles of Software Validation G...'?",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"A": "1982",
"B": "Number 1",
"C": "January-February 1995",
"D": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, ____.",
"reference": "Page 40General Principles of Software Validation Guidance for Industry and FDA Staff M. S. Deutsch, Software Verification and Validation, Realistic Project Approaches , Prentice Hall, 1982.",
"options": {
"D": "1982",
"A": "Number 1",
"B": "January-February 1995",
"C": "Inc.\nGeneral Software Quality References Boris Beizer"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Boris Beizer, Software System Testing and Quality ...'?",
"reference": "Boris Beizer, Software System Testing and Quality Assurance , International Thomson Computer Press, 1996.",
"options": {
"D": "Boris Beizer",
"A": "John Wiley Sons",
"B": "Richard Bender",
"C": "Software Testing Techniques"
},
"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 45 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
BACKGROUND ............................................................................................................... 2 III. QUESTIONS AND ANSWERS ....................................................................................... Please clarify the following terms as they relate to CGMP records: .........................................
4 a. What is data integrity? ................................................................................................................
4 b. What is metadata? .......................................................................................................................
4 c. What is an audit trail? .................................................................................................................
4 d. How does FDA use the terms static and dynamic as they relate to record for mats? 5 e. How does FDA use the term backup in 211.68(b)? ..................................................................
5 f. What are the systems in computer or related systems in 211.68? ........................................ When is it permissible to invalidate a CGMP result and exclude it from the determination of batch conformance? ........................................................................................................................... Does each CGMP workflow on a 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 systems? How should blank forms be controlled? ......................................................................................
Who should review audit trails? ...................................................................................................
How often should audit trails be reviewed?
[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: '.....................................................'?",
"reference": ".................................................................................................................\n4 d. How does FDA use the terms static and dynamic as they relate to record for mats?",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "CGMP computer systems",
"C": "computer or related systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .................................................................................................................\n____ d. How does FDA use the terms static and dynamic as they relate to record for mats?",
"reference": ".................................................................................................................\n4 d. How does FDA use the terms static and dynamic as they relate to record for mats?",
"options": {
"D": "4",
"A": "4 d.",
"B": "211.68(b",
"C": "CGMP computer systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: '5 e. How does FDA use the term backup in 211.68(b...'?",
"reference": "5 e. How does FDA use the term backup in 211.68(b)?",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "CGMP computer systems",
"C": "computer or related systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ____ e. How does FDA use the term backup in 211.68(b)?",
"reference": "5 e. How does FDA use the term backup in 211.68(b)?",
"options": {
"C": "5",
"A": "4 d.",
"B": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: '...............................\nHow should access ...'?",
"reference": "...............................\nHow should access to CGMP computer systems be restricted?",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "computer or related systems",
"D": "computer systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: .......................................................................................................................\n____ c. What is an audit trail?",
"reference": ".......................................................................................................................\n4 c. What is an audit trail?",
"options": {
"A": "4",
"B": "4 d.",
"C": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: .......................................................................................................................\n____ c. What is an audit trail?",
"reference": ".......................................................................................................................\n4 c. What is an audit trail?",
"options": {
"D": "4",
"A": "4 d.",
"B": "211.68(b",
"C": "CGMP computer systems"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: .......................................................................................................................\n____ c. What is an audit trail?",
"reference": ".......................................................................................................................\n4 c. What is an audit trail?",
"options": {
"B": "4",
"A": "4 d.",
"C": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: BACKGROUND ............................................................................................................... ____ III.",
"reference": "BACKGROUND ............................................................................................................... 2 III.",
"options": {
"B": "2",
"A": "4 d.",
"C": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Does each CGMP workflow on a computer system need ...'?",
"reference": "Does each CGMP workflow on a computer system need to be validated?",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "computer or related systems",
"D": "computer systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '.....................................................'?",
"reference": ".................................................................................................................\n4 d. How does FDA use the terms static and dynamic as they relate to record for mats?",
"options": {
"C": "FDA",
"A": "CGMP",
"B": "CGMP computer systems",
"D": "computer or related systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Does each CGMP workflow on a computer system need ...'?",
"reference": "Does each CGMP workflow on a computer system need to be validated?",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "computer or related systems",
"D": "computer systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .......................................................................................................................\n____ c. What is an audit trail?",
"reference": ".......................................................................................................................\n4 c. What is an audit trail?",
"options": {
"C": "4",
"A": "4 d.",
"B": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '................................................\nW...'?",
"reference": "................................................\nWhy is FDA concerned with the use of shared login accounts for computer systems?",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "CGMP computer systems",
"D": "computer or related systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: BACKGROUND ............................................................................................................... ____ III.",
"reference": "BACKGROUND ............................................................................................................... 2 III.",
"options": {
"D": "2",
"A": "4 d.",
"B": "211.68(b",
"C": "CGMP computer systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .......................................................................................................................\n____ c. What is an audit trail?",
"reference": ".......................................................................................................................\n4 c. What is an audit trail?",
"options": {
"C": "4",
"A": "4 d.",
"B": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '................................................\nW...'?",
"reference": "................................................\nWhy is FDA concerned with the use of shared login accounts for computer systems?",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "CGMP computer systems",
"C": "computer or related systems"
},
"answer": "D",
"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 systems?",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "CGMP computer systems",
"C": "computer or related systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ..................................................................\n____ f. What are the systems in computer or related systems in 211.68?",
"reference": "..................................................................\n5 f. What are the systems in computer or related systems in 211.68?",
"options": {
"C": "5",
"A": "4 d.",
"B": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ..................................................................\n5 f. What are the systems in computer or related systems in ____?",
"reference": "..................................................................\n5 f. What are the systems in computer or related systems in 211.68?",
"options": {
"B": "211.68",
"A": "4 d.",
"C": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When is it permissible to invalidate a CGMP result...'?",
"reference": "When is it permissible to invalidate a CGMP result and exclude it from the determination of batch conformance?",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "computer or related systems",
"D": "computer systems"
},
"answer": "C",
"difficulty": "easy",
"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: .........................................\n4 a.",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "computer or related systems",
"D": "computer systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Does each CGMP workflow on a computer system need ...'?",
"reference": "Does each CGMP workflow on a computer system need to be validated?",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "computer or related systems",
"D": "computer systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ..................................................................\n____ f. What are the systems in computer or related systems in 211.68?",
"reference": "..................................................................\n5 f. What are the systems in computer or related systems in 211.68?",
"options": {
"A": "5",
"B": "4 d.",
"C": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ..................................................................\n5 f. What are the systems in computer or related systems in ____?",
"reference": "..................................................................\n5 f. What are the systems in computer or related systems in 211.68?",
"options": {
"B": "211.68",
"A": "4 d.",
"C": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: BACKGROUND ............................................................................................................... ____ III.",
"reference": "BACKGROUND ............................................................................................................... 2 III.",
"options": {
"C": "2",
"A": "4 d.",
"B": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '5 e. How does FDA use the term backup in 211.68(b...'?",
"reference": "5 e. How does FDA use the term backup in 211.68(b)?",
"options": {
"C": "FDA",
"A": "CGMP",
"B": "CGMP computer systems",
"D": "computer or related systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ____ e. How does FDA use the term backup in 211.68(b)?",
"reference": "5 e. How does FDA use the term backup in 211.68(b)?",
"options": {
"D": "5",
"A": "4 d.",
"B": "211.68(b",
"C": "CGMP computer systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: '...............................\nHow should access ...'?",
"reference": "...............................\nHow should access to CGMP computer systems be restricted?",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "computer or related systems",
"C": "computer systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'Does each CGMP workflow on a computer system need ...'?",
"reference": "Does each CGMP workflow on a computer system need to be validated?",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "computer or related systems",
"D": "computer systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ................................................................................................................\n____ b.",
"reference": "................................................................................................................\n4 b.",
"options": {
"B": "4",
"A": "4 d.",
"C": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When is it permissible to invalidate a CGMP result...'?",
"reference": "When is it permissible to invalidate a CGMP result and exclude it from the determination of batch conformance?",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "computer or related systems",
"D": "computer systems"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '.....................................................'?",
"reference": ".................................................................................................................\n4 d. How does FDA use the terms static and dynamic as they relate to record for mats?",
"options": {
"C": "FDA",
"A": "CGMP",
"B": "CGMP computer systems",
"D": "computer or related systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .................................................................................................................\n____ d. How does FDA use the terms static and dynamic as they relate to record for mats?",
"reference": ".................................................................................................................\n4 d. How does FDA use the terms static and dynamic as they relate to record for mats?",
"options": {
"D": "4",
"A": "4 d.",
"B": "211.68(b",
"C": "CGMP computer systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: '...............................\nHow should access ...'?",
"reference": "...............................\nHow should access to CGMP computer systems be restricted?",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "computer or related systems",
"C": "computer systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: '................................................\nW...'?",
"reference": "................................................\nWhy is FDA concerned with the use of shared login accounts for computer systems?",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "CGMP computer systems",
"C": "computer or related systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When is it permissible to invalidate a CGMP result...'?",
"reference": "When is it permissible to invalidate a CGMP result and exclude it from the determination of batch conformance?",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "computer or related systems",
"C": "computer systems"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '................................................\nW...'?",
"reference": "................................................\nWhy is FDA concerned with the use of shared login accounts for computer systems?",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "CGMP computer systems",
"D": "computer or related systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Does each CGMP workflow on a computer system need ...'?",
"reference": "Does each CGMP workflow on a computer system need to be validated?",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "computer or related systems",
"C": "computer systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .......................................................................................................................\n____ c. What is an audit trail?",
"reference": ".......................................................................................................................\n4 c. What is an audit trail?",
"options": {
"D": "4",
"A": "4 d.",
"B": "211.68(b",
"C": "CGMP computer systems"
},
"answer": "D",
"difficulty": "easy",
"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: .........................................\n4 a.",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "computer or related systems",
"D": "computer systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Please clarify the following terms as they relate to CGMP records: .........................................\n____ a.",
"reference": "Please clarify the following terms as they relate to CGMP records: .........................................\n4 a.",
"options": {
"A": "4",
"B": "4 d.",
"C": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .......................................................................................................................\n____ c. What is an audit trail?",
"reference": ".......................................................................................................................\n4 c. What is an audit trail?",
"options": {
"D": "4",
"A": "4 d.",
"B": "211.68(b",
"C": "CGMP computer systems"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '...............................\nHow should access ...'?",
"reference": "...............................\nHow should access to CGMP computer systems be restricted?",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "computer or related systems",
"D": "computer systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"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: .........................................\n4 a.",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "computer or related systems",
"D": "computer systems"
},
"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]
DEFINED USER REQUIREMENTS A very important key to software validation is a documented user requirements specification that defines: the intended use of the software or automated equipment; and the extent to which the device manufacturer is dependent upon that software or equipment for production of a quality medical device. The device manufacturer (user) needs to define the expected operating environment including any required hardware and software configurations, software versions, utilities, etc. The user also needs to: document requirements for system performance, quality, error handling, startup, shutdown, security, etc. ; identify any safety related functions or features, such as sensors, alarms, interlocks, logical processing steps, or command sequences; and define objective criteria for determining acceptable performance. The validation must be conducted in accordance with a documented protocol, and the validation results must also be documented. (See 21 CFR 820.70(i).) Test cases should be documented that will exercise the system to challenge its performance against the pre-determined criteria, especially for its most critical parameters. Test cases should address error and alarm conditions, startup, shutdown, all applicable user functions and operator controls, potential operator errors, maximum and minimum ranges of allowed values, and stress conditions applicable to the intended use of the equipment. The test cases should be executed and the results should be recorded and evaluated to determine whether the results support a conclusion that the software is validated for its intended use. A device manufacturer may conduct a validation using their own personnel or may depend on a third party such as the equipment/software vendor or a consultant.
[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: A device manufacturer may conduct a validation using their own personnel or may depend on a ____ party such as the equipment/software vendor or a consultant.",
"reference": "A device manufacturer may conduct a validation using their own personnel or may depend on a third party such as the equipment/software vendor or a consultant.",
"options": {
"A": "third",
"B": "software validation",
"C": "any required hardware and software configurations",
"D": "3rd"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A device manufacturer may conduct a validation using their own personnel or may depend on a ____ party such as the equipment/software vendor or a consultant.",
"reference": "A device manufacturer may conduct a validation using their own personnel or may depend on a third party such as the equipment/software vendor or a consultant.",
"options": {
"B": "third",
"A": "software validation",
"C": "any required hardware and software configurations",
"D": "3rd"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A device manufacturer may conduct a validation using their own personnel or may depend on a ____ party such as the equipment/software vendor or a consultant.",
"reference": "A device manufacturer may conduct a validation using their own personnel or may depend on a third party such as the equipment/software vendor or a consultant.",
"options": {
"D": "third",
"A": "software validation",
"B": "any required hardware and software configurations",
"C": "3rd"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A device manufacturer may conduct a validation using their own personnel or may depend on a ____ party such as the equipment/software vendor or a consultant.",
"reference": "A device manufacturer may conduct a validation using their own personnel or may depend on a third party such as the equipment/software vendor or a consultant.",
"options": {
"A": "third",
"B": "software validation",
"C": "any required hardware and software configurations",
"D": "3rd"
},
"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]
On the other hand, extensive testing may be needed for: a plant-wide electronic record and electronic signature system; an automated controller for a sterilization cycle; or automated test equipment used for inspection and acceptance of finished circuit boards in a life- sustaining / life-supporting device. Numerous commercial software applications may be used as part of the quality system (e.g., a spreadsheet or statistical package used for quality system calculations, a graphics package used for trend analysis, or a commercial database used for recording device history records or for complaint management). The extent of validation evidence needed for such software depends on the device manufacturers documented intended use of that software. For example, a device manufacturer who chooses not to use all the vendor-supplied capabilities of the software only needs to validate those functions that will be used and for which the device manufacturer is dependent upon the software results as part of production or the quality system. However, high risk applications should not be running in the same operating environment with non-validated software functions, even if those software functions are not used. Risk mitigation techniques such as memory partitioning or other approaches to resource protection may need to be considered when high risk applications and lower risk applications are to be used in the same operating environment. When software is upgraded or any changes are made to the software, the device manufacturer should consider how those changes may impact the used portions of the software and must reconfirm the validation of those portions of the software that are used. (See 21 CFR 820.70(i).) Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Page 32General Principles of Software Validation G...'?",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"D": "FDA",
"A": "Numerous commercial software applications",
"B": "Software Validation Guidance",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"A": "6.2",
"B": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "FDA"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 32General Principles of Software Validation G...'?",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"B": "FDA",
"A": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"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": {
"A": "6.2",
"B": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "FDA"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 32General Principles of Software Validation G...'?",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"C": "FDA",
"A": "Numerous commercial software applications",
"B": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"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": {
"B": "FDA",
"A": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"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": {
"B": "FDA",
"A": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"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": {
"B": "FDA",
"A": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"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": {
"B": "FDA",
"A": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"A": "6.2",
"B": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "FDA"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 32General Principles of Software Validation G...'?",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"D": "FDA",
"A": "Numerous commercial software applications",
"B": "Software Validation Guidance",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"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": {
"B": "FDA",
"A": "Numerous commercial software applications",
"C": "Software Validation Guidance",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 32General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 32General Principles of Software Validation Guidance for Industry and FDA Staff 6.2.",
"options": {
"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": {
"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 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
It facilitates continual improve ment of process performance and product quality throughout the product lifecycle. IC H Q9 provides principles and ex amples of tools for quality risk management that can be applied to di fferent aspects of pharmaceutical quality. F. Design and Content Considerations (1.7) (a) The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to f acilitate common understanding and consistent application. (b) The elements of ICH Q10 should be applie d in a manner that is appropriate and proportionate to each of the product lifecycl e stages, recognizing the different goals 4 and knowledge available for each stage. (c) The size and complexity of the companys ac tivities should be taken into consideration when developing a new pharmaceutical quality system or modifying an existing one. The design of the pharmaceutical quality system should incorporate appropriate risk management principles. While some aspect s of the pharmaceutical quality system can be company wide and others site specific , the effectiveness of the pharmaceutical quality system is normally demonstrated at the site level. The pharmaceutical quality system should in clude appropriate processes, resources, and responsibilities to provide assurance of the quality of outsourced activities and purchased materials as described in section III.G (2.7). (e) Management responsibilities, as described in section III (2), should be identified within the pharmaceutical quality system. (f) The pharmaceutical quality system should include the following elements, as described in section IV (3): process performance and product quality monitoring, corrective and preventive action , change management, and management review. (g) Performance indicators , as described in section V (4), should be identified and used to monitor the effectiveness of processes w ithin the pharmaceutical quality system.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: '(b) The elements of ICH Q10 should be applie d in ...'?",
"reference": "(b) The elements of ICH Q10 should be applie d in a manner that is appropriate and proportionate to each of the product lifecycl e stages, recognizing the different goals 4 and knowledge available for each stage.",
"options": {
"C": "ICH Q10",
"A": "a new pharmaceutical quality system",
"B": "pharmaceutical quality",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (b) The elements of ICH Q10 should be applie d in a manner that is appropriate and proportionate to each of the product lifecycl e stages, recognizing the different goals ____ and knowledge available for each stage.",
"reference": "(b) The elements of ICH Q10 should be applie d in a manner that is appropriate and proportionate to each of the product lifecycl e stages, recognizing the different goals 4 and knowledge available for each stage.",
"options": {
"D": "4",
"A": "1.7",
"B": "2.7",
"C": "a new pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (c) The size and complexity of the companys ac tivities should be taken into consideration when developing a new pharmaceutical quality system or modifying an existing ____.",
"reference": "(c) The size and complexity of the companys ac tivities should be taken into consideration when developing a new pharmaceutical quality system or modifying an existing one.",
"options": {
"B": "one",
"A": "1.7",
"C": "2.7",
"D": "a new pharmaceutical quality system"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(b) The elements of ICH Q10 should be applie d in ...'?",
"reference": "(b) The elements of ICH Q10 should be applie d in a manner that is appropriate and proportionate to each of the product lifecycl e stages, recognizing the different goals 4 and knowledge available for each stage.",
"options": {
"A": "ICH Q10",
"B": "a new pharmaceutical quality system",
"C": "pharmaceutical quality",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (b) The elements of ICH Q10 should be applie d in a manner that is appropriate and proportionate to each of the product lifecycl e stages, recognizing the different goals ____ and knowledge available for each stage.",
"reference": "(b) The elements of ICH Q10 should be applie d in a manner that is appropriate and proportionate to each of the product lifecycl e stages, recognizing the different goals 4 and knowledge available for each stage.",
"options": {
"B": "4",
"A": "1.7",
"C": "2.7",
"D": "a new pharmaceutical quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (g) Performance indicators , as described in section V (____), should be identified and used to monitor the effectiveness of processes w ithin the pharmaceutical quality system.",
"reference": "(g) Performance indicators , as described in section V (4), should be identified and used to monitor the effectiveness of processes w ithin the pharmaceutical quality system.",
"options": {
"B": "4",
"A": "1.7",
"C": "2.7",
"D": "a new pharmaceutical quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'F. Design and Content Considerations (1.7) (a) The...'?",
"reference": "F. Design and Content Considerations (1.7) (a) The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to f acilitate common understanding and consistent application.",
"options": {
"B": "Content Considerations",
"A": "ICH Q10",
"C": "a new pharmaceutical quality system",
"D": "pharmaceutical quality"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: F. Design and Content Considerations (____) (a) The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to f acilitate common understanding and consistent application.",
"reference": "F. Design and Content Considerations (1.7) (a) The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to f acilitate common understanding and consistent application.",
"options": {
"D": "1.7",
"A": "2.7",
"B": "a new pharmaceutical quality system",
"C": "pharmaceutical quality"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (e) Management responsibilities, as described in section III (____), should be identified within the pharmaceutical quality system.",
"reference": "(e) Management responsibilities, as described in section III (2), should be identified within the pharmaceutical quality system.",
"options": {
"B": "2",
"A": "1.7",
"C": "2.7",
"D": "a new pharmaceutical quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'F. Design and Content Considerations (1.7) (a) The...'?",
"reference": "F. Design and Content Considerations (1.7) (a) The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to f acilitate common understanding and consistent application.",
"options": {
"D": "Content Considerations",
"A": "ICH Q10",
"B": "a new pharmaceutical quality system",
"C": "pharmaceutical quality"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'F. Design and Content Considerations (1.7) (a) The...'?",
"reference": "F. Design and Content Considerations (1.7) (a) The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to f acilitate common understanding and consistent application.",
"options": {
"D": "Content Considerations",
"A": "ICH Q10",
"B": "a new pharmaceutical quality system",
"C": "pharmaceutical quality"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: F. Design and Content Considerations (____) (a) The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to f acilitate common understanding and consistent application.",
"reference": "F. Design and Content Considerations (1.7) (a) The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to f acilitate common understanding and consistent application.",
"options": {
"B": "1.7",
"A": "2.7",
"C": "a new pharmaceutical quality system",
"D": "pharmaceutical quality"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (e) Management responsibilities, as described in section III (____), should be identified within the pharmaceutical quality system.",
"reference": "(e) Management responsibilities, as described in section III (2), should be identified within the pharmaceutical quality system.",
"options": {
"D": "2",
"A": "1.7",
"B": "2.7",
"C": "a new pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The pharmaceutical quality system should in clude appropriate processes, resources, and responsibilities to provide assurance of the quality of outsourced activities and purchased materials as described in section III.G (____).",
"reference": "The pharmaceutical quality system should in clude appropriate processes, resources, and responsibilities to provide assurance of the quality of outsourced activities and purchased materials as described in section III.G (2.7).",
"options": {
"B": "2.7",
"A": "1.7",
"C": "a new pharmaceutical quality system",
"D": "pharmaceutical quality"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (g) Performance indicators , as described in section V (____), should be identified and used to monitor the effectiveness of processes w ithin the pharmaceutical quality system.",
"reference": "(g) Performance indicators , as described in section V (4), should be identified and used to monitor the effectiveness of processes w ithin the pharmaceutical quality system.",
"options": {
"D": "4",
"A": "1.7",
"B": "2.7",
"C": "a new pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'F. Design and Content Considerations (1.7) (a) The...'?",
"reference": "F. Design and Content Considerations (1.7) (a) The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to f acilitate common understanding and consistent application.",
"options": {
"B": "Content Considerations",
"A": "ICH Q10",
"C": "a new pharmaceutical quality system",
"D": "pharmaceutical quality"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: F. Design and Content Considerations (____) (a) The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to f acilitate common understanding and consistent application.",
"reference": "F. Design and Content Considerations (1.7) (a) The design, organization, and documentation of the pharmaceutical quality system should be well structured and clear to f acilitate common understanding and consistent application.",
"options": {
"A": "1.7",
"B": "2.7",
"C": "a new pharmaceutical quality system",
"D": "pharmaceutical quality"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (e) Management responsibilities, as described in section III (____), should be identified within the pharmaceutical quality system.",
"reference": "(e) Management responsibilities, as described in section III (2), should be identified within the pharmaceutical quality system.",
"options": {
"A": "2",
"B": "1.7",
"C": "2.7",
"D": "a new pharmaceutical quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'IC H Q9 provides principles and ex amples of tools...'?",
"reference": "IC H Q9 provides principles and ex amples of tools for quality risk management that can be applied to di fferent aspects of pharmaceutical quality.",
"options": {
"B": "IC H Q9",
"A": "Content Considerations",
"C": "ICH Q10",
"D": "a new pharmaceutical quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(b) The elements of ICH Q10 should be applie d in ...'?",
"reference": "(b) The elements of ICH Q10 should be applie d in a manner that is appropriate and proportionate to each of the product lifecycl e stages, recognizing the different goals 4 and knowledge available for each stage.",
"options": {
"A": "ICH Q10",
"B": "a new pharmaceutical quality system",
"C": "pharmaceutical quality",
"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 35 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
This section describes management's role in developing, implementing, and managing a robust quality system . There is some overlap with the CGMP regulations in this sect ion (see the table at the end of the section). 1. Provide Leadership In a robust, modern quality system, senior management should dem onstrate commitment to developing and ma intaining their quality system. Quality system plans should be aligned with a manufacturers strategic plans to ensure that the system is part of the manufacturers mission and quality strategies. For example, quality systems departments normally have equal standing with 10 See Reference 3. 8
Contains Nonbinding Recommendations other departments within an organization. Quality systems staff are effectively integrated into manufacturing activities and are involved in activities such as nonconformance investigations. Senior managers set implementation priorities and develop action pl ans. All levels of ma nagement can provide support of the quality system by: Actively participating in system design, implementation, and monitoring, including system review (see IV.A.5.) Advocating continual improvement of operations of the quality system Committing necessary resources In a robust quality systems environment, all managers should demonstrate strong and visible support for the quality system and ensure its implementation throughout the organization (e.g., across multiple sites). All managers should encourage internal communication on quality issues at all levels in the organization. Communicati on should be ongoing among research and development, regulatory affairs, manufacturing, and QU personnel on issu es that affect quality, with management included whenever appropriate. 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: 'There is some overlap with the CGMP regulations in...'?",
"reference": "There is some overlap with the CGMP regulations in this sect ion (see the table at the end of the section).",
"options": {
"D": "CGMP",
"A": "Communicati",
"B": "a robust quality systems environment",
"C": "quality systems departments"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Communicati on should be ongoing among research an...'?",
"reference": "Communicati on should be ongoing among research and development, regulatory affairs, manufacturing, and QU personnel on issu es that affect quality, with management included whenever appropriate.",
"options": {
"D": "Communicati",
"A": "CGMP",
"B": "a robust quality systems environment",
"C": "quality systems departments"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nContains Nonbinding Recommendations other departments within an organization.",
"reference": "8\nContains Nonbinding Recommendations other departments within an organization.",
"options": {
"B": "8",
"A": "a robust quality systems environment",
"C": "quality systems departments",
"D": "octonary"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, quality systems departments normally have equal standing with ____ See Reference 3.",
"reference": "For example, quality systems departments normally have equal standing with 10 See Reference 3.",
"options": {
"C": "10",
"A": "a robust quality systems environment",
"B": "quality systems departments",
"D": "tenner"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, quality systems departments normally have equal standing with 10 See Reference ____.",
"reference": "For example, quality systems departments normally have equal standing with 10 See Reference 3.",
"options": {
"D": "3",
"A": "a robust quality systems environment",
"B": "quality systems departments",
"C": "troika"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Communicati on should be ongoing among research an...'?",
"reference": "Communicati on should be ongoing among research and development, regulatory affairs, manufacturing, and QU personnel on issu es that affect quality, with management included whenever appropriate.",
"options": {
"B": "Communicati",
"A": "CGMP",
"C": "a robust quality systems environment",
"D": "quality systems departments"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nContains Nonbinding Recommendations other departments within an organization.",
"reference": "8\nContains Nonbinding Recommendations other departments within an organization.",
"options": {
"B": "8",
"A": "a robust quality systems environment",
"C": "quality systems departments",
"D": "octonary"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, quality systems departments normally have equal standing with ____ See Reference 3.",
"reference": "For example, quality systems departments normally have equal standing with 10 See Reference 3.",
"options": {
"D": "10",
"A": "a robust quality systems environment",
"B": "quality systems departments",
"C": "tenner"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, quality systems departments normally have equal standing with 10 See Reference ____.",
"reference": "For example, quality systems departments normally have equal standing with 10 See Reference 3.",
"options": {
"C": "3",
"A": "a robust quality systems environment",
"B": "quality systems departments",
"D": "troika"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nContains Nonbinding Recommendations other departments within an organization.",
"reference": "8\nContains Nonbinding Recommendations other departments within an organization.",
"options": {
"D": "8",
"A": "a robust quality systems environment",
"B": "quality systems departments",
"C": "octonary"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, quality systems departments normally have equal standing with ____ See Reference 3.",
"reference": "For example, quality systems departments normally have equal standing with 10 See Reference 3.",
"options": {
"D": "10",
"A": "a robust quality systems environment",
"B": "quality systems departments",
"C": "tenner"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, quality systems departments normally have equal standing with 10 See Reference ____.",
"reference": "For example, quality systems departments normally have equal standing with 10 See Reference 3.",
"options": {
"A": "3",
"B": "a robust quality systems environment",
"C": "quality systems departments",
"D": "troika"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nContains Nonbinding Recommendations other departments within an organization.",
"reference": "8\nContains Nonbinding Recommendations other departments within an organization.",
"options": {
"A": "8",
"B": "a robust quality systems environment",
"C": "quality systems departments",
"D": "octonary"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Communicati on should be ongoing among research an...'?",
"reference": "Communicati on should be ongoing among research and development, regulatory affairs, manufacturing, and QU personnel on issu es that affect quality, with management included whenever appropriate.",
"options": {
"A": "Communicati",
"B": "CGMP",
"C": "a robust quality systems environment",
"D": "quality systems departments"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nContains Nonbinding Recommendations other departments within an organization.",
"reference": "8\nContains Nonbinding Recommendations other departments within an organization.",
"options": {
"C": "8",
"A": "a robust quality systems environment",
"B": "quality systems departments",
"D": "octonary"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, quality systems departments normally have equal standing with ____ See Reference 3.",
"reference": "For example, quality systems departments normally have equal standing with 10 See Reference 3.",
"options": {
"D": "10",
"A": "a robust quality systems environment",
"B": "quality systems departments",
"C": "tenner"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, quality systems departments normally have equal standing with 10 See Reference ____.",
"reference": "For example, quality systems departments normally have equal standing with 10 See Reference 3.",
"options": {
"C": "3",
"A": "a robust quality systems environment",
"B": "quality systems departments",
"D": "troika"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'There is some overlap with the CGMP regulations in...'?",
"reference": "There is some overlap with the CGMP regulations in this sect ion (see the table at the end of the section).",
"options": {
"C": "CGMP",
"A": "Communicati",
"B": "a robust quality systems environment",
"D": "quality systems departments"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nContains Nonbinding Recommendations other departments within an organization.",
"reference": "8\nContains Nonbinding Recommendations other departments within an organization.",
"options": {
"C": "8",
"A": "a robust quality systems environment",
"B": "quality systems departments",
"D": "octonary"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, quality systems departments normally have equal standing with ____ See Reference 3.",
"reference": "For example, quality systems departments normally have equal standing with 10 See Reference 3.",
"options": {
"A": "10",
"B": "a robust quality systems environment",
"C": "quality systems departments",
"D": "tenner"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, quality systems departments normally have equal standing with 10 See Reference ____.",
"reference": "For example, quality systems departments normally have equal standing with 10 See Reference 3.",
"options": {
"A": "3",
"B": "a robust quality systems environment",
"C": "quality systems departments",
"D": "troika"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nContains Nonbinding Recommendations other departments within an organization.",
"reference": "8\nContains Nonbinding Recommendations other departments within an organization.",
"options": {
"A": "8",
"B": "a robust quality systems environment",
"C": "quality systems departments",
"D": "octonary"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Communicati on should be ongoing among research an...'?",
"reference": "Communicati on should be ongoing among research and development, regulatory affairs, manufacturing, and QU personnel on issu es that affect quality, with management included whenever appropriate.",
"options": {
"D": "Communicati",
"A": "CGMP",
"B": "a robust quality systems environment",
"C": "quality systems departments"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Communicati on should be ongoing among research an...'?",
"reference": "Communicati on should be ongoing among research and development, regulatory affairs, manufacturing, and QU personnel on issu es that affect quality, with management included whenever appropriate.",
"options": {
"A": "Communicati",
"B": "CGMP",
"C": "a robust quality systems environment",
"D": "quality systems departments"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Communicati on should be ongoing among research an...'?",
"reference": "Communicati on should be ongoing among research and development, regulatory affairs, manufacturing, and QU personnel on issu es that affect quality, with management included whenever appropriate.",
"options": {
"C": "Communicati",
"A": "CGMP",
"B": "a robust quality systems environment",
"D": "quality systems departments"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'There is some overlap with the CGMP regulations in...'?",
"reference": "There is some overlap with the CGMP regulations in this sect ion (see the table at the end of the section).",
"options": {
"D": "CGMP",
"A": "Communicati",
"B": "a robust quality systems environment",
"C": "quality systems departments"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Communicati on should be ongoing among research an...'?",
"reference": "Communicati on should be ongoing among research and development, regulatory affairs, manufacturing, and QU personnel on issu es that affect quality, with management included whenever appropriate.",
"options": {
"A": "Communicati",
"B": "CGMP",
"C": "a robust quality systems environment",
"D": "quality systems departments"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Communicati on should be ongoing among research an...'?",
"reference": "Communicati on should be ongoing among research and development, regulatory affairs, manufacturing, and QU personnel on issu es that affect quality, with management included whenever appropriate.",
"options": {
"A": "Communicati",
"B": "CGMP",
"C": "a robust quality systems environment",
"D": "quality systems departments"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'There is some overlap with the CGMP regulations in...'?",
"reference": "There is some overlap with the CGMP regulations in this sect ion (see the table at the end of the section).",
"options": {
"B": "CGMP",
"A": "Communicati",
"C": "a robust quality systems environment",
"D": "quality systems departments"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nContains Nonbinding Recommendations other departments within an organization.",
"reference": "8\nContains Nonbinding Recommendations other departments within an organization.",
"options": {
"B": "8",
"A": "a robust quality systems environment",
"C": "quality systems departments",
"D": "octonary"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nContains Nonbinding Recommendations other departments within an organization.",
"reference": "8\nContains Nonbinding Recommendations other departments within an organization.",
"options": {
"C": "8",
"A": "a robust quality systems environment",
"B": "quality systems departments",
"D": "octonary"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nContains Nonbinding Recommendations other departments within an organization.",
"reference": "8\nContains Nonbinding Recommendations other departments within an organization.",
"options": {
"C": "8",
"A": "a robust quality systems environment",
"B": "quality systems departments",
"D": "octonary"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, quality systems departments normally have equal standing with ____ See Reference 3.",
"reference": "For example, quality systems departments normally have equal standing with 10 See Reference 3.",
"options": {
"A": "10",
"B": "a robust quality systems environment",
"C": "quality systems departments",
"D": "tenner"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, quality systems departments normally have equal standing with 10 See Reference ____.",
"reference": "For example, quality systems departments normally have equal standing with 10 See Reference 3.",
"options": {
"C": "3",
"A": "a robust quality systems environment",
"B": "quality systems departments",
"D": "troika"
},
"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 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Data should be maintained throughout the record s retention period with all associated metadata required to reconstruct the CGMP activity (e.g. , 211.188 and 211.194) . The relationships between data and their metadata should be preserved in a secure and traceable manner. What is an audit trail ? For purposes of this guidance, audit t rail means a secure, computer -generated, time- stamped electronic record that allows for reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record. For example, the audit trail for a high performance l iquid c hromatography (HPLC ) run should include the user name, date/time of the run, the integration parameters used, and details of a reprocessing , if any . Documentation should include change justification for the reprocessing . These characteristics are important to ensuring data integrity and are addressed throughout the CGMP regulations for drugs. 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 contemporaneously recorded (at the time of performance), see 211.100(b) and 211.160(a); for original or a true copy , see 211.18 0 and 211.194(a); and for accurate , see 211.22(a), 211.68, 211.188, and 212.60(g). For examples of record retention periods, see 211.180 and 212.110(c). Contains Nonbinding Recommendations 5 Audit trails include those that tra ck creation, modification, or deletion of data (such as processing parameters and results) and those that track actions at the record or system level (such as attempts to access the system or rename or delete a file). CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and 211.194). Electronic record -keeping systems, which include audit trails, can support these CGMP 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: 'These characteristics are important to ensuring da...'?",
"reference": "These characteristics are important to ensuring data integrity and are addressed throughout the CGMP regulations for drugs.",
"options": {
"C": "CGMP",
"A": "data integrity",
"B": "Recommendations 5 Audit trails",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CGMP -compliant record -keeping practices prevent ...'?",
"reference": "CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and 211.194).",
"options": {
"B": "CGMP",
"A": "data integrity",
"C": "Recommendations 5 Audit trails",
"D": "211.68"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'CGMP -compliant record -keeping practices prevent ...'?",
"reference": "CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and 211.194).",
"options": {
"C": "211.160(a",
"A": "211.188",
"B": "211.194",
"D": "CGMP -compliant record -keeping practices"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see ____, 211.100, 211.160(a), 211.188, and 211.194).",
"reference": "CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and 211.194).",
"options": {
"D": "211.68",
"A": "211.188",
"B": "211.194",
"C": "CGMP -compliant record -keeping practices"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, ____, 211.160(a), 211.188, and 211.194).",
"reference": "CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and 211.194).",
"options": {
"B": "211.100",
"A": "211.188",
"C": "211.194",
"D": "CGMP -compliant record -keeping practices"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), ____, and 211.194).",
"reference": "CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and 211.194).",
"options": {
"A": "211.188",
"B": "211.194",
"C": "211.101(d",
"D": "CGMP -compliant record -keeping practices"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and ____).",
"reference": "CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and 211.194).",
"options": {
"B": "211.194",
"A": "211.188",
"C": "211.101(d",
"D": "CGMP -compliant record -keeping practices"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'These characteristics are important to ensuring da...'?",
"reference": "These characteristics are important to ensuring data integrity and are addressed throughout the CGMP regulations for drugs.",
"options": {
"D": "CGMP",
"A": "data integrity",
"B": "Recommendations 5 Audit trails",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For examples of record retention periods, see ____ and 212.110(c).",
"reference": "For examples of record retention periods, see 211.180 and 212.110(c).",
"options": {
"B": "211.180",
"A": "211.188",
"C": "211.194",
"D": "CGMP -compliant record -keeping practices"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ Audit trails include those that tra ck creation, modification, or deletion of data (such as processing parameters and results) and those that track actions at the record or system level (such as attempts to access the system or rename or delete a file).",
"reference": "Contains Nonbinding Recommendations 5 Audit trails include those that tra ck creation, modification, or deletion of data (such as processing parameters and results) and those that track actions at the record or system level (such as attempts to access the system or rename or delete a file).",
"options": {
"D": "5",
"A": "211.188",
"B": "211.194",
"C": "CGMP -compliant record -keeping practices"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Data should be maintained throughout the record s ...'?",
"reference": "Data should be maintained throughout the record s retention period with all associated metadata required to reconstruct the CGMP activity (e.g.",
"options": {
"C": "CGMP",
"A": "data integrity",
"B": "Recommendations 5 Audit trails",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ Audit trails include those that tra ck creation, modification, or deletion of data (such as processing parameters and results) and those that track actions at the record or system level (such as attempts to access the system or rename or delete a file).",
"reference": "Contains Nonbinding Recommendations 5 Audit trails include those that tra ck creation, modification, or deletion of data (such as processing parameters and results) and those that track actions at the record or system level (such as attempts to access the system or rename or delete a file).",
"options": {
"B": "5",
"A": "211.188",
"C": "211.194",
"D": "CGMP -compliant record -keeping practices"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Electronic record -keeping systems, which include ...'?",
"reference": "Electronic record -keeping systems, which include audit trails, can support these CGMP requirements.",
"options": {
"B": "CGMP",
"A": "data integrity",
"C": "Recommendations 5 Audit trails",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CGMP -compliant record -keeping practices prevent ...'?",
"reference": "CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and 211.194).",
"options": {
"B": "CGMP",
"A": "data integrity",
"C": "Recommendations 5 Audit trails",
"D": "211.68"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'CGMP -compliant record -keeping practices prevent ...'?",
"reference": "CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and 211.194).",
"options": {
"B": "211.160(a",
"A": "211.188",
"C": "211.194",
"D": "CGMP -compliant record -keeping practices"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see ____, 211.100, 211.160(a), 211.188, and 211.194).",
"reference": "CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and 211.194).",
"options": {
"C": "211.68",
"A": "211.188",
"B": "211.194",
"D": "CGMP -compliant record -keeping practices"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, ____, 211.160(a), 211.188, and 211.194).",
"reference": "CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and 211.194).",
"options": {
"D": "211.100",
"A": "211.188",
"B": "211.194",
"C": "CGMP -compliant record -keeping practices"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), ____, and 211.194).",
"reference": "CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and 211.194).",
"options": {
"C": "211.188",
"A": "211.194",
"B": "211.101(d",
"D": "CGMP -compliant record -keeping practices"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and ____).",
"reference": "CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and 211.194).",
"options": {
"C": "211.194",
"A": "211.188",
"B": "211.101(d",
"D": "CGMP -compliant record -keeping practices"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CGMP -compliant record -keeping practices prevent ...'?",
"reference": "CGMP -compliant record -keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see 211.68, 211.100, 211.160(a), 211.188, and 211.194).",
"options": {
"D": "CGMP",
"A": "data integrity",
"B": "Recommendations 5 Audit trails",
"C": "211.68"
},
"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]
For example, you must implement documentation controls that ensure that the actions as described in question 4 are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 211.194(a)(7) and (8) , and 212.50(c)(10) ). Shared , read-only user accounts that do not allow the user to modify data or settings are acceptable for viewing data , but they do not conform with the part 211 and 212 requirements for actions , such as second person review, to be attributable to a specific individual . How should blank forms be controlled ? There must be document controls in place to as sure product quality (see 211.100, 211.160(a) , 211.186, 212.20(d) , and 212.60(g)). For example, bound paginated notebooks, stamped for official use by a document control group, provide good document control because they allow easy detection of unofficial notebooks a s well as any gaps in notebook pages . If used, blank forms (e.g., electronic worksheets, laboratory notebooks, and MPCRs ) should be controlled by the quality unit or by another document control method. As appropriate , numbered sets of blank forms may be issued and should be reconciled upon completion of all issued forms. Incomplete or erroneous forms should be kept as part of the permanent record along with written justification for their replacement ( see, e.g., 21 1.192, 211.194, 212.50(a) , and Contains Nonbinding Recommendations 8 212.70(f)(1)(vi)). All data required to recre ate a CGMP activity should be main tained as part of the complete record. Who should review audit trails? Audit trail review is similar to assessing cross- outs on paper when reviewing data. Personnel responsible for record review under CGMP should review the audit trails that capture changes to data associated with the record as they review the rest of the record ( e.g., 211.22(a), 211.101( c) and (d) , 211.103, 211.182, 211.186(a), 211.192, 211.194(a)(8) , and 212.20(d) ).
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: For example, you must implement documentation controls that ensure that the actions as described in question ____ are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "For example, you must implement documentation controls that ensure that the actions as described in question 4 are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"C": "4",
"A": "211.68(b",
"B": "211.188(b)(11",
"D": "record review"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'All data required to recre ate a CGMP activity sho...'?",
"reference": "All data required to recre ate a CGMP activity should be main tained as part of the complete record.",
"options": {
"D": "CGMP",
"A": "record review",
"B": "should blank forms",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Shared , read-only user accounts that do not allow the user to modify data or settings are acceptable for viewing data , but they do not conform with the part ____ and 212 requirements for actions , such as second person review, to be attributable to a specific individual .",
"reference": "Shared , read-only user accounts that do not allow the user to modify data or settings are acceptable for viewing data , but they do not conform with the part 211 and 212 requirements for actions , such as second person review, to be attributable to a specific individual .",
"options": {
"C": "211",
"A": "211.68(b",
"B": "211.188(b)(11",
"D": "record review"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Shared , read-only user accounts that do not allow the user to modify data or settings are acceptable for viewing data , but they do not conform with the part 211 and ____ requirements for actions , such as second person review, to be attributable to a specific individual .",
"reference": "Shared , read-only user accounts that do not allow the user to modify data or settings are acceptable for viewing data , but they do not conform with the part 211 and 212 requirements for actions , such as second person review, to be attributable to a specific individual .",
"options": {
"D": "212",
"A": "211.68(b",
"B": "211.188(b)(11",
"C": "record review"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Shared , read-only user accounts that do not allow the user to modify data or settings are acceptable for viewing data , but they do not conform with the part 211 and 212 requirements for actions , such as ____ person review, to be attributable to a specific individual .",
"reference": "Shared , read-only user accounts that do not allow the user to modify data or settings are acceptable for viewing data , but they do not conform with the part 211 and 212 requirements for actions , such as second person review, to be attributable to a specific individual .",
"options": {
"D": "second",
"A": "record review",
"B": "should blank forms",
"C": "secondly"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, you must implement documentation controls that ensure that the actions as described in question ____ are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "For example, you must implement documentation controls that ensure that the actions as described in question 4 are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"C": "4",
"A": "211.68(b",
"B": "211.188(b)(11",
"D": "record review"
},
"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]
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: '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"
},
{
"question": "When did this occur: 'Electronic Records; Electronic Signatures Final Ru...'?",
"reference": "Electronic Records; Electronic Signatures Final Rule, 62 Federal Register 13430 (March 20, 1997).",
"options": {
"A": "March 20, 1997",
"B": "March 1997",
"C": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"D": "Software Validation Guidance"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic Records; Electronic Signatures Final Rule, ____ Federal Register 13430 (March 20, 1997).",
"reference": "Electronic Records; Electronic Signatures Final Rule, 62 Federal Register 13430 (March 20, 1997).",
"options": {
"C": "62",
"A": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"B": "Software Validation Guidance",
"D": "sixty-two"
},
"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]
According to section 501(a)(2)(B) of the FDC Act, a drug shall be deemed adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of th e act as to safety and has the identity a nd strength, and meets the quality and purity characteristics, which it purpor ts or is represented to possess. Contains Nonbinding Recommendations 3 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ). 211.182, 211.186(a), 211.188(b)(11), and 211.194(a)(8) ( requir ing that records be checked, verified, or reviewed ). When considering how to meet many of these regulatory requirements , it may be useful to ask the following questions: Are controls in place to ensure that data is complete? Are activities documented at the time of performance? Are activities attributable to a specific individual? Can only authorized individuals make changes to records? Is there a record of changes to data? Are records reviewed for accuracy, completeness, and compliance with established standards? Are data maintained securely from data creation through disposition after the records retention period? This guidance helps answer these questions and enable s an understanding of key concepts behind the regulatory requirements . While not in the scope of this guidance, data integrity -related CGMP violations can also impact or be directly linked to application filing , review , and regulatory actions . Electronic signature and record -keeping requirements are laid out in 21 CFR part 11 and apply to certain records subject to records requirements set forth in A gency regula tions, including parts 210, 211, and 212.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"reference": "Contains Nonbinding Recommendations 3 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"options": {
"C": "3",
"A": "211.22",
"B": "211.192",
"D": "records requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations 3 ____, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"reference": "Contains Nonbinding Recommendations 3 211.22, 211.192, and 211.194(a) (requiring that production and control records be reviewed and that labora tory records be reviewed for accuracy, completeness, and compliance with established standards ).",
"options": {
"C": "211.22",
"A": "211.192",
"B": "211.194(a",
"D": "records requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
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]
ISO/IEC 14598:1999, Information technology Software product evaluation, Joint Technical Committee ISO/IEC JTC 1, Subcommittee SC 7, International Organization for Standardization and International Electrotechnical Commission, 1999. ISO 14971-1:1998 , Medical Devices Risk Management Part 1: Application of Risk Analysis. International Organization for Standardization, 1998 . Software Considerations in Airborne Systems and Equipment Certification . Special Committee 167 of RTCA. RTCA Inc., Washington, D.C.
Tel: 202-833-9339. Document No. RTCA/DO- 178B, December 1992. Production Process Software References The Application of the Principles of GLP to Computerized Systems, Environmental Monograph 116 , Organization for Economic Cooperation and Development (OECD), 1995. George J. Grigonis, Jr., Edward J. Subak, Jr., and Michael Wyrick, Validation Key Practices for Computer Systems Used in Regulated Operations , Pharmaceutical Technology , June 1997. Guide to Inspection of Computerized Systems in Drug Processing, Reference Materials and Page 39General Principles of Software Validation Guidance for Industry and FDA Staff Training Aids for Investigators , Division of Drug Quality Compliance, Associate Director for Compliance, Office of Drugs, National Center for Drugs and Biologics, Division of Field Investigations, Associate Director for Field Support, Executive Director of Regional Operations, Food and Drug Administration, February 1983. Daniel P. Olivier, Validating Process Software, FDA Investigator Course: Medical Device Process Validation , Food and Drug Administration. GAMP Guide For Validation of Automated Systems in Pharmaceutical Manufacture,Version V3.0, Good Automated Manufacturing Practice (GAMP)
Forum, March 1998:
Volume 1, Part 1: User Guide Part 2: Supplier Guide Volume 2: Best Practice for User and Suppliers. Technical Report
No. 18, Validation of Computer-Related Systems . PDA Committee on Validation of Computer-Related 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: 'Production Process Software References The Applica...'?",
"reference": "Production Process Software References The Application of the Principles of GLP to Computerized Systems, Environmental Monograph 116 , Organization for Economic Cooperation and Development (OECD), 1995.",
"options": {
"C": "GLP",
"A": "ISO",
"B": "Information",
"D": "Software Validation Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Production Process Software References The Applica...'?",
"reference": "Production Process Software References The Application of the Principles of GLP to Computerized Systems, Environmental Monograph 116 , Organization for Economic Cooperation and Development (OECD), 1995.",
"options": {
"D": "Computerized Systems",
"A": "ISO",
"B": "Information",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Production Process Software References The Applica...'?",
"reference": "Production Process Software References The Application of the Principles of GLP to Computerized Systems, Environmental Monograph 116 , Organization for Economic Cooperation and Development (OECD), 1995.",
"options": {
"B": "Organization for Economic Cooperation and Development",
"A": "ISO",
"C": "Information",
"D": "Software 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 10 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 25Features, Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Usability Feature: The software provides the user a help menu for the application. This feature is intended to facilitate the interaction of the user with the system and provide assistance on use of all the system features .The
failure of the feature to perform as intended is unlikely to result in a quality problem that would lead to compromised safety . Therefore, the manufa cturer determined that the feature does not pose high process risk. The feature does not necessitate any additional assurance effort beyond what the manufacturer has already performed in assessing the system capability, supplier evaluation, and installation activities .The manufacturer documents: the intended use risk determination the date of assessment and who pe rformed the assessment a concluding statement noting that the performance is acceptable given the intended use and risk . Reporting Functions: The software is able to create and perform queries and join data from various sources to perform data mining . The software allows for various statistical analysis and data summarization. The software is able to create graphs from the data. The software provides the capability to generate reports of the analysis. These functions are intended to allow the user to query the data sources, join data from various sources , perform analysis, and generate visuals and summaries . These functions are intended for collection and recording data for monitoring and review purposes that do not have a direct impact on production or process performance . In this example, the software is not intended to inform quality decisions.
[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 25Features, Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Usability Feature: The software provides the user a help menu for the application.",
"options": {
"D": "Functions",
"A": "the data sources",
"B": "the appropriate record Usability Feature",
"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 25Features, Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Usability Feature: The software provides the user a help menu for the application.",
"options": {
"C": "Function",
"A": "the data sources",
"B": "the appropriate record Usability Feature",
"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 25Features, Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Usability Feature: The software provides the user a help menu for the application.",
"options": {
"B": "Usability Feature",
"A": "Functions",
"C": "Function",
"D": "the data sources"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Therefore, the manufa cturer determined that the feature doe...'?",
"reference": "Therefore, the manufa cturer determined that the feature does not pose high process risk.",
"options": {
"A": "Therefore, the manufa cturer determined that the feature does not pose high process risk.",
"B": "the data sources",
"C": "the appropriate record Usability Feature",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Therefore, the manufa cturer determined that the feature doe...'?",
"reference": "Therefore, the manufa cturer determined that the feature does not pose high process risk.",
"options": {
"D": "Therefore, the manufa cturer determined that the feature does not pose high process risk.",
"A": "the data sources",
"B": "the appropriate record Usability Feature",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Therefore, the manufa cturer determined that the feature doe...'?",
"reference": "Therefore, the manufa cturer determined that the feature does not pose high process risk.",
"options": {
"B": "Therefore, the manufa cturer determined that the feature does not pose high process risk.",
"A": "the data sources",
"C": "the appropriate record Usability Feature",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'Therefore, the manufa cturer determined that the feature doe...'?",
"reference": "Therefore, the manufa cturer determined that the feature does not pose high process risk.",
"options": {
"B": "Therefore, the manufa cturer determined that the feature does not pose high process risk.",
"A": "the data sources",
"C": "the appropriate record Usability Feature",
"D": "This information is not mentioned in the context"
},
"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 25Features, Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Usability Feature: The software provides the user a help menu for the application.",
"options": {
"C": "Functions",
"A": "the data sources",
"B": "the appropriate record Usability Feature",
"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 25Features, Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Usability Feature: The software provides the user a help menu for the application.",
"options": {
"D": "Function",
"A": "the data sources",
"B": "the appropriate record Usability Feature",
"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 25Features, Functions, or OperationsIntended Use of the Feature s, Function s or Operat ionsRisk -Based Analysis Assurance Activities Establishing the appropriate record Usability Feature: The software provides the user a help menu for the application.",
"options": {
"A": "Usability Feature",
"B": "Functions",
"C": "Function",
"D": "the data sources"
},
"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]
Delores R. Wallace, Laura M. Ippolito, D. Richard Kuhn, NIST Special Publication 500-204, High Integrity Software, Standards and Guidelines , Computer Systems Laboratory, National Institute of Page 37General Principles of Software Validation Guidance for Industry and FDA Staff Standards and Technology, U.S. Department of Commerce, September 1992. Delores R. Wallace, et.al. NIST Special Publication 500-234, Reference Information for the Software Verification and Validation Process . Computer Systems Laboratory, National Institute of Standards and Technology, U.S. Department of Commerce, March 1996. Delores R. Wallace, Editor. NIST Special Publication 500-235, Structured Testing: A Testing Methodology Using the Cyclomatic Complexity Metric . Computer Systems Laboratory, National Institute of Standards and Technology, U.S. Department of Commerce, August 1996.
International and National Consensus Standards ANSI / ANS-10.4-1987, Guidelines for the Verification and Validation of Scientific and Engineering Computer Programs for the Nuclear Industry , American National Standards Institute, 1987. ANSI / ASQC Standard D1160-1995, Formal Design Reviews , American Society for Quality Control, 1995. ANSI / UL 1998:1998, Standard for Safety for Software in Programmable Components, Underwriters Laboratories, Inc., 1998. AS 3563.1-1991, Software Quality Management System, Part 1: Requirements . Published by Standards Australia [Standards Association of Australia], 1 The Crescent, Homebush, NSW 2140. AS 3563.2-1991, Software Quality Management System, Part 2: Implementation Guide . Published by Standards Australia [Standards Association of Australia], 1 The Crescent, Homebush, NSW 2140. IEC 60601-1-4:1996 , Medical electrical equipment, Part 1: General requirements for safety, 4. Collateral Standard: Programmable electrical medical systems . International Electrotechnical Commission, 1996.
[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: 'ANSI / UL 1998:1998, Standard for Safety for Softw...'?",
"reference": "ANSI / UL 1998:1998, Standard for Safety for Software in Programmable Components, Underwriters Laboratories, Inc., 1998.",
"options": {
"B": "ANSI",
"A": "National Institute of Page 37General Principles of Software Validation Guidance for Industry",
"C": "FDA",
"D": "American National Standards Institute"
},
"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]
D. Organization of this Guidance To provide a reference familiar to industry, th e quality systems model described in section IV of this guidance is organized in its major secti ons according to the structure of in ternational quality standards. Majo r sections of the model include the following: Management Responsibilities Resources Manufacturing Operations Evaluation Activities Under each of these sections the key elements found in modern quality systems are discussed. When an elem ent correlates with a CGMP regulator y requirement, that correlation is noted. In some cases, a specific CGMP regulation is discusse d in more detail as it relates to a quality system element. At the end of each section, a table is included lis ting the quality system elements of that section and the specific CGMP regulations with which they correlate. A glossary is included at the end of the document. CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS
Several key concepts are critical for any discussion of modern quality systems. The following concepts are used throughout this guidance as th ey relate to the manuf acture of pharmaceutical products. A. Quality Every pharmaceutical product has established id entity, strength, purity, and other quality characteristics designed to ensure the required levels of safety and effectiv eness. For the purposes of this guidance document, the phrase achieving quality means achieving these characteristics for a product. 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: 'When an elem ent correlates with a CGMP regulator ...'?",
"reference": "When an elem ent correlates with a CGMP regulator y requirement, that correlation is noted.",
"options": {
"A": "CGMP",
"B": "D. Organization of this Guidance",
"C": "Management Responsibilities Resources Manufacturing Operations Evaluation Activities",
"D": "MODERN QUALITY SYSTEMS\nSeveral key concepts"
},
"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 3 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": "When did this occur: 'Su ch activities do not substitute for, or preclud...'?",
"reference": "Su ch activities do not substitute for, or preclude, the daily responsibility of manuf acturing personnel to build quality in to the product.",
"options": {
"C": "daily",
"A": "modern quality systems",
"B": "product quality standards",
"D": "day-to-day"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"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": {
"D": "CGMP",
"A": "scientists.8 Manufacturing",
"B": "modern quality systems",
"C": "product quality standards"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Other CGMP assigned responsibilities of the QU are...'?",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"C": "CGMP",
"A": "scientists.8 Manufacturing",
"B": "modern quality systems",
"D": "product quality standards"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 40 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
71, Room 3128 Silver Spring, MD 20993- 0002
Phone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I. INTRODUCTION............................................................................................................. 1 II. BACKGROUND ............................................................................................................... 1 III. QUESTIONS AND ANSWERS ....................................................................................... Please clarify the following terms as they relate to CGMP records: .........................................
2 a. What is data integrity? ................................................................................................................
b. What is metadata? ....................................................................................................................... 3 c.
What is an audit trail? .................................................................................................................
3 d. How does FDA use the terms static and dynamic as they relate to record formats? ............. 3 e. How does FDA use the term backup in 211.68( b)?
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'BACKGROUND ..........................................'?",
"reference": "BACKGROUND ............................................................................................................... 1 III.",
"options": {
"A": "BACKGROUND",
"B": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Pharmaceutical Quality/Manufacturing Standards",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: BACKGROUND ............................................................................................................... ____ III.",
"reference": "BACKGROUND ............................................................................................................... 1 III.",
"options": {
"A": "1",
"B": "800",
"C": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'BACKGROUND ..........................................'?",
"reference": "BACKGROUND ............................................................................................................... 1 III.",
"options": {
"D": "BACKGROUND",
"A": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Pharmaceutical Quality/Manufacturing Standards",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: BACKGROUND ............................................................................................................... ____ III.",
"reference": "BACKGROUND ............................................................................................................... 1 III.",
"options": {
"C": "1",
"A": "800",
"B": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'BACKGROUND ..........................................'?",
"reference": "BACKGROUND ............................................................................................................... 1 III.",
"options": {
"C": "BACKGROUND",
"A": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Pharmaceutical Quality/Manufacturing Standards",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: BACKGROUND ............................................................................................................... ____ III.",
"reference": "BACKGROUND ............................................................................................................... 1 III.",
"options": {
"B": "1",
"A": "800",
"C": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ....................................................................................................................... ____ c.\nWhat is an audit trail?",
"reference": "....................................................................................................................... 3 c.\nWhat is an audit trail?",
"options": {
"D": "3",
"A": "800",
"B": "240",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '............. 3 e. How does FDA use the term backu...'?",
"reference": "............. 3 e. How does FDA use the term backup in 211.68( b)?",
"options": {
"C": "FDA",
"A": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Pharmaceutical Quality/Manufacturing Standards",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ............. ____ e. How does FDA use the term backup in 211.68( b)?",
"reference": "............. 3 e. How does FDA use the term backup in 211.68( b)?",
"options": {
"B": "3",
"A": "800",
"C": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ............. 3 e. How does FDA use the term backup in ____( b)?",
"reference": "............. 3 e. How does FDA use the term backup in 211.68( b)?",
"options": {
"D": "211.68",
"A": "800",
"B": "240",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: '............. 3 e. How does FDA use the term backu...'?",
"reference": "............. 3 e. How does FDA use the term backup in 211.68( b)?",
"options": {
"A": "FDA",
"B": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Pharmaceutical Quality/Manufacturing Standards",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ............. ____ e. How does FDA use the term backup in 211.68( b)?",
"reference": "............. 3 e. How does FDA use the term backup in 211.68( b)?",
"options": {
"D": "3",
"A": "800",
"B": "240",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ............. 3 e. How does FDA use the term backup in ____( b)?",
"reference": "............. 3 e. How does FDA use the term backup in 211.68( b)?",
"options": {
"B": "211.68",
"A": "800",
"C": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'BACKGROUND ..........................................'?",
"reference": "BACKGROUND ............................................................................................................... 1 III.",
"options": {
"D": "BACKGROUND",
"A": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Pharmaceutical Quality/Manufacturing Standards",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: BACKGROUND ............................................................................................................... ____ III.",
"reference": "BACKGROUND ............................................................................................................... 1 III.",
"options": {
"C": "1",
"A": "800",
"B": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ....................................................................................................................... ____ c.\nWhat is an audit trail?",
"reference": "....................................................................................................................... 3 c.\nWhat is an audit trail?",
"options": {
"D": "3",
"A": "800",
"B": "240",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"A": "71, Room 3128",
"B": "20993- 0002",
"C": "April 2016",
"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": "What location is mentioned: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"A": "MD",
"B": "Rockville",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center",
"D": "Veterinary Medicine Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"B": "20993- 0002",
"A": "71, Room 3128",
"C": "April 2016",
"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": "Who is mentioned in the context: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"D": "Standish Place",
"A": "Recommendations Draft Not for",
"B": "metadata",
"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: INTRODUCTION............................................................................................................. ____ II.",
"reference": "INTRODUCTION............................................................................................................. 1 II.",
"options": {
"D": "1",
"A": "800",
"B": "240",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION............................................................................................................. ____ II.",
"reference": "INTRODUCTION............................................................................................................. 1 II.",
"options": {
"B": "1",
"A": "800",
"C": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '............. 3 e. How does FDA use the term backu...'?",
"reference": "............. 3 e. How does FDA use the term backup in 211.68( b)?",
"options": {
"A": "FDA",
"B": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"C": "Pharmaceutical Quality/Manufacturing Standards",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ............. ____ e. How does FDA use the term backup in 211.68( b)?",
"reference": "............. 3 e. How does FDA use the term backup in 211.68( b)?",
"options": {
"A": "3",
"B": "800",
"C": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ............. 3 e. How does FDA use the term backup in ____( b)?",
"reference": "............. 3 e. How does FDA use the term backup in 211.68( b)?",
"options": {
"D": "211.68",
"A": "800",
"B": "240",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "When did this occur: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"B": "71, Room 3128",
"A": "20993- 0002",
"C": "April 2016",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"A": "MD",
"B": "Rockville",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center",
"D": "Veterinary Medicine Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"B": "20993- 0002",
"A": "71, Room 3128",
"C": "April 2016",
"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": "Who is mentioned in the context: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"D": "Standish Place",
"A": "Recommendations Draft Not for",
"B": "metadata",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"C": "Rockville",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center",
"B": "Veterinary Medicine Food and Drug Administration",
"D": "71, Room 3128"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION............................................................................................................. ____ II.",
"reference": "INTRODUCTION............................................................................................................. 1 II.",
"options": {
"C": "1",
"A": "800",
"B": "240",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Please clarify the following terms as they relate ...'?",
"reference": "Please clarify the following terms as they relate to CGMP records: .........................................\n2 a.",
"options": {
"D": "CGMP",
"A": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"B": "Pharmaceutical Quality/Manufacturing Standards",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Please clarify the following terms as they relate to CGMP records: .........................................\n____ a.",
"reference": "Please clarify the following terms as they relate to CGMP records: .........................................\n2 a.",
"options": {
"D": "2",
"A": "800",
"B": "240",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"D": "71, Room 3128",
"A": "20993- 0002",
"B": "April 2016",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"A": "MD",
"B": "Rockville",
"C": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center",
"D": "Veterinary Medicine Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"B": "20993- 0002",
"A": "71, Room 3128",
"C": "April 2016",
"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": "Who is mentioned in the context: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"B": "Standish Place",
"A": "Recommendations Draft Not for",
"C": "metadata",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"D": "Rockville",
"A": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center",
"B": "Veterinary Medicine Food and Drug Administration",
"C": "71, Room 3128"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"D": "MD",
"A": "Rockville",
"B": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center",
"C": "Veterinary Medicine Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '71, Room 3128 Silver Spring, MD 20993- 0002\nPhone ...'?",
"reference": "71, Room 3128 Silver Spring, MD 20993- 0002\nPhone : 800 -835-4709 or 240 -402-8010 Email: ocodfda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/defaul t.htm and/or Policy and Regulations Staff, HFV -6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eval uation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) Contains Non binding Recommendations Draft Not for Implementation TABLE OF CONTENTS I.",
"options": {
"B": "http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research",
"A": "Pharmaceutical Quality/Manufacturing Standards",
"C": "CGMP",
"D": "Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
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]
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: '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": {
"D": "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",
"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": {
"D": "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",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"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": {
"C": "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",
"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": {
"B": "Therefore, the manufacturer determined t hat these functions do not pose high process risk.",
"A": "the intended use risk determination",
"C": "performed supplier evaluation and installation activities",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"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": {
"C": "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",
"D": "This information is not mentioned in the context"
},
"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]
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to d iscuss an alternativ e approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify th e appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. INTRODUCTION This guidance is intended to he lp manufacturers implementing mode rn quality systems and risk management approaches to m eet the requireme nts of the Agency's current good manufacturing practice (CGMP) regulations (2l CFR part s 210 and 211). The guidance describes a comprehensive quality systems (QS) model, highlighting the model's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products. The guidance also explains how manufacturers implem enting such quality systems can be in full compliance with parts 210 and 211. This guidance is not intended to place new expectations on manufacturers, nor to replac e the CGMP requirements. Readers are advised to always refer to parts 210 and 211 to ensu re full compliance with the regulations. FDA's guidance documents, including this guida nce, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinki ng on a topic and should be viewed only as recommendations, unless spec ific regulatory or stat utory requireme nts are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. BACKGROUND AND PURPOSE A. Background In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative. In that announcement, the FDA explaine d the Agencys intent to integrate quality systems and risk management approaches into its existing programs with the goal of encouraging industry to adopt modern and innovative manufacturing technologies.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "When did this occur: 'Background In August 2002, the FDA announced the P...'?",
"reference": "Background In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative.",
"options": {
"D": "August 2002",
"A": "the 21st Century",
"B": "FDA's guidance documents",
"C": "this guidance"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Background In August 2002, the FDA announced the P...'?",
"reference": "Background In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative.",
"options": {
"B": "FDA",
"A": "Agency",
"C": "CGMP",
"D": "this guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Background In August 2002, the FDA announced the P...'?",
"reference": "Background In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative.",
"options": {
"D": "the 21st Century",
"A": "August 2002",
"B": "FDA's guidance documents",
"C": "this guidance"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Background In August ____, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative.",
"reference": "Background In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative.",
"options": {
"A": "2002",
"B": "August 2002",
"C": "the 21st Century",
"D": "FDA's guidance documents"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Background In August 2002, the FDA announced the Pharmaceutical CGMPs for the ____ Century Initiative.",
"reference": "Background In August 2002, the FDA announced the Pharmaceutical CGMPs for the 21st Century Initiative.",
"options": {
"D": "21st",
"A": "FDA's guidance documents",
"B": "this guidance",
"C": "twenty-first"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Readers are advised to always refer to parts ____ and 211 to ensu re full compliance with the regulations.",
"reference": "Readers are advised to always refer to parts 210 and 211 to ensu re full compliance with the regulations.",
"options": {
"C": "210",
"A": "211",
"B": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Readers are advised to always refer to parts 210 and ____ to ensu re full compliance with the regulations.",
"reference": "Readers are advised to always refer to parts 210 and 211 to ensu re full compliance with the regulations.",
"options": {
"D": "211",
"A": "210",
"B": "FDA's guidance documents",
"C": "this guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance is not intended to place new expecta...'?",
"reference": "This guidance is not intended to place new expectations on manufacturers, nor to replac e the CGMP requirements.",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'If you cannot identify th e appropriate FDA staff,...'?",
"reference": "If you cannot identify th e appropriate FDA staff, call the appropriate number listed on the title page of this guidance.",
"options": {
"A": "FDA",
"B": "Agency",
"C": "CGMP",
"D": "this guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA's guidance documents, including this guida nce...'?",
"reference": "FDA's guidance documents, including this guida nce, do not establish legally enforceable responsibilities.",
"options": {
"C": "FDA",
"A": "Agency",
"B": "CGMP",
"D": "this guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'If you want to d iscuss an alternativ e approach, ...'?",
"reference": "If you want to d iscuss an alternativ e approach, contact the FDA staff responsible for implementing this guidance.",
"options": {
"D": "FDA",
"A": "Agency",
"B": "CGMP",
"C": "this guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Readers are advised to always refer to parts ____ and 211 to ensu re full compliance with the regulations.",
"reference": "Readers are advised to always refer to parts 210 and 211 to ensu re full compliance with the regulations.",
"options": {
"A": "210",
"B": "211",
"C": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Readers are advised to always refer to parts 210 and ____ to ensu re full compliance with the regulations.",
"reference": "Readers are advised to always refer to parts 210 and 211 to ensu re full compliance with the regulations.",
"options": {
"D": "211",
"A": "210",
"B": "FDA's guidance documents",
"C": "this guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The guidance describes a comprehensive quality sys...'?",
"reference": "The guidance describes a comprehensive quality systems (QS) model, highlighting the model's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products.",
"options": {
"C": "QS",
"A": "FDA",
"B": "FDA's guidance documents",
"D": "this guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The guidance describes a comprehensive quality sys...'?",
"reference": "The guidance describes a comprehensive quality systems (QS) model, highlighting the model's consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products.",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "FDA's guidance documents",
"D": "this 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 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record . 167 168 Both kinds of software are used as part of production or the quality system and must be 169 validated under 21 CFR 820.70(i). However , as further discussed below, supporting software 170 often carries lower risk, such that under a risk -based computer software assurance approach, the 171 effort of validation may be reduced accordingly without compromising safety . 172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations . 181 182 FDA recognizes that software used in production or the quality system is often complex and 183 comprised of several features, functions, and operations;5 software may have one or more 184 intended uses depending on the individual features, functions, and operat ions of that software.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: However , as further discussed below, supporting software ____ often carries lower risk, such that under a risk -based computer software assurance approach, the 171 effort of validation may be reduced accordingly without compromising safety .",
"reference": "However , as further discussed below, supporting software 170 often carries lower risk, such that under a risk -based computer software assurance approach, the 171 effort of validation may be reduced accordingly without compromising safety .",
"options": {
"B": "170",
"A": "158",
"C": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: However , as further discussed below, supporting software 170 often carries lower risk, such that under a risk -based computer software assurance approach, the ____ effort of validation may be reduced accordingly without compromising safety .",
"reference": "However , as further discussed below, supporting software 170 often carries lower risk, such that under a risk -based computer software assurance approach, the 171 effort of validation may be reduced accordingly without compromising safety .",
"options": {
"B": "171",
"A": "158",
"C": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: However , as further discussed below, supporting software ____ often carries lower risk, such that under a risk -based computer software assurance approach, the 171 effort of validation may be reduced accordingly without compromising safety .",
"reference": "However , as further discussed below, supporting software 170 often carries lower risk, such that under a risk -based computer software assurance approach, the 171 effort of validation may be reduced accordingly without compromising safety .",
"options": {
"C": "170",
"A": "158",
"B": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: However , as further discussed below, supporting software 170 often carries lower risk, such that under a risk -based computer software assurance approach, the ____ effort of validation may be reduced accordingly without compromising safety .",
"reference": "However , as further discussed below, supporting software 170 often carries lower risk, such that under a risk -based computer software assurance approach, the 171 effort of validation may be reduced accordingly without compromising safety .",
"options": {
"D": "171",
"A": "158",
"B": "160",
"C": "a risk -based computer software assurance approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: '181 182 FDA recognizes that software used in produ...'?",
"reference": "181 182 FDA recognizes that software used in production or the quality system is often complex and 183 comprised of several features, functions, and operations;5 software may have one or more 184 intended uses depending on the individual features, functions, and operat ions of that software.",
"options": {
"C": "FDA",
"A": "Software",
"B": "a risk -based computer software assurance approach",
"D": "161 162 Software"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 182 FDA recognizes that software used in production or the quality system is often complex and 183 comprised of several features, functions, and operations;5 software may have one or more 184 intended uses depending on the individual features, functions, and operat ions of that software.",
"reference": "181 182 FDA recognizes that software used in production or the quality system is often complex and 183 comprised of several features, functions, and operations;5 software may have one or more 184 intended uses depending on the individual features, functions, and operat ions of that software.",
"options": {
"B": "181",
"A": "158",
"C": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 181 ____ FDA recognizes that software used in production or the quality system is often complex and 183 comprised of several features, functions, and operations;5 software may have one or more 184 intended uses depending on the individual features, functions, and operat ions of that software.",
"reference": "181 182 FDA recognizes that software used in production or the quality system is often complex and 183 comprised of several features, functions, and operations;5 software may have one or more 184 intended uses depending on the individual features, functions, and operat ions of that software.",
"options": {
"A": "182",
"B": "158",
"C": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 181 182 FDA recognizes that software used in production or the quality system is often complex and ____ comprised of several features, functions, and operations;5 software may have one or more 184 intended uses depending on the individual features, functions, and operat ions of that software.",
"reference": "181 182 FDA recognizes that software used in production or the quality system is often complex and 183 comprised of several features, functions, and operations;5 software may have one or more 184 intended uses depending on the individual features, functions, and operat ions of that software.",
"options": {
"C": "183",
"A": "158",
"B": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 181 182 FDA recognizes that software used in production or the quality system is often complex and 183 comprised of several features, functions, and operations;5 software may have ____ or more 184 intended uses depending on the individual features, functions, and operat ions of that software.",
"reference": "181 182 FDA recognizes that software used in production or the quality system is often complex and 183 comprised of several features, functions, and operations;5 software may have one or more 184 intended uses depending on the individual features, functions, and operat ions of that software.",
"options": {
"A": "one",
"B": "158",
"C": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 181 182 FDA recognizes that software used in production or the quality system is often complex and 183 comprised of several features, functions, and operations;5 software may have one or more ____ intended uses depending on the individual features, functions, and operat ions of that software.",
"reference": "181 182 FDA recognizes that software used in production or the quality system is often complex and 183 comprised of several features, functions, and operations;5 software may have one or more 184 intended uses depending on the individual features, functions, and operat ions of that software.",
"options": {
"B": "184",
"A": "158",
"C": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '158 Contains Nonbinding Recommendations Draft Not ...'?",
"reference": "158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"options": {
"A": "Software",
"B": "FDA",
"C": "the quality 166 record",
"D": "the quality 164 system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '158 Contains Nonbinding Recommendations Draft Not ...'?",
"reference": "158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"options": {
"D": "Software",
"A": "FDA",
"B": "the quality 166 record",
"C": "the quality 164 system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"reference": "158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"options": {
"B": "158",
"A": "160",
"C": "161",
"D": "a risk -based computer software assurance approach"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 158 Contains Nonbinding Recommendations Draft Not for Implementation ____ Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"reference": "158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"options": {
"D": "8159",
"A": "under 21",
"B": "21 175",
"C": "a risk -based computer software assurance approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or ____ the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"reference": "158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"options": {
"D": "160",
"A": "158",
"B": "161",
"C": "a risk -based computer software assurance approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: ____ 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"reference": "158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"options": {
"D": "161",
"A": "158",
"B": "160",
"C": "a risk -based computer software assurance approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 ____ Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"reference": "158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"options": {
"D": "162",
"A": "158",
"B": "160",
"C": "a risk -based computer software assurance approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or ____ that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"reference": "158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"options": {
"A": "163",
"B": "158",
"C": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality ____ system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"reference": "158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"options": {
"A": "164",
"B": "158",
"C": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and ____ Software intended for automating general record -keeping that is not part of the quality 166 record .",
"reference": "158 Contains Nonbinding Recommendations Draft Not for Implementation 8159 Software with the following intended uses are considered to be used to support production or 160 the quality system: 161 162 Software intended for use as development tools that test or monitor software systems or 163 that automate testing activities for the software used as part of production or the quality 164 system, such as those used for developi ng and running scripts ; and 165 Software intended for automating general record -keeping that is not part of the quality 166 record .",
"options": {
"C": "165",
"A": "158",
"B": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '172 173 On the other hand, software with the follo...'?",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"D": "21 175",
"A": "under 21",
"B": "a risk -based computer software assurance approach",
"C": "161 162 Software"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '172 173 On the other hand, software with the follo...'?",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"A": "Software",
"B": "FDA",
"C": "the quality 166 record",
"D": "the quality 164 system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '172 173 On the other hand, software with the follo...'?",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"B": "Software",
"A": "FDA",
"C": "the quality 166 record",
"D": "the quality 164 system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"D": "172",
"A": "158",
"B": "160",
"C": "a risk -based computer software assurance approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 172 ____ On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"B": "173",
"A": "158",
"C": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 172 173 On the other hand, software with the following intended uses generally are not considered to be ____ used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"A": "174",
"B": "158",
"C": "160",
"D": "a risk -based computer software assurance approach"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in ____ 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"D": "21",
"A": "158",
"B": "160",
"C": "a risk -based computer software assurance approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 ____ CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"D": "175",
"A": "158",
"B": "160",
"C": "a risk -based computer software assurance approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: ____ 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"D": "176",
"A": "158",
"B": "160",
"C": "a risk -based computer software assurance approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 ____ Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"reference": "172 173 On the other hand, software with the following intended uses generally are not considered to be 174 used as part of production or the quality system, such that the requirement for validation in 21 175 CFR 820.70(i) would not apply: 176 177 Software intended for managem ent of general business processes or operations, such as 178 email or accounting applications ; and 179 Software intended for establishing or supporting infrastructure not specific to production 180 or the quality system, such as networking or continuity of operations .",
"options": {
"B": "177",
"A": "158",
"C": "160",
"D": "a risk -based computer software assurance approach"
},
"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]
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: 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": {
"D": "333",
"A": "323",
"B": "324",
"C": "324 only the remaining identified assurance activities"
},
"answer": "D",
"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": "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": {
"D": "328",
"A": "323",
"B": "324",
"C": "324 only the remaining identified assurance activities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Since the failure would compromise safety , ____ 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 .",
"reference": "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 .",
"options": {
"B": "331",
"A": "323",
"C": "324",
"D": "324 only the remaining identified assurance activities"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Since the failure would compromise safety , 331 the manufacturer will next determine the related increase in device risk and identify the ____ assurance activities that are commensurate with th e device risk .",
"reference": "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 .",
"options": {
"A": "332",
"B": "323",
"C": "324",
"D": "324 only the remaining identified assurance activities"
},
"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]
CBER Additional copies are available from the Center for Biologics Evaluation a nd Research (CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances . Contains Nonbinding Recommendations Draft Not for Implementation Table of Contents I. Introduction ................................ ................................ ................................ ................................
..........................
Background ................................ ................................
................................ ................................
.......................... Scope ................................ ................................
................................ ................................
................................ ....
Computer Software Assurance ................................ ................................
................................ .............................
6 V. Computer Software Assurance Risk Framework ................................ ................................
................................ . Identifying the Intended Use ................................ ................................ ................................
........................ Determining the Risk -Based Approach ................................ ................................ ................................ Determining the Appropriate Assurance Activities ................................ ................................
...................
Establishing the Appropriate Record ................................ ................................ ................................
16 Appendix A.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Scope ................................ ..............'?",
"reference": "Scope ................................ ................................\n................................ ................................\n................................ ....\nComputer Software Assurance ................................ ................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework ................................ ................................\n................................ .",
"options": {
"D": "Computer Software Assurance",
"A": "the Center for Biologics Evaluation",
"B": "Office of Communication",
"C": "the Appropriate Assurance Activities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Scope ................................ ................................\n................................ ................................\n................................ ....\nComputer Software Assurance ................................ ................................\n................................ .............................\n____ V. Computer Software Assurance Risk Framework ................................ ................................\n................................ .",
"reference": "Scope ................................ ................................\n................................ ................................\n................................ ....\nComputer Software Assurance ................................ ................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework ................................ ................................\n................................ .",
"options": {
"D": "6",
"A": "240",
"B": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance",
"C": "the Appropriate Assurance Activities"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Determining the Appropriate Assurance Activities ....'?",
"reference": "Determining the Appropriate Assurance Activities ................................ ................................\n...................\nEstablishing the Appropriate Record ................................ ................................ ................................\n16 Appendix A.",
"options": {
"C": "16 Appendix A.",
"A": "240",
"B": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"D": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Determining the Appropriate Assurance Activities ................................ ................................\n...................\nEstablishing the Appropriate Record ................................ ................................ ................................\n____ Appendix A.",
"reference": "Determining the Appropriate Assurance Activities ................................ ................................\n...................\nEstablishing the Appropriate Record ................................ ................................ ................................\n16 Appendix A.",
"options": {
"D": "16",
"A": "240",
"B": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"C": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Determining the Appropriate Assurance Activities ....'?",
"reference": "Determining the Appropriate Assurance Activities ................................ ................................\n...................\nEstablishing the Appropriate Record ................................ ................................ ................................\n16 Appendix A.",
"options": {
"B": "16 Appendix A.",
"A": "240",
"C": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"D": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Determining the Appropriate Assurance Activities ................................ ................................\n...................\nEstablishing the Appropriate Record ................................ ................................ ................................\n____ Appendix A.",
"reference": "Determining the Appropriate Assurance Activities ................................ ................................\n...................\nEstablishing the Appropriate Record ................................ ................................ ................................\n16 Appendix A.",
"options": {
"D": "16",
"A": "240",
"B": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"C": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CBER Additional copies are available from the Cent...'?",
"reference": "CBER Additional copies are available from the Center for Biologics Evaluation a nd Research (CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg.",
"options": {
"A": "the Center for Biologics Evaluation",
"B": "Office of Communication",
"C": "OCOD",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CBER Additional copies are available from the Cent...'?",
"reference": "CBER Additional copies are available from the Center for Biologics Evaluation a nd Research (CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg.",
"options": {
"B": "Office of Communication",
"A": "the Center for Biologics Evaluation",
"C": "OCOD",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CBER Additional copies are available from the Cent...'?",
"reference": "CBER Additional copies are available from the Center for Biologics Evaluation a nd Research (CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg.",
"options": {
"A": "OCOD",
"B": "16 Appendix A.",
"C": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"D": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'CBER Additional copies are available from the Cent...'?",
"reference": "CBER Additional copies are available from the Center for Biologics Evaluation a nd Research (CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg.",
"options": {
"D": "10903",
"A": "Room 3128",
"B": "20993",
"C": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CBER Additional copies are available from the Cent...'?",
"reference": "CBER Additional copies are available from the Center for Biologics Evaluation a nd Research (CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg.",
"options": {
"A": "the Center for Biologics Evaluation",
"B": "Office of Communication",
"C": "OCOD",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CBER Additional copies are available from the Cent...'?",
"reference": "CBER Additional copies are available from the Center for Biologics Evaluation a nd Research (CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg.",
"options": {
"B": "Office of Communication",
"A": "the Center for Biologics Evaluation",
"C": "OCOD",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CBER Additional copies are available from the Cent...'?",
"reference": "CBER Additional copies are available from the Center for Biologics Evaluation a nd Research (CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg.",
"options": {
"B": "OCOD",
"A": "16 Appendix A.",
"C": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"D": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'CBER Additional copies are available from the Cent...'?",
"reference": "CBER Additional copies are available from the Center for Biologics Evaluation a nd Research (CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg.",
"options": {
"B": "10903",
"A": "Room 3128",
"C": "20993",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'CBER Additional copies are available from the Cent...'?",
"reference": "CBER Additional copies are available from the Center for Biologics Evaluation a nd Research (CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg.",
"options": {
"C": "Bldg",
"A": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"B": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance",
"D": "the Center for Biologics Evaluation"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: CBER Additional copies are available from the Center for Biologics Evaluation a nd Research (CBER), Office of Communication, Outreach, and Development (OCOD), ____ New Hampshire Ave., Bldg.",
"reference": "CBER Additional copies are available from the Center for Biologics Evaluation a nd Research (CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg.",
"options": {
"D": "10903",
"A": "Room 3128",
"B": "20993",
"C": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Determining the Appropriate Assurance Activities ....'?",
"reference": "Determining the Appropriate Assurance Activities ................................ ................................\n...................\nEstablishing the Appropriate Record ................................ ................................ ................................\n16 Appendix A.",
"options": {
"B": "16 Appendix A.",
"A": "240",
"C": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"D": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Determining the Appropriate Assurance Activities ................................ ................................\n...................\nEstablishing the Appropriate Record ................................ ................................ ................................\n____ Appendix A.",
"reference": "Determining the Appropriate Assurance Activities ................................ ................................\n...................\nEstablishing the Appropriate Record ................................ ................................ ................................\n16 Appendix A.",
"options": {
"B": "16",
"A": "240",
"C": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"D": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CBER Additional copies are available from the Cent...'?",
"reference": "CBER Additional copies are available from the Center for Biologics Evaluation a nd Research (CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg.",
"options": {
"A": "the Center for Biologics Evaluation",
"B": "Office of Communication",
"C": "OCOD",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CBER Additional copies are available from the Cent...'?",
"reference": "CBER Additional copies are available from the Center for Biologics Evaluation a nd Research (CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., Bldg.",
"options": {
"A": "Office of Communication",
"B": "the Center for Biologics Evaluation",
"C": "OCOD",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Determining the Appropriate Assurance Activities ....'?",
"reference": "Determining the Appropriate Assurance Activities ................................ ................................\n...................\nEstablishing the Appropriate Record ................................ ................................ ................................\n16 Appendix A.",
"options": {
"C": "16 Appendix A.",
"A": "240",
"B": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"D": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Determining the Appropriate Assurance Activities ................................ ................................\n...................\nEstablishing the Appropriate Record ................................ ................................ ................................\n____ Appendix A.",
"reference": "Determining the Appropriate Assurance Activities ................................ ................................\n...................\nEstablishing the Appropriate Record ................................ ................................ ................................\n16 Appendix A.",
"options": {
"B": "16",
"A": "240",
"C": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"D": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '71, Room 3128, Silver Spring, MD 20993 -0002, or b...'?",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"A": "71, Room 3128",
"B": "10903",
"C": "Room 3128",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: '71, Room 3128, Silver Spring, MD 20993 -0002, or b...'?",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"B": "Silver Spring",
"A": "New Hampshire Ave",
"C": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"D": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: '71, Room 3128, Silver Spring, MD 20993 -0002, or b...'?",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"A": "MD",
"B": "Bldg",
"C": "Silver Spring",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '71, Room 3128, Silver Spring, MD 20993 -0002, or b...'?",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"C": "20993",
"A": "10903",
"B": "Room 3128",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"C": "71",
"A": "240",
"B": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"D": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 71, Room ____, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"A": "3128",
"B": "10903",
"C": "Room 3128",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 71, Room 3128, Silver Spring, MD ____ -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"C": "20993",
"A": "10903",
"B": "Room 3128",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 71, Room 3128, Silver Spring, MD 20993 ____, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"C": "-0002",
"A": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"B": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance",
"D": "71, Room 3128"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '71, Room 3128, Silver Spring, MD 20993 -0002, or b...'?",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"C": "71, Room 3128",
"A": "10903",
"B": "Room 3128",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What location is mentioned: '71, Room 3128, Silver Spring, MD 20993 -0002, or b...'?",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"B": "Silver Spring",
"A": "New Hampshire Ave",
"C": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"D": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: '71, Room 3128, Silver Spring, MD 20993 -0002, or b...'?",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"A": "MD",
"B": "Bldg",
"C": "Silver Spring",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '71, Room 3128, Silver Spring, MD 20993 -0002, or b...'?",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"D": "20993",
"A": "10903",
"B": "Room 3128",
"C": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"D": "71",
"A": "240",
"B": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"C": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 71, Room ____, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"C": "3128",
"A": "10903",
"B": "Room 3128",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 71, Room 3128, Silver Spring, MD ____ -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"B": "20993",
"A": "10903",
"C": "Room 3128",
"D": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 71, Room 3128, Silver Spring, MD 20993 ____, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"B": "-0002",
"A": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"C": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance",
"D": "71, Room 3128"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 7____, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"A": "1",
"B": "240",
"C": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"D": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 ____-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"reference": "71, Room 3128, Silver Spring, MD 20993 -0002, or by calling 1 -800-835-4709 or 240 -402- 8010, by email, ocodfda.hhs.gov or from the Internet at https://www.fda.gov/vaccines -blood - biologics/guidance -compliance -regulatory -infor mation -biologics/biologics -guidances .",
"options": {
"D": "-800",
"A": "................................\n................................ .............................\n6 V. Computer Software Assurance Risk Framework",
"B": "................................\n................................ ................................\n................................ ....\nComputer Software Assurance",
"C": "71, Room 3128"
},
"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]
BACKGROUND ............................................................................................................... 2 III. QUESTIONS AND ANSWERS ....................................................................................... Please clarify the following terms as they relate to CGMP records: .........................................
4 a. What is data integrity? ................................................................................................................
4 b. What is metadata? .......................................................................................................................
4 c. What is an audit trail? .................................................................................................................
4 d. How does FDA use the terms static and dynamic as they relate to record for mats? 5 e. How does FDA use the term backup in 211.68(b)? ..................................................................
5 f. What are the systems in computer or related systems in 211.68? ........................................ When is it permissible to invalidate a CGMP result and exclude it from the determination of batch conformance? ........................................................................................................................... Does each CGMP workflow on a 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 systems? How should blank forms be controlled? ......................................................................................
Who should review audit trails? ...................................................................................................
How often should audit trails be reviewed?
[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: '...............................\nHow should access ...'?",
"reference": "...............................\nHow should access to CGMP computer systems be restricted?",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "computer or related systems",
"D": "computer systems"
},
"answer": "A",
"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": "..................................................................\n5 f. What are the systems in computer or related systems in 211.68?",
"options": {
"B": "5",
"A": "4 d.",
"C": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ..................................................................\n5 f. What are the systems in computer or related systems in ____?",
"reference": "..................................................................\n5 f. What are the systems in computer or related systems in 211.68?",
"options": {
"C": "211.68",
"A": "4 d.",
"B": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .......................................................................................................................\n____ c. What is an audit trail?",
"reference": ".......................................................................................................................\n4 c. What is an audit trail?",
"options": {
"C": "4",
"A": "4 d.",
"B": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '................................................\nW...'?",
"reference": "................................................\nWhy is FDA concerned with the use of shared login accounts for computer systems?",
"options": {
"C": "FDA",
"A": "CGMP",
"B": "CGMP computer systems",
"D": "computer or related systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '5 e. How does FDA use the term backup in 211.68(b...'?",
"reference": "5 e. How does FDA use the term backup in 211.68(b)?",
"options": {
"A": "FDA",
"B": "CGMP",
"C": "CGMP computer systems",
"D": "computer or related systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ____ e. How does FDA use the term backup in 211.68(b)?",
"reference": "5 e. How does FDA use the term backup in 211.68(b)?",
"options": {
"A": "5",
"B": "4 d.",
"C": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: '5 e. How does FDA use the term backup in 211.68(b...'?",
"reference": "5 e. How does FDA use the term backup in 211.68(b)?",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "CGMP computer systems",
"D": "computer or related systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ____ e. How does FDA use the term backup in 211.68(b)?",
"reference": "5 e. How does FDA use the term backup in 211.68(b)?",
"options": {
"B": "5",
"A": "4 d.",
"C": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: '...............................\nHow should access ...'?",
"reference": "...............................\nHow should access to CGMP computer systems be restricted?",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "computer or related systems",
"C": "computer systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'When is it permissible to invalidate a CGMP result...'?",
"reference": "When is it permissible to invalidate a CGMP result and exclude it from the determination of batch conformance?",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "computer or related systems",
"D": "computer systems"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '5 e. How does FDA use the term backup in 211.68(b...'?",
"reference": "5 e. How does FDA use the term backup in 211.68(b)?",
"options": {
"A": "FDA",
"B": "CGMP",
"C": "CGMP computer systems",
"D": "computer or related systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: ____ e. How does FDA use the term backup in 211.68(b)?",
"reference": "5 e. How does FDA use the term backup in 211.68(b)?",
"options": {
"C": "5",
"A": "4 d.",
"B": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: '.....................................................'?",
"reference": ".................................................................................................................\n4 d. How does FDA use the terms static and dynamic as they relate to record for mats?",
"options": {
"C": "FDA",
"A": "CGMP",
"B": "CGMP computer systems",
"D": "computer or related systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: .................................................................................................................\n____ d. How does FDA use the terms static and dynamic as they relate to record for mats?",
"reference": ".................................................................................................................\n4 d. How does FDA use the terms static and dynamic as they relate to record for mats?",
"options": {
"A": "4",
"B": "4 d.",
"C": "211.68(b",
"D": "CGMP computer systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 30 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
220 221 We suggest that your decision to validate computerized systems, and the extent of the validation, 222 take into account the impact the systems have on your ability to meet predicate rule 223 requireme nts. You should also consider the impact those systems might have on the accuracy, 224 reliability, integrity, availability, and authenticity of required records and signatures. Even if 225 there is no predicate rule requirement to validate a system, in some insta nces it may still be 226 important to validate the system. We recommend that you base your approach on a justified and documented risk assessment and 229 a determination of the potential of the system to affect product quality and safety, and record 230 integrity. For instance, validation would not be important for a word processor used only to 231 generate SOPs. 232 233 For further guidance on validation of computerized systems, see FDAs guidance for industry 234 and FDA staff General Principles of Software Validation and also industry guidance such as the 235 GAMP 4 Guide (See References). Audit Trail 238 239
The Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30). Persons must still comply with all applicable predicate 242 rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or 243 sequencing of events, as well as any requirements for ensuring t hat changes to records do not 244 obscure previous entries.
[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: 'Audit Trail 238 239\nThe Agency intends to exercise...'?",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"A": "Agency",
"B": "all applicable predicate 242 rule requirements",
"C": "computerized systems",
"D": "government agency"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail ____ 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"B": "238",
"A": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail 238 ____\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"D": "239",
"A": "220 221",
"B": "222",
"C": "all applicable predicate 242 rule requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part ____ requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"B": "11",
"A": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements ____ related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"D": "240",
"A": "220 221",
"B": "222",
"C": "all applicable predicate 242 rule requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( ____ (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"B": "11.10",
"A": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y ____ corresponding requirement in 11.30).",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"A": "241",
"B": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in ____).",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"C": "11.30",
"A": "220 221",
"B": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: We recommend that you base your approach on a justified and documented risk assessment and ____ a determination of the potential of the system to affect product quality and safety, and record 230 integrity.",
"reference": "We recommend that you base your approach on a justified and documented risk assessment and 229 a determination of the potential of the system to affect product quality and safety, and record 230 integrity.",
"options": {
"B": "229",
"A": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: We recommend that you base your approach on a justified and documented risk assessment and 229 a determination of the potential of the system to affect product quality and safety, and record ____ integrity.",
"reference": "We recommend that you base your approach on a justified and documented risk assessment and 229 a determination of the potential of the system to affect product quality and safety, and record 230 integrity.",
"options": {
"A": "230",
"B": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Even if ____ there is no predicate rule requirement to validate a system, in some insta nces it may still be 226 important to validate the system.",
"reference": "Even if 225 there is no predicate rule requirement to validate a system, in some insta nces it may still be 226 important to validate the system.",
"options": {
"B": "225",
"A": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Even if 225 there is no predicate rule requirement to validate a system, in some insta nces it may still be ____ important to validate the system.",
"reference": "Even if 225 there is no predicate rule requirement to validate a system, in some insta nces it may still be 226 important to validate the system.",
"options": {
"D": "226",
"A": "220 221",
"B": "222",
"C": "all applicable predicate 242 rule requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 221 We suggest that your decision to validate computerized systems, and the extent of the validation, 222 take into account the impact the systems have on your ability to meet predicate rule 223 requireme nts.",
"reference": "220 221 We suggest that your decision to validate computerized systems, and the extent of the validation, 222 take into account the impact the systems have on your ability to meet predicate rule 223 requireme nts.",
"options": {
"C": "220",
"A": "220 221",
"B": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 220 ____ We suggest that your decision to validate computerized systems, and the extent of the validation, 222 take into account the impact the systems have on your ability to meet predicate rule 223 requireme nts.",
"reference": "220 221 We suggest that your decision to validate computerized systems, and the extent of the validation, 222 take into account the impact the systems have on your ability to meet predicate rule 223 requireme nts.",
"options": {
"C": "221",
"A": "220 221",
"B": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 220 221 We suggest that your decision to validate computerized systems, and the extent of the validation, ____ take into account the impact the systems have on your ability to meet predicate rule 223 requireme nts.",
"reference": "220 221 We suggest that your decision to validate computerized systems, and the extent of the validation, 222 take into account the impact the systems have on your ability to meet predicate rule 223 requireme nts.",
"options": {
"A": "222",
"B": "220 221",
"C": "223",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 220 221 We suggest that your decision to validate computerized systems, and the extent of the validation, 222 take into account the impact the systems have on your ability to meet predicate rule ____ requireme nts.",
"reference": "220 221 We suggest that your decision to validate computerized systems, and the extent of the validation, 222 take into account the impact the systems have on your ability to meet predicate rule 223 requireme nts.",
"options": {
"B": "223",
"A": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Persons must still comply with all applicable pred...'?",
"reference": "Persons must still comply with all applicable predicate 242 rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or 243 sequencing of events, as well as any requirements for ensuring t hat changes to records do not 244 obscure previous entries.",
"options": {
"A": "58.130(e",
"B": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Persons must still comply with all applicable predicate ____ rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or 243 sequencing of events, as well as any requirements for ensuring t hat changes to records do not 244 obscure previous entries.",
"reference": "Persons must still comply with all applicable predicate 242 rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or 243 sequencing of events, as well as any requirements for ensuring t hat changes to records do not 244 obscure previous entries.",
"options": {
"D": "242",
"A": "220 221",
"B": "222",
"C": "computerized systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Persons must still comply with all applicable predicate 242 rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or ____ sequencing of events, as well as any requirements for ensuring t hat changes to records do not 244 obscure previous entries.",
"reference": "Persons must still comply with all applicable predicate 242 rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or 243 sequencing of events, as well as any requirements for ensuring t hat changes to records do not 244 obscure previous entries.",
"options": {
"B": "243",
"A": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Persons must still comply with all applicable predicate 242 rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or 243 sequencing of events, as well as any requirements for ensuring t hat changes to records do not ____ obscure previous entries.",
"reference": "Persons must still comply with all applicable predicate 242 rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or 243 sequencing of events, as well as any requirements for ensuring t hat changes to records do not 244 obscure previous entries.",
"options": {
"D": "244",
"A": "220 221",
"B": "222",
"C": "all applicable predicate 242 rule requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: We recommend that you base your approach on a justified and documented risk assessment and ____ a determination of the potential of the system to affect product quality and safety, and record 230 integrity.",
"reference": "We recommend that you base your approach on a justified and documented risk assessment and 229 a determination of the potential of the system to affect product quality and safety, and record 230 integrity.",
"options": {
"A": "229",
"B": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: We recommend that you base your approach on a justified and documented risk assessment and 229 a determination of the potential of the system to affect product quality and safety, and record ____ integrity.",
"reference": "We recommend that you base your approach on a justified and documented risk assessment and 229 a determination of the potential of the system to affect product quality and safety, and record 230 integrity.",
"options": {
"C": "230",
"A": "220 221",
"B": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Even if ____ there is no predicate rule requirement to validate a system, in some insta nces it may still be 226 important to validate the system.",
"reference": "Even if 225 there is no predicate rule requirement to validate a system, in some insta nces it may still be 226 important to validate the system.",
"options": {
"C": "225",
"A": "220 221",
"B": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Even if 225 there is no predicate rule requirement to validate a system, in some insta nces it may still be ____ important to validate the system.",
"reference": "Even if 225 there is no predicate rule requirement to validate a system, in some insta nces it may still be 226 important to validate the system.",
"options": {
"A": "226",
"B": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Persons must still comply with all applicable pred...'?",
"reference": "Persons must still comply with all applicable predicate 242 rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or 243 sequencing of events, as well as any requirements for ensuring t hat changes to records do not 244 obscure previous entries.",
"options": {
"B": "58.130(e",
"A": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Persons must still comply with all applicable predicate ____ rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or 243 sequencing of events, as well as any requirements for ensuring t hat changes to records do not 244 obscure previous entries.",
"reference": "Persons must still comply with all applicable predicate 242 rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or 243 sequencing of events, as well as any requirements for ensuring t hat changes to records do not 244 obscure previous entries.",
"options": {
"C": "242",
"A": "220 221",
"B": "222",
"D": "computerized systems"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Persons must still comply with all applicable predicate 242 rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or ____ sequencing of events, as well as any requirements for ensuring t hat changes to records do not 244 obscure previous entries.",
"reference": "Persons must still comply with all applicable predicate 242 rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or 243 sequencing of events, as well as any requirements for ensuring t hat changes to records do not 244 obscure previous entries.",
"options": {
"C": "243",
"A": "220 221",
"B": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Persons must still comply with all applicable predicate 242 rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or 243 sequencing of events, as well as any requirements for ensuring t hat changes to records do not ____ obscure previous entries.",
"reference": "Persons must still comply with all applicable predicate 242 rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or 243 sequencing of events, as well as any requirements for ensuring t hat changes to records do not 244 obscure previous entries.",
"options": {
"B": "244",
"A": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 221 We suggest that your decision to validate computerized systems, and the extent of the validation, 222 take into account the impact the systems have on your ability to meet predicate rule 223 requireme nts.",
"reference": "220 221 We suggest that your decision to validate computerized systems, and the extent of the validation, 222 take into account the impact the systems have on your ability to meet predicate rule 223 requireme nts.",
"options": {
"C": "220",
"A": "220 221",
"B": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 220 ____ We suggest that your decision to validate computerized systems, and the extent of the validation, 222 take into account the impact the systems have on your ability to meet predicate rule 223 requireme nts.",
"reference": "220 221 We suggest that your decision to validate computerized systems, and the extent of the validation, 222 take into account the impact the systems have on your ability to meet predicate rule 223 requireme nts.",
"options": {
"A": "221",
"B": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 10 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
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: '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": {
"C": "Marilyn Keller",
"A": "Ken Shumate",
"B": "John Wiley Sons",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "C",
"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": {
"C": "John Wiley Sons",
"A": "Ken Shumate",
"B": "Marilyn Keller",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "C",
"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": {
"C": "1992",
"A": "1999",
"B": "1989",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"answer": "C",
"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": {
"C": "1992",
"A": "1999",
"B": "1989",
"D": "Compliance and Biologics Quality Alice Godziemski Office"
},
"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": {
"D": "Dennis D. Smith",
"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: '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"
}
]
|
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 addition, an effective quality system, by lowering the risk of manufacturing problem s, may result in shorter and fewer FDA inspections. A quality system can provide the necessary framework for implementing quality by design 4 (building in quality from the development phase and throughout a products life cycle), continual improvement, and risk management in the drug ma nufacturing process. A quality system adopted by a manufacturer can be tailored to fit the specific environment, taking into account factors such as scope of operations, complexity of processes, and appropriate use of finite resources. C. Scope of the Guidance This guidance applies to manufacturers of dr ug products (finished pharmaceuticals), including products regulated by the Center for Biologics Evaluation and Res earch (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Veterina ry Medicine (CVM). It may also be useful to manufacturers of components (including active pharmaceutical ingredients) used in the manufacture of these products. This document is not intended to create new requirements for pharmaceutical manufacturing that go beyond those established in the current regulati ons, nor is the guidance intended to be a guide for the conduct of FDA inspections. Rath er, the document explains how implementing comprehensive quality systems can help manufacturers achieve compliance with 21 CFR parts 4
See ICH Q8 Pharmaceutical Development. Contains Nonbinding Recommendations 210 and 211. Although the QS working group found th at many of the quality system elements correlate with specific CGMP requirements, some do not. The Agency expects com pliance with CGMP regulations, and FDAs inspection program will remain focused on compliance with those regulations.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Although the QS working group found th at many of ...'?",
"reference": "Although the QS working group found th at many of the quality system elements correlate with specific CGMP requirements, some do not.",
"options": {
"B": "QS",
"A": "FDA",
"C": "the Center for Biologics Evaluation",
"D": "comprehensive quality systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Although the QS working group found th at many of ...'?",
"reference": "Although the QS working group found th at many of the quality system elements correlate with specific CGMP requirements, some do not.",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "the Center for Biologics Evaluation",
"D": "comprehensive quality systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ and 211.",
"reference": "Contains Nonbinding Recommendations 210 and 211.",
"options": {
"A": "210",
"B": "211",
"C": "comprehensive quality systems",
"D": "an effective quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations 210 and ____.",
"reference": "Contains Nonbinding Recommendations 210 and 211.",
"options": {
"B": "211",
"A": "comprehensive quality systems",
"C": "an effective quality system",
"D": "210"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Although the QS working group found th at many of ...'?",
"reference": "Although the QS working group found th at many of the quality system elements correlate with specific CGMP requirements, some do not.",
"options": {
"A": "QS",
"B": "FDA",
"C": "the Center for Biologics Evaluation",
"D": "comprehensive quality systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Although the QS working group found th at many of ...'?",
"reference": "Although the QS working group found th at many of the quality system elements correlate with specific CGMP requirements, some do not.",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "the Center for Biologics Evaluation",
"D": "comprehensive quality systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The Agency expects com pliance with CGMP regulatio...'?",
"reference": "The Agency expects com pliance with CGMP regulations, and FDAs inspection program will remain focused on compliance with those regulations.",
"options": {
"A": "Agency",
"B": "comprehensive quality systems",
"C": "an effective quality system",
"D": "government agency"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The Agency expects com pliance with CGMP regulatio...'?",
"reference": "The Agency expects com pliance with CGMP regulations, and FDAs inspection program will remain focused on compliance with those regulations.",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "the Center for Biologics Evaluation",
"C": "comprehensive quality systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'C. Scope of the Guidance This guidance applies to ...'?",
"reference": "C. Scope of the Guidance This guidance applies to manufacturers of dr ug products (finished pharmaceuticals), including products regulated by the Center for Biologics Evaluation and Res earch (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Veterina ry Medicine (CVM).",
"options": {
"D": "C. Scope",
"A": "Res",
"B": "comprehensive quality systems",
"C": "an effective quality system"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'C. Scope of the Guidance This guidance applies to ...'?",
"reference": "C. Scope of the Guidance This guidance applies to manufacturers of dr ug products (finished pharmaceuticals), including products regulated by the Center for Biologics Evaluation and Res earch (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Veterina ry Medicine (CVM).",
"options": {
"D": "the Center for Biologics Evaluation",
"A": "FDA",
"B": "the Center for Drug Evaluation and Research",
"C": "comprehensive quality systems"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'C. Scope of the Guidance This guidance applies to ...'?",
"reference": "C. Scope of the Guidance This guidance applies to manufacturers of dr ug products (finished pharmaceuticals), including products regulated by the Center for Biologics Evaluation and Res earch (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Veterina ry Medicine (CVM).",
"options": {
"C": "Res",
"A": "C. Scope",
"B": "comprehensive quality systems",
"D": "an effective quality system"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'C. Scope of the Guidance This guidance applies to ...'?",
"reference": "C. Scope of the Guidance This guidance applies to manufacturers of dr ug products (finished pharmaceuticals), including products regulated by the Center for Biologics Evaluation and Res earch (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Veterina ry Medicine (CVM).",
"options": {
"B": "the Center for Drug Evaluation and Research",
"A": "FDA",
"C": "the Center for Biologics Evaluation",
"D": "comprehensive quality systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A quality system can provide the necessary framework for implementing quality by design ____ (building in quality from the development phase and throughout a products life cycle), continual improvement, and risk management in the drug ma nufacturing process.",
"reference": "A quality system can provide the necessary framework for implementing quality by design 4 (building in quality from the development phase and throughout a products life cycle), continual improvement, and risk management in the drug ma nufacturing process.",
"options": {
"B": "4",
"A": "211",
"C": "comprehensive quality systems",
"D": "an effective quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ and 211.",
"reference": "Contains Nonbinding Recommendations 210 and 211.",
"options": {
"C": "210",
"A": "211",
"B": "comprehensive quality systems",
"D": "an effective quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations 210 and ____.",
"reference": "Contains Nonbinding Recommendations 210 and 211.",
"options": {
"A": "211",
"B": "comprehensive quality systems",
"C": "an effective quality system",
"D": "210"
},
"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 8 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
13 Risks to data include, but are not limited to, the potential to be deleted, amended, or excluded without authorization or without detection. Examples of audit trails that may be appr opriate to review on a risk -based frequency include audit trails that capture instrument operational status, instrument communication logs, and alert records. Contains Nonbinding Recommendations 9 required to reconstruct the CGMP activity and the static or dynamic nature of the original records. True copies of dynamic electronic records may be made and maintained in the format of the original records or in a format that allows for the content and meaning of the original records to be preserved if a suitable reader and copying equipment ( e.g., software and hardware, including media readers) are readily available ( 211.180(d) and 212.110). 10. 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? A paper printout or static record may satisfy retention requirements if it is the original record or a true copy of the original re cord ( see 211.68(b) , 211.188, 211.194, and 212.60). During data acquisition, f or example, pH meters and balances may create a paper printout or static record as the original record. In this case , the paper printout or static record , or a true copy , must be retained ( 211.180). However, electronic records from certain types of laboratory instruments whether stand -alone or networked are dynamic, and a printout or a static record does not preserve the dynamic record format that is part of the complet e original record. For example, the spectral file created by FT -IR (Fourier transform infrared spectroscopy ) is dynamic and can be reprocessed . However, a static record or printout is fixed and would not satisfy CGMP requirements to retain original records or true copies ( 211.180(d)) .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Who is mentioned in the context: 'For example, the spectral file created by FT -IR (...'?",
"reference": "For example, the spectral file created by FT -IR (Fourier transform infrared spectroscopy ) is dynamic and can be reprocessed .",
"options": {
"C": "Fourier",
"A": "A paper printout or static record",
"B": "a paper printout or static record",
"D": "Jean Baptiste Joseph Fourier"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: A paper printout or static record may satisfy retention requirements if it is the original record or a true copy of the original re cord ( see 211.68(b) , ____, 211.194, and 212.60).",
"reference": "A paper printout or static record may satisfy retention requirements if it is the original record or a true copy of the original re cord ( see 211.68(b) , 211.188, 211.194, and 212.60).",
"options": {
"A": "211.188",
"B": "211.180(d",
"C": "212.110",
"D": "A paper printout or static record"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A paper printout or static record may satisfy retention requirements if it is the original record or a true copy of the original re cord ( see 211.68(b) , 211.188, ____, and 212.60).",
"reference": "A paper printout or static record may satisfy retention requirements if it is the original record or a true copy of the original re cord ( see 211.68(b) , 211.188, 211.194, and 212.60).",
"options": {
"A": "211.194",
"B": "211.180(d",
"C": "212.110",
"D": "A paper printout or static record"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: A paper printout or static record may satisfy retention requirements if it is the original record or a true copy of the original re cord ( see 211.68(b) , 211.188, 211.194, and ____).",
"reference": "A paper printout or static record may satisfy retention requirements if it is the original record or a true copy of the original re cord ( see 211.68(b) , 211.188, 211.194, and 212.60).",
"options": {
"B": "212.60",
"A": "211.180(d",
"C": "212.110",
"D": "A paper printout or static record"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'However, a static record or printout is fixed and ...'?",
"reference": "However, a static record or printout is fixed and would not satisfy CGMP requirements to retain original records or true copies ( 211.180(d)) .",
"options": {
"D": "CGMP",
"A": "A paper printout or static record",
"B": "a paper printout or static record",
"C": "211.180(d"
},
"answer": "D",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'Contains Nonbinding Recommendations 9 required to ...'?",
"reference": "Contains Nonbinding Recommendations 9 required to reconstruct the CGMP activity and the static or dynamic nature of the original records.",
"options": {
"C": "CGMP",
"A": "A paper printout or static record",
"B": "a paper printout or static record",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ required to reconstruct the CGMP activity and the static or dynamic nature of the original records.",
"reference": "Contains Nonbinding Recommendations 9 required to reconstruct the CGMP activity and the static or dynamic nature of the original records.",
"options": {
"C": "9",
"A": "211.180(d",
"B": "212.110",
"D": "A paper printout or static record"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'However, a static record or printout is fixed and ...'?",
"reference": "However, a static record or printout is fixed and would not satisfy CGMP requirements to retain original records or true copies ( 211.180(d)) .",
"options": {
"A": "CGMP",
"B": "A paper printout or static record",
"C": "a paper printout or static record",
"D": "211.180(d"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
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, 1997.",
"options": {
"C": "International Organization for Standardization",
"A": "International Electrotechnical Commission",
"B": "IEC 61508:1998",
"D": "1997"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'International Organization for Standardization, 19...'?",
"reference": "International Organization for Standardization, 1997.",
"options": {
"A": "1997",
"B": "1998",
"C": "1012-1986",
"D": "International Electrotechnical Commission"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: International Organization for Standardization, ____.",
"reference": "International Organization for Standardization, 1997.",
"options": {
"B": "1997",
"A": "1998",
"C": "1012-1986",
"D": "International Electrotechnical Commission"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ISO 9000-3:1997, Quality management and quality as...'?",
"reference": "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 .",
"options": {
"A": "Quality",
"B": "International Electrotechnical Commission",
"C": "caliber",
"D": "character"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ISO 9000-3:1997, Quality management and quality as...'?",
"reference": "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 .",
"options": {
"B": "ISO 9001:1994",
"A": "International Electrotechnical Commission",
"C": "IEC 61508:1998",
"D": "ISO 9000-3:1997"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ISO ____-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 .",
"reference": "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 .",
"options": {
"B": "9000",
"A": "38General",
"C": "International Electrotechnical Commission",
"D": "ISO 9000-3:1997"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ISO 9000-____: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 .",
"reference": "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 .",
"options": {
"D": "3",
"A": "38General",
"B": "International Electrotechnical Commission",
"C": "troika"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'International Organization for Standardization, 19...'?",
"reference": "International Organization for Standardization, 1997.",
"options": {
"B": "International Organization for Standardization",
"A": "International Electrotechnical Commission",
"C": "IEC 61508:1998",
"D": "1997"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'International Organization for Standardization, 19...'?",
"reference": "International Organization for Standardization, 1997.",
"options": {
"A": "1997",
"B": "1998",
"C": "1012-1986",
"D": "International Electrotechnical Commission"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: International Organization for Standardization, ____.",
"reference": "International Organization for Standardization, 1997.",
"options": {
"D": "1997",
"A": "1998",
"B": "1012-1986",
"C": "International Electrotechnical Commission"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ISO 9001:1994, Quality systems Model for quality ...'?",
"reference": "ISO 9001:1994, Quality systems Model for quality assurance in design, development, production, installation, and servicing.",
"options": {
"D": "ISO 9001:1994",
"A": "International Electrotechnical Commission",
"B": "IEC 61508:1998",
"C": "Quality"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ISO 9001:1994, Quality systems Model for quality ...'?",
"reference": "ISO 9001:1994, Quality systems Model for quality assurance in design, development, production, installation, and servicing.",
"options": {
"B": "Quality",
"A": "International Electrotechnical Commission",
"C": "caliber",
"D": "character"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ISO 8402:1994, Quality management and quality assu...'?",
"reference": "ISO 8402:1994, Quality management and quality assurance Vocabulary.",
"options": {
"B": "ISO",
"A": "International Electrotechnical Commission",
"C": "IEC 61508:1998",
"D": "Vocabulary"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ISO 8402:1994, Quality management and quality assu...'?",
"reference": "ISO 8402:1994, Quality management and quality assurance Vocabulary.",
"options": {
"C": "Vocabulary",
"A": "International Electrotechnical Commission",
"B": "lexicon",
"D": "mental lexicon"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'IEEE Std 1012-1986, Software Verification and Vali...'?",
"reference": "IEEE Std 1012-1986, Software Verification and Validation Plans , Institute for Electrical and Electronics Engineers, 1986.",
"options": {
"C": "IEEE Std",
"A": "International Electrotechnical Commission",
"B": "1012-1986",
"D": "Software Verification and Validation Plans"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'IEEE Std 1012-1986, Software Verification and Vali...'?",
"reference": "IEEE Std 1012-1986, Software Verification and Validation Plans , Institute for Electrical and Electronics Engineers, 1986.",
"options": {
"A": "1012-1986",
"B": "1997",
"C": "1998",
"D": "International Electrotechnical Commission"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'IEEE Std 1012-1986, Software Verification and Vali...'?",
"reference": "IEEE Std 1012-1986, Software Verification and Validation Plans , Institute for Electrical and Electronics Engineers, 1986.",
"options": {
"A": "Software Verification and Validation Plans",
"B": "International Electrotechnical Commission",
"C": "IEC 61508:1998",
"D": "IEEE Std"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'IEEE Std 1012-1986, Software Verification and Vali...'?",
"reference": "IEEE Std 1012-1986, Software Verification and Validation Plans , Institute for Electrical and Electronics Engineers, 1986.",
"options": {
"C": "Institute for Electrical and Electronics Engineers",
"A": "International Electrotechnical Commission",
"B": "IEC 61508:1998",
"D": "IEEE Std"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'IEEE Std 1012-1986, Software Verification and Vali...'?",
"reference": "IEEE Std 1012-1986, Software Verification and Validation Plans , Institute for Electrical and Electronics Engineers, 1986.",
"options": {
"A": "1986",
"B": "1997",
"C": "1998",
"D": "International Electrotechnical Commission"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: IEEE Std ____-1986, Software Verification and Validation Plans , Institute for Electrical and Electronics Engineers, 1986.",
"reference": "IEEE Std 1012-1986, Software Verification and Validation Plans , Institute for Electrical and Electronics Engineers, 1986.",
"options": {
"C": "1012",
"A": "1997",
"B": "1998",
"D": "International Electrotechnical Commission"
},
"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 7 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Where possible and depending upon the device risk involved, the device manufacturer should consider auditing the vendors design and development methodologies used in the construction of the OTS software and should assess the development and validation documentation generated for the OTS software. Such audits can be conducted by the device manufacturer or by a qualified third party. The audit should demonstrate that the vendors procedures for and results of the verification and validation activities performed the OTS software are appropriate and sufficient for the safety and effectiveness requirements of the medical device to be produced using that software. Some vendors who are not accustomed to operating in a regulated environment may not have a documented life cycle process that can support the device manufacturers validation requirement. Other vendors may not permit an audit. Where necessary validation information is not available from the vendor, the device manufacturer will need to perform sufficient system level black box testing to establish that the software meets their user needs and intended uses. For many applications black box testing alone is not sufficient. Depending upon the risk of the device produced, the role of the OTS software in the process, the ability to audit the vendor, and the sufficiency of vendor-supplied information, the use of OTS software or equipment may or may not be appropriate, especially if there are suitable alternatives available. The device manufacturer should also consider the implications (if any) for continued maintenance and support of the OTS software should the vendor terminate their support. For some off-the-shelf software development tools, such as software compilers, linkers, editors, and operating systems, exhaustive black-box testing by the device manufacturer may be impractical. Without such testing a key element of the validation effort it may not be possible to validate these software tools.
[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: 'Where possible and depending upon the device risk ...'?",
"reference": "Where possible and depending upon the device risk involved, the device manufacturer should consider auditing the vendors design and development methodologies used in the construction of the OTS software and should assess the development and validation documentation generated for the OTS software.",
"options": {
"C": "OTS",
"A": "the device manufacturer",
"B": "This information is not mentioned in the context",
"D": "The context does not provide this detail"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Where possible and depending upon the device risk ...'?",
"reference": "Where possible and depending upon the device risk involved, the device manufacturer should consider auditing the vendors design and development methodologies used in the construction of the OTS software and should assess the development and validation documentation generated for the OTS software.",
"options": {
"D": "OTS",
"A": "the device manufacturer",
"B": "This information is not mentioned in the context",
"C": "The context does not provide this detail"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The audit should demonstrate that the vendors proc...'?",
"reference": "The audit should demonstrate that the vendors procedures for and results of the verification and validation activities performed the OTS software are appropriate and sufficient for the safety and effectiveness requirements of the medical device to be produced using that software.",
"options": {
"A": "OTS",
"B": "the device manufacturer",
"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": "Which organization is referenced: 'The device manufacturer should also consider the i...'?",
"reference": "The device manufacturer should also consider the implications (if any) for continued maintenance and support of the OTS software should the vendor terminate their support.",
"options": {
"D": "OTS",
"A": "the device manufacturer",
"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: 'Depending upon the risk of the device produced, th...'?",
"reference": "Depending upon the risk of the device produced, the role of the OTS software in the process, the ability to audit the vendor, and the sufficiency of vendor-supplied information, the use of OTS software or equipment may or may not be appropriate, especially if there are suitable alternatives available.",
"options": {
"B": "OTS",
"A": "the device manufacturer",
"C": "This information is not mentioned in the context",
"D": "The context does not provide this detail"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Depending upon the risk of the device produced, th...'?",
"reference": "Depending upon the risk of the device produced, the role of the OTS software in the process, the ability to audit the vendor, and the sufficiency of vendor-supplied information, the use of OTS software or equipment may or may not be appropriate, especially if there are suitable alternatives available.",
"options": {
"D": "OTS",
"A": "the device manufacturer",
"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: 'The audit should demonstrate that the vendors proc...'?",
"reference": "The audit should demonstrate that the vendors procedures for and results of the verification and validation activities performed the OTS software are appropriate and sufficient for the safety and effectiveness requirements of the medical device to be produced using that software.",
"options": {
"A": "OTS",
"B": "the device manufacturer",
"C": "This information is not mentioned in the context",
"D": "The context does not provide this detail"
},
"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]
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": "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": {
"A": "August 20, 1997",
"B": "Part 11 273 records",
"C": "electronic records",
"D": "270 271"
},
"answer": "A",
"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": {
"C": "270",
"A": "270 271",
"B": "272",
"D": "Part 11 273 records"
},
"answer": "C",
"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": {
"C": "271",
"A": "270 271",
"B": "272",
"D": "Part 11 273 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 35 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
See ICH guidance for industry Q2(R1)
Validation of Analytical Procedure s: Text and Methodology . Contains Nonbinding Recommendations 12 but is not limited to notebooks, worksheets, graphs, charts, spectra, and other types of data from laboratory instruments ( 211.194(a) and 212.60(g)(3) ). Can an internal tip or information regarding a quality issue, such as potential data falsification, be handled informally outside of the documented CGMP quality system? Regardless of intent or how or from whom the information was received, s uspected or known falsification or alteration of records required under parts 210, 211, and 212 must be fully investigated under the CGMP quality system to determine the effect of the event on patient safety, product quality, and data reliability ; to determine the root cause ; and to ensure the necessary corrective actions are taken ( see 211.22(a), 211.125(c), 211.192, 211.198, 211.204, and 212.100). FDA invites individuals to report suspected data integrity issues that may affect the safety, identity, strength, quality, or purity of drug products at DrugInfofda.hhs.gov . CGMP data integrity should be included in the subject line of the email . This reporting method is not intended to supersede other FDA reports ( e.g., field a lert r eports or biologi cal product deviation reports that help identify drug products that pose potential saf ety threats ). Should personnel be trained in preventing and detecting data integrity issues as part of a routine CGMP training program? Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under 211.25 and 212.10, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties . Is FDA allowed to look at electronic records? All records required under CGMP are subject to FDA inspection.
[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: 'CGMP data integrity should be included in the sub...'?",
"reference": "CGMP data integrity should be included in the subject line of the email .",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "suspected data integrity issues",
"D": "data integrity issues"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under ____ and 212.10, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties .",
"reference": "Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under 211.25 and 212.10, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties .",
"options": {
"D": "211.25",
"A": "211.194(a",
"B": "211",
"C": "CGMP data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under 211.25 and ____, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties .",
"reference": "Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under 211.25 and 212.10, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties .",
"options": {
"B": "212.10",
"A": "211.194(a",
"C": "211",
"D": "CGMP data integrity"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CGMP data integrity should be included in the sub...'?",
"reference": "CGMP data integrity should be included in the subject line of the email .",
"options": {
"A": "CGMP",
"B": "FDA",
"C": "suspected data integrity issues",
"D": "data integrity issues"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ but is not limited to notebooks, worksheets, graphs, charts, spectra, and other types of data from laboratory instruments ( 211.194(a) and 212.60(g)(3) ).",
"reference": "Contains Nonbinding Recommendations 12 but is not limited to notebooks, worksheets, graphs, charts, spectra, and other types of data from laboratory instruments ( 211.194(a) and 212.60(g)(3) ).",
"options": {
"C": "12",
"A": "211.194(a",
"B": "211",
"D": "CGMP data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA invites individuals to report suspected data i...'?",
"reference": "FDA invites individuals to report suspected data integrity issues that may affect the safety, identity, strength, quality, or purity of drug products at DrugInfofda.hhs.gov .",
"options": {
"C": "FDA",
"A": "CGMP",
"B": "CGMP data integrity",
"D": "suspected data integrity issues"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This reporting method is not intended to supersede...'?",
"reference": "This reporting method is not intended to supersede other FDA reports ( e.g., field a lert r eports or biologi cal product deviation reports that help identify drug products that pose potential saf ety threats ).",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "CGMP data integrity",
"D": "suspected data integrity issues"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA invites individuals to report suspected data i...'?",
"reference": "FDA invites individuals to report suspected data integrity issues that may affect the safety, identity, strength, quality, or purity of drug products at DrugInfofda.hhs.gov .",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "CGMP data integrity",
"C": "suspected data integrity issues"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Is FDA allowed to look at electronic records?...'?",
"reference": "Is FDA allowed to look at electronic records?",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "CGMP data integrity",
"C": "suspected data integrity issues"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Should personnel be trained in preventing and dete...'?",
"reference": "Should personnel be trained in preventing and detecting data integrity issues as part of a routine CGMP training program?",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "suspected data integrity issues",
"D": "data integrity issues"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under ____ and 212.10, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties .",
"reference": "Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under 211.25 and 212.10, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties .",
"options": {
"D": "211.25",
"A": "211.194(a",
"B": "211",
"C": "CGMP data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Should personnel be trained in preventing and dete...'?",
"reference": "Should personnel be trained in preventing and detecting data integrity issues as part of a routine CGMP training program?",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "suspected data integrity issues",
"D": "data integrity issues"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA invites individuals to report suspected data i...'?",
"reference": "FDA invites individuals to report suspected data integrity issues that may affect the safety, identity, strength, quality, or purity of drug products at DrugInfofda.hhs.gov .",
"options": {
"A": "FDA",
"B": "CGMP",
"C": "CGMP data integrity",
"D": "suspected data integrity issues"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This reporting method is not intended to supersede...'?",
"reference": "This reporting method is not intended to supersede other FDA reports ( e.g., field a lert r eports or biologi cal product deviation reports that help identify drug products that pose potential saf ety threats ).",
"options": {
"A": "FDA",
"B": "CGMP",
"C": "CGMP data integrity",
"D": "suspected data integrity issues"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This reporting method is not intended to supersede...'?",
"reference": "This reporting method is not intended to supersede other FDA reports ( e.g., field a lert r eports or biologi cal product deviation reports that help identify drug products that pose potential saf ety threats ).",
"options": {
"C": "FDA",
"A": "CGMP",
"B": "CGMP data integrity",
"D": "suspected data integrity issues"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'See ICH guidance for industry Q2(R1)\nValidation of...'?",
"reference": "See ICH guidance for industry Q2(R1)\nValidation of Analytical Procedure s: Text and Methodology .",
"options": {
"D": "Q2(R1",
"A": "CGMP data integrity",
"B": "suspected data integrity issues",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This reporting method is not intended to supersede...'?",
"reference": "This reporting method is not intended to supersede other FDA reports ( e.g., field a lert r eports or biologi cal product deviation reports that help identify drug products that pose potential saf ety threats ).",
"options": {
"D": "FDA",
"A": "CGMP",
"B": "CGMP data integrity",
"C": "suspected data integrity issues"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Should personnel be trained in preventing and dete...'?",
"reference": "Should personnel be trained in preventing and detecting data integrity issues as part of a routine CGMP training program?",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "suspected data integrity issues",
"C": "data integrity issues"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CGMP data integrity should be included in the sub...'?",
"reference": "CGMP data integrity should be included in the subject line of the email .",
"options": {
"C": "CGMP",
"A": "FDA",
"B": "suspected data integrity issues",
"D": "data integrity issues"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'See ICH guidance for industry Q2(R1)\nValidation of...'?",
"reference": "See ICH guidance for industry Q2(R1)\nValidation of Analytical Procedure s: Text and Methodology .",
"options": {
"B": "Q2(R1",
"A": "CGMP data integrity",
"C": "suspected data integrity issues",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under ____ and 212.10, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties .",
"reference": "Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under 211.25 and 212.10, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties .",
"options": {
"D": "211.25",
"A": "211.194(a",
"B": "211",
"C": "CGMP data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under 211.25 and ____, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties .",
"reference": "Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under 211.25 and 212.10, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties .",
"options": {
"D": "212.10",
"A": "211.194(a",
"B": "211",
"C": "CGMP data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CGMP data integrity should be included in the sub...'?",
"reference": "CGMP data integrity should be included in the subject line of the email .",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "suspected data integrity issues",
"D": "data integrity issues"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under ____ and 212.10, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties .",
"reference": "Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under 211.25 and 212.10, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties .",
"options": {
"C": "211.25",
"A": "211.194(a",
"B": "211",
"D": "CGMP data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under 211.25 and ____, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties .",
"reference": "Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under 211.25 and 212.10, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties .",
"options": {
"C": "212.10",
"A": "211.194(a",
"B": "211",
"D": "CGMP data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Can an internal tip or information regarding a qua...'?",
"reference": "Can an internal tip or information regarding a quality issue, such as potential data falsification, be handled informally outside of the documented CGMP quality system?",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "suspected data integrity issues",
"D": "data integrity issues"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This reporting method is not intended to supersede...'?",
"reference": "This reporting method is not intended to supersede other FDA reports ( e.g., field a lert r eports or biologi cal product deviation reports that help identify drug products that pose potential saf ety threats ).",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "CGMP data integrity",
"D": "suspected data integrity issues"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'CGMP data integrity should be included in the sub...'?",
"reference": "CGMP data integrity should be included in the subject line of the email .",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "suspected data integrity issues",
"C": "data integrity issues"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'All records required under CGMP are subject to FDA...'?",
"reference": "All records required under CGMP are subject to FDA inspection.",
"options": {
"B": "CGMP",
"A": "FDA",
"C": "suspected data integrity issues",
"D": "data integrity issues"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'All records required under CGMP are subject to FDA...'?",
"reference": "All records required under CGMP are subject to FDA inspection.",
"options": {
"B": "FDA",
"A": "CGMP",
"C": "CGMP data integrity",
"D": "suspected data integrity issues"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Regardless of intent or how or from whom the infor...'?",
"reference": "Regardless of intent or how or from whom the information was received, s uspected or known falsification or alteration of records required under parts 210, 211, and 212 must be fully investigated under the CGMP quality system to determine the effect of the event on patient safety, product quality, and data reliability ; to determine the root cause ; and to ensure the necessary corrective actions are taken ( see 211.22(a), 211.125(c), 211.192, 211.198, 211.204, and 212.100).",
"options": {
"D": "CGMP",
"A": "FDA",
"B": "suspected data integrity issues",
"C": "data integrity issues"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Regardless of intent or how or from whom the information was received, s uspected or known falsification or alteration of records required under parts ____, 211, and 212 must be fully investigated under the CGMP quality system to determine the effect of the event on patient safety, product quality, and data reliability ; to determine the root cause ; and to ensure the necessary corrective actions are taken ( see 211.22(a), 211.125(c), 211.192, 211.198, 211.204, and 212.100).",
"reference": "Regardless of intent or how or from whom the information was received, s uspected or known falsification or alteration of records required under parts 210, 211, and 212 must be fully investigated under the CGMP quality system to determine the effect of the event on patient safety, product quality, and data reliability ; to determine the root cause ; and to ensure the necessary corrective actions are taken ( see 211.22(a), 211.125(c), 211.192, 211.198, 211.204, and 212.100).",
"options": {
"D": "210",
"A": "211.194(a",
"B": "211",
"C": "CGMP data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Regardless of intent or how or from whom the information was received, s uspected or known falsification or alteration of records required under parts 210, ____, and 212 must be fully investigated under the CGMP quality system to determine the effect of the event on patient safety, product quality, and data reliability ; to determine the root cause ; and to ensure the necessary corrective actions are taken ( see 211.22(a), 211.125(c), 211.192, 211.198, 211.204, and 212.100).",
"reference": "Regardless of intent or how or from whom the information was received, s uspected or known falsification or alteration of records required under parts 210, 211, and 212 must be fully investigated under the CGMP quality system to determine the effect of the event on patient safety, product quality, and data reliability ; to determine the root cause ; and to ensure the necessary corrective actions are taken ( see 211.22(a), 211.125(c), 211.192, 211.198, 211.204, and 212.100).",
"options": {
"B": "211",
"A": "211.194(a",
"C": "212",
"D": "CGMP data integrity"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Regardless of intent or how or from whom the information was received, s uspected or known falsification or alteration of records required under parts 210, 211, and ____ must be fully investigated under the CGMP quality system to determine the effect of the event on patient safety, product quality, and data reliability ; to determine the root cause ; and to ensure the necessary corrective actions are taken ( see 211.22(a), 211.125(c), 211.192, 211.198, 211.204, and 212.100).",
"reference": "Regardless of intent or how or from whom the information was received, s uspected or known falsification or alteration of records required under parts 210, 211, and 212 must be fully investigated under the CGMP quality system to determine the effect of the event on patient safety, product quality, and data reliability ; to determine the root cause ; and to ensure the necessary corrective actions are taken ( see 211.22(a), 211.125(c), 211.192, 211.198, 211.204, and 212.100).",
"options": {
"B": "212",
"A": "211.194(a",
"C": "211",
"D": "CGMP data integrity"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Regardless of intent or how or from whom the information was received, s uspected or known falsification or alteration of records required under parts 210, 211, and 212 must be fully investigated under the CGMP quality system to determine the effect of the event on patient safety, product quality, and data reliability ; to determine the root cause ; and to ensure the necessary corrective actions are taken ( see 211.22(a), 211.125(c), ____, 211.198, 211.204, and 212.100).",
"reference": "Regardless of intent or how or from whom the information was received, s uspected or known falsification or alteration of records required under parts 210, 211, and 212 must be fully investigated under the CGMP quality system to determine the effect of the event on patient safety, product quality, and data reliability ; to determine the root cause ; and to ensure the necessary corrective actions are taken ( see 211.22(a), 211.125(c), 211.192, 211.198, 211.204, and 212.100).",
"options": {
"B": "211.192",
"A": "211.194(a",
"C": "211",
"D": "CGMP data integrity"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 35 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Historically, software components have not been as frequently standardized and interchangeable as hardware components. However, medical device software developers are beginning to use component-based development tools and techniques. Object-oriented methodologies and the use of off-the-shelf software components hold promise for faster and less expensive software development. However, component-based approaches require very careful attention during integration. Prior to integration, time is needed to fully define and develop reusable software code and to fully understand the behavior of off-the-shelf components. For these and other reasons, software engineering needs an even greater level of managerial scrutiny and control than does hardware engineering. 3.4. BENEFITS OF SOFTWARE VALIDATION Software validation is a critical tool used to assure the quality of device software and software automated operations. Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers. Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes. Software maintenance can represent a very large percentage of the total cost of software over its entire life cycle. An established comprehensive software validation process helps to reduce the long-term cost of software by reducing the cost of validation for each subsequent release of the software. 3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.
[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: ____ DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"reference": "3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"options": {
"D": "3.5",
"A": "3.4",
"B": "device software and software automated operations",
"C": "An established comprehensive software validation process"
},
"answer": "D",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Fill in the blank: ____ DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"reference": "3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"options": {
"D": "3.5",
"A": "3.4",
"B": "device software and software automated operations",
"C": "An established comprehensive software validation process"
},
"answer": "D",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Fill in the blank: ____ DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"reference": "3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"options": {
"A": "3.5",
"B": "3.4",
"C": "device software and software automated operations",
"D": "An established comprehensive software validation process"
},
"answer": "A",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Software validation can increase the usability and...'?",
"reference": "Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.",
"options": {
"B": "Software",
"A": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can increase the usability and...'?",
"reference": "Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.",
"options": {
"C": "Software",
"A": "REVIEW Design",
"B": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can also reduce long term cost...'?",
"reference": "Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes.",
"options": {
"D": "Software",
"A": "REVIEW Design",
"B": "3.5 DESIGN REVIEW Design reviews",
"C": "the design requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can also reduce long term cost...'?",
"reference": "Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes.",
"options": {
"C": "Software",
"A": "REVIEW Design",
"B": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can increase the usability and...'?",
"reference": "Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.",
"options": {
"C": "Software",
"A": "REVIEW Design",
"B": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can increase the usability and...'?",
"reference": "Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.",
"options": {
"D": "Software",
"A": "REVIEW Design",
"B": "3.5 DESIGN REVIEW Design reviews",
"C": "the design requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"reference": "3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"options": {
"A": "3.5",
"B": "3.4",
"C": "device software and software automated operations",
"D": "An established comprehensive software validation process"
},
"answer": "A",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Software validation can also reduce long term cost...'?",
"reference": "Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes.",
"options": {
"A": "Software",
"B": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can increase the usability and...'?",
"reference": "Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.",
"options": {
"B": "Software",
"A": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can also reduce long term cost...'?",
"reference": "Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes.",
"options": {
"B": "Software",
"A": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can increase the usability and...'?",
"reference": "Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.",
"options": {
"A": "Software",
"B": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can also reduce long term cost...'?",
"reference": "Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes.",
"options": {
"B": "Software",
"A": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can increase the usability and...'?",
"reference": "Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.",
"options": {
"D": "Software",
"A": "REVIEW Design",
"B": "3.5 DESIGN REVIEW Design reviews",
"C": "the design requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can also reduce long term cost...'?",
"reference": "Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes.",
"options": {
"C": "Software",
"A": "REVIEW Design",
"B": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"reference": "3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"options": {
"A": "3.5",
"B": "3.4",
"C": "device software and software automated operations",
"D": "An established comprehensive software validation process"
},
"answer": "A",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Software validation can also reduce long term cost...'?",
"reference": "Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes.",
"options": {
"A": "Software",
"B": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can increase the usability and...'?",
"reference": "Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.",
"options": {
"B": "Software",
"A": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can increase the usability and...'?",
"reference": "Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.",
"options": {
"D": "Software",
"A": "REVIEW Design",
"B": "3.5 DESIGN REVIEW Design reviews",
"C": "the design requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can increase the usability and...'?",
"reference": "Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.",
"options": {
"B": "Software",
"A": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can also reduce long term cost...'?",
"reference": "Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes.",
"options": {
"B": "Software",
"A": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can increase the usability and...'?",
"reference": "Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.",
"options": {
"B": "Software",
"A": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can also reduce long term cost...'?",
"reference": "Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes.",
"options": {
"A": "Software",
"B": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"reference": "3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"options": {
"B": "3.5",
"A": "3.4",
"C": "device software and software automated operations",
"D": "An established comprehensive software validation process"
},
"answer": "B",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Fill in the blank: ____ DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"reference": "3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"options": {
"C": "3.5",
"A": "3.4",
"B": "device software and software automated operations",
"D": "An established comprehensive software validation process"
},
"answer": "C",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Fill in the blank: ____ DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"reference": "3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"options": {
"B": "3.5",
"A": "3.4",
"C": "device software and software automated operations",
"D": "An established comprehensive software validation process"
},
"answer": "B",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Software validation can increase the usability and...'?",
"reference": "Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.",
"options": {
"B": "Software",
"A": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can also reduce long term cost...'?",
"reference": "Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes.",
"options": {
"A": "Software",
"B": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"reference": "3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"options": {
"B": "3.5",
"A": "3.4",
"C": "device software and software automated operations",
"D": "An established comprehensive software validation process"
},
"answer": "B",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Software validation can also reduce long term cost...'?",
"reference": "Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes.",
"options": {
"B": "Software",
"A": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can increase the usability and...'?",
"reference": "Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.",
"options": {
"B": "Software",
"A": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design 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 40 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance. The device manufacturer has latitude and flexibility in defining how validation of that software will be accomplished, but validation should be a key consideration in deciding how and by whom the software will be developed or from whom it will be purchased. The software developer defines a life cycle model. Validation is typically supported by: verifications of the outputs from each stage of that software development life cycle; and checking for proper operation of the finished software in the device manufacturers intended use environment. HOW MUCH VALIDATION EVIDENCE IS NEEDED? The level of validation effort should be commensurate with the risk posed by the automated operation. In addition to risk other factors, such as the complexity of the process software and the degree to which the device manufacturer is dependent upon that automated process to produce a safe and effective device, determine the nature and extent of testing needed as part of the validation effort. Documented requirements and risk analysis of the automated process help to define the scope of the evidence needed to show that the software is validated for its intended use. For example, an automated milling machine may require very little testing if the device manufacturer can show that the output of the operation is subsequently fully verified against the specification before release.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "What is developer?",
"reference": "The software developer defines a life cycle model.",
"options": {
"C": "model",
"A": "Software Validation Guidance",
"B": "that software development life cycle",
"D": "pattern"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"B": "that software development life cycle",
"C": "the process software",
"D": "FDA"
},
"answer": "A",
"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": {
"A": "model",
"B": "Software Validation Guidance",
"C": "that software development life cycle",
"D": "pattern"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"B": "Page 31General Principles of Software Validation Guidance for Industry",
"A": "that software development life cycle",
"C": "the process software",
"D": "FDA"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"A": "FDA",
"B": "Page 31General Principles of Software Validation Guidance for Industry",
"C": "Software Validation Guidance",
"D": "that software development life cycle"
},
"answer": "A",
"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": "Page 31General Principles of Software Validation Guidance for Industry",
"A": "that software development life cycle",
"B": "the process software",
"D": "FDA"
},
"answer": "C",
"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": {
"B": "FDA",
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"C": "Software Validation Guidance",
"D": "that software development life cycle"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"D": "Page 31General Principles of Software Validation Guidance for Industry",
"A": "that software development life cycle",
"B": "the process software",
"C": "FDA"
},
"answer": "D",
"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": {
"B": "FDA",
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"C": "Software Validation Guidance",
"D": "that software development life cycle"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is developer?",
"reference": "The software developer defines a life cycle model.",
"options": {
"B": "model",
"A": "Software Validation Guidance",
"C": "that software development life cycle",
"D": "pattern"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is developer?",
"reference": "The software developer defines a life cycle model.",
"options": {
"D": "model",
"A": "Software Validation Guidance",
"B": "that software development life cycle",
"C": "pattern"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is developer?",
"reference": "The software developer defines a life cycle model.",
"options": {
"B": "model",
"A": "Software Validation Guidance",
"C": "that software development life cycle",
"D": "pattern"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is developer?",
"reference": "The software developer defines a life cycle model.",
"options": {
"D": "model",
"A": "Software Validation Guidance",
"B": "that software development life cycle",
"C": "pattern"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"D": "Page 31General Principles of Software Validation Guidance for Industry",
"A": "that software development life cycle",
"B": "the process software",
"C": "FDA"
},
"answer": "D",
"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": {
"B": "FDA",
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"C": "Software Validation Guidance",
"D": "that software development life cycle"
},
"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": {
"B": "Page 31General Principles of Software Validation Guidance for Industry",
"A": "that software development life cycle",
"C": "the process software",
"D": "FDA"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"D": "FDA",
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"B": "Software Validation Guidance",
"C": "that software development life cycle"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"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": "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": "Page 31General Principles of Software Validation Guidance for Industry",
"A": "that software development life cycle",
"B": "the process software",
"D": "FDA"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is developer?",
"reference": "The software developer defines a life cycle model.",
"options": {
"B": "model",
"A": "Software Validation Guidance",
"C": "that software development life cycle",
"D": "pattern"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"B": "Page 31General Principles of Software Validation Guidance for Industry",
"A": "that software development life cycle",
"C": "the process software",
"D": "FDA"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"B": "FDA",
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"C": "Software Validation Guidance",
"D": "that software development life cycle"
},
"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": "Page 31General Principles of Software Validation Guidance for Industry",
"A": "that software development life cycle",
"B": "the process software",
"D": "FDA"
},
"answer": "C",
"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": {
"A": "FDA",
"B": "Page 31General Principles of Software Validation Guidance for Industry",
"C": "Software Validation Guidance",
"D": "that software development life cycle"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is developer?",
"reference": "The software developer defines a life cycle model.",
"options": {
"A": "model",
"B": "Software Validation Guidance",
"C": "that software development life cycle",
"D": "pattern"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"B": "that software development life cycle",
"C": "the process software",
"D": "FDA"
},
"answer": "A",
"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": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"D": "Page 31General Principles of Software Validation Guidance for Industry",
"A": "that software development life cycle",
"B": "the process software",
"C": "FDA"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"D": "FDA",
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"B": "Software Validation Guidance",
"C": "that software development life cycle"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is developer?",
"reference": "The software developer defines a life cycle model.",
"options": {
"B": "model",
"A": "Software Validation Guidance",
"C": "that software development life cycle",
"D": "pattern"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is developer?",
"reference": "The software developer defines a life cycle model.",
"options": {
"A": "model",
"B": "Software Validation Guidance",
"C": "that software development life cycle",
"D": "pattern"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"B": "that software development life cycle",
"C": "the process software",
"D": "FDA"
},
"answer": "A",
"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": {
"B": "FDA",
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"C": "Software Validation Guidance",
"D": "that software development life cycle"
},
"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": {
"B": "Page 31General Principles of Software Validation Guidance for Industry",
"A": "that software development life cycle",
"C": "the process software",
"D": "FDA"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Whether production or quality system software is d...'?",
"reference": "Whether production or quality system software is developed in-house by the device manufacturer, developed by a contractor, or purchased off-the-shelf, it should be developed using the basic principles Page 31General Principles of Software Validation Guidance for Industry and FDA Staff outlined elsewhere in this guidance.",
"options": {
"D": "FDA",
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"B": "Software Validation Guidance",
"C": "that software development life cycle"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"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": {
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"B": "that software development life cycle",
"C": "the process software",
"D": "FDA"
},
"answer": "A",
"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": "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": "Page 31General Principles of Software Validation Guidance for Industry",
"A": "that software development life cycle",
"B": "the process software",
"D": "FDA"
},
"answer": "C",
"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": {
"B": "FDA",
"A": "Page 31General Principles of Software Validation Guidance for Industry",
"C": "Software Validation Guidance",
"D": "that software development life cycle"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 35 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
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": {
"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 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": {
"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": "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": "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 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": {
"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": {
"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": "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": {
"A": "5.2.7",
"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": "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": {
"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": {
"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 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": {
"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 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": {
"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": "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 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": {
"A": "5.2.7",
"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": "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 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": "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": "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": {
"A": "5.2.7",
"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 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": "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": {
"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": "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"
}
]
|
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]
198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ). When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and 212. FDA requires that systems controls, 206 including documentation control s, be designed to follow CGMP to assure product quality 207 (for example, 211.100 and 212.50). How should blank forms be controlled ? 210 211 There must be document controls in place to as sure product quality (see 211.100, 212 211.160(a) , 211.186, 212.20(d) , and 212.60(g) ). FDA recommends that, if used, blank 213 forms (including, but not limited to, worksheets, laboratory notebooks, and MPCRs ) be 214 controlled by the quality unit or by another document control method. For example, 215 numbered sets of blank forms may be issued as appropriate and should be reconciled 216 upon completion of all issued forms. Incomplete or erroneous forms should be kept as 217 part of the permanent record along with written justification for their re placement ( for 218 example, see 211.192, 211.194, 212.50(a) , and 212.70(f)(1)(vi)). 219 220 Similarly, bound paginated notebooks, stamped for official use by a document control 221 group, allow detection of unofficial notebooks as well as of any gaps in notebook pages. How often should audit trails be reviewed ? 224 225 FDA recommends that audit trails that capture change s to critical data be reviewed with 226 each record and before final approval of the record .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'FDA requires that systems controls, 206 including ...'?",
"reference": "FDA requires that systems controls, 206 including documentation control s, be designed to follow CGMP to assure product quality 207 (for example, 211.100 and 212.50).",
"options": {
"C": "FDA",
"A": "laborat ory data",
"B": "CGMP",
"D": "a document control 221 group"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'FDA requires that systems controls, 206 including ...'?",
"reference": "FDA requires that systems controls, 206 including documentation control s, be designed to follow CGMP to assure product quality 207 (for example, 211.100 and 212.50).",
"options": {
"C": "CGMP",
"A": "laborat ory data",
"B": "FDA",
"D": "a document control 221 group"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA requires that systems controls, ____ including documentation control s, be designed to follow CGMP to assure product quality 207 (for example, 211.100 and 212.50).",
"reference": "FDA requires that systems controls, 206 including documentation control s, be designed to follow CGMP to assure product quality 207 (for example, 211.100 and 212.50).",
"options": {
"C": "206",
"A": "198 199",
"B": "200",
"D": "a document control 221 group"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA requires that systems controls, 206 including documentation control s, be designed to follow CGMP to assure product quality ____ (for example, 211.100 and 212.50).",
"reference": "FDA requires that systems controls, 206 including documentation control s, be designed to follow CGMP to assure product quality 207 (for example, 211.100 and 212.50).",
"options": {
"A": "207",
"B": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA requires that systems controls, 206 including documentation control s, be designed to follow CGMP to assure product quality 207 (for example, ____ and 212.50).",
"reference": "FDA requires that systems controls, 206 including documentation control s, be designed to follow CGMP to assure product quality 207 (for example, 211.100 and 212.50).",
"options": {
"B": "211.100",
"A": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: FDA requires that systems controls, 206 including documentation control s, be designed to follow CGMP to assure product quality 207 (for example, 211.100 and ____).",
"reference": "FDA requires that systems controls, 206 including documentation control s, be designed to follow CGMP to assure product quality 207 (for example, 211.100 and 212.50).",
"options": {
"B": "212.50",
"A": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: '210 211 There must be document controls in place t...'?",
"reference": "210 211 There must be document controls in place to as sure product quality (see 211.100, 212 211.160(a) , 211.186, 212.20(d) , and 212.60(g) ).",
"options": {
"C": "212 211.160(a",
"A": "a document control 221 group",
"B": "should blank forms",
"D": "210 211"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 211 There must be document controls in place to as sure product quality (see 211.100, 212 211.160(a) , 211.186, 212.20(d) , and 212.60(g) ).",
"reference": "210 211 There must be document controls in place to as sure product quality (see 211.100, 212 211.160(a) , 211.186, 212.20(d) , and 212.60(g) ).",
"options": {
"A": "210",
"B": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 210 ____ There must be document controls in place to as sure product quality (see 211.100, 212 211.160(a) , 211.186, 212.20(d) , and 212.60(g) ).",
"reference": "210 211 There must be document controls in place to as sure product quality (see 211.100, 212 211.160(a) , 211.186, 212.20(d) , and 212.60(g) ).",
"options": {
"B": "211",
"A": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 210 211 There must be document controls in place to as sure product quality (see ____, 212 211.160(a) , 211.186, 212.20(d) , and 212.60(g) ).",
"reference": "210 211 There must be document controls in place to as sure product quality (see 211.100, 212 211.160(a) , 211.186, 212.20(d) , and 212.60(g) ).",
"options": {
"B": "211.100",
"A": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 210 211 There must be document controls in place to as sure product quality (see 211.100, ____ 211.160(a) , 211.186, 212.20(d) , and 212.60(g) ).",
"reference": "210 211 There must be document controls in place to as sure product quality (see 211.100, 212 211.160(a) , 211.186, 212.20(d) , and 212.60(g) ).",
"options": {
"B": "212",
"A": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 220 Similarly, bound paginated notebooks, stamped for official use by a document control 221 group, allow detection of unofficial notebooks as well as of any gaps in notebook pages.",
"reference": "219 220 Similarly, bound paginated notebooks, stamped for official use by a document control 221 group, allow detection of unofficial notebooks as well as of any gaps in notebook pages.",
"options": {
"B": "219",
"A": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 219 ____ Similarly, bound paginated notebooks, stamped for official use by a document control 221 group, allow detection of unofficial notebooks as well as of any gaps in notebook pages.",
"reference": "219 220 Similarly, bound paginated notebooks, stamped for official use by a document control 221 group, allow detection of unofficial notebooks as well as of any gaps in notebook pages.",
"options": {
"B": "220",
"A": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 219 220 Similarly, bound paginated notebooks, stamped for official use by a document control ____ group, allow detection of unofficial notebooks as well as of any gaps in notebook pages.",
"reference": "219 220 Similarly, bound paginated notebooks, stamped for official use by a document control 221 group, allow detection of unofficial notebooks as well as of any gaps in notebook pages.",
"options": {
"B": "221",
"A": "198 199",
"C": "200",
"D": "should blank forms"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Incomplete or erroneous forms should be kept as ____ part of the permanent record along with written justification for their re placement ( for 218 example, see 211.192, 211.194, 212.50(a) , and 212.70(f)(1)(vi)).",
"reference": "Incomplete or erroneous forms should be kept as 217 part of the permanent record along with written justification for their re placement ( for 218 example, see 211.192, 211.194, 212.50(a) , and 212.70(f)(1)(vi)).",
"options": {
"C": "217",
"A": "198 199",
"B": "200",
"D": "a document control 221 group"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Incomplete or erroneous forms should be kept as 217 part of the permanent record along with written justification for their re placement ( for ____ example, see 211.192, 211.194, 212.50(a) , and 212.70(f)(1)(vi)).",
"reference": "Incomplete or erroneous forms should be kept as 217 part of the permanent record along with written justification for their re placement ( for 218 example, see 211.192, 211.194, 212.50(a) , and 212.70(f)(1)(vi)).",
"options": {
"C": "218",
"A": "198 199",
"B": "200",
"D": "a document control 221 group"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Incomplete or erroneous forms should be kept as 217 part of the permanent record along with written justification for their re placement ( for 218 example, see ____, 211.194, 212.50(a) , and 212.70(f)(1)(vi)).",
"reference": "Incomplete or erroneous forms should be kept as 217 part of the permanent record along with written justification for their re placement ( for 218 example, see 211.192, 211.194, 212.50(a) , and 212.70(f)(1)(vi)).",
"options": {
"D": "211.192",
"A": "198 199",
"B": "200",
"C": "a document control 221 group"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Incomplete or erroneous forms should be kept as 217 part of the permanent record along with written justification for their re placement ( for 218 example, see 211.192, ____, 212.50(a) , and 212.70(f)(1)(vi)).",
"reference": "Incomplete or erroneous forms should be kept as 217 part of the permanent record along with written justification for their re placement ( for 218 example, see 211.192, 211.194, 212.50(a) , and 212.70(f)(1)(vi)).",
"options": {
"B": "211.194",
"A": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When login credentials are shared, a unique 204 in...'?",
"reference": "When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and 212.",
"options": {
"D": "CGMP",
"A": "laborat ory data",
"B": "FDA",
"C": "a document control 221 group"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When login credentials are shared, a unique ____ individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and 212.",
"reference": "When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and 212.",
"options": {
"D": "204",
"A": "198 199",
"B": "200",
"C": "a document control 221 group"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform ____ to the CGMP requirements in parts 211 and 212.",
"reference": "When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and 212.",
"options": {
"A": "205",
"B": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts ____ and 212.",
"reference": "When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and 212.",
"options": {
"B": "211",
"A": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and ____.",
"reference": "When login credentials are shared, a unique 204 individual cannot be identified through the login and the system would thus not conform 205 to the CGMP requirements in parts 211 and 212.",
"options": {
"C": "212",
"A": "198 199",
"B": "200",
"D": "a document control 221 group"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '198 199 You must exercise appropriate controls to ...'?",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"B": "laborat ory data",
"A": "CGMP",
"C": "FDA",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"C": "198",
"A": "198 199",
"B": "200",
"D": "a document control 221 group"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 198 ____ You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"D": "199",
"A": "198 199",
"B": "200",
"C": "a document control 221 group"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 198 199 You must exercise appropriate controls to as sure that only authorized personnel make ____ changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"B": "200",
"A": "198 199",
"C": "201",
"D": "a document control 221 group"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into ____ computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"A": "201",
"B": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure ____ actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"A": "202",
"B": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), ____ 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"A": "203",
"B": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '198 199 You must exercise appropriate controls to ...'?",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"C": "laborat ory data",
"A": "CGMP",
"B": "FDA",
"D": "a document control 221 group"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"D": "198",
"A": "198 199",
"B": "200",
"C": "a document control 221 group"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 198 ____ You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"A": "199",
"B": "198 199",
"C": "200",
"D": "a document control 221 group"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 198 199 You must exercise appropriate controls to as sure that only authorized personnel make ____ changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"A": "200",
"B": "198 199",
"C": "201",
"D": "a document control 221 group"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into ____ computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"reference": "198 199 You must exercise appropriate controls to as sure that only authorized personnel make 200 changes to computerized MPCR s, or other records, or input laborat ory data into 201 computerized records, and you must implement documentation controls that ensure 202 actions are attributable to a specific individual ( see 211.68(b), 211.188(b)(11), 203 211.194(a)(7) and (8) , and 212.50(c)(10) ).",
"options": {
"D": "201",
"A": "198 199",
"B": "200",
"C": "a document control 221 group"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
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]
(CGMP regulations 211.180 require the review and evaluation of records to determine the need for any change. These reco rds contain data and in formation from production that provide insight into the products state of control. Change control systems should provide a 14 See Reference 5. 15
Even with good design and development work, initial conformance batches will provide confidence that future batches will meet specifications only if the process is repeated within defined operating parameters, equipment tolerances, personnel practices, environmental attributes, and material quality. See Reference 6. 17
Contains Nonbinding Recommendations dependable mechanism for prompt implemen tation of technically sound manufacturing improvements.) Under a quality system, written procedures a re f ollowed and deviations from them are justified and documented (CGMP requires th is; see 211.100(b)) to ensure that the manufacturer can trace the history of the product, as appropriate, concerning personnel, materials, equipment, and chronology and that processes for product release are complete and recorded. Both the CGMP regulations ( 211.110) and qual ity systems models call for the monitoring of critical processes that may be responsible for causing variability during production. For exam ple: Process steps must be verified by a second pe rson ( 211.188). Process steps can also be performed using a validated computer sy stem. Batch production records must be prepared contemporaneously with each phase of production ( 211.100(b)). Although time limits for production can be established when they are important to the quality of the finished product (CGMP addresses this; see 211.111), the manufacturer should have the ability to establish production controls us ing in-process parameters that are based on desired process endpoints measured using real time testing or monitoring apparatus (e.g., blend until mixed vs. blend for 10 minutes).
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: For exam ple: Process steps must be verified by a ____ pe rson ( 211.188).",
"reference": "For exam ple: Process steps must be verified by a second pe rson ( 211.188).",
"options": {
"D": "second",
"A": "Batch production records",
"B": "production",
"C": "secondly"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For exam ple: Process steps must be verified by a second pe rson ( ____).",
"reference": "For exam ple: Process steps must be verified by a second pe rson ( 211.188).",
"options": {
"D": "211.188",
"A": "211.180",
"B": "211.100(b",
"C": "Batch production records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nEven with good design and development work, initial conformance batches will provide confidence that future batches will meet specifications only if the process is repeated within defined operating parameters, equipment tolerances, personnel practices, environmental attributes, and material quality.",
"reference": "15\nEven with good design and development work, initial conformance batches will provide confidence that future batches will meet specifications only if the process is repeated within defined operating parameters, equipment tolerances, personnel practices, environmental attributes, and material quality.",
"options": {
"A": "15",
"B": "211.180",
"C": "211.100(b",
"D": "Batch production records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Both the CGMP regulations ( 211.110) and qual ity ...'?",
"reference": "Both the CGMP regulations ( 211.110) and qual ity systems models call for the monitoring of critical processes that may be responsible for causing variability during production.",
"options": {
"C": "CGMP",
"A": "Contains Nonbinding Recommendations",
"B": "Batch production records",
"D": "production"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Both the CGMP regulations ( ____) and qual ity systems models call for the monitoring of critical processes that may be responsible for causing variability during production.",
"reference": "Both the CGMP regulations ( 211.110) and qual ity systems models call for the monitoring of critical processes that may be responsible for causing variability during production.",
"options": {
"B": "211.110",
"A": "211.180",
"C": "211.100(b",
"D": "Batch production records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nEven with good design and development work, initial conformance batches will provide confidence that future batches will meet specifications only if the process is repeated within defined operating parameters, equipment tolerances, personnel practices, environmental attributes, and material quality.",
"reference": "15\nEven with good design and development work, initial conformance batches will provide confidence that future batches will meet specifications only if the process is repeated within defined operating parameters, equipment tolerances, personnel practices, environmental attributes, and material quality.",
"options": {
"B": "15",
"A": "211.180",
"C": "211.100(b",
"D": "Batch production records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system, written procedures a re f ...'?",
"reference": "Under a quality system, written procedures a re f ollowed and deviations from them are justified and documented (CGMP requires th is; see 211.100(b)) to ensure that the manufacturer can trace the history of the product, as appropriate, concerning personnel, materials, equipment, and chronology and that processes for product release are complete and recorded.",
"options": {
"A": "CGMP",
"B": "Contains Nonbinding Recommendations",
"C": "Batch production records",
"D": "production"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For exam ple: Process steps must be verified by a ____ pe rson ( 211.188).",
"reference": "For exam ple: Process steps must be verified by a second pe rson ( 211.188).",
"options": {
"D": "second",
"A": "Batch production records",
"B": "production",
"C": "secondly"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For exam ple: Process steps must be verified by a second pe rson ( ____).",
"reference": "For exam ple: Process steps must be verified by a second pe rson ( 211.188).",
"options": {
"B": "211.188",
"A": "211.180",
"C": "211.100(b",
"D": "Batch production records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Both the CGMP regulations ( 211.110) and qual ity ...'?",
"reference": "Both the CGMP regulations ( 211.110) and qual ity systems models call for the monitoring of critical processes that may be responsible for causing variability during production.",
"options": {
"D": "CGMP",
"A": "Contains Nonbinding Recommendations",
"B": "Batch production records",
"C": "production"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Both the CGMP regulations ( ____) and qual ity systems models call for the monitoring of critical processes that may be responsible for causing variability during production.",
"reference": "Both the CGMP regulations ( 211.110) and qual ity systems models call for the monitoring of critical processes that may be responsible for causing variability during production.",
"options": {
"C": "211.110",
"A": "211.180",
"B": "211.100(b",
"D": "Batch production records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nEven with good design and development work, initial conformance batches will provide confidence that future batches will meet specifications only if the process is repeated within defined operating parameters, equipment tolerances, personnel practices, environmental attributes, and material quality.",
"reference": "15\nEven with good design and development work, initial conformance batches will provide confidence that future batches will meet specifications only if the process is repeated within defined operating parameters, equipment tolerances, personnel practices, environmental attributes, and material quality.",
"options": {
"C": "15",
"A": "211.180",
"B": "211.100(b",
"D": "Batch production records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Change control systems should provide a ____ See Reference 5.",
"reference": "Change control systems should provide a 14 See Reference 5.",
"options": {
"C": "14",
"A": "211.180",
"B": "211.100(b",
"D": "Batch production records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Change control systems should provide a 14 See Reference ____.",
"reference": "Change control systems should provide a 14 See Reference 5.",
"options": {
"A": "5",
"B": "211.180",
"C": "211.100(b",
"D": "Batch production records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nEven with good design and development work, initial conformance batches will provide confidence that future batches will meet specifications only if the process is repeated within defined operating parameters, equipment tolerances, personnel practices, environmental attributes, and material quality.",
"reference": "15\nEven with good design and development work, initial conformance batches will provide confidence that future batches will meet specifications only if the process is repeated within defined operating parameters, equipment tolerances, personnel practices, environmental attributes, and material quality.",
"options": {
"B": "15",
"A": "211.180",
"C": "211.100(b",
"D": "Batch production records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Both the CGMP regulations ( 211.110) and qual ity ...'?",
"reference": "Both the CGMP regulations ( 211.110) and qual ity systems models call for the monitoring of critical processes that may be responsible for causing variability during production.",
"options": {
"D": "CGMP",
"A": "Contains Nonbinding Recommendations",
"B": "Batch production records",
"C": "production"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Both the CGMP regulations ( ____) and qual ity systems models call for the monitoring of critical processes that may be responsible for causing variability during production.",
"reference": "Both the CGMP regulations ( 211.110) and qual ity systems models call for the monitoring of critical processes that may be responsible for causing variability during production.",
"options": {
"B": "211.110",
"A": "211.180",
"C": "211.100(b",
"D": "Batch production records"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system, written procedures a re f ...'?",
"reference": "Under a quality system, written procedures a re f ollowed and deviations from them are justified and documented (CGMP requires th is; see 211.100(b)) to ensure that the manufacturer can trace the history of the product, as appropriate, concerning personnel, materials, equipment, and chronology and that processes for product release are complete and recorded.",
"options": {
"C": "CGMP",
"A": "Contains Nonbinding Recommendations",
"B": "Batch production records",
"D": "production"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '17\nContains Nonbinding Recommendations dependable ...'?",
"reference": "17\nContains Nonbinding Recommendations dependable mechanism for prompt implemen tation of technically sound manufacturing improvements.)",
"options": {
"C": "Contains Nonbinding Recommendations",
"A": "Batch production records",
"B": "production",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nContains Nonbinding Recommendations dependable mechanism for prompt implemen tation of technically sound manufacturing improvements.)",
"reference": "17\nContains Nonbinding Recommendations dependable mechanism for prompt implemen tation of technically sound manufacturing improvements.)",
"options": {
"C": "17",
"A": "211.180",
"B": "211.100(b",
"D": "Batch production records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Change control systems should provide a ____ See Reference 5.",
"reference": "Change control systems should provide a 14 See Reference 5.",
"options": {
"D": "14",
"A": "211.180",
"B": "211.100(b",
"C": "Batch production records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Change control systems should provide a 14 See Reference ____.",
"reference": "Change control systems should provide a 14 See Reference 5.",
"options": {
"D": "5",
"A": "211.180",
"B": "211.100(b",
"C": "Batch production records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nEven with good design and development work, initial conformance batches will provide confidence that future batches will meet specifications only if the process is repeated within defined operating parameters, equipment tolerances, personnel practices, environmental attributes, and material quality.",
"reference": "15\nEven with good design and development work, initial conformance batches will provide confidence that future batches will meet specifications only if the process is repeated within defined operating parameters, equipment tolerances, personnel practices, environmental attributes, and material quality.",
"options": {
"C": "15",
"A": "211.180",
"B": "211.100(b",
"D": "Batch production records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(CGMP regulations 211.180 require the review and ...'?",
"reference": "(CGMP regulations 211.180 require the review and evaluation of records to determine the need for any change.",
"options": {
"C": "CGMP",
"A": "Contains Nonbinding Recommendations",
"B": "Batch production records",
"D": "production"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (CGMP regulations ____ require the review and evaluation of records to determine the need for any change.",
"reference": "(CGMP regulations 211.180 require the review and evaluation of records to determine the need for any change.",
"options": {
"D": "211.180",
"A": "211.100(b",
"B": "211.110",
"C": "Batch production records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system, written procedures a re f ...'?",
"reference": "Under a quality system, written procedures a re f ollowed and deviations from them are justified and documented (CGMP requires th is; see 211.100(b)) to ensure that the manufacturer can trace the history of the product, as appropriate, concerning personnel, materials, equipment, and chronology and that processes for product release are complete and recorded.",
"options": {
"B": "CGMP",
"A": "Contains Nonbinding Recommendations",
"C": "Batch production records",
"D": "production"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Although time limits for production can be establi...'?",
"reference": "Although time limits for production can be established when they are important to the quality of the finished product (CGMP addresses this; see 211.111), the manufacturer should have the ability to establish production controls us ing in-process parameters that are based on desired process endpoints measured using real time testing or monitoring apparatus (e.g., blend until mixed vs. blend for 10 minutes).",
"options": {
"A": "CGMP",
"B": "Contains Nonbinding Recommendations",
"C": "Batch production records",
"D": "production"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Although time limits for production can be established when they are important to the quality of the finished product (CGMP addresses this; see ____), the manufacturer should have the ability to establish production controls us ing in-process parameters that are based on desired process endpoints measured using real time testing or monitoring apparatus (e.g., blend until mixed vs. blend for 10 minutes).",
"reference": "Although time limits for production can be established when they are important to the quality of the finished product (CGMP addresses this; see 211.111), the manufacturer should have the ability to establish production controls us ing in-process parameters that are based on desired process endpoints measured using real time testing or monitoring apparatus (e.g., blend until mixed vs. blend for 10 minutes).",
"options": {
"A": "211.111",
"B": "211.180",
"C": "211.100(b",
"D": "Batch production records"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Although time limits for production can be established when they are important to the quality of the finished product (CGMP addresses this; see 211.111), the manufacturer should have the ability to establish production controls us ing in-process parameters that are based on desired process endpoints measured using real time testing or monitoring apparatus (e.g., blend until mixed vs. blend for ____ minutes).",
"reference": "Although time limits for production can be established when they are important to the quality of the finished product (CGMP addresses this; see 211.111), the manufacturer should have the ability to establish production controls us ing in-process parameters that are based on desired process endpoints measured using real time testing or monitoring apparatus (e.g., blend until mixed vs. blend for 10 minutes).",
"options": {
"C": "10",
"A": "211.180",
"B": "211.100(b",
"D": "Batch production records"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Although time limits for production can be establi...'?",
"reference": "Although time limits for production can be established when they are important to the quality of the finished product (CGMP addresses this; see 211.111), the manufacturer should have the ability to establish production controls us ing in-process parameters that are based on desired process endpoints measured using real time testing or monitoring apparatus (e.g., blend until mixed vs. blend for 10 minutes).",
"options": {
"C": "CGMP",
"A": "Contains Nonbinding Recommendations",
"B": "Batch production records",
"D": "production"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Although time limits for production can be established when they are important to the quality of the finished product (CGMP addresses this; see ____), the manufacturer should have the ability to establish production controls us ing in-process parameters that are based on desired process endpoints measured using real time testing or monitoring apparatus (e.g., blend until mixed vs. blend for 10 minutes).",
"reference": "Although time limits for production can be established when they are important to the quality of the finished product (CGMP addresses this; see 211.111), the manufacturer should have the ability to establish production controls us ing in-process parameters that are based on desired process endpoints measured using real time testing or monitoring apparatus (e.g., blend until mixed vs. blend for 10 minutes).",
"options": {
"C": "211.111",
"A": "211.180",
"B": "211.100(b",
"D": "Batch production records"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Although time limits for production can be established when they are important to the quality of the finished product (CGMP addresses this; see 211.111), the manufacturer should have the ability to establish production controls us ing in-process parameters that are based on desired process endpoints measured using real time testing or monitoring apparatus (e.g., blend until mixed vs. blend for ____ minutes).",
"reference": "Although time limits for production can be established when they are important to the quality of the finished product (CGMP addresses this; see 211.111), the manufacturer should have the ability to establish production controls us ing in-process parameters that are based on desired process endpoints measured using real time testing or monitoring apparatus (e.g., blend until mixed vs. blend for 10 minutes).",
"options": {
"C": "10",
"A": "211.180",
"B": "211.100(b",
"D": "Batch production records"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(CGMP regulations 211.180 require the review and ...'?",
"reference": "(CGMP regulations 211.180 require the review and evaluation of records to determine the need for any change.",
"options": {
"A": "CGMP",
"B": "Contains Nonbinding Recommendations",
"C": "Batch production records",
"D": "production"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (CGMP regulations ____ require the review and evaluation of records to determine the need for any change.",
"reference": "(CGMP regulations 211.180 require the review and evaluation of records to determine the need for any change.",
"options": {
"D": "211.180",
"A": "211.100(b",
"B": "211.110",
"C": "Batch production records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____\nEven with good design and development work, initial conformance batches will provide confidence that future batches will meet specifications only if the process is repeated within defined operating parameters, equipment tolerances, personnel practices, environmental attributes, and material quality.",
"reference": "15\nEven with good design and development work, initial conformance batches will provide confidence that future batches will meet specifications only if the process is repeated within defined operating parameters, equipment tolerances, personnel practices, environmental attributes, and material quality.",
"options": {
"A": "15",
"B": "211.180",
"C": "211.100(b",
"D": "Batch production 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]
For more information, see guidance for i ndustry Part 11, Electronic Records; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the scope and application of part 11 pending FDAs reexamination of part 11 as it applies to all FDA -regulated products. Contains Nonbinding Recommendations 4 III. QUESTIONS AND ANSWERS 1. Please clarify the following terms as they relate to CGMP records: a. What is data integrity ? For the purpose s of this guidance, data integrity refers to the complete ness, consistency , and accuracy of data. Complete, consistent, and accurate data should be a ttributable , legible , contemporaneous ly recorded, original or a true copy, and accurate (ALCOA) . 5 Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archiv al, retrieval, transmission, and disposition of data after the records retention period ends . 6 System design and controls should enable easy detection of errors, omissions, and aberrant results throughout the datas life cycle . What is metadata ? Metadata is the contextual information required to understand data. A data value is by itself meaningless without additional information about t he data. Metadata is often described as data about data. Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data. For example, the number 23 is meaningless without metadata, such as an in dication of the unit mg. Among other things, metadata for a particular piece of data could include a date/time stamp documenting when the data w ere acquired, a user ID of the person who conducted the test or analysis that generated the data, the instrume nt ID used to acquire the data, material status data, the material identification number, and audit trails.
[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: 'Metadata is the contextual information required to...'?",
"reference": "Metadata is the contextual information required to understand data.",
"options": {
"A": "Metadata",
"B": "the CGMP data life cycle",
"C": "data integrity",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Metadata is often described as data about data....'?",
"reference": "Metadata is often described as data about data.",
"options": {
"C": "Metadata",
"A": "the CGMP data life cycle",
"B": "data integrity",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"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; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the scope and application of part 11 pending FDAs reexamination of part 11 as it applies to all FDA -regulated products.",
"options": {
"B": "Electronic Records",
"A": "the CGMP data life cycle",
"C": "data integrity",
"D": "FDA"
},
"answer": "B",
"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; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the scope and application of part 11 pending FDAs reexamination of part 11 as it applies to all FDA -regulated products.",
"options": {
"C": "FDA",
"A": "Electronic Records",
"B": "CGMP",
"D": "the CGMP data life cycle"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part ____, Electronic Records; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the 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; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the scope and application of part 11 pending FDAs reexamination of part 11 as it applies to all FDA -regulated products.",
"options": {
"C": "11",
"A": "the CGMP data life cycle",
"B": "data integrity",
"D": "Electronic Records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part ____, Electronic Records; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the 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; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the scope and application of part 11 pending FDAs reexamination of part 11 as it applies to all FDA -regulated products.",
"options": {
"A": "11",
"B": "the CGMP data life cycle",
"C": "data integrity",
"D": "Electronic Records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part ____, Electronic Records; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the 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; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the scope and application of part 11 pending FDAs reexamination of part 11 as it applies to all FDA -regulated products.",
"options": {
"D": "11",
"A": "the CGMP data life cycle",
"B": "data integrity",
"C": "Electronic Records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Metadata is often described as data about data....'?",
"reference": "Metadata is often described as data about data.",
"options": {
"C": "Metadata",
"A": "the CGMP data life cycle",
"B": "data integrity",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"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; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the scope and application of part 11 pending FDAs reexamination of part 11 as it applies to all FDA -regulated products.",
"options": {
"B": "Electronic Records",
"A": "the CGMP data life cycle",
"C": "data integrity",
"D": "FDA"
},
"answer": "B",
"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; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the scope and application of part 11 pending FDAs reexamination of part 11 as it applies to all FDA -regulated products.",
"options": {
"A": "FDA",
"B": "Electronic Records",
"C": "CGMP",
"D": "the CGMP data life cycle"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the number ____ is meaningless without metadata, such as an in dication of the unit mg.",
"reference": "For example, the number 23 is meaningless without metadata, such as an in dication of the unit mg.",
"options": {
"C": "23",
"A": "the CGMP data life cycle",
"B": "data integrity",
"D": "XXIII"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '5 Data integrity is critical throughout the CGMP d...'?",
"reference": "5 Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archiv al, retrieval, transmission, and disposition of data after the records retention period ends .",
"options": {
"B": "CGMP",
"A": "Electronic Records",
"C": "FDA",
"D": "data integrity"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: '5 Data integrity is critical throughout the CGMP d...'?",
"reference": "5 Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archiv al, retrieval, transmission, and disposition of data after the records retention period ends .",
"options": {
"B": "al",
"A": "the CGMP data life cycle",
"C": "data integrity",
"D": "Alabama"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archiv al, retrieval, transmission, and disposition of data after the records retention period ends .",
"reference": "5 Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archiv al, retrieval, transmission, and disposition of data after the records retention period ends .",
"options": {
"C": "5",
"A": "the CGMP data life cycle",
"B": "data integrity",
"D": "Little Phoebe"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the number ____ is meaningless without metadata, such as an in dication of the unit mg.",
"reference": "For example, the number 23 is meaningless without metadata, such as an in dication of the unit mg.",
"options": {
"C": "23",
"A": "the CGMP data life cycle",
"B": "data integrity",
"D": "XXIII"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For more information, see guidance for i ndustry P...'?",
"reference": "For more information, see guidance for i ndustry Part 11, Electronic Records; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the scope and application of part 11 pending FDAs reexamination of part 11 as it applies to all FDA -regulated products.",
"options": {
"D": "Electronic Records",
"A": "the CGMP data life cycle",
"B": "data integrity",
"C": "FDA"
},
"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; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the scope and application of part 11 pending FDAs reexamination of part 11 as it applies to all FDA -regulated products.",
"options": {
"A": "FDA",
"B": "Electronic Records",
"C": "CGMP",
"D": "the CGMP data life cycle"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part ____, Electronic Records; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the 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; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the scope and application of part 11 pending FDAs reexamination of part 11 as it applies to all FDA -regulated products.",
"options": {
"D": "11",
"A": "the CGMP data life cycle",
"B": "data integrity",
"C": "Electronic Records"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part ____, Electronic Records; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the 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; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the scope and application of part 11 pending FDAs reexamination of part 11 as it applies to all FDA -regulated products.",
"options": {
"A": "11",
"B": "the CGMP data life cycle",
"C": "data integrity",
"D": "Electronic Records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For more information, see guidance for i ndustry Part ____, Electronic Records; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the 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; Electronic Signatures Scope and Application, which outlines FDAs current thinking regarding the scope and application of part 11 pending FDAs reexamination of part 11 as it applies to all FDA -regulated products.",
"options": {
"C": "11",
"A": "the CGMP data life cycle",
"B": "data integrity",
"D": "Electronic Records"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ System design and controls should enable easy detection of errors, omissions, and aberrant results throughout the datas life cycle .",
"reference": "6 System design and controls should enable easy detection of errors, omissions, and aberrant results throughout the datas life cycle .",
"options": {
"A": "6",
"B": "the CGMP data life cycle",
"C": "data integrity",
"D": "half a dozen"
},
"answer": "A",
"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: a.",
"options": {
"D": "CGMP",
"A": "Electronic Records",
"B": "FDA",
"C": "data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '5 Data integrity is critical throughout the CGMP d...'?",
"reference": "5 Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archiv al, retrieval, transmission, and disposition of data after the records retention period ends .",
"options": {
"B": "CGMP",
"A": "Electronic Records",
"C": "FDA",
"D": "data integrity"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: '5 Data integrity is critical throughout the CGMP d...'?",
"reference": "5 Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archiv al, retrieval, transmission, and disposition of data after the records retention period ends .",
"options": {
"B": "al",
"A": "the CGMP data life cycle",
"C": "data integrity",
"D": "Alabama"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archiv al, retrieval, transmission, and disposition of data after the records retention period ends .",
"reference": "5 Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archiv al, retrieval, transmission, and disposition of data after the records retention period ends .",
"options": {
"D": "5",
"A": "the CGMP data life cycle",
"B": "data integrity",
"C": "Little Phoebe"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ III.",
"reference": "Contains Nonbinding Recommendations 4 III.",
"options": {
"A": "4",
"B": "the CGMP data life cycle",
"C": "data integrity",
"D": "quaternity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Metadata is structured information that describes,...'?",
"reference": "Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data.",
"options": {
"D": "Metadata",
"A": "the CGMP data life cycle",
"B": "data integrity",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Metadata is often described as data about data....'?",
"reference": "Metadata is often described as data about data.",
"options": {
"D": "Metadata",
"A": "the CGMP data life cycle",
"B": "data integrity",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: For example, the number ____ is meaningless without metadata, such as an in dication of the unit mg.",
"reference": "For example, the number 23 is meaningless without metadata, such as an in dication of the unit mg.",
"options": {
"A": "23",
"B": "the CGMP data life cycle",
"C": "data integrity",
"D": "XXIII"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Metadata is structured information that describes,...'?",
"reference": "Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data.",
"options": {
"B": "Metadata",
"A": "the CGMP data life cycle",
"C": "data integrity",
"D": "This information is not mentioned in the context"
},
"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 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Examine Inputs In a modern quality systems model, the term input includes any ma terial that goes into a final product, no matter whether the material is purc hased by the manufacturer or produced by the manufacturer for the purpose of processing. Materials can include item s such as components (e.g., ingredients, process water, and gas), containe rs, and closures. A robust quality system will ensure that all inputs to the manufacturing proc ess are reliable because quality controls will have been established for the receipt, produc tion, storage, and use of all inputs. The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing. In the preamble to the CGMP regulations, these requirements were explicitly interpreted.12 The preamble states that reliability can be validated by conducting tests or examinations and comparing the results to the suppliers COA. Sufficient initial tests should be done to establis h reliability and to determine a schedule for periodic reassessment. As an e ssential element of purchasing controls, it is recommended that data trends for acceptance and rejection of materials be analyzed for information on supplier performance.13
The quality systems approach also calls for periodic auditing of suppliers based on risk assessment. During the audit, a manufacturer can observe the testing or examinations conducted by the supplier to help determine the reliability of the suppliers COA. An audit shou ld also include a systematic examination of the suppliers quality system to ensure that reliability is maintained. It is recommended that a combination approach be used (i.e., verify the suppliers' COA through analysis and audits of the supplier). Under a quality systems approach, if full analytical testing is not done, the audit should cover the suppliers analysis (i.e., a specific identity test is still re quired under 211.84(d)(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: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"A": "CGMP",
"B": "COA",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"D": "COA",
"A": "CGMP",
"B": "the suppliers analysis",
"C": "the suppliers quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( ____) for th e release of materials for ma nufacturing.",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"D": "211.84",
"A": "under 211.84(d)(2",
"B": "the suppliers analysis",
"C": "the suppliers quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Examine Inputs In a modern quality systems model, ...'?",
"reference": "Examine Inputs In a modern quality systems model, the term input includes any ma terial that goes into a final product, no matter whether the material is purc hased by the manufacturer or produced by the manufacturer for the purpose of processing.",
"options": {
"B": "Examine Inputs",
"A": "the suppliers analysis",
"C": "the suppliers quality system",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the preamble to the CGMP regulations, these req...'?",
"reference": "In the preamble to the CGMP regulations, these requirements were explicitly interpreted.12 The preamble states that reliability can be validated by conducting tests or examinations and comparing the results to the suppliers COA.",
"options": {
"B": "CGMP",
"A": "COA",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In the preamble to the CGMP regulations, these req...'?",
"reference": "In the preamble to the CGMP regulations, these requirements were explicitly interpreted.12 The preamble states that reliability can be validated by conducting tests or examinations and comparing the results to the suppliers COA.",
"options": {
"B": "COA",
"A": "CGMP",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"A": "CGMP",
"B": "COA",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"B": "COA",
"A": "CGMP",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( ____) for th e release of materials for ma nufacturing.",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"A": "211.84",
"B": "under 211.84(d)(2",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"A": "CGMP",
"B": "COA",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Examine Inputs In a modern quality systems model, ...'?",
"reference": "Examine Inputs In a modern quality systems model, the term input includes any ma terial that goes into a final product, no matter whether the material is purc hased by the manufacturer or produced by the manufacturer for the purpose of processing.",
"options": {
"A": "Examine Inputs",
"B": "the suppliers analysis",
"C": "the suppliers quality system",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'During the audit, a manufacturer can observe the t...'?",
"reference": "During the audit, a manufacturer can observe the testing or examinations conducted by the supplier to help determine the reliability of the suppliers COA.",
"options": {
"B": "COA",
"A": "CGMP",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"C": "CGMP",
"A": "COA",
"B": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"D": "COA",
"A": "CGMP",
"B": "the suppliers analysis",
"C": "the suppliers quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( ____) for th e release of materials for ma nufacturing.",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"A": "211.84",
"B": "under 211.84(d)(2",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Examine Inputs In a modern quality systems model, ...'?",
"reference": "Examine Inputs In a modern quality systems model, the term input includes any ma terial that goes into a final product, no matter whether the material is purc hased by the manufacturer or produced by the manufacturer for the purpose of processing.",
"options": {
"C": "Examine Inputs",
"A": "the suppliers analysis",
"B": "the suppliers quality system",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It is recommended that a combination approach be u...'?",
"reference": "It is recommended that a combination approach be used (i.e., verify the suppliers' COA through analysis and audits of the supplier).",
"options": {
"B": "COA",
"A": "CGMP",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'A robust quality system will ensure that all inputs to the m...'?",
"reference": "A robust quality system will ensure that all inputs to the manufacturing proc ess are reliable because quality controls will have been established for the receipt, produc tion, storage, and use of all inputs.",
"options": {
"B": "A robust quality system will ensure that all inputs to the manufacturing proc ess are reliable becau...",
"A": "the suppliers analysis",
"C": "the suppliers quality system",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"A": "CGMP",
"B": "COA",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The CGMP regulations require eith er testing or us...'?",
"reference": "The CGMP regulations require eith er testing or use of a certificat e of analysis (COA) plus an identity analysis ( 211.84) for th e release of materials for ma nufacturing.",
"options": {
"A": "COA",
"B": "CGMP",
"C": "the suppliers analysis",
"D": "the suppliers quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 20 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Similarly, it is not acceptable to store dat a electronically in temporary 316 memory, in a manner that allows for manipulation, before creating a permanent record. 317 Electronic data that are automatic ally saved into temporary memory do not meet CGMP 318 documentation or retention requirements. 319 320 You may employ a combination of technical and procedural controls to meet CGMP 321 documentation practices for electronic systems. For example, a computer system, such as 322 a Laboratory Information Management System (LIMS) or an Electronic Batch Record 323 (EBR) system , can be de signed to automatically save after each separate entry. This 324 would be similar to recording each entry contemporaneously on a paper batch record to 325 satisfy CGMP requirements . The computer system could be combined with a procedure 326 requiring data be entered i mmediately when generated. 327 328 For PET drugs, see the Laboratory Controls section of the guidance for industry PET 329 Drugs Current Good Manufacturing Practice (CGMP) . 330 331 Contains Nonbinding Recommendations Draft Not for Implementation 9 13. Why has the FDA cited use of actual samples during s ystem s uitability or 332 test, prep, or equilibration runs in warning letters? 333 334 FDA prohibits sampling and testing with the goal of achieving a specific result or to 335 overcome an unacceptable result ( e.g., testing different samples until the desired passing 336 result is obtained ). This practice, also referred to as testing into compliance , is not 337 consistent with CGMP (see the guidance for i ndustry Investigating Out -of-Specification 338 (OOS) Test Results for Pharmaceutical Production) . In some situations, use of actual 339 samples to perform system suitability testing has been used as a means of testing into 340 compliance. We would consider it a violative practice to use an actual sample in test, 341 prep, or equilibration runs as a means of disguising testing into compliance.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: Similarly, it is not acceptable to store dat a electronically in temporary ____ memory, in a manner that allows for manipulation, before creating a permanent record.",
"reference": "Similarly, it is not acceptable to store dat a electronically in temporary 316 memory, in a manner that allows for manipulation, before creating a permanent record.",
"options": {
"D": "316",
"A": "317",
"B": "319 320",
"C": "CGMP 318 documentation or retention requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In some situations, use of actual ____ samples to perform system suitability testing has been used as a means of testing into 340 compliance.",
"reference": "In some situations, use of actual 339 samples to perform system suitability testing has been used as a means of testing into 340 compliance.",
"options": {
"C": "339",
"A": "316",
"B": "317",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In some situations, use of actual 339 samples to perform system suitability testing has been used as a means of testing into ____ compliance.",
"reference": "In some situations, use of actual 339 samples to perform system suitability testing has been used as a means of testing into 340 compliance.",
"options": {
"D": "340",
"A": "316",
"B": "317",
"C": "CGMP 318 documentation or retention requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The computer system could be combined with a procedure ____ requiring data be entered i mmediately when generated.",
"reference": "The computer system could be combined with a procedure 326 requiring data be entered i mmediately when generated.",
"options": {
"B": "326",
"A": "316",
"C": "317",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 331 Contains Nonbinding Recommendations Draft Not for Implementation 9 13.",
"reference": "330 331 Contains Nonbinding Recommendations Draft Not for Implementation 9 13.",
"options": {
"C": "330",
"A": "316",
"B": "317",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 330 ____ Contains Nonbinding Recommendations Draft Not for Implementation 9 13.",
"reference": "330 331 Contains Nonbinding Recommendations Draft Not for Implementation 9 13.",
"options": {
"A": "331",
"B": "316",
"C": "317",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 330 331 Contains Nonbinding Recommendations Draft Not for Implementation ____ 13.",
"reference": "330 331 Contains Nonbinding Recommendations Draft Not for Implementation 9 13.",
"options": {
"D": "9",
"A": "316",
"B": "317",
"C": "CGMP 318 documentation or retention requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 330 331 Contains Nonbinding Recommendations Draft Not for Implementation 9 ____.",
"reference": "330 331 Contains Nonbinding Recommendations Draft Not for Implementation 9 13.",
"options": {
"D": "13",
"A": "316",
"B": "317",
"C": "CGMP 318 documentation or retention requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: We would consider it a violative practice to use an actual sample in test, ____ prep, or equilibration runs as a means of disguising testing into compliance.",
"reference": "We would consider it a violative practice to use an actual sample in test, 341 prep, or equilibration runs as a means of disguising testing into compliance.",
"options": {
"B": "341",
"A": "316",
"C": "317",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'For example, a computer system, such as 322 a Labo...'?",
"reference": "For example, a computer system, such as 322 a Laboratory Information Management System (LIMS) or an Electronic Batch Record 323 (EBR) system , can be de signed to automatically save after each separate entry.",
"options": {
"D": "Laboratory Information Management System",
"A": "CGMP",
"B": "PET",
"C": "CGMP 318 documentation or retention requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Similarly, it is not acceptable to store dat a electronically in temporary ____ memory, in a manner that allows for manipulation, before creating a permanent record.",
"reference": "Similarly, it is not acceptable to store dat a electronically in temporary 316 memory, in a manner that allows for manipulation, before creating a permanent record.",
"options": {
"C": "316",
"A": "317",
"B": "319 320",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Why has the FDA cited use of actual samples during...'?",
"reference": "Why has the FDA cited use of actual samples during s ystem s uitability or 332 test, prep, or equilibration runs in warning letters?",
"options": {
"A": "FDA",
"B": "Laboratory Information Management System",
"C": "CGMP",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: Why has the FDA cited use of actual samples during s ystem s uitability or ____ test, prep, or equilibration runs in warning letters?",
"reference": "Why has the FDA cited use of actual samples during s ystem s uitability or 332 test, prep, or equilibration runs in warning letters?",
"options": {
"B": "332",
"A": "316",
"C": "317",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Which organization is referenced: 'Why has the FDA cited use of actual samples during...'?",
"reference": "Why has the FDA cited use of actual samples during s ystem s uitability or 332 test, prep, or equilibration runs in warning letters?",
"options": {
"A": "FDA",
"B": "Laboratory Information Management System",
"C": "CGMP",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: Why has the FDA cited use of actual samples during s ystem s uitability or ____ test, prep, or equilibration runs in warning letters?",
"reference": "Why has the FDA cited use of actual samples during s ystem s uitability or 332 test, prep, or equilibration runs in warning letters?",
"options": {
"B": "332",
"A": "316",
"C": "317",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "conceptual"
},
{
"question": "Fill in the blank: In some situations, use of actual ____ samples to perform system suitability testing has been used as a means of testing into 340 compliance.",
"reference": "In some situations, use of actual 339 samples to perform system suitability testing has been used as a means of testing into 340 compliance.",
"options": {
"A": "339",
"B": "316",
"C": "317",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In some situations, use of actual 339 samples to perform system suitability testing has been used as a means of testing into ____ compliance.",
"reference": "In some situations, use of actual 339 samples to perform system suitability testing has been used as a means of testing into 340 compliance.",
"options": {
"C": "340",
"A": "316",
"B": "317",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '327 328 For PET drugs, see the Laboratory Controls...'?",
"reference": "327 328 For PET drugs, see the Laboratory Controls section of the guidance for industry PET 329 Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"A": "PET",
"B": "Laboratory Information Management System",
"C": "CGMP",
"D": "CGMP 318 documentation or retention requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '327 328 For PET drugs, see the Laboratory Controls...'?",
"reference": "327 328 For PET drugs, see the Laboratory Controls section of the guidance for industry PET 329 Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"B": "Laboratory Controls",
"A": "CGMP 318 documentation or retention requirements",
"C": "industry PET 329 Drugs Current Good Manufacturing Practice",
"D": "PET"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '327 328 For PET drugs, see the Laboratory Controls...'?",
"reference": "327 328 For PET drugs, see the Laboratory Controls section of the guidance for industry PET 329 Drugs Current Good Manufacturing Practice (CGMP) .",
"options": {
"D": "CGMP",
"A": "Laboratory Information Management System",
"B": "PET",
"C": "industry PET 329 Drugs 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 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: ____ 385 Afeature, function, or operation that could lead to severe harm to a patient or user would 386 generally be high device risk.",
"reference": "384 385 Afeature, function, or operation that could lead to severe harm to a patient or user would 386 generally be high device risk.",
"options": {
"A": "384",
"B": "382",
"C": "383",
"D": "i.e., not high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 384 ____ Afeature, function, or operation that could lead to severe harm to a patient or user would 386 generally be high device risk.",
"reference": "384 385 Afeature, function, or operation that could lead to severe harm to a patient or user would 386 generally be high device risk.",
"options": {
"C": "385",
"A": "382",
"B": "383",
"D": "i.e., not high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 384 385 Afeature, function, or operation that could lead to severe harm to a patient or user would ____ generally be high device risk.",
"reference": "384 385 Afeature, function, or operation that could lead to severe harm to a patient or user would 386 generally be high device risk.",
"options": {
"C": "386",
"A": "382",
"B": "383",
"D": "i.e., not high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This is because the failure would not compromise safety, so the ____ failure would not introduce additional medical device risk.",
"reference": "This is because the failure would not compromise safety, so the 395 failure would not introduce additional medical device risk.",
"options": {
"C": "395",
"A": "382",
"B": "383",
"D": "i.e., not high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'This is because the failure would not compromise safety, so ...'?",
"reference": "This is because the failure would not compromise safety, so the 395 failure would not introduce additional medical device risk.",
"options": {
"C": "This is because the failure would not compromise safety, so the 395 failure would not introduce addi...",
"A": "382",
"B": "383",
"D": "i.e., not high process risk"
},
"answer": "C",
"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": {
"C": "382",
"A": "383",
"B": "384 385",
"D": "i.e., not high process risk"
},
"answer": "C",
"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: This is because the failure would not compromise safety, so the ____ failure would not introduce additional medical device risk.",
"reference": "This is because the failure would not compromise safety, so the 395 failure would not introduce additional medical device risk.",
"options": {
"D": "395",
"A": "382",
"B": "383",
"C": "i.e., not high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'This is because the failure would not compromise safety, so ...'?",
"reference": "This is because the failure would not compromise safety, so the 395 failure would not introduce additional medical device risk.",
"options": {
"C": "This is because the failure would not compromise safety, so the 395 failure would not introduce addi...",
"A": "382",
"B": "383",
"D": "i.e., not high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In either case, the risk of ____ the softwares failure to perform as intended is commensurate with the resulting medical device 389 risk.",
"reference": "In either case, the risk of 388 the softwares failure to perform as intended is commensurate with the resulting medical device 389 risk.",
"options": {
"C": "388",
"A": "382",
"B": "383",
"D": "i.e., not high 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 45 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
G. Quality Manual (1.8) A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical qu ality system. The description should include: (a) The quality policy (see section III (2)). (b) The scope of the pharmaceutical quality system. (c) Identification of the pharmaceutical quality system processes, as well as their sequences, linkages, and interdependencies. Process maps and flow charts can be useful tools to facilitate depicting pharmaceutical quality system processes in a visual manner. (d) Management responsibilities within the pharmaceutical quality system (see section III (2)). MANAGEMENT RESPONSIBILITY (2) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system. A. Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company. (b) Management should: (1) Participate in the design, implementation, monitoring, and maintenance of an effective pharmaceutical quality system. (2) Demonstrate strong and visible support for the pharmaceutical quality system and ensure its implementation throughout their organization. (3) Ensure a timely and effective communicat ion and escalation process exists to raise quality issues to the appr opriate levels of management. (4) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system. Ensure these interactions are communicated and understood at all levels of the organization.
[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 description should include: (a) The quality policy (see section III (____)).",
"reference": "The description should include: (a) The quality policy (see section III (2)).",
"options": {
"B": "2",
"A": "1.8",
"C": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Demonstrate strong and visible support for the pharmaceutical quality system and ensure its implementation throughout their organization.",
"reference": "(2) Demonstrate strong and visible support for the pharmaceutical quality system and ensure its implementation throughout their organization.",
"options": {
"D": "2",
"A": "1.8",
"B": "2.1",
"C": "an effective pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (d) Management responsibilities within the pharmaceutical quality system (see section III (____)).",
"reference": "(d) Management responsibilities within the pharmaceutical quality system (see section III (2)).",
"options": {
"A": "2",
"B": "1.8",
"C": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'MANAGEMENT RESPONSIBILITY (2) Leadership is essent...'?",
"reference": "MANAGEMENT RESPONSIBILITY (2) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system.",
"options": {
"C": "MANAGEMENT RESPONSIBILITY",
"A": "an effective pharmaceutical quality system",
"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": "Fill in the blank: MANAGEMENT RESPONSIBILITY (____) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system.",
"reference": "MANAGEMENT RESPONSIBILITY (2) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system.",
"options": {
"D": "2",
"A": "1.8",
"B": "2.1",
"C": "an effective pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system.",
"reference": "(4) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system.",
"options": {
"D": "4",
"A": "1.8",
"B": "2.1",
"C": "an effective pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system.",
"reference": "(4) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system.",
"options": {
"B": "4",
"A": "1.8",
"C": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Demonstrate strong and visible support for the pharmaceutical quality system and ensure its implementation throughout their organization.",
"reference": "(2) Demonstrate strong and visible support for the pharmaceutical quality system and ensure its implementation throughout their organization.",
"options": {
"C": "2",
"A": "1.8",
"B": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Ensure a timely and effective communicat ion and escalation process exists to raise quality issues to the appr opriate levels of management.",
"reference": "(3) Ensure a timely and effective communicat ion and escalation process exists to raise quality issues to the appr opriate levels of management.",
"options": {
"C": "3",
"A": "1.8",
"B": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'MANAGEMENT RESPONSIBILITY (2) Leadership is essent...'?",
"reference": "MANAGEMENT RESPONSIBILITY (2) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system.",
"options": {
"C": "MANAGEMENT RESPONSIBILITY",
"A": "an effective pharmaceutical quality system",
"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": "Fill in the blank: MANAGEMENT RESPONSIBILITY (____) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system.",
"reference": "MANAGEMENT RESPONSIBILITY (2) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system.",
"options": {
"D": "2",
"A": "1.8",
"B": "2.1",
"C": "an effective pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: G. Quality Manual (____) A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical qu ality system.",
"reference": "G. Quality Manual (1.8) A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical qu ality system.",
"options": {
"D": "1.8",
"A": "2.1",
"B": "an effective pharmaceutical quality system",
"C": "This information is not provided in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Demonstrate strong and visible support for the pharmaceutical quality system and ensure its implementation throughout their organization.",
"reference": "(2) Demonstrate strong and visible support for the pharmaceutical quality system and ensure its implementation throughout their organization.",
"options": {
"D": "2",
"A": "1.8",
"B": "2.1",
"C": "an effective pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The description should include: (a) The quality policy (see section III (____)).",
"reference": "The description should include: (a) The quality policy (see section III (2)).",
"options": {
"D": "2",
"A": "1.8",
"B": "2.1",
"C": "an effective pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (b) Management should: (____) Participate in the design, implementation, monitoring, and maintenance of an effective pharmaceutical quality system.",
"reference": "(b) Management should: (1) Participate in the design, implementation, monitoring, and maintenance of an effective pharmaceutical quality system.",
"options": {
"D": "1",
"A": "1.8",
"B": "2.1",
"C": "an effective pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Ensure a timely and effective communicat ion and escalation process exists to raise quality issues to the appr opriate levels of management.",
"reference": "(3) Ensure a timely and effective communicat ion and escalation process exists to raise quality issues to the appr opriate levels of management.",
"options": {
"C": "3",
"A": "1.8",
"B": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (b) Management should: (____) Participate in the design, implementation, monitoring, and maintenance of an effective pharmaceutical quality system.",
"reference": "(b) Management should: (1) Participate in the design, implementation, monitoring, and maintenance of an effective pharmaceutical quality system.",
"options": {
"B": "1",
"A": "1.8",
"C": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Management Commitment (2.1) (a) Senior management ...'?",
"reference": "Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"options": {
"C": "Management Commitment",
"A": "an effective pharmaceutical quality system",
"B": "2.1",
"D": "This information is not provided in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Management Commitment (____) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"reference": "Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"options": {
"B": "2.1",
"A": "1.8",
"C": "an effective pharmaceutical quality system",
"D": "Management Commitment"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that ____ roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"reference": "Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"options": {
"C": "5",
"A": "1.8",
"B": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The description should include: (a) The quality policy (see section III (____)).",
"reference": "The description should include: (a) The quality policy (see section III (2)).",
"options": {
"A": "2",
"B": "1.8",
"C": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Demonstrate strong and visible support for the pharmaceutical quality system and ensure its implementation throughout their organization.",
"reference": "(2) Demonstrate strong and visible support for the pharmaceutical quality system and ensure its implementation throughout their organization.",
"options": {
"B": "2",
"A": "1.8",
"C": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system.",
"reference": "(4) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system.",
"options": {
"B": "4",
"A": "1.8",
"C": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system.",
"reference": "(4) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system.",
"options": {
"D": "4",
"A": "1.8",
"B": "2.1",
"C": "an effective pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Ensure a timely and effective communicat ion and escalation process exists to raise quality issues to the appr opriate levels of management.",
"reference": "(3) Ensure a timely and effective communicat ion and escalation process exists to raise quality issues to the appr opriate levels of management.",
"options": {
"A": "3",
"B": "1.8",
"C": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The description should include: (a) The quality policy (see section III (____)).",
"reference": "The description should include: (a) The quality policy (see section III (2)).",
"options": {
"C": "2",
"A": "1.8",
"B": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system.",
"reference": "(4) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system.",
"options": {
"B": "4",
"A": "1.8",
"C": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (b) Management should: (____) Participate in the design, implementation, monitoring, and maintenance of an effective pharmaceutical quality system.",
"reference": "(b) Management should: (1) Participate in the design, implementation, monitoring, and maintenance of an effective pharmaceutical quality system.",
"options": {
"A": "1",
"B": "1.8",
"C": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (d) Management responsibilities within the pharmaceutical quality system (see section III (____)).",
"reference": "(d) Management responsibilities within the pharmaceutical quality system (see section III (2)).",
"options": {
"C": "2",
"A": "1.8",
"B": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: G. Quality Manual (____) A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical qu ality system.",
"reference": "G. Quality Manual (1.8) A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical qu ality system.",
"options": {
"B": "1.8",
"A": "2.1",
"C": "an effective pharmaceutical quality system",
"D": "This information is not provided in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Management Commitment (2.1) (a) Senior management ...'?",
"reference": "Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"options": {
"D": "Management Commitment",
"A": "an effective pharmaceutical quality system",
"B": "2.1",
"C": "This information is not provided in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Management Commitment (____) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"reference": "Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"options": {
"B": "2.1",
"A": "1.8",
"C": "an effective pharmaceutical quality system",
"D": "Management Commitment"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that ____ roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"reference": "Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"options": {
"B": "5",
"A": "1.8",
"C": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'MANAGEMENT RESPONSIBILITY (2) Leadership is essent...'?",
"reference": "MANAGEMENT RESPONSIBILITY (2) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system.",
"options": {
"A": "MANAGEMENT RESPONSIBILITY",
"B": "an effective pharmaceutical quality system",
"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: MANAGEMENT RESPONSIBILITY (____) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system.",
"reference": "MANAGEMENT RESPONSIBILITY (2) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system.",
"options": {
"D": "2",
"A": "1.8",
"B": "2.1",
"C": "an effective pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system.",
"reference": "(4) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system.",
"options": {
"B": "4",
"A": "1.8",
"C": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The description should include: (a) The quality policy (see section III (____)).",
"reference": "The description should include: (a) The quality policy (see section III (2)).",
"options": {
"A": "2",
"B": "1.8",
"C": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Ensure a timely and effective communicat ion and escalation process exists to raise quality issues to the appr opriate levels of management.",
"reference": "(3) Ensure a timely and effective communicat ion and escalation process exists to raise quality issues to the appr opriate levels of management.",
"options": {
"D": "3",
"A": "1.8",
"B": "2.1",
"C": "an effective pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (d) Management responsibilities within the pharmaceutical quality system (see section III (____)).",
"reference": "(d) Management responsibilities within the pharmaceutical quality system (see section III (2)).",
"options": {
"D": "2",
"A": "1.8",
"B": "2.1",
"C": "an effective pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: G. Quality Manual (____) A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical qu ality system.",
"reference": "G. Quality Manual (1.8) A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical qu ality system.",
"options": {
"D": "1.8",
"A": "2.1",
"B": "an effective pharmaceutical quality system",
"C": "This information is not provided in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'MANAGEMENT RESPONSIBILITY (2) Leadership is essent...'?",
"reference": "MANAGEMENT RESPONSIBILITY (2) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system.",
"options": {
"D": "MANAGEMENT RESPONSIBILITY",
"A": "an effective pharmaceutical quality system",
"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": "Fill in the blank: MANAGEMENT RESPONSIBILITY (____) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system.",
"reference": "MANAGEMENT RESPONSIBILITY (2) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system.",
"options": {
"A": "2",
"B": "1.8",
"C": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (b) Management should: (____) Participate in the design, implementation, monitoring, and maintenance of an effective pharmaceutical quality system.",
"reference": "(b) Management should: (1) Participate in the design, implementation, monitoring, and maintenance of an effective pharmaceutical quality system.",
"options": {
"D": "1",
"A": "1.8",
"B": "2.1",
"C": "an effective pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Management Commitment (2.1) (a) Senior management ...'?",
"reference": "Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"options": {
"A": "Management Commitment",
"B": "an effective pharmaceutical quality system",
"C": "2.1",
"D": "This information is not provided in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Management Commitment (____) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"reference": "Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"options": {
"B": "2.1",
"A": "1.8",
"C": "an effective pharmaceutical quality system",
"D": "Management Commitment"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 50 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
GLOSSARY (5) ...............................................................................................................
Annex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic. It does not create or confer any rights for or on any pe rson and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alterna tive approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. INTRODUCTION (1, 1.1)2
This internationally harmonized guidance is in tended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system . Throughout this guidance, the term pharmaceutical quality system refers to the ICH Q10 model. ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "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": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"C": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'If you cannot identify the appropriate FDA staff, ...'?",
"reference": "If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.",
"options": {
"D": "FDA",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"C": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'If you cannot identify the appropriate FDA staff, ...'?",
"reference": "If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.",
"options": {
"B": "FDA",
"A": "Risk-Based Regulatory Approaches",
"C": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Much of the content of ICH Q10 applicable to manuf...'?",
"reference": "Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements.",
"options": {
"B": "GMP",
"A": "Risk-Based Regulatory Approaches",
"C": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"B": "GLOSSARY",
"A": "Annex",
"C": "the ICH Q10 Ph armaceutical Quality System Model",
"D": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"C": "Annex",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"C": "the Food and Drug Administration'",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"A": "Q10 Pharmaceutical Quality System",
"B": "Risk-Based Regulatory Approaches",
"C": "the Food and Drug Administration'",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"B": "the Food and Drug Administration'",
"A": "Risk-Based Regulatory Approaches",
"C": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (____) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"D": "5",
"A": "one",
"B": "the ICH Q10 Ph armaceutical Quality System Model",
"C": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... ____ Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"C": "18",
"A": "one",
"B": "the ICH Q10 Ph armaceutical Quality System Model",
"D": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex ____: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"C": "2",
"A": "one",
"B": "the ICH Q10 Ph armaceutical Quality System Model",
"D": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..____ i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"A": "19",
"B": "one",
"C": "the ICH Q10 Ph armaceutical Quality System Model",
"D": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ICH Q10 describes one comprehensive model for an e...'?",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"A": "Q10",
"B": "an effective pharmaceutical quality system",
"C": "the term pharmaceutical quality system",
"D": "one"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ICH Q10 describes one comprehensive model for an e...'?",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"A": "GMP",
"B": "Risk-Based Regulatory Approaches",
"C": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ICH Q10 describes one comprehensive model for an e...'?",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"D": "ICH Q8 Pharmaceutical Development",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"C": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ICH Q10 describes one comprehensive model for an e...'?",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"D": "IC H Q9 Quality Risk Management.3 ICH",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"C": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ICH Q10 describes ____ comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"C": "one",
"A": "the ICH Q10 Ph armaceutical Quality System Model",
"B": "Industry1 Q10 Pharmaceutical Quality System",
"D": "ace"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'If you cannot identify the appropriate FDA staff, ...'?",
"reference": "If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.",
"options": {
"D": "FDA",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"C": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'If you want to discuss an alterna tive approach, c...'?",
"reference": "If you want to discuss an alterna tive approach, contact the FDA staff responsible for implementing this guidance.",
"options": {
"C": "alterna tive approach",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'If you want to discuss an alterna tive approach, c...'?",
"reference": "If you want to discuss an alterna tive approach, contact the FDA staff responsible for implementing this guidance.",
"options": {
"A": "FDA",
"B": "Risk-Based Regulatory Approaches",
"C": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'If you want to discuss an alterna tive approach, c...'?",
"reference": "If you want to discuss an alterna tive approach, contact the FDA staff responsible for implementing this guidance.",
"options": {
"B": "alterna tive approach",
"A": "Risk-Based Regulatory Approaches",
"C": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'If you want to discuss an alterna tive approach, c...'?",
"reference": "If you want to discuss an alterna tive approach, contact the FDA staff responsible for implementing this guidance.",
"options": {
"A": "FDA",
"B": "Risk-Based Regulatory Approaches",
"C": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'It does not create or confer any rights for or on ...'?",
"reference": "It does not create or confer any rights for or on any pe rson and does not operate to bind FDA or the public.",
"options": {
"D": "FDA",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"C": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ICH Q10 describes one comprehensive model for an e...'?",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"D": "Q10",
"A": "an effective pharmaceutical quality system",
"B": "the term pharmaceutical quality system",
"C": "one"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION (____, 1.1)2\nThis internationally harmonized guidance is in tended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system .",
"reference": "INTRODUCTION (1, 1.1)2\nThis internationally harmonized guidance is in tended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system .",
"options": {
"D": "1",
"A": "one",
"B": "an effective pharmaceutical quality system",
"C": "the term pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'If you cannot identify the appropriate FDA staff, ...'?",
"reference": "If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.",
"options": {
"C": "FDA",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"A": "GLOSSARY",
"B": "Annex",
"C": "the ICH Q10 Ph armaceutical Quality System Model",
"D": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"D": "Annex",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"C": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"D": "Risk-Based Regulatory Approaches",
"A": "Q10 Pharmaceutical Quality System",
"B": "the Food and Drug Administration'",
"C": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"C": "Q10 Pharmaceutical Quality System",
"A": "Risk-Based Regulatory Approaches",
"B": "the Food and Drug Administration'",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'GLOSSARY (5) ........................................'?",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"C": "the Food and Drug Administration'",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (____) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"B": "5",
"A": "one",
"C": "the ICH Q10 Ph armaceutical Quality System Model",
"D": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... ____ Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"D": "18",
"A": "one",
"B": "the ICH Q10 Ph armaceutical Quality System Model",
"C": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex ____: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"B": "2",
"A": "one",
"C": "the ICH Q10 Ph armaceutical Quality System Model",
"D": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..____ i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"reference": "GLOSSARY (5) ...............................................................................................................\nAnnex I: Potential Opportunities To Enha nce Science- and Risk-Based Regulatory Approaches ............................................................................................................... 18 Annex 2: Diagram of the ICH Q10 Ph armaceutical Quality System Model..19 i Guidance for Industry1 Q10 Pharmaceutical Quality System This guidance represents the Food and Drug Administration' s (FDAs) current thinking on this topic.",
"options": {
"C": "19",
"A": "one",
"B": "the ICH Q10 Ph armaceutical Quality System Model",
"D": "Industry1 Q10 Pharmaceutical Quality System"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"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": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"C": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION (____, 1.1)2\nThis internationally harmonized guidance is in tended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system .",
"reference": "INTRODUCTION (1, 1.1)2\nThis internationally harmonized guidance is in tended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system .",
"options": {
"C": "1",
"A": "one",
"B": "an effective pharmaceutical quality system",
"D": "the term pharmaceutical quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ICH Q10 describes one comprehensive model for an e...'?",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"D": "Q10",
"A": "an effective pharmaceutical quality system",
"B": "the term pharmaceutical quality system",
"C": "one"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ICH Q10 describes one comprehensive model for an e...'?",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"D": "GMP",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"C": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ICH Q10 describes one comprehensive model for an e...'?",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"C": "ICH Q8 Pharmaceutical Development",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ICH Q10 describes one comprehensive model for an e...'?",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"B": "IC H Q9 Quality Risk Management.3 ICH",
"A": "Risk-Based Regulatory Approaches",
"C": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ICH Q10 describes ____ comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"A": "one",
"B": "the ICH Q10 Ph armaceutical Quality System Model",
"C": "Industry1 Q10 Pharmaceutical Quality System",
"D": "ace"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ICH Q10 describes one comprehensive model for an e...'?",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"C": "Q10",
"A": "an effective pharmaceutical quality system",
"B": "the term pharmaceutical quality system",
"D": "one"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ICH Q10 describes one comprehensive model for an e...'?",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"A": "GMP",
"B": "Risk-Based Regulatory Approaches",
"C": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ICH Q10 describes one comprehensive model for an e...'?",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"B": "ICH Q8 Pharmaceutical Development",
"A": "Risk-Based Regulatory Approaches",
"C": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'ICH Q10 describes one comprehensive model for an e...'?",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"D": "IC H Q9 Quality Risk Management.3 ICH",
"A": "Risk-Based Regulatory Approaches",
"B": "Q10 Pharmaceutical Quality System",
"C": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ICH Q10 describes ____ comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"reference": "ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Orga nization for Standardization (IS O) quality concepts, includes applicable good manufacturi ng practice (GMP) regulations , and complements ICH Q8 Pharmaceutical Development and IC H Q9 Quality Risk Management.3 ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.",
"options": {
"A": "one",
"B": "the ICH Q10 Ph armaceutical Quality System Model",
"C": "Industry1 Q10 Pharmaceutical Quality System",
"D": "ace"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: INTRODUCTION (____, 1.1)2\nThis internationally harmonized guidance is in tended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system .",
"reference": "INTRODUCTION (1, 1.1)2\nThis internationally harmonized guidance is in tended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system .",
"options": {
"C": "1",
"A": "one",
"B": "an effective pharmaceutical quality system",
"D": "the term pharmaceutical quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Much of the content of ICH Q10 applicable to manuf...'?",
"reference": "Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements.",
"options": {
"B": "GMP",
"A": "Risk-Based Regulatory Approaches",
"C": "Q10 Pharmaceutical Quality System",
"D": "the ICH Q10 Ph armaceutical Quality System Model"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
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]
The use of the word should in Agency guidances means that s omething is suggested or recommended, but not required. In recent years, FDA has increas ingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industrys responsibility to ensure the safety, efficacy, and quality of drugs, and of FDAs ability to protect the public health . These data integrity -related CGMP violations have led to numerous regulatory actions , including warning letters, import alerts , and consent decrees . The underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity. 4 Requirements with respect to data integrity in parts 211 and 212 include , among other things : 211.68 (requiring that backup data are exact and complete and secure from alteration, inadvertent erasur es, or loss and that output from the computer be checked for accuracy ). 212.110(b) (requiring that data be stored to prevent deterioration or loss ). 211.100 and 211.160 ( requiring that certain activities be documented at the time of performa nce and that laboratory controls be scientifically sound ). 211.180 ( requiring that records be retained as original records , or true copies , or other accurate reproductions of the original records) . 211.188, 211.194, and 212.60( g) (requiring complete information, complete data derived from all tests , complete record of all data, and complete records of all tests performed ).
[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 use of the word should in Agency guidances mea...'?",
"reference": "The use of the word should in Agency guidances means that s omething is suggested or recommended, but not required.",
"options": {
"C": "Agency",
"A": "data integrity",
"B": "government agency",
"D": "way"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The use of the word should in Agency guidances mea...'?",
"reference": "The use of the word should in Agency guidances means that s omething is suggested or recommended, but not required.",
"options": {
"C": "Agency",
"A": "data integrity",
"B": "government agency",
"D": "way"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'In recent years, FDA has increas ingly observed CG...'?",
"reference": "In recent years, FDA has increas ingly observed CGMP violations involving data integrity during CGMP inspections.",
"options": {
"C": "recent years",
"A": "data integrity",
"B": "FDA",
"D": "CGMP"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In recent years, FDA has increas ingly observed CG...'?",
"reference": "In recent years, FDA has increas ingly observed CGMP violations involving data integrity during CGMP inspections.",
"options": {
"A": "FDA",
"B": "Agency",
"C": "CGMP",
"D": "data integrity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In recent years, FDA has increas ingly observed CG...'?",
"reference": "In recent years, FDA has increas ingly observed CGMP violations involving data integrity during CGMP inspections.",
"options": {
"D": "CGMP",
"A": "Agency",
"B": "FDA",
"C": "data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In recent years, FDA has increas ingly observed CG...'?",
"reference": "In recent years, FDA has increas ingly observed CGMP violations involving data integrity during CGMP inspections.",
"options": {
"B": "CGMP",
"A": "Agency",
"C": "FDA",
"D": "data integrity"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The underlying premise in 210.1 and 212.2 is that...'?",
"reference": "The underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"options": {
"C": "CGMP",
"A": "Agency",
"B": "FDA",
"D": "data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The underlying premise in ____ and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"reference": "The underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"options": {
"C": "210.1",
"A": "212.2",
"B": "211",
"D": "data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The underlying premise in 210.1 and ____ is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"reference": "The underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"options": {
"A": "212.2",
"B": "210.1",
"C": "211",
"D": "data integrity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Requirements with respect to data integrity in parts 211 and 212 include , among other things : 211.68 (requiring that backup data are exact and complete and secure from alteration, inadvertent erasur es, or loss and that output from the computer be checked for accuracy ).",
"reference": "4 Requirements with respect to data integrity in parts 211 and 212 include , among other things : 211.68 (requiring that backup data are exact and complete and secure from alteration, inadvertent erasur es, or loss and that output from the computer be checked for accuracy ).",
"options": {
"A": "4",
"B": "210.1",
"C": "212.2",
"D": "data integrity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Requirements with respect to data integrity in parts 211 and 212 include , among other things : 211.68 (requiring that backup data are exact and complete and secure from alteration, inadvertent erasur es, or loss and that output from the computer be checked for accuracy ).",
"reference": "4 Requirements with respect to data integrity in parts 211 and 212 include , among other things : 211.68 (requiring that backup data are exact and complete and secure from alteration, inadvertent erasur es, or loss and that output from the computer be checked for accuracy ).",
"options": {
"A": "4",
"B": "210.1",
"C": "212.2",
"D": "data integrity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 4 Requirements with respect to data integrity in parts ____ and 212 include , among other things : 211.68 (requiring that backup data are exact and complete and secure from alteration, inadvertent erasur es, or loss and that output from the computer be checked for accuracy ).",
"reference": "4 Requirements with respect to data integrity in parts 211 and 212 include , among other things : 211.68 (requiring that backup data are exact and complete and secure from alteration, inadvertent erasur es, or loss and that output from the computer be checked for accuracy ).",
"options": {
"B": "211",
"A": "210.1",
"C": "212.2",
"D": "data integrity"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 4 Requirements with respect to data integrity in parts 211 and ____ include , among other things : 211.68 (requiring that backup data are exact and complete and secure from alteration, inadvertent erasur es, or loss and that output from the computer be checked for accuracy ).",
"reference": "4 Requirements with respect to data integrity in parts 211 and 212 include , among other things : 211.68 (requiring that backup data are exact and complete and secure from alteration, inadvertent erasur es, or loss and that output from the computer be checked for accuracy ).",
"options": {
"B": "212",
"A": "210.1",
"C": "212.2",
"D": "data integrity"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 4 Requirements with respect to data integrity in parts 211 and 212 include , among other things : ____ (requiring that backup data are exact and complete and secure from alteration, inadvertent erasur es, or loss and that output from the computer be checked for accuracy ).",
"reference": "4 Requirements with respect to data integrity in parts 211 and 212 include , among other things : 211.68 (requiring that backup data are exact and complete and secure from alteration, inadvertent erasur es, or loss and that output from the computer be checked for accuracy ).",
"options": {
"C": "211.68",
"A": "210.1",
"B": "212.2",
"D": "data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'In recent years, FDA has increas ingly observed CG...'?",
"reference": "In recent years, FDA has increas ingly observed CGMP violations involving data integrity during CGMP inspections.",
"options": {
"B": "recent years",
"A": "data integrity",
"C": "FDA",
"D": "CGMP"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In recent years, FDA has increas ingly observed CG...'?",
"reference": "In recent years, FDA has increas ingly observed CGMP violations involving data integrity during CGMP inspections.",
"options": {
"C": "FDA",
"A": "Agency",
"B": "CGMP",
"D": "data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In recent years, FDA has increas ingly observed CG...'?",
"reference": "In recent years, FDA has increas ingly observed CGMP violations involving data integrity during CGMP inspections.",
"options": {
"C": "CGMP",
"A": "Agency",
"B": "FDA",
"D": "data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'In recent years, FDA has increas ingly observed CG...'?",
"reference": "In recent years, FDA has increas ingly observed CGMP violations involving data integrity during CGMP inspections.",
"options": {
"D": "CGMP",
"A": "Agency",
"B": "FDA",
"C": "data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'This is troubling because ensuring data integrity is an impo...'?",
"reference": "This is troubling because ensuring data integrity is an important component of industrys responsibility to ensure the safety, efficacy, and quality of drugs, and of FDAs ability to protect the public health .",
"options": {
"C": "This is troubling because ensuring data integrity is an important component of industrys responsibil...",
"A": "These data integrity",
"B": "complete data",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The underlying premise in 210.1 and 212.2 is that...'?",
"reference": "The underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"options": {
"D": "CGMP",
"A": "Agency",
"B": "FDA",
"C": "data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The use of the word should in Agency guidances mea...'?",
"reference": "The use of the word should in Agency guidances means that s omething is suggested or recommended, but not required.",
"options": {
"D": "Agency",
"A": "data integrity",
"B": "government agency",
"C": "way"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____, 211.194, and 212.60( g) (requiring complete information, complete data derived from all tests , complete record of all data, and complete records of all tests performed ).",
"reference": "211.188, 211.194, and 212.60( g) (requiring complete information, complete data derived from all tests , complete record of all data, and complete records of all tests performed ).",
"options": {
"C": "211.188",
"A": "210.1",
"B": "212.2",
"D": "data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 211.188, ____, and 212.60( g) (requiring complete information, complete data derived from all tests , complete record of all data, and complete records of all tests performed ).",
"reference": "211.188, 211.194, and 212.60( g) (requiring complete information, complete data derived from all tests , complete record of all data, and complete records of all tests performed ).",
"options": {
"D": "211.194",
"A": "210.1",
"B": "212.2",
"C": "data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 211.188, 211.194, and ____( g) (requiring complete information, complete data derived from all tests , complete record of all data, and complete records of all tests performed ).",
"reference": "211.188, 211.194, and 212.60( g) (requiring complete information, complete data derived from all tests , complete record of all data, and complete records of all tests performed ).",
"options": {
"C": "212.60",
"A": "210.1",
"B": "212.2",
"D": "data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ ( requiring that records be retained as original records , or true copies , or other accurate reproductions of the original records) .",
"reference": "211.180 ( requiring that records be retained as original records , or true copies , or other accurate reproductions of the original records) .",
"options": {
"D": "211.180",
"A": "210.1",
"B": "212.2",
"C": "data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ and 211.160 ( requiring that certain activities be documented at the time of performa nce and that laboratory controls be scientifically sound ).",
"reference": "211.100 and 211.160 ( requiring that certain activities be documented at the time of performa nce and that laboratory controls be scientifically sound ).",
"options": {
"C": "211.100",
"A": "210.1",
"B": "212.2",
"D": "data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 211.100 and ____ ( requiring that certain activities be documented at the time of performa nce and that laboratory controls be scientifically sound ).",
"reference": "211.100 and 211.160 ( requiring that certain activities be documented at the time of performa nce and that laboratory controls be scientifically sound ).",
"options": {
"D": "211.160",
"A": "210.1",
"B": "212.2",
"C": "data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ ( requiring that records be retained as original records , or true copies , or other accurate reproductions of the original records) .",
"reference": "211.180 ( requiring that records be retained as original records , or true copies , or other accurate reproductions of the original records) .",
"options": {
"A": "211.180",
"B": "210.1",
"C": "212.2",
"D": "data integrity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'This is troubling because ensuring data integrity is an impo...'?",
"reference": "This is troubling because ensuring data integrity is an important component of industrys responsibility to ensure the safety, efficacy, and quality of drugs, and of FDAs ability to protect the public health .",
"options": {
"C": "This is troubling because ensuring data integrity is an important component of industrys responsibil...",
"A": "These data integrity",
"B": "complete data",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____, 211.194, and 212.60( g) (requiring complete information, complete data derived from all tests , complete record of all data, and complete records of all tests performed ).",
"reference": "211.188, 211.194, and 212.60( g) (requiring complete information, complete data derived from all tests , complete record of all data, and complete records of all tests performed ).",
"options": {
"D": "211.188",
"A": "210.1",
"B": "212.2",
"C": "data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The underlying premise in 210.1 and 212.2 is that...'?",
"reference": "The underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"options": {
"A": "CGMP",
"B": "Agency",
"C": "FDA",
"D": "data integrity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The underlying premise in ____ and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"reference": "The underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"options": {
"D": "210.1",
"A": "212.2",
"B": "211",
"C": "data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The underlying premise in 210.1 and ____ is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"reference": "The underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"options": {
"D": "212.2",
"A": "210.1",
"B": "211",
"C": "data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'The underlying premise in 210.1 and 212.2 is that...'?",
"reference": "The underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"options": {
"A": "CGMP",
"B": "Agency",
"C": "FDA",
"D": "data integrity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The underlying premise in ____ and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"reference": "The underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"options": {
"D": "210.1",
"A": "212.2",
"B": "211",
"C": "data integrity"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The underlying premise in 210.1 and ____ is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"reference": "The underlying premise in 210.1 and 212.2 is that CGMP sets forth minimum requirements to assure that drugs meet the standards of the FDC Act regarding safety, identity, strength, quality, and purity.",
"options": {
"B": "212.2",
"A": "210.1",
"C": "211",
"D": "data integrity"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ ( requiring that records be retained as original records , or true copies , or other accurate reproductions of the original records) .",
"reference": "211.180 ( requiring that records be retained as original records , or true copies , or other accurate reproductions of the original records) .",
"options": {
"C": "211.180",
"A": "210.1",
"B": "212.2",
"D": "data integrity"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ ( requiring that records be retained as original records , or true copies , or other accurate reproductions of the original records) .",
"reference": "211.180 ( requiring that records be retained as original records , or true copies , or other accurate reproductions of the original records) .",
"options": {
"A": "211.180",
"B": "210.1",
"C": "212.2",
"D": "data integrity"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'This is troubling because ensuring data integrity is an impo...'?",
"reference": "This is troubling because ensuring data integrity is an important component of industrys responsibility to ensure the safety, efficacy, and quality of drugs, and of FDAs ability to protect the public health .",
"options": {
"B": "This is troubling because ensuring data integrity is an important component of industrys responsibil...",
"A": "These data integrity",
"C": "complete data",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Requirements with respect to data integrity in parts 211 and 212 include , among other things : 211.68 (requiring that backup data are exact and complete and secure from alteration, inadvertent erasur es, or loss and that output from the computer be checked for accuracy ).",
"reference": "4 Requirements with respect to data integrity in parts 211 and 212 include , among other things : 211.68 (requiring that backup data are exact and complete and secure from alteration, inadvertent erasur es, or loss and that output from the computer be checked for accuracy ).",
"options": {
"B": "4",
"A": "210.1",
"C": "212.2",
"D": "data integrity"
},
"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]
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": {
"A": "FDA",
"B": "Software Validation",
"C": "SaMD",
"D": "the Software Validation 102 guidance"
},
"answer": "A",
"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": {
"A": "FDA",
"B": "Software Validation",
"C": "SaMD",
"D": "the Software Validation 102 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]
Preparation for software validation should begin early, i.e., during design and development planning and design input. The final conclusion that the software is validated should be based on evidence collected from planned efforts conducted throughout the software lifecycle. SOFTWARE LIFE CYCLE Software validation takes place within the environment of an established software life cycle. The software life cycle contains software engineering tasks and documentation necessary to support the software validation effort. In addition, the software life cycle contains specific verification and validation tasks that are appropriate for the intended use of the software. This guidance does not recommend any particular life cycle models only that they should be selected and used for a software development project. Page 12General Principles of Software Validation Guidance for Industry and FDA Staff 4.5. PLANS The software validation process is defined and controlled through the use of a plan. The software validation plan defines what is to be accomplished through the software validation effort. Software validation plans are a significant quality system tool. Software validation plans specify areas such as scope, approach, resources, schedules and the types and extent of activities, tasks, and work items. The software validation process is executed through the use of procedures. These procedures establish how to conduct the software validation effort. The procedures should identify the specific actions or sequence of actions that must be taken to complete individual validation activities, tasks, and work items. 4.7. SOFTWARE VALIDATION AFTER A CHANGE Due to the complexity of software, a seemingly small local change may have a significant global system impact. When any change (even a small change) is made to the software, the validation status of the software needs to be re-established.
[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 validation plans specify areas such as sc...'?",
"reference": "Software validation plans specify areas such as scope, approach, resources, schedules and the types and extent of activities, tasks, and work items.",
"options": {
"D": "Software",
"A": "FDA",
"B": "package",
"C": "computer software"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 12General Principles of Software Validation G...'?",
"reference": "Page 12General Principles of Software Validation Guidance for Industry and FDA Staff 4.5.",
"options": {
"B": "FDA",
"A": "SOFTWARE LIFE CYCLE Software validation",
"C": "the software validation effort",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Page 12General Principles of Software Validation G...'?",
"reference": "Page 12General Principles of Software Validation Guidance for Industry and FDA Staff 4.5.",
"options": {
"A": "4.5",
"B": "12General",
"C": "4.7",
"D": "SOFTWARE LIFE CYCLE Software validation"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Page 12General Principles of Software Validation Guidance for Industry and FDA Staff ____.",
"reference": "Page 12General Principles of Software Validation Guidance for Industry and FDA Staff 4.5.",
"options": {
"D": "4.5",
"A": "12General",
"B": "4.7",
"C": "SOFTWARE LIFE CYCLE 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 10 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": "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": {
"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": {
"B": "193",
"A": "185",
"C": "186",
"D": "a software function"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Manufacturers may decide to conduct different assurance activities for individual ____ features, functions, or op erations.",
"reference": "Manufacturers may decide to conduct different assurance activities for individual 190 features, functions, or op erations.",
"options": {
"D": "190",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: In ____ cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"reference": "In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"options": {
"A": "185",
"B": "186",
"C": "187",
"D": "a software function"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In 185 cases where the individual features, functions, and operations have different roles within ____ production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"reference": "In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"options": {
"D": "186",
"A": "185",
"B": "187",
"C": "a software function"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of ____ validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"reference": "In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"options": {
"D": "187",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the ____ individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"reference": "In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"options": {
"C": "188",
"A": "185",
"B": "186",
"D": "a software function"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance ____ strategy.",
"reference": "In 185 cases where the individual features, functions, and operations have different roles within 186 production or the quality system , they may present different risks with different levels of 187 validation effort .FDA recommends that manufact urers examine the intended uses of the 188 individual features, functions, and operations to facilitate development of a risk -based assurance 189 strategy.",
"options": {
"D": "189",
"A": "185",
"B": "186",
"C": "a software function"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 45 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: 'Other CGMP assigned responsibilities of the QU are...'?",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"B": "CGMP",
"A": "scientists.8 Manufacturing",
"C": "modern quality systems",
"D": "product quality standards"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'Other CGMP assigned responsibilities of the QU are...'?",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"A": "QU",
"B": "the product and pro cess developm ent units",
"C": "development scientists.8 Manufacturing personnel",
"D": "CGMP"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( ____):\nEnsuring 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.",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"A": "211.22",
"B": "modern quality systems",
"C": "product quality standards",
"D": "CGMP"
},
"answer": "A",
"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 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": {
"C": "CGMP",
"A": "scientists.8 Manufacturing",
"B": "modern quality systems",
"D": "product quality standards"
},
"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": {
"D": "scientists.8 Manufacturing",
"A": "modern quality systems",
"B": "product quality standards",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance uses the term quality unit7 (QU) to ...'?",
"reference": "This guidance uses the term quality unit7 (QU) to reflect modern practice while remaining consistent with the CGMP definition in 210.3(b)(15).",
"options": {
"C": "CGMP",
"A": "scientists.8 Manufacturing",
"B": "modern quality systems",
"D": "product quality standards"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance uses the term quality unit7 (QU) to ...'?",
"reference": "This guidance uses the term quality unit7 (QU) to reflect modern practice while remaining consistent with the CGMP definition in 210.3(b)(15).",
"options": {
"C": "CGMP",
"A": "scientists.8 Manufacturing",
"B": "modern quality systems",
"D": "product quality standards"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"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": {
"A": "CGMP",
"B": "scientists.8 Manufacturing",
"C": "modern quality systems",
"D": "product quality standards"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance uses the term quality unit7 (QU) to ...'?",
"reference": "This guidance uses the term quality unit7 (QU) to reflect modern practice while remaining consistent with the CGMP definition in 210.3(b)(15).",
"options": {
"D": "CGMP",
"A": "scientists.8 Manufacturing",
"B": "modern quality systems",
"C": "product quality standards"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"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": {
"A": "CGMP",
"B": "scientists.8 Manufacturing",
"C": "modern quality systems",
"D": "product quality standards"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Su ch activities do not substitute for, or preclud...'?",
"reference": "Su ch activities do not substitute for, or preclude, the daily responsibility of manuf acturing personnel to build quality in to the product.",
"options": {
"C": "daily",
"A": "modern quality systems",
"B": "product quality standards",
"D": "day-to-day"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Other CGMP assigned responsibilities of the QU are...'?",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"A": "CGMP",
"B": "scientists.8 Manufacturing",
"C": "modern quality systems",
"D": "product quality standards"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'Other CGMP assigned responsibilities of the QU are...'?",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"A": "QU",
"B": "the product and pro cess developm ent units",
"C": "development scientists.8 Manufacturing personnel",
"D": "CGMP"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( ____):\nEnsuring 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.",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"C": "211.22",
"A": "modern quality systems",
"B": "product quality standards",
"D": "CGMP"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance uses the term quality unit7 (QU) to ...'?",
"reference": "This guidance uses the term quality unit7 (QU) to reflect modern practice while remaining consistent with the CGMP definition in 210.3(b)(15).",
"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: 'This guidance uses the term quality unit7 (QU) to ...'?",
"reference": "This guidance uses the term quality unit7 (QU) to reflect modern practice while remaining consistent with the CGMP definition in 210.3(b)(15).",
"options": {
"C": "CGMP",
"A": "scientists.8 Manufacturing",
"B": "modern quality systems",
"D": "product quality standards"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance uses the term quality unit7 (QU) to ...'?",
"reference": "This guidance uses the term quality unit7 (QU) to reflect modern practice while remaining consistent with the CGMP definition in 210.3(b)(15).",
"options": {
"C": "CGMP",
"A": "scientists.8 Manufacturing",
"B": "modern quality systems",
"D": "product quality standards"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"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: 'Other CGMP assigned responsibilities of the QU are...'?",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"A": "CGMP",
"B": "scientists.8 Manufacturing",
"C": "modern quality systems",
"D": "product quality standards"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'Other CGMP assigned responsibilities of the QU are...'?",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"A": "QU",
"B": "the product and pro cess developm ent units",
"C": "development scientists.8 Manufacturing personnel",
"D": "CGMP"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( ____):\nEnsuring 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.",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"D": "211.22",
"A": "modern quality systems",
"B": "product quality standards",
"C": "CGMP"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"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": "When did this occur: 'Su ch activities do not substitute for, or preclud...'?",
"reference": "Su ch activities do not substitute for, or preclude, the daily responsibility of manuf acturing personnel to build quality in to the product.",
"options": {
"B": "daily",
"A": "modern quality systems",
"C": "product quality standards",
"D": "day-to-day"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Su ch activities do not substitute for, or preclud...'?",
"reference": "Su ch activities do not substitute for, or preclude, the daily responsibility of manuf acturing personnel to build quality in to the product.",
"options": {
"C": "daily",
"A": "modern quality systems",
"B": "product quality standards",
"D": "day-to-day"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "When did this occur: 'Su ch activities do not substitute for, or preclud...'?",
"reference": "Su ch activities do not substitute for, or preclude, the daily responsibility of manuf acturing personnel to build quality in to the product.",
"options": {
"B": "daily",
"A": "modern quality systems",
"C": "product quality standards",
"D": "day-to-day"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"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 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": {
"D": "CGMP",
"A": "scientists.8 Manufacturing",
"B": "modern quality systems",
"C": "product quality standards"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Su ch activities do not substitute for, or preclud...'?",
"reference": "Su ch activities do not substitute for, or preclude, the daily responsibility of manuf acturing personnel to build quality in to the product.",
"options": {
"B": "daily",
"A": "modern quality systems",
"C": "product quality standards",
"D": "day-to-day"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Other CGMP assigned responsibilities of the QU are...'?",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"C": "CGMP",
"A": "scientists.8 Manufacturing",
"B": "modern quality systems",
"D": "product quality standards"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'Other CGMP assigned responsibilities of the QU are...'?",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"B": "QU",
"A": "the product and pro cess developm ent units",
"C": "development scientists.8 Manufacturing personnel",
"D": "CGMP"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( ____):\nEnsuring 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.",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"C": "211.22",
"A": "modern quality systems",
"B": "product quality standards",
"D": "CGMP"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Other CGMP assigned responsibilities of the QU are...'?",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"D": "CGMP",
"A": "scientists.8 Manufacturing",
"B": "modern quality systems",
"C": "product quality standards"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What location is mentioned: 'Other CGMP assigned responsibilities of the QU are...'?",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"B": "QU",
"A": "the product and pro cess developm ent units",
"C": "development scientists.8 Manufacturing personnel",
"D": "CGMP"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Su ch activities do not substitute for, or preclud...'?",
"reference": "Su ch activities do not substitute for, or preclude, the daily responsibility of manuf acturing personnel to build quality in to the product.",
"options": {
"B": "daily",
"A": "modern quality systems",
"C": "product quality standards",
"D": "day-to-day"
},
"answer": "B",
"difficulty": "easy",
"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"
},
{
"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": {
"C": "CGMP",
"A": "scientists.8 Manufacturing",
"B": "modern quality systems",
"D": "product quality standards"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance uses the term quality unit7 (QU) to ...'?",
"reference": "This guidance uses the term quality unit7 (QU) to reflect modern practice while remaining consistent with the CGMP definition in 210.3(b)(15).",
"options": {
"C": "CGMP",
"A": "scientists.8 Manufacturing",
"B": "modern quality systems",
"D": "product quality standards"
},
"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": {
"D": "scientists.8 Manufacturing",
"A": "modern quality systems",
"B": "product quality standards",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance uses the term quality unit7 (QU) to ...'?",
"reference": "This guidance uses the term quality unit7 (QU) to reflect modern practice while remaining consistent with the CGMP definition in 210.3(b)(15).",
"options": {
"C": "CGMP",
"A": "scientists.8 Manufacturing",
"B": "modern quality systems",
"D": "product quality standards"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'This guidance uses the term quality unit7 (QU) to ...'?",
"reference": "This guidance uses the term quality unit7 (QU) to reflect modern practice while remaining consistent with the CGMP definition in 210.3(b)(15).",
"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": {
"D": "scientists.8 Manufacturing",
"A": "modern quality systems",
"B": "product quality standards",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"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: 'Other CGMP assigned responsibilities of the QU are...'?",
"reference": "Other CGMP assigned responsibilities of the QU are consistent with modern quality system approaches ( 211.22):\nEnsuring 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.",
"options": {
"B": "CGMP",
"A": "scientists.8 Manufacturing",
"C": "modern quality systems",
"D": "product quality standards"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 8 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Software testing that finds no errors should not be interpreted to mean that errors do not exist in the software product; it may mean the testing was superficial. An essential element of a software test case is the expected result. It is the key detail that permits objective evaluation of the actual test result. This necessary testing information is obtained from the corresponding, predefined definition or specification. A software specification document must identify what, when, how, why, etc., is to be achieved with an engineering (i.e., measurable or objectively verifiable) level of detail in order for it to be confirmed through testing. The real effort of effective software testing lies in the definition of what is to be tested rather than in the performance of the test. A software testing process should be based on principles that foster effective examinations of a software product. Applicable software testing tenets include: The expected test outcome is predefined; A good test case has a high probability of exposing an error; A successful test is one that finds an error; There is independence from coding; Both application (user) and software (programming) expertise are employed; Testers use different tools from coders;
Examining only the usual case is insufficient; Test documentation permits its reuse and an independent confirmation of the pass/fail status of a test outcome during subsequent review. Once the prerequisite tasks (e.g., code inspection) have been successfully completed, software testing begins. It starts with unit level testing and concludes with system level testing. There may be a distinct integration level of testing. A software product should be challenged with test cases based on its internal structure and with test cases based on its external specification. These tests should provide a thorough and rigorous examination of the software product's compliance with its functional, performance, and interface definitions and requirements.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Software testing that finds no errors should not b...'?",
"reference": "Software testing that finds no errors should not be interpreted to mean that errors do not exist in the software product; it may mean the testing was superficial.",
"options": {
"D": "Software",
"A": "unit level testing",
"B": "system level testing",
"C": "package"
},
"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]
, user manuals and standard operating procedures).8 7 American National Standard for Information Systems, Dictionary for Information Systems , Ameri can National Standards Institute, 1991. 8 See guidance for industry and FDA staff General Principles of Software Validation . Contains Nonbinding Recommendations 6 2. When is it permissible to invalidate a CGMP result and exclude it from the determination of batch conformance ? Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see 211.22 and 212.70) and maintained for CGMP purposes ( e.g., 211.180).9 Electronic data generated to fulfill CGMP requirements include relevant metadata required to reconstruct the CGMP activity captured in the record. Invalidating test results to exclude them from quality unit decisions about conformance to a sp ecification requires a valid , documented, scientific ally sound justification . See, for example, 211.160(b), 211.188, 211.192, and 212.71(b) and the guidance for industry Investigating Out -of-Specification (OOS) Test Results for Pharmaceutical Production. Even if test results are legitimately invalidated on the basis of a scientifically sound investigation, the full CGMP batch record provided to the quality unit would include the original (invalidated) data , along with the investigation report that justif ies invalidating the result . The requirements for record retention and review do not differ depending on the data format ; paper-based and electronic data record -keeping systems are subject to the same requirements . 3. Does each CGMP workflow on a computer sy stem need to be validated? Yes, a CGMP workflow, such as creation of an electronic master p roduction and c ontrol r ecord (MPCR), is a n intended use of a c omputer system to be checked through validation (see 211.63, 211.68(b), and 211.110(a)) . The extent of validation studies should be commensurate with the risk posed by the automated system.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Yes, a CGMP workflow, such as creation of an elect...'?",
"reference": "Yes, a CGMP workflow, such as creation of an electronic master p roduction and c ontrol r ecord (MPCR), is a n intended use of a c omputer system to be checked through validation (see 211.63, 211.68(b), and 211.110(a)) .",
"options": {
"B": "CGMP",
"A": "American National Standard for Information Systems",
"C": "Ameri",
"D": "paper-based and electronic data record -keeping systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Yes, a CGMP workflow, such as creation of an electronic master p roduction and c ontrol r ecord (MPCR), is a n intended use of a c omputer system to be checked through validation (see ____, 211.68(b), and 211.110(a)) .",
"reference": "Yes, a CGMP workflow, such as creation of an electronic master p roduction and c ontrol r ecord (MPCR), is a n intended use of a c omputer system to be checked through validation (see 211.63, 211.68(b), and 211.110(a)) .",
"options": {
"A": "211.63",
"B": "6 2",
"C": "211.22",
"D": "paper-based and electronic data record -keeping systems"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When is it permissible to invalidate a CGMP result...'?",
"reference": "When is it permissible to invalidate a CGMP result and exclude it from the determination of batch conformance ?",
"options": {
"D": "CGMP",
"A": "American National Standard for Information Systems",
"B": "Ameri",
"C": "paper-based and electronic data record -keeping systems"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When is it permissible to invalidate a CGMP result...'?",
"reference": "When is it permissible to invalidate a CGMP result and exclude it from the determination of batch conformance ?",
"options": {
"B": "CGMP",
"A": "American National Standard for Information Systems",
"C": "Ameri",
"D": "paper-based and electronic data record -keeping systems"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'When is it permissible to invalidate a CGMP result...'?",
"reference": "When is it permissible to invalidate a CGMP result and exclude it from the determination of batch conformance ?",
"options": {
"D": "CGMP",
"A": "American National Standard for Information Systems",
"B": "Ameri",
"C": "paper-based and electronic data record -keeping systems"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Even if test results are legitimately invalidated ...'?",
"reference": "Even if test results are legitimately invalidated on the basis of a scientifically sound investigation, the full CGMP batch record provided to the quality unit would include the original (invalidated) data , along with the investigation report that justif ies invalidating the result .",
"options": {
"B": "CGMP",
"A": "American National Standard for Information Systems",
"C": "Ameri",
"D": "paper-based and electronic data record -keeping systems"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 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, 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: '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": {
"B": "Technical Report",
"A": "Food and Drug Administration",
"C": "Software Validation Guidance",
"D": "Software Development Activities"
},
"answer": "B",
"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": {
"C": "Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs",
"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: '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": "Food and Drug Administration",
"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": "Software Validation Guidance"
},
"answer": "A",
"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": {
"D": "July 1987",
"A": "September 1999",
"B": "May 1987",
"C": "Food and Drug Administration"
},
"answer": "D",
"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": {
"A": "1987",
"B": "September 1999",
"C": "May 1987",
"D": "Food and Drug Administration"
},
"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": {
"C": "Validation",
"A": "Food and Drug Administration",
"B": "Blood Establishment Computer Software",
"D": "substantiation"
},
"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": "Testing of Computer Software",
"A": "Food and Drug Administration",
"B": "Software Validation Guidance",
"D": "Validation"
},
"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": "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": {
"D": "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",
"C": "Food and Drug Administration"
},
"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": "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: 'Guidance for Industry, FDA Reviewers and Complianc...'?",
"reference": "Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, September 1999.",
"options": {
"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": "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: 'Guidance for Industry, FDA Reviewers and Complianc...'?",
"reference": "Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, September 1999.",
"options": {
"D": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Center For Devices and Radiological Health, Food and Drug Administration",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Guidance for Industry, FDA Reviewers and Complianc...'?",
"reference": "Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, September 1999.",
"options": {
"B": "September 1999",
"A": "May 1987",
"C": "October 7, 1996",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 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 ____.",
"reference": "Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, September 1999.",
"options": {
"C": "1999",
"A": "September 1999",
"B": "May 1987",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Guidance for Industry, FDA Reviewers and Complianc...'?",
"reference": "Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, September 1999.",
"options": {
"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": "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: 'Guidance for Industry, FDA Reviewers and Complianc...'?",
"reference": "Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, September 1999.",
"options": {
"D": "Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration",
"A": "FDA Reviewers and Compliance on Off-the-Shelf Software Use",
"B": "Center For Devices and Radiological Health, Food and Drug Administration",
"C": "Software Validation Guidance"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Guidance for Industry, FDA Reviewers and Complianc...'?",
"reference": "Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, September 1999.",
"options": {
"D": "September 1999",
"A": "May 1987",
"B": "October 7, 1996",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 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 ____.",
"reference": "Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, September 1999.",
"options": {
"B": "1999",
"A": "September 1999",
"C": "May 1987",
"D": "Food and Drug Administration"
},
"answer": "B",
"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": {
"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: '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": "John C Cherniavsky",
"B": "Reviewer Guidance",
"C": "Martha A. Branstad",
"D": "Food and Drug Administration"
},
"answer": "A",
"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": {
"D": "W. Richards Adrion",
"A": "Reviewer Guidance",
"B": "Martha A. Branstad",
"C": "Food and Drug Administration"
},
"answer": "D",
"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": {
"C": "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",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Reviewer Guidance for a Pre-Market Notification Su...'?",
"reference": "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.",
"options": {
"B": "Center for Biologics Evaluation and Research, Food and Drug Administration",
"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": "Software Validation Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Reviewer Guidance for a Pre-Market Notification Su...'?",
"reference": "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.",
"options": {
"B": "January 1997",
"A": "September 1999",
"C": "May 1987",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Reviewer Guidance for a Pre-Market Notification Su...'?",
"reference": "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.",
"options": {
"A": "Course INV545",
"B": "Food and Drug Administration",
"C": "Software Validation Guidance",
"D": "Center for Biologics Evaluation and Research, Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Reviewer Guidance for a Pre-Market Notification Su...'?",
"reference": "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.",
"options": {
"B": "Computer System Validation",
"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: 'Reviewer Guidance for a Pre-Market Notification Su...'?",
"reference": "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.",
"options": {
"C": "Division of Human Resource Development, Office of Regulatory Affairs",
"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: 'Reviewer Guidance for a Pre-Market Notification Su...'?",
"reference": "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.",
"options": {
"D": "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: 'Reviewer Guidance for a Pre-Market Notification Su...'?",
"reference": "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.",
"options": {
"B": "1997",
"A": "September 1999",
"C": "May 1987",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Reviewer Guidance for a Pre-Market Notification Submission for Blood Establishment Computer Software , Center for Biologics Evaluation and Research, Food and Drug Administration, January ____ Student Manual 1, Course INV545, Computer System Validation , Division of Human Resource Development, Office of Regulatory Affairs, Food and Drug Administration, 1997.",
"reference": "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.",
"options": {
"A": "1997",
"B": "September 1999",
"C": "May 1987",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Reviewer Guidance for a Pre-Market Notification Submission for Blood Establishment Computer Software , Center for Biologics Evaluation and Research, Food and Drug Administration, January ____997 Student Manual 1, Course INV545, Computer System Validation , Division of Human Resource Development, Office of Regulatory Affairs, Food and Drug Administration, 1997.",
"reference": "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.",
"options": {
"B": "1",
"A": "36General",
"C": "Food and Drug Administration",
"D": "Software Validation Guidance"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Reviewer Guidance for a Pre-Market Notification Submission for Blood Establishment Computer Software , Center for Biologics Evaluation and Research, Food and Drug Administration, January ____ Student Manual 1, Course INV545, Computer System Validation , Division of Human Resource Development, Office of Regulatory Affairs, Food and Drug Administration, 1997.",
"reference": "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.",
"options": {
"C": "1997",
"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": {
"A": "Current Good Manufacturing Practice",
"B": "Food and Drug Administration",
"C": "Software Validation Guidance",
"D": "Medical Devices"
},
"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]
below, assurance activities should be conduct ed for software that is 302 high process risk and not high process risk commensurate with the risk. 303 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking . This feature ensure s that the right materials are 306 ordered and delivered to appropriate production operations . However, a qualified person checks 307 the materials before their use in production. The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered . However , the delivery of the wrong materials 310 to the qualified person should result in the rejection of those materials before use in production ; 311 as such, the quality problem should not foreseeably lead to compromise d safety . The 312 manufacturer identifies this as an intermediate (not high) process risk and determine s assurance 313 activities commensurate with the process risk . The manufacturer already undertakes some of 314 those identified assurance activities so implements only the re maining identified assurance 315 activities . 316 317 Example 2 : A similar feature in an other ERP management system performs the same tasks as in 318 the previous example except that it also automates checking the material s before their use in 319 production . A qualified person does not check the material first. The manufactu rer identifies this 320 as a high process risk because the failure of the feature to perform as intended may result in a 321 quality problem that foreseeably compromise s safety . As such, the manufacturer will determine 322 assurance activities that are commensurate with the related medical device 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: The ____ manufacturer identifies this as an intermediate (not high) process risk and determine s assurance 313 activities commensurate with the process risk .",
"reference": "The 312 manufacturer identifies this as an intermediate (not high) process risk and determine s assurance 313 activities commensurate with the process risk .",
"options": {
"C": "312",
"A": "302",
"B": "303",
"D": "302 high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 312 manufacturer identifies this as an intermediate (not high) process risk and determine s assurance ____ activities commensurate with the process risk .",
"reference": "The 312 manufacturer identifies this as an intermediate (not high) process risk and determine s assurance 313 activities commensurate with the process risk .",
"options": {
"A": "313",
"B": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '303 304 Example 1 : An Enterprise Resource Plannin...'?",
"reference": "303 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"options": {
"C": "An Enterprise Resource Planning",
"A": "302 high process risk",
"B": "not high process risk commensurate",
"D": "303"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '303 304 Example 1 : An Enterprise Resource Plannin...'?",
"reference": "303 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"options": {
"C": "ERP",
"A": "An Enterprise Resource Planning",
"B": "302 high process risk",
"D": "not high process risk commensurate"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"reference": "303 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"options": {
"C": "303",
"A": "302",
"B": "304",
"D": "302 high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 303 ____ Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"reference": "303 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"options": {
"A": "304",
"B": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 303 304 Example ____ : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"reference": "303 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"options": {
"D": "1",
"A": "302",
"B": "303",
"C": "302 high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 303 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that ____ automate s manufacturing material restocking .",
"reference": "303 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"options": {
"C": "305",
"A": "302",
"B": "303",
"D": "302 high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The failure of this feature to perform as intended ____ may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered .",
"reference": "The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered .",
"options": {
"A": "308",
"B": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the ____ wrong materials would be restocked and delivered .",
"reference": "The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered .",
"options": {
"D": "309",
"A": "302",
"B": "303",
"C": "302 high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The failure of this feature to perform as intended ____ may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered .",
"reference": "The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered .",
"options": {
"B": "308",
"A": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the ____ wrong materials would be restocked and delivered .",
"reference": "The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered .",
"options": {
"C": "309",
"A": "302",
"B": "303",
"D": "302 high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The failure of this feature to perform as intended 308 may r...'?",
"reference": "The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered .",
"options": {
"B": "The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and del...",
"A": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The ____ manufacturer identifies this as an intermediate (not high) process risk and determine s assurance 313 activities commensurate with the process risk .",
"reference": "The 312 manufacturer identifies this as an intermediate (not high) process risk and determine s assurance 313 activities commensurate with the process risk .",
"options": {
"B": "312",
"A": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The 312 manufacturer identifies this as an intermediate (not high) process risk and determine s assurance ____ activities commensurate with the process risk .",
"reference": "The 312 manufacturer identifies this as an intermediate (not high) process risk and determine s assurance 313 activities commensurate with the process risk .",
"options": {
"C": "313",
"A": "302",
"B": "303",
"D": "302 high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '303 304 Example 1 : An Enterprise Resource Plannin...'?",
"reference": "303 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"options": {
"A": "An Enterprise Resource Planning",
"B": "302 high process risk",
"C": "not high process risk commensurate",
"D": "303"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '303 304 Example 1 : An Enterprise Resource Plannin...'?",
"reference": "303 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"options": {
"B": "ERP",
"A": "An Enterprise Resource Planning",
"C": "302 high process risk",
"D": "not high process risk commensurate"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"reference": "303 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"options": {
"A": "303",
"B": "302",
"C": "304",
"D": "302 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 303 ____ Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"reference": "303 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"options": {
"B": "304",
"A": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 303 304 Example ____ : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"reference": "303 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"options": {
"A": "1",
"B": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '316 317 Example 2 : A similar feature in an other ...'?",
"reference": "316 317 Example 2 : A similar feature in an other ERP management system performs the same tasks as in 318 the previous example except that it also automates checking the material s before their use in 319 production .",
"options": {
"A": "ERP",
"B": "An Enterprise Resource Planning",
"C": "302 high process risk",
"D": "not high process risk commensurate"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 317 Example 2 : A similar feature in an other ERP management system performs the same tasks as in 318 the previous example except that it also automates checking the material s before their use in 319 production .",
"reference": "316 317 Example 2 : A similar feature in an other ERP management system performs the same tasks as in 318 the previous example except that it also automates checking the material s before their use in 319 production .",
"options": {
"B": "316",
"A": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 316 ____ Example 2 : A similar feature in an other ERP management system performs the same tasks as in 318 the previous example except that it also automates checking the material s before their use in 319 production .",
"reference": "316 317 Example 2 : A similar feature in an other ERP management system performs the same tasks as in 318 the previous example except that it also automates checking the material s before their use in 319 production .",
"options": {
"A": "317",
"B": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 316 317 Example ____ : A similar feature in an other ERP management system performs the same tasks as in 318 the previous example except that it also automates checking the material s before their use in 319 production .",
"reference": "316 317 Example 2 : A similar feature in an other ERP management system performs the same tasks as in 318 the previous example except that it also automates checking the material s before their use in 319 production .",
"options": {
"D": "2",
"A": "302",
"B": "303",
"C": "not high process risk commensurate"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 316 317 Example 2 : A similar feature in an other ERP management system performs the same tasks as in ____ the previous example except that it also automates checking the material s before their use in 319 production .",
"reference": "316 317 Example 2 : A similar feature in an other ERP management system performs the same tasks as in 318 the previous example except that it also automates checking the material s before their use in 319 production .",
"options": {
"A": "318",
"B": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 316 317 Example 2 : A similar feature in an other ERP management system performs the same tasks as in 318 the previous example except that it also automates checking the material s before their use in ____ production .",
"reference": "316 317 Example 2 : A similar feature in an other ERP management system performs the same tasks as in 318 the previous example except that it also automates checking the material s before their use in 319 production .",
"options": {
"A": "319",
"B": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The manufactu rer identifies this ____ as a high process risk because the failure of the feature to perform as intended may result in a 321 quality problem that foreseeably compromise s safety .",
"reference": "The manufactu rer identifies this 320 as a high process risk because the failure of the feature to perform as intended may result in a 321 quality problem that foreseeably compromise s safety .",
"options": {
"B": "320",
"A": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The manufactu rer identifies this 320 as a high process risk because the failure of the feature to perform as intended may result in a ____ quality problem that foreseeably compromise s safety .",
"reference": "The manufactu rer identifies this 320 as a high process risk because the failure of the feature to perform as intended may result in a 321 quality problem that foreseeably compromise s safety .",
"options": {
"D": "321",
"A": "302",
"B": "303",
"C": "302 high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The manufactu rer identifies this 320 as a high process risk...'?",
"reference": "The manufactu rer identifies this 320 as a high process risk because the failure of the feature to perform as intended may result in a 321 quality problem that foreseeably compromise s safety .",
"options": {
"B": "The manufactu rer identifies this 320 as a high process risk because the failure of the feature to p...",
"A": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: As such, the manufacturer will determine ____ assurance activities that are commensurate with the related medical device risk.",
"reference": "As such, the manufacturer will determine 322 assurance activities that are commensurate with the related medical device risk.",
"options": {
"B": "322",
"A": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This feature ensure s that the right materials are ____ ordered and delivered to appropriate production operations .",
"reference": "This feature ensure s that the right materials are 306 ordered and delivered to appropriate production operations .",
"options": {
"D": "306",
"A": "302",
"B": "303",
"C": "302 high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The manufactu rer identifies this ____ as a high process risk because the failure of the feature to perform as intended may result in a 321 quality problem that foreseeably compromise s safety .",
"reference": "The manufactu rer identifies this 320 as a high process risk because the failure of the feature to perform as intended may result in a 321 quality problem that foreseeably compromise s safety .",
"options": {
"D": "320",
"A": "302",
"B": "303",
"C": "302 high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The manufactu rer identifies this 320 as a high process risk because the failure of the feature to perform as intended may result in a ____ quality problem that foreseeably compromise s safety .",
"reference": "The manufactu rer identifies this 320 as a high process risk because the failure of the feature to perform as intended may result in a 321 quality problem that foreseeably compromise s safety .",
"options": {
"D": "321",
"A": "302",
"B": "303",
"C": "302 high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The manufactu rer identifies this 320 as a high process risk...'?",
"reference": "The manufactu rer identifies this 320 as a high process risk because the failure of the feature to perform as intended may result in a 321 quality problem that foreseeably compromise s safety .",
"options": {
"C": "The manufactu rer identifies this 320 as a high process risk because the failure of the feature to p...",
"A": "302",
"B": "303",
"D": "302 high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The failure of this feature to perform as intended ____ may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered .",
"reference": "The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered .",
"options": {
"D": "308",
"A": "302",
"B": "303",
"C": "302 high process risk"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the ____ wrong materials would be restocked and delivered .",
"reference": "The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered .",
"options": {
"B": "309",
"A": "302",
"C": "303",
"D": "302 high process risk"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What causal relationship is described: 'The failure of this feature to perform as intended 308 may r...'?",
"reference": "The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and delivery , which would be a quality problem because the 309 wrong materials would be restocked and delivered .",
"options": {
"C": "The failure of this feature to perform as intended 308 may result in a mix-up in r estocking and del...",
"A": "302",
"B": "303",
"D": "302 high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: This feature ensure s that the right materials are ____ ordered and delivered to appropriate production operations .",
"reference": "This feature ensure s that the right materials are 306 ordered and delivered to appropriate production operations .",
"options": {
"C": "306",
"A": "302",
"B": "303",
"D": "302 high process risk"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: below, assurance activities should be conduct ed for software that is ____ high process risk and not high process risk commensurate with the risk.",
"reference": "below, assurance activities should be conduct ed for software that is 302 high process risk and not high process risk commensurate with the risk.",
"options": {
"A": "302",
"B": "303",
"C": "304",
"D": "not high process risk commensurate"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '303 304 Example 1 : An Enterprise Resource Plannin...'?",
"reference": "303 304 Example 1 : An Enterprise Resource Planning (ERP) Management system contain s a feature that 305 automate s manufacturing material restocking .",
"options": {
"C": "An Enterprise Resource Planning",
"A": "302 high process risk",
"B": "not high process risk commensurate",
"D": "303"
},
"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]
Part 11 a lso applies to electronic records submitted to the Agency 27 under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the 28 PHS Act), even if such records are not specifically identified in Agency regulations ( 11.1). The un derlying requirements set forth in the Act, PHS Act, and FDA regulations (other than part 30 11) are referred to in this guidance document as predicate rules. 31 32 1 This guidance has been prepared by the Office of Compliance in the Center for Drug Evaluation and Res earch (CDER) in consultation with the other Agency centers and the Office of Regulatory Affairs at the Food and Drug Administration. These requirements include, for example, certain provisions of the Current Good Manufacturing Practice regulations (21 CFR Part 211), the Quality System regulation (21 CFR Part 820), and the Good Laboratory Practice for Nonclinical Laboratory Studies regulations (21 CFR Part 58). Contains Nonbinding Recommendations 2 As an outgrowth of its current good manufacturing practice (CGMP) initiative for human and 33 animal d rugs and biologics,4 FDA is re -examining part 11 as it applies to all FDA regulated 34 products. We anticipate initiating rulemaking to change part 11 as a result of that re - 35 examination. This guidance explains that we will narrowly interpret the scope of pa rt 11. While 36 the re -examination of part 11 is under way, we intend to exercise enforcement discretion with 37 respect to certain part 11 requirements. That is, we do not intend to take enforcement action to 38 enforce compliance with the validation, audit trai l, record retention, and record copying 39 requirements of part 11 as explained in this guidance. However, records must still be maintained 40 or submitted in accordance with the underlying predicate rules, and the Agency can take 41 regulatory action for noncompl iance with such predicate rules.
[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: 'Part 11 a lso applies to electronic records submit...'?",
"reference": "Part 11 a lso applies to electronic records submitted to the Agency 27 under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the 28 PHS Act), even if such records are not specifically identified in Agency regulations ( 11.1).",
"options": {
"B": "Agency",
"A": "the Current Good Manufacturing Practice regulations",
"C": "the 28 PHS Act",
"D": "government agency"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Part 11 a lso applies to electronic records submit...'?",
"reference": "Part 11 a lso applies to electronic records submitted to the Agency 27 under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the 28 PHS Act), even if such records are not specifically identified in Agency regulations ( 11.1).",
"options": {
"A": "the Federal Food, Drug",
"B": "Agency",
"C": "the Public Health Service Act",
"D": "the Current Good Manufacturing Practice regulations"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Part 11 a lso applies to electronic records submit...'?",
"reference": "Part 11 a lso applies to electronic records submitted to the Agency 27 under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the 28 PHS Act), even if such records are not specifically identified in Agency regulations ( 11.1).",
"options": {
"C": "the Public Health Service Act",
"A": "Agency",
"B": "the Federal Food, Drug",
"D": "the Current Good Manufacturing Practice regulations"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What amount is specified: 'Part 11 a lso applies to electronic records submit...'?",
"reference": "Part 11 a lso applies to electronic records submitted to the Agency 27 under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the 28 PHS Act), even if such records are not specifically identified in Agency regulations ( 11.1).",
"options": {
"B": "28 PHS Act",
"A": "11.1",
"C": "211",
"D": "the Current Good Manufacturing Practice regulations"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
220 221 We suggest that your decision to validate computerized systems, and the extent of the validation, 222 take into account the impact the systems have on your ability to meet predicate rule 223 requireme nts. You should also consider the impact those systems might have on the accuracy, 224 reliability, integrity, availability, and authenticity of required records and signatures. Even if 225 there is no predicate rule requirement to validate a system, in some insta nces it may still be 226 important to validate the system. We recommend that you base your approach on a justified and documented risk assessment and 229 a determination of the potential of the system to affect product quality and safety, and record 230 integrity. For instance, validation would not be important for a word processor used only to 231 generate SOPs. 232 233 For further guidance on validation of computerized systems, see FDAs guidance for industry 234 and FDA staff General Principles of Software Validation and also industry guidance such as the 235 GAMP 4 Guide (See References). Audit Trail 238 239
The Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30). Persons must still comply with all applicable predicate 242 rule requirements related to documentation of, for example, date (e.g., 58.130(e)), time, or 243 sequencing of events, as well as any requirements for ensuring t hat changes to records do not 244 obscure previous entries.
[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: 'Audit Trail 238 239\nThe Agency intends to exercise...'?",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"B": "Agency",
"A": "all applicable predicate 242 rule requirements",
"C": "computerized systems",
"D": "government agency"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail ____ 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"C": "238",
"A": "220 221",
"B": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail 238 ____\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"B": "239",
"A": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part ____ requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"A": "11",
"B": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements ____ related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"D": "240",
"A": "220 221",
"B": "222",
"C": "all applicable predicate 242 rule requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( ____ (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"B": "11.10",
"A": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y ____ corresponding requirement in 11.30).",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"C": "241",
"A": "220 221",
"B": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in ____).",
"reference": "Audit Trail 238 239\nThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements 240 related to computer -generated, time -stamped audit trails ( 11.10 (e), (k)(2) and an y 241 corresponding requirement in 11.30).",
"options": {
"B": "11.30",
"A": "220 221",
"C": "222",
"D": "all applicable predicate 242 rule requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: For instance, validation would not be important for a word processor used only to ____ generate SOPs.",
"reference": "For instance, validation would not be important for a word processor used only to 231 generate SOPs.",
"options": {
"D": "231",
"A": "220 221",
"B": "222",
"C": "all applicable predicate 242 rule requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 1 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
As described in the Part 11, Electronic 586 Records; Electronic Signatures Scope and Application guidance,16 the Agency intends to 587 exercise enforcement discretion regarding Part 11 requirements for validation of computerized 588 systems used to create, modify, maintain, or transmit electronic records (see 21 CFR 11.10(a) 589 and 11.30). In general, Part 11 applies to rec ords in electronic form that are created, modified, 590 maintained, archived, retrieved, or transmitted under any records requirements set forth in 591 Agency regulations (see 21 CFR 11.1(b)). Part 11 also applies to electronic records submitted to 592 the Agency unde r requirements of the Federal Food, Drug, and Cosmetic Act (FDC Act) and 593 the Public Health Service Act (PHS Act), even if such records are not specifically identified in 594 Agency regulations (see 21 CFR 11.1(b)). In the context of computer or automated da ta processing systems , for computer software used as 597 part of production or the quality system, a document required under Part 820 and maintained in 598 electronic form would generally be an electronic record within the meaning of Part 11 (see 21 599 CFR 11.3(b)( 6)). For example, if a document requires a signature under Part 820 and is 600 maintained in electronic form, then Part 11 applies (see, e.g., 21 CFR 820.40 (requiring 601 signatures for control of required documents)) . 602 16 https://www.fda.gov/regulatory -information/search -fda-guidance -documents/part -11-electronic -records - electronic -signatures -scope -and-application . Contains Nonbinding Recommendations Draft Not for Implementation 20Appendix A. Examples 603
The examples in this section outline possible application of the principles in this draft guidance to various software assurance 604 situations cases .
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Fill in the blank: ____ 16 https://www.fda.gov/regulatory -information/search -fda-guidance -documents/part -11-electronic -records - electronic -signatures -scope -and-application .",
"reference": "602 16 https://www.fda.gov/regulatory -information/search -fda-guidance -documents/part -11-electronic -records - electronic -signatures -scope -and-application .",
"options": {
"A": "602",
"B": "586",
"C": "587",
"D": "electronic records"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Structure the Organization When designing a robust quality system, management has the responsibility to structure the organization and ensure that assigned authorities and responsibilities support the production, quality, and management activities needed to produce quality products. Senior managers have the responsibility to ensure that the organizations structure is documented. All managers have the responsibility to comm unicate employee roles, responsibilities, and authorities within the system and ensure that interactions are defined and understood. An organization also has the responsibility to give the individual who is appointed to manage the quality system the authority to detect problems and implement solutions. Usually, a senior m anager administers the quality system and can, thus, ensure that the organization receives prompt feedback on quality issues. 3. Build Your Quality System to Meet Requirements Implementing a robust quality system can help ensure compliance with CGMP regulations rela ted to drug safety, identity, strength, quality, and purity. U nder the quality systems model, the Agency recommends that senior managers ensu re that the quality system that is designed and implemented provides clear organizational guidan ce and facilitates systematic evaluation of issues. For example, according to the model, when documenting the implementation of a quality system, the following should be addressed:
The quality standard th at will be followed The scope of the quality system, including any outsourcing (see IV.B.4.) The manufacturers policies to implemen t the quality systems criteria and the supporting objectives (see IV.A.4.) 9 Contains Nonbinding Recommendations
The procedures needed to establish and maintain the quality system It is recommended under a modern quality systems a pproach that a formal process be established to change procedures in a controlled manner .
[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 nder the quality systems model, the Agency recom...'?",
"reference": "U nder the quality systems model, the Agency recommends that senior managers ensu re that the quality system that is designed and implemented provides clear organizational guidan ce and facilitates systematic evaluation of issues.",
"options": {
"D": "U",
"A": "Senior managers",
"B": "the Organization",
"C": "uracil"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder the quality systems model, the Agency recom...'?",
"reference": "U nder the quality systems model, the Agency recommends that senior managers ensu re that the quality system that is designed and implemented provides clear organizational guidan ce and facilitates systematic evaluation of issues.",
"options": {
"B": "Agency",
"A": "the quality systems model",
"C": "the quality systems criteria",
"D": "government agency"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder the quality systems model, the Agency recom...'?",
"reference": "U nder the quality systems model, the Agency recommends that senior managers ensu re that the quality system that is designed and implemented provides clear organizational guidan ce and facilitates systematic evaluation of issues.",
"options": {
"A": "U",
"B": "Senior managers",
"C": "the Organization",
"D": "uracil"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder the quality systems model, the Agency recom...'?",
"reference": "U nder the quality systems model, the Agency recommends that senior managers ensu re that the quality system that is designed and implemented provides clear organizational guidan ce and facilitates systematic evaluation of issues.",
"options": {
"D": "Agency",
"A": "the quality systems model",
"B": "the quality systems criteria",
"C": "government agency"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Contains Nonbinding Recommendations\nThe procedures needed to establish and maintain the quality system It is recommended under a modern quality systems a pproach that a formal process be established to change procedures in a controlled manner .",
"reference": "9 Contains Nonbinding Recommendations\nThe procedures needed to establish and maintain the quality system It is recommended under a modern quality systems a pproach that a formal process be established to change procedures in a controlled manner .",
"options": {
"D": "9",
"A": "the quality systems model",
"B": "the quality systems criteria",
"C": "nine"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Build Your Quality System to Meet Requirements Imp...'?",
"reference": "Build Your Quality System to Meet Requirements Implementing a robust quality system can help ensure compliance with CGMP regulations rela ted to drug safety, identity, strength, quality, and purity.",
"options": {
"A": "CGMP",
"B": "Structure the Organization",
"C": "Agency",
"D": "the quality systems model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Contains Nonbinding Recommendations\nThe procedures needed to establish and maintain the quality system It is recommended under a modern quality systems a pproach that a formal process be established to change procedures in a controlled manner .",
"reference": "9 Contains Nonbinding Recommendations\nThe procedures needed to establish and maintain the quality system It is recommended under a modern quality systems a pproach that a formal process be established to change procedures in a controlled manner .",
"options": {
"A": "9",
"B": "the quality systems model",
"C": "the quality systems criteria",
"D": "nine"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Structure the Organization When designing a robust...'?",
"reference": "Structure the Organization When designing a robust quality system, management has the responsibility to structure the organization and ensure that assigned authorities and responsibilities support the production, quality, and management activities needed to produce quality products.",
"options": {
"B": "Structure the Organization",
"A": "the quality systems model",
"C": "the quality systems criteria",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Contains Nonbinding Recommendations\nThe procedures needed to establish and maintain the quality system It is recommended under a modern quality systems a pproach that a formal process be established to change procedures in a controlled manner .",
"reference": "9 Contains Nonbinding Recommendations\nThe procedures needed to establish and maintain the quality system It is recommended under a modern quality systems a pproach that a formal process be established to change procedures in a controlled manner .",
"options": {
"C": "9",
"A": "the quality systems model",
"B": "the quality systems criteria",
"D": "nine"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder the quality systems model, the Agency recom...'?",
"reference": "U nder the quality systems model, the Agency recommends that senior managers ensu re that the quality system that is designed and implemented provides clear organizational guidan ce and facilitates systematic evaluation of issues.",
"options": {
"D": "U",
"A": "Senior managers",
"B": "the Organization",
"C": "uracil"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder the quality systems model, the Agency recom...'?",
"reference": "U nder the quality systems model, the Agency recommends that senior managers ensu re that the quality system that is designed and implemented provides clear organizational guidan ce and facilitates systematic evaluation of issues.",
"options": {
"A": "Agency",
"B": "the quality systems model",
"C": "the quality systems criteria",
"D": "government agency"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Contains Nonbinding Recommendations\nThe procedures needed to establish and maintain the quality system It is recommended under a modern quality systems a pproach that a formal process be established to change procedures in a controlled manner .",
"reference": "9 Contains Nonbinding Recommendations\nThe procedures needed to establish and maintain the quality system It is recommended under a modern quality systems a pproach that a formal process be established to change procedures in a controlled manner .",
"options": {
"C": "9",
"A": "the quality systems model",
"B": "the quality systems criteria",
"D": "nine"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Structure the Organization When designing a robust...'?",
"reference": "Structure the Organization When designing a robust quality system, management has the responsibility to structure the organization and ensure that assigned authorities and responsibilities support the production, quality, and management activities needed to produce quality products.",
"options": {
"C": "Structure the Organization",
"A": "the quality systems model",
"B": "the quality systems criteria",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Contains Nonbinding Recommendations\nThe procedures needed to establish and maintain the quality system It is recommended under a modern quality systems a pproach that a formal process be established to change procedures in a controlled manner .",
"reference": "9 Contains Nonbinding Recommendations\nThe procedures needed to establish and maintain the quality system It is recommended under a modern quality systems a pproach that a formal process be established to change procedures in a controlled manner .",
"options": {
"C": "9",
"A": "the quality systems model",
"B": "the quality systems criteria",
"D": "nine"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Structure the Organization When designing a robust...'?",
"reference": "Structure the Organization When designing a robust quality system, management has the responsibility to structure the organization and ensure that assigned authorities and responsibilities support the production, quality, and management activities needed to produce quality products.",
"options": {
"D": "Structure the Organization",
"A": "the quality systems model",
"B": "the quality systems criteria",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Structure the Organization When designing a robust...'?",
"reference": "Structure the Organization When designing a robust quality system, management has the responsibility to structure the organization and ensure that assigned authorities and responsibilities support the production, quality, and management activities needed to produce quality products.",
"options": {
"C": "Structure the Organization",
"A": "the quality systems model",
"B": "the quality systems criteria",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Build Your Quality System to Meet Requirements Imp...'?",
"reference": "Build Your Quality System to Meet Requirements Implementing a robust quality system can help ensure compliance with CGMP regulations rela ted to drug safety, identity, strength, quality, and purity.",
"options": {
"A": "CGMP",
"B": "Structure the Organization",
"C": "Agency",
"D": "the quality systems model"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Contains Nonbinding Recommendations\nThe procedures needed to establish and maintain the quality system It is recommended under a modern quality systems a pproach that a formal process be established to change procedures in a controlled manner .",
"reference": "9 Contains Nonbinding Recommendations\nThe procedures needed to establish and maintain the quality system It is recommended under a modern quality systems a pproach that a formal process be established to change procedures in a controlled manner .",
"options": {
"B": "9",
"A": "the quality systems model",
"C": "the quality systems criteria",
"D": "nine"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Contains Nonbinding Recommendations\nThe procedures needed to establish and maintain the quality system It is recommended under a modern quality systems a pproach that a formal process be established to change procedures in a controlled manner .",
"reference": "9 Contains Nonbinding Recommendations\nThe procedures needed to establish and maintain the quality system It is recommended under a modern quality systems a pproach that a formal process be established to change procedures in a controlled manner .",
"options": {
"B": "9",
"A": "the quality systems model",
"C": "the quality systems criteria",
"D": "nine"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Build Your Quality System to Meet Requirements Imp...'?",
"reference": "Build Your Quality System to Meet Requirements Implementing a robust quality system can help ensure compliance with CGMP regulations rela ted to drug safety, identity, strength, quality, and purity.",
"options": {
"D": "CGMP",
"A": "Structure the Organization",
"B": "Agency",
"C": "the quality systems model"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Build Your Quality System to Meet Requirements Imp...'?",
"reference": "Build Your Quality System to Meet Requirements Implementing a robust quality system can help ensure compliance with CGMP regulations rela ted to drug safety, identity, strength, quality, and purity.",
"options": {
"C": "CGMP",
"A": "Structure the Organization",
"B": "Agency",
"D": "the quality systems model"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder the quality systems model, the Agency recom...'?",
"reference": "U nder the quality systems model, the Agency recommends that senior managers ensu re that the quality system that is designed and implemented provides clear organizational guidan ce and facilitates systematic evaluation of issues.",
"options": {
"C": "U",
"A": "Senior managers",
"B": "the Organization",
"D": "uracil"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder the quality systems model, the Agency recom...'?",
"reference": "U nder the quality systems model, the Agency recommends that senior managers ensu re that the quality system that is designed and implemented provides clear organizational guidan ce and facilitates systematic evaluation of issues.",
"options": {
"B": "Agency",
"A": "the quality systems model",
"C": "the quality systems criteria",
"D": "government agency"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Structure the Organization When designing a robust...'?",
"reference": "Structure the Organization When designing a robust quality system, management has the responsibility to structure the organization and ensure that assigned authorities and responsibilities support the production, quality, and management activities needed to produce quality products.",
"options": {
"B": "Structure the Organization",
"A": "the quality systems model",
"C": "the quality systems criteria",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'U nder the quality systems model, the Agency recom...'?",
"reference": "U nder the quality systems model, the Agency recommends that senior managers ensu re that the quality system that is designed and implemented provides clear organizational guidan ce and facilitates systematic evaluation of issues.",
"options": {
"C": "U",
"A": "Senior managers",
"B": "the Organization",
"D": "uracil"
},
"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]
INTRODUCTION ................................ ................................
................................ .............
BACKGROUND ................................ ................................ ................................ DISCUSSION ................................
................................ ................................
....................
3 A. Overall Approach to Part 11 Requirements ................................ ................................ .........
3 B. Details of Approach Scope of Part 11 ................................ ................................
................ Narrow Interpretation of Scope ................................ ................................
............................. Definition of Part 11 Records ................................ ................................
................................
5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........
Validation ................................
................................ ................................
.............................
6 2. Audit Trail ................................
................................ ................................
............................
6 3. Legacy 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: 'Narrow Interpretation of Scope ......................'?",
"reference": "Narrow Interpretation of Scope ................................ ................................\n.............................",
"options": {
"A": "Narrow Interpretation of Scope",
"B": "BACKGROUND",
"C": "Approach Scope of Part",
"D": "Approach Scope"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'DISCUSSION ................................\n.........'?",
"reference": "DISCUSSION ................................\n................................ ................................\n....................\n3 A.",
"options": {
"C": "DISCUSSION ................................\n................................",
"A": "3 B. Details",
"B": "Approach Scope",
"D": "................................\n....................\n3 A. Overall Approach"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: DISCUSSION ................................\n................................ ................................\n....................\n____ A.",
"reference": "DISCUSSION ................................\n................................ ................................\n....................\n3 A.",
"options": {
"D": "3",
"A": "6 2",
"B": "6 3",
"C": "Approach Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Narrow Interpretation of Scope ......................'?",
"reference": "Narrow Interpretation of Scope ................................ ................................\n.............................",
"options": {
"D": "Narrow Interpretation of Scope",
"A": "BACKGROUND",
"B": "Approach Scope of Part",
"C": "Approach Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'DISCUSSION ................................\n.........'?",
"reference": "DISCUSSION ................................\n................................ ................................\n....................\n3 A.",
"options": {
"A": "DISCUSSION ................................\n................................",
"B": "3 B. Details",
"C": "Approach Scope",
"D": "................................\n....................\n3 A. Overall Approach"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: DISCUSSION ................................\n................................ ................................\n....................\n____ A.",
"reference": "DISCUSSION ................................\n................................ ................................\n....................\n3 A.",
"options": {
"A": "3",
"B": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Audit Trail ................................\n........'?",
"reference": "Audit Trail ................................\n................................ ................................\n............................\n6 3.",
"options": {
"D": "6 3",
"A": "6 2",
"B": "Approach Scope",
"C": "................................\n....................\n3 A. Overall Approach"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail ................................\n................................ ................................\n............................\n____ 3.",
"reference": "Audit Trail ................................\n................................ ................................\n............................\n6 3.",
"options": {
"B": "6",
"A": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Audit Trail ................................\n................................ ................................\n............................\n6 ____.",
"reference": "Audit Trail ................................\n................................ ................................\n............................\n6 3.",
"options": {
"B": "3",
"A": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Narrow Interpretation of Scope ......................'?",
"reference": "Narrow Interpretation of Scope ................................ ................................\n.............................",
"options": {
"B": "Narrow Interpretation of Scope",
"A": "BACKGROUND",
"C": "Approach Scope of Part",
"D": "Approach Scope"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INTRODUCTION ................................ .......'?",
"reference": "INTRODUCTION ................................ ................................\n................................ .............\nBACKGROUND ................................ ................................ ................................",
"options": {
"C": "BACKGROUND",
"A": "Approach Scope of Part",
"B": "Narrow Interpretation of Scope",
"D": "Approach Scope"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Details of Approach Scope of Part 11 ...............'?",
"reference": "Details of Approach Scope of Part 11 ................................ ................................\n................",
"options": {
"D": "Approach Scope of Part",
"A": "BACKGROUND",
"B": "Narrow Interpretation of Scope",
"C": "................................\n....................\n3 A. Overall Approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Overall Approach to Part ____ Requirements ................................ ................................ .........\n3 B.",
"reference": "Overall Approach to Part 11 Requirements ................................ ................................ .........\n3 B.",
"options": {
"D": "11",
"A": "6 2",
"B": "6 3",
"C": "Approach Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Overall Approach to Part 11 Requirements ................................ ................................ .........\n____ B.",
"reference": "Overall Approach to Part 11 Requirements ................................ ................................ .........\n3 B.",
"options": {
"B": "3",
"A": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'DISCUSSION ................................\n.........'?",
"reference": "DISCUSSION ................................\n................................ ................................\n....................\n3 A.",
"options": {
"A": "DISCUSSION ................................\n................................",
"B": "3 B. Details",
"C": "Approach Scope",
"D": "................................\n....................\n3 A. Overall Approach"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: DISCUSSION ................................\n................................ ................................\n....................\n____ A.",
"reference": "DISCUSSION ................................\n................................ ................................\n....................\n3 A.",
"options": {
"C": "3",
"A": "6 2",
"B": "6 3",
"D": "Approach Scope"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Details of Approach Scope of Part 11 ...............'?",
"reference": "Details of Approach Scope of Part 11 ................................ ................................\n................",
"options": {
"D": "Approach Scope of Part",
"A": "BACKGROUND",
"B": "Narrow Interpretation of Scope",
"C": "................................\n....................\n3 A. Overall Approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Details of Approach Scope of Part ____ ................................ ................................\n................",
"reference": "Details of Approach Scope of Part 11 ................................ ................................\n................",
"options": {
"D": "11",
"A": "6 2",
"B": "6 3",
"C": "Approach Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part ____ Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"C": "11",
"A": "6 2",
"B": "6 3",
"D": "Approach Scope"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part 11 Records ................................ ................................\n................................\n____ C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"C": "5",
"A": "6 2",
"B": "6 3",
"D": "Approach Scope"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part ____ Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"D": "11",
"A": "6 2",
"B": "6 3",
"C": "Approach Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n____ 2.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"A": "6",
"B": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 ____.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"A": "2",
"B": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Narrow Interpretation of Scope ......................'?",
"reference": "Narrow Interpretation of Scope ................................ ................................\n.............................",
"options": {
"A": "Narrow Interpretation of Scope",
"B": "BACKGROUND",
"C": "Approach Scope of Part",
"D": "Approach Scope"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Narrow Interpretation of Scope ......................'?",
"reference": "Narrow Interpretation of Scope ................................ ................................\n.............................",
"options": {
"B": "Narrow Interpretation of Scope",
"A": "BACKGROUND",
"C": "Approach Scope of Part",
"D": "Approach Scope"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Overall Approach to Part ____ Requirements ................................ ................................ .........\n3 B.",
"reference": "Overall Approach to Part 11 Requirements ................................ ................................ .........\n3 B.",
"options": {
"B": "11",
"A": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Overall Approach to Part 11 Requirements ................................ ................................ .........\n____ B.",
"reference": "Overall Approach to Part 11 Requirements ................................ ................................ .........\n3 B.",
"options": {
"B": "3",
"A": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Narrow Interpretation of Scope ......................'?",
"reference": "Narrow Interpretation of Scope ................................ ................................\n.............................",
"options": {
"D": "Narrow Interpretation of Scope",
"A": "BACKGROUND",
"B": "Approach Scope of Part",
"C": "Approach Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Details of Approach Scope of Part 11 ...............'?",
"reference": "Details of Approach Scope of Part 11 ................................ ................................\n................",
"options": {
"D": "Approach Scope of Part",
"A": "BACKGROUND",
"B": "Narrow Interpretation of Scope",
"C": "................................\n....................\n3 A. Overall Approach"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Details of Approach Scope of Part ____ ................................ ................................\n................",
"reference": "Details of Approach Scope of Part 11 ................................ ................................\n................",
"options": {
"C": "11",
"A": "6 2",
"B": "6 3",
"D": "Approach Scope"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Overall Approach to Part ____ Requirements ................................ ................................ .........\n3 B.",
"reference": "Overall Approach to Part 11 Requirements ................................ ................................ .........\n3 B.",
"options": {
"D": "11",
"A": "6 2",
"B": "6 3",
"C": "Approach Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Overall Approach to Part 11 Requirements ................................ ................................ .........\n____ B.",
"reference": "Overall Approach to Part 11 Requirements ................................ ................................ .........\n3 B.",
"options": {
"B": "3",
"A": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INTRODUCTION ................................ .......'?",
"reference": "INTRODUCTION ................................ ................................\n................................ .............\nBACKGROUND ................................ ................................ ................................",
"options": {
"D": "BACKGROUND",
"A": "Approach Scope of Part",
"B": "Narrow Interpretation of Scope",
"C": "Approach Scope"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INTRODUCTION ................................ .......'?",
"reference": "INTRODUCTION ................................ ................................\n................................ .............\nBACKGROUND ................................ ................................ ................................",
"options": {
"B": "BACKGROUND",
"A": "Approach Scope of Part",
"C": "Narrow Interpretation of Scope",
"D": "Approach Scope"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part ____ Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"C": "11",
"A": "6 2",
"B": "6 3",
"D": "Approach Scope"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part 11 Records ................................ ................................\n................................\n____ C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"B": "5",
"A": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part ____ Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"A": "11",
"B": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n____ 2.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"A": "6",
"B": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'DISCUSSION ................................\n.........'?",
"reference": "DISCUSSION ................................\n................................ ................................\n....................\n3 A.",
"options": {
"A": "DISCUSSION ................................\n................................",
"B": "3 B. Details",
"C": "Approach Scope",
"D": "................................\n....................\n3 A. Overall Approach"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: DISCUSSION ................................\n................................ ................................\n....................\n____ A.",
"reference": "DISCUSSION ................................\n................................ ................................\n....................\n3 A.",
"options": {
"A": "3",
"B": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'INTRODUCTION ................................ .......'?",
"reference": "INTRODUCTION ................................ ................................\n................................ .............\nBACKGROUND ................................ ................................ ................................",
"options": {
"B": "BACKGROUND",
"A": "Approach Scope of Part",
"C": "Narrow Interpretation of Scope",
"D": "Approach Scope"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Narrow Interpretation of Scope ......................'?",
"reference": "Narrow Interpretation of Scope ................................ ................................\n.............................",
"options": {
"C": "Narrow Interpretation of Scope",
"A": "BACKGROUND",
"B": "Approach Scope of Part",
"D": "Approach Scope"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part ____ Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"B": "11",
"A": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part 11 Records ................................ ................................\n................................\n____ C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"A": "5",
"B": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part ____ Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"C": "11",
"A": "6 2",
"B": "6 3",
"D": "Approach Scope"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n____ 2.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"A": "6",
"B": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 ____.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"C": "2",
"A": "6 2",
"B": "6 3",
"D": "Approach Scope"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part ____ Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"A": "11",
"B": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part 11 Records ................................ ................................\n................................\n____ C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"B": "5",
"A": "6 2",
"C": "6 3",
"D": "Approach Scope"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Definition of Part ____ Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"reference": "Definition of Part 11 Records ................................ ................................\n................................\n5 C. Approach to Specific Part 11 Requi rements ................................ ................................ ........\nValidation ................................\n................................ ................................\n.............................\n6 2.",
"options": {
"C": "11",
"A": "6 2",
"B": "6 3",
"D": "Approach Scope"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 10 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
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: '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": "Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs",
"A": "Page 34General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"D": "A - REFERENCES Food and Drug Administration References Design Control Guidance"
},
"answer": "C",
"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": {
"D": "Food and Drug Administration",
"A": "Page 34General 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: '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": {
"B": "August 1995",
"A": "March 1997",
"C": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"D": "Software Validation Guidance"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: 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 ____.",
"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": {
"D": "1995",
"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: '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": {
"B": "Submissions for Software Contained",
"A": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"C": "Software Validation Guidance",
"D": "Medical Devices , Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration"
},
"answer": "B",
"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": {
"B": "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",
"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: '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": {
"B": "May 1998",
"A": "March 1997",
"C": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"D": "Software Validation Guidance"
},
"answer": "B",
"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": {
"B": "1998",
"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": "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": {
"C": "Federal Register 13430",
"A": "Page 34General Principles of Software Validation Guidance for Industry",
"B": "FDA",
"D": "A - REFERENCES Food and Drug Administration References Design Control Guidance"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "When did this occur: 'Electronic Records; Electronic Signatures Final Ru...'?",
"reference": "Electronic Records; Electronic Signatures Final Rule, 62 Federal Register 13430 (March 20, 1997).",
"options": {
"D": "March 20, 1997",
"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"
}
]
|
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, 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": "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": {
"C": "third",
"A": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"B": "Software Validation Guidance",
"D": "3rd"
},
"answer": "C",
"difficulty": "hard",
"question_type": "analytical"
},
{
"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"
},
{
"question": "When did this occur: 'Electronic Records; Electronic Signatures Final Ru...'?",
"reference": "Electronic Records; Electronic Signatures Final Rule, 62 Federal Register 13430 (March 20, 1997).",
"options": {
"D": "March 20, 1997",
"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: Electronic Records; Electronic Signatures Final Rule, ____ Federal Register 13430 (March 20, 1997).",
"reference": "Electronic Records; Electronic Signatures Final Rule, 62 Federal Register 13430 (March 20, 1997).",
"options": {
"D": "62",
"A": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"B": "Software Validation Guidance",
"C": "sixty-two"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic Records; Electronic Signatures Final Rule, 62 Federal Register ____ (March 20, 1997).",
"reference": "Electronic Records; Electronic Signatures Final Rule, 62 Federal Register 13430 (March 20, 1997).",
"options": {
"D": "13430",
"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": "Fill in the blank: Electronic Records; Electronic Signatures Final Rule, 62 Federal Register 13430 (March ____, 1997).",
"reference": "Electronic Records; Electronic Signatures Final Rule, 62 Federal Register 13430 (March 20, 1997).",
"options": {
"B": "20",
"A": "A - REFERENCES Food and Drug Administration References Design Control Guidance",
"C": "Software Validation Guidance",
"D": "Federal Register 13430"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Electronic Records; Electronic Signatures Final Rule, 62 Federal Register 13430 (March 20, ____).",
"reference": "Electronic Records; Electronic Signatures Final Rule, 62 Federal Register 13430 (March 20, 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": "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": {
"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"
}
]
|
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]
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": {
"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": {
"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: 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": {
"D": "one",
"A": "531",
"B": "532",
"C": "a high 549 process risk"
},
"answer": "D",
"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": {
"A": "537",
"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": {
"A": "549",
"B": "531",
"C": "532",
"D": "531 established additional process controls"
},
"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": {
"A": "538",
"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 ____ 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"
}
]
|
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]
Historically, software components have not been as frequently standardized and interchangeable as hardware components. However, medical device software developers are beginning to use component-based development tools and techniques. Object-oriented methodologies and the use of off-the-shelf software components hold promise for faster and less expensive software development. However, component-based approaches require very careful attention during integration. Prior to integration, time is needed to fully define and develop reusable software code and to fully understand the behavior of off-the-shelf components. For these and other reasons, software engineering needs an even greater level of managerial scrutiny and control than does hardware engineering. 3.4. BENEFITS OF SOFTWARE VALIDATION Software validation is a critical tool used to assure the quality of device software and software automated operations. Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers. Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes. Software maintenance can represent a very large percentage of the total cost of software over its entire life cycle. An established comprehensive software validation process helps to reduce the long-term cost of software by reducing the cost of validation for each subsequent release of the software. 3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.
[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: ____ DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"reference": "3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"options": {
"D": "3.5",
"A": "3.4",
"B": "device software and software automated operations",
"C": "An established comprehensive software validation process"
},
"answer": "D",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Software validation can also reduce long term cost...'?",
"reference": "Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes.",
"options": {
"D": "Software",
"A": "REVIEW Design",
"B": "3.5 DESIGN REVIEW Design reviews",
"C": "the design requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software validation can increase the usability and...'?",
"reference": "Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.",
"options": {
"B": "Software",
"A": "REVIEW Design",
"C": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"reference": "3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"options": {
"C": "3.5",
"A": "3.4",
"B": "device software and software automated operations",
"D": "An established comprehensive software validation process"
},
"answer": "C",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Fill in the blank: ____ DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"reference": "3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"options": {
"B": "3.5",
"A": "3.4",
"C": "device software and software automated operations",
"D": "An established comprehensive software validation process"
},
"answer": "B",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Fill in the blank: ____ DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"reference": "3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"options": {
"A": "3.5",
"B": "3.4",
"C": "device software and software automated operations",
"D": "An established comprehensive software validation process"
},
"answer": "A",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Fill in the blank: ____ DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"reference": "3.5 DESIGN REVIEW Design reviews are documented, comprehensive, and systematic examinations of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.",
"options": {
"D": "3.5",
"A": "3.4",
"B": "device software and software automated operations",
"C": "An established comprehensive software validation process"
},
"answer": "D",
"difficulty": "hard",
"question_type": "analytical"
},
{
"question": "Which organization is referenced: 'Software validation can also reduce long term cost...'?",
"reference": "Software validation can also reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes.",
"options": {
"C": "Software",
"A": "REVIEW Design",
"B": "3.5 DESIGN REVIEW Design reviews",
"D": "the design requirements"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 9 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
G. Quality Manual (1.8) A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical qu ality system. The description should include: (a) The quality policy (see section III (2)). (b) The scope of the pharmaceutical quality system. (c) Identification of the pharmaceutical quality system processes, as well as their sequences, linkages, and interdependencies. Process maps and flow charts can be useful tools to facilitate depicting pharmaceutical quality system processes in a visual manner. (d) Management responsibilities within the pharmaceutical quality system (see section III (2)). MANAGEMENT RESPONSIBILITY (2) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system. A. Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company. (b) Management should: (1) Participate in the design, implementation, monitoring, and maintenance of an effective pharmaceutical quality system. (2) Demonstrate strong and visible support for the pharmaceutical quality system and ensure its implementation throughout their organization. (3) Ensure a timely and effective communicat ion and escalation process exists to raise quality issues to the appr opriate levels of management. (4) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system. Ensure these interactions are communicated and understood at all levels of the organization.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Management Commitment (2.1) (a) Senior management ...'?",
"reference": "Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"options": {
"B": "Management Commitment",
"A": "an effective pharmaceutical quality system",
"C": "2.1",
"D": "This information is not provided in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Management Commitment (____) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"reference": "Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"options": {
"B": "2.1",
"A": "1.8",
"C": "an effective pharmaceutical quality system",
"D": "Management Commitment"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that ____ roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"reference": "Management Commitment (2.1) (a) Senior management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that 5 roles, responsibilities, an d authorities are defined, communicated, and implemented throughout the company.",
"options": {
"D": "5",
"A": "1.8",
"B": "2.1",
"C": "an effective pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Ensure a timely and effective communicat ion and escalation process exists to raise quality issues to the appr opriate levels of management.",
"reference": "(3) Ensure a timely and effective communicat ion and escalation process exists to raise quality issues to the appr opriate levels of management.",
"options": {
"D": "3",
"A": "1.8",
"B": "2.1",
"C": "an effective pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (____) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system.",
"reference": "(4) Define individual and collective roles, responsibilities, authorities, and inter- relationships of all organizational unit s related to the pharmaceutical quality system.",
"options": {
"C": "4",
"A": "1.8",
"B": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: (b) Management should: (____) Participate in the design, implementation, monitoring, and maintenance of an effective pharmaceutical quality system.",
"reference": "(b) Management should: (1) Participate in the design, implementation, monitoring, and maintenance of an effective pharmaceutical quality system.",
"options": {
"D": "1",
"A": "1.8",
"B": "2.1",
"C": "an effective pharmaceutical quality system"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: The description should include: (a) The quality policy (see section III (____)).",
"reference": "The description should include: (a) The quality policy (see section III (2)).",
"options": {
"A": "2",
"B": "1.8",
"C": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'MANAGEMENT RESPONSIBILITY (2) Leadership is essent...'?",
"reference": "MANAGEMENT RESPONSIBILITY (2) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system.",
"options": {
"A": "MANAGEMENT RESPONSIBILITY",
"B": "an effective pharmaceutical quality system",
"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: MANAGEMENT RESPONSIBILITY (____) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system.",
"reference": "MANAGEMENT RESPONSIBILITY (2) Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pha rmaceutical quality system.",
"options": {
"C": "2",
"A": "1.8",
"B": "2.1",
"D": "an effective pharmaceutical quality system"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 25 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:
To supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 12 Contains Nonbinding Recommendations 2. Personnel Development Under a quality system, senior manageme nt should support a problem-solving and communicative organizational culture. Manage rs should encourage communication by creating an environment that values em ployee suggestio ns and acts on suggestions for improvement. Management should also develop cross-functional groups to share ideas to improve procedures and processes. In a quality system, personnel should be qualified to do the operations that are assigned to them in accordance with the n ature of, and potential risk of, their operational activities. Under a quality system, m anagers should define appropr iate qualifications for each position to help ensure that individuals are as signed appropriate responsibilit ies. Personnel should also understand the effect of their activities on the product and th e customer. Although QU personnel should not take on the responsibilities of other units of the organization, these personnel should be selected based on their sc ientific and technical understa nding, product knowledge, process knowledge and/or risk assessment ab ilities to appropriate ly execute certain quality functions (this quality systems feature is al so found in the CGMP regulations, which identify specific qualifications, such as educa tion, training, and experience or any combination thereof (see 211.25(a) and (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": "Who is mentioned in the context: 'Although QU personnel should not take on the respo...'?",
"reference": "Although QU personnel should not take on the responsibilities of other units of the organization, these personnel should be selected based on their sc ientific and technical understa nding, product knowledge, process knowledge and/or risk assessment ab ilities to appropriate ly execute certain quality functions (this quality systems feature is al so found in the CGMP regulations, which identify specific qualifications, such as educa tion, training, and experience or any combination thereof (see 211.25(a) and (b)).",
"options": {
"A": "al",
"B": "the finished drug product",
"C": "Alabama",
"D": "Heart of Dixie"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Although QU personnel should not take on the respo...'?",
"reference": "Although QU personnel should not take on the responsibilities of other units of the organization, these personnel should be selected based on their sc ientific and technical understa nding, product knowledge, process knowledge and/or risk assessment ab ilities to appropriate ly execute certain quality functions (this quality systems feature is al so found in the CGMP regulations, which identify specific qualifications, such as educa tion, training, and experience or any combination thereof (see 211.25(a) and (b)).",
"options": {
"D": "CGMP",
"A": "a quality product",
"B": "certain quality functions",
"C": "This information is not mentioned in the context"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples ____ Contains Nonbinding Recommendations 2.",
"reference": "Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 12 Contains Nonbinding Recommendations 2.",
"options": {
"A": "12",
"B": "a quality product",
"C": "certain quality functions",
"D": "xii"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 1____ Contains Nonbinding Recommendations 2.",
"reference": "Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 12 Contains Nonbinding Recommendations 2.",
"options": {
"B": "2",
"A": "a quality product",
"C": "certain quality functions",
"D": "two"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Although QU personnel should not take on the respo...'?",
"reference": "Although QU personnel should not take on the responsibilities of other units of the organization, these personnel should be selected based on their sc ientific and technical understa nding, product knowledge, process knowledge and/or risk assessment ab ilities to appropriate ly execute certain quality functions (this quality systems feature is al so found in the CGMP regulations, which identify specific qualifications, such as educa tion, training, and experience or any combination thereof (see 211.25(a) and (b)).",
"options": {
"C": "al",
"A": "the finished drug product",
"B": "Alabama",
"D": "Heart of Dixie"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Although QU personnel should not take on the respo...'?",
"reference": "Although QU personnel should not take on the responsibilities of other units of the organization, these personnel should be selected based on their sc ientific and technical understa nding, product knowledge, process knowledge and/or risk assessment ab ilities to appropriate ly execute certain quality functions (this quality systems feature is al so found in the CGMP regulations, which identify specific qualifications, such as educa tion, training, and experience or any combination thereof (see 211.25(a) and (b)).",
"options": {
"C": "CGMP",
"A": "a quality product",
"B": "certain quality functions",
"D": "This information is not mentioned in the context"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Personnel Development Under a quality system, seni...'?",
"reference": "Personnel Development Under a quality system, senior manageme nt should support a problem-solving and communicative organizational culture.",
"options": {
"B": "Personnel Development",
"A": "CGMP",
"C": "a quality product",
"D": "certain quality functions"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Although QU personnel should not take on the respo...'?",
"reference": "Although QU personnel should not take on the responsibilities of other units of the organization, these personnel should be selected based on their sc ientific and technical understa nding, product knowledge, process knowledge and/or risk assessment ab ilities to appropriate ly execute certain quality functions (this quality systems feature is al so found in the CGMP regulations, which identify specific qualifications, such as educa tion, training, and experience or any combination thereof (see 211.25(a) and (b)).",
"options": {
"B": "al",
"A": "the finished drug product",
"C": "Alabama",
"D": "Heart of Dixie"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Although QU personnel should not take on the respo...'?",
"reference": "Although QU personnel should not take on the responsibilities of other units of the organization, these personnel should be selected based on their sc ientific and technical understa nding, product knowledge, process knowledge and/or risk assessment ab ilities to appropriate ly execute certain quality functions (this quality systems feature is al so found in the CGMP regulations, which identify specific qualifications, such as educa tion, training, and experience or any combination thereof (see 211.25(a) and (b)).",
"options": {
"A": "CGMP",
"B": "a quality product",
"C": "certain quality functions",
"D": "This information is not mentioned in the context"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples ____ Contains Nonbinding Recommendations 2.",
"reference": "Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 12 Contains Nonbinding Recommendations 2.",
"options": {
"A": "12",
"B": "a quality product",
"C": "certain quality functions",
"D": "xii"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 1____ Contains Nonbinding Recommendations 2.",
"reference": "Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 12 Contains Nonbinding Recommendations 2.",
"options": {
"D": "2",
"A": "a quality product",
"B": "certain quality functions",
"C": "two"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is m?",
"reference": "Under a quality system, m anagers should define appropr iate qualifications for each position to help ensure that individuals are as signed appropriate responsibilit ies.",
"options": {
"B": "qualifications",
"A": "a quality product",
"C": "certain quality functions",
"D": "qualification"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples ____ Contains Nonbinding Recommendations 2.",
"reference": "Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 12 Contains Nonbinding Recommendations 2.",
"options": {
"A": "12",
"B": "a quality product",
"C": "certain quality functions",
"D": "xii"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 1____ Contains Nonbinding Recommendations 2.",
"reference": "Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 12 Contains Nonbinding Recommendations 2.",
"options": {
"D": "2",
"A": "a quality product",
"B": "certain quality functions",
"C": "two"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Who is mentioned in the context: 'Although QU personnel should not take on the respo...'?",
"reference": "Although QU personnel should not take on the responsibilities of other units of the organization, these personnel should be selected based on their sc ientific and technical understa nding, product knowledge, process knowledge and/or risk assessment ab ilities to appropriate ly execute certain quality functions (this quality systems feature is al so found in the CGMP regulations, which identify specific qualifications, such as educa tion, training, and experience or any combination thereof (see 211.25(a) and (b)).",
"options": {
"A": "al",
"B": "the finished drug product",
"C": "Alabama",
"D": "Heart of Dixie"
},
"answer": "A",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Although QU personnel should not take on the respo...'?",
"reference": "Although QU personnel should not take on the responsibilities of other units of the organization, these personnel should be selected based on their sc ientific and technical understa nding, product knowledge, process knowledge and/or risk assessment ab ilities to appropriate ly execute certain quality functions (this quality systems feature is al so found in the CGMP regulations, which identify specific qualifications, such as educa tion, training, and experience or any combination thereof (see 211.25(a) and (b)).",
"options": {
"B": "CGMP",
"A": "a quality product",
"C": "certain quality functions",
"D": "This information is not mentioned in the context"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "What is m?",
"reference": "Under a quality system, m anagers should define appropr iate qualifications for each position to help ensure that individuals are as signed appropriate responsibilit ies.",
"options": {
"D": "qualifications",
"A": "a quality product",
"B": "certain quality functions",
"C": "qualification"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "What is m?",
"reference": "Under a quality system, m anagers should define appropr iate qualifications for each position to help ensure that individuals are as signed appropriate responsibilit ies.",
"options": {
"B": "qualifications",
"A": "a quality product",
"C": "certain quality functions",
"D": "qualification"
},
"answer": "B",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Personnel Development Under a quality system, seni...'?",
"reference": "Personnel Development Under a quality system, senior manageme nt should support a problem-solving and communicative organizational culture.",
"options": {
"A": "Personnel Development",
"B": "CGMP",
"C": "a quality product",
"D": "certain quality functions"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples ____ Contains Nonbinding Recommendations 2.",
"reference": "Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 12 Contains Nonbinding Recommendations 2.",
"options": {
"D": "12",
"A": "a quality product",
"B": "certain quality functions",
"C": "xii"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 1____ Contains Nonbinding Recommendations 2.",
"reference": "Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 12 Contains Nonbinding Recommendations 2.",
"options": {
"C": "2",
"A": "a quality product",
"B": "certain quality functions",
"D": "two"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples ____ Contains Nonbinding Recommendations 2.",
"reference": "Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 12 Contains Nonbinding Recommendations 2.",
"options": {
"D": "12",
"A": "a quality product",
"B": "certain quality functions",
"C": "xii"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 1____ Contains Nonbinding Recommendations 2.",
"reference": "Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 12 Contains Nonbinding Recommendations 2.",
"options": {
"D": "2",
"A": "a quality product",
"B": "certain quality functions",
"C": "two"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples ____ Contains Nonbinding Recommendations 2.",
"reference": "Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 12 Contains Nonbinding Recommendations 2.",
"options": {
"B": "12",
"A": "a quality product",
"C": "certain quality functions",
"D": "xii"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 1____ Contains Nonbinding Recommendations 2.",
"reference": "Under the model, se nior management, or a designee, should be responsible for providing adequa te resources for the following:\nTo supply and maintain the appropriate f acilities and equipmen t to consistently manufacture a quality product To acquire and receive materials that are suitable for their intended purpose For processing the materials to produce the finished drug product For laboratory analysis of the finished drug product, including colle ction, storage, and examination of in-process, stability, and reserve samples 12 Contains Nonbinding Recommendations 2.",
"options": {
"B": "2",
"A": "a quality product",
"C": "certain quality functions",
"D": "two"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 1 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
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": "When did this occur: '82 83 FDA believes that applying a r isk-based app...'?",
"reference": "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).",
"options": {
"D": "82 83",
"A": "FDAs Software Validation guidance",
"B": "the Software Validation 102 guidance",
"C": "FDA"
},
"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 45 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Statistical testing uses randomly generated test data from defined distributions based on an operational profile (e.g., expected use, hazardous use, or malicious use of the software product). Large amounts of test data are generated and can be targeted to cover particular areas or concerns, providing an increased possibility of identifying individual and multiple rare operating conditions that were not anticipated by either the software product's designers or its testers. Statistical testing also provides high structural coverage. It does require a stable software product. Thus, structural and functional testing are prerequisites for statistical testing of a software product. Another aspect of software testing is the testing of software changes. Changes occur frequently during software development. These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements ("requirements creep"), and 3) modified designs as more effective or efficient implementations are found. Once a software product has been baselined (approved), any change to that product should have its own mini life cycle, including testing. Testing of a changed software product requires additional effort. Not only should it demonstrate that the change was implemented correctly, testing should also demonstrate that the change did not adversely impact other parts of the software product. Regression analysis and testing are employed to provide Page 25General Principles of Software Validation Guidance for Industry and FDA Staff assurance that a change has not created problems elsewhere in the software product. Regression analysis is the determination of the impact of a change based on review of the relevant documentation (e.g., software requirements specification, software design specification, source code, test plans, test cases, test scripts, etc.) in order to identify the necessary regression tests to be run.
[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: 'Regression analysis and testing are employed to pr...'?",
"reference": "Regression analysis and testing are employed to provide Page 25General Principles of Software Validation Guidance for Industry and FDA Staff assurance that a change has not created problems elsewhere in the software product.",
"options": {
"C": "FDA",
"A": "software testing",
"B": "a changed software product",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of ____) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"B": "1",
"A": "software testing",
"C": "a changed software product",
"D": "ace"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, ____) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"B": "2",
"A": "software testing",
"C": "a changed software product",
"D": "two"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and ____) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"D": "3",
"A": "software testing",
"B": "a changed software product",
"C": "troika"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of ____) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"A": "1",
"B": "software testing",
"C": "a changed software product",
"D": "ace"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, ____) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"C": "2",
"A": "software testing",
"B": "a changed software product",
"D": "two"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and ____) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"D": "3",
"A": "software testing",
"B": "a changed software product",
"C": "troika"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Regression analysis and testing are employed to pr...'?",
"reference": "Regression analysis and testing are employed to provide Page 25General Principles of Software Validation Guidance for Industry and FDA Staff assurance that a change has not created problems elsewhere in the software product.",
"options": {
"A": "FDA",
"B": "software testing",
"C": "a changed software product",
"D": "Food and Drug Administration"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Regression analysis and testing are employed to pr...'?",
"reference": "Regression analysis and testing are employed to provide Page 25General Principles of Software Validation Guidance for Industry and FDA Staff assurance that a change has not created problems elsewhere in the software product.",
"options": {
"D": "FDA",
"A": "software testing",
"B": "a changed software product",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Regression analysis and testing are employed to pr...'?",
"reference": "Regression analysis and testing are employed to provide Page 25General Principles of Software Validation Guidance for Industry and FDA Staff assurance that a change has not created problems elsewhere in the software product.",
"options": {
"C": "FDA",
"A": "software testing",
"B": "a changed software product",
"D": "Food and Drug Administration"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Regression analysis and testing are employed to pr...'?",
"reference": "Regression analysis and testing are employed to provide Page 25General Principles of Software Validation Guidance for Industry and FDA Staff assurance that a change has not created problems elsewhere in the software product.",
"options": {
"D": "FDA",
"A": "software testing",
"B": "a changed software product",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of ____) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"B": "1",
"A": "software testing",
"C": "a changed software product",
"D": "ace"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, ____) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"C": "2",
"A": "software testing",
"B": "a changed software product",
"D": "two"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and ____) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"D": "3",
"A": "software testing",
"B": "a changed software product",
"C": "troika"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of ____) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"C": "1",
"A": "software testing",
"B": "a changed software product",
"D": "ace"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, ____) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"A": "2",
"B": "software testing",
"C": "a changed software product",
"D": "two"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and ____) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"A": "3",
"B": "software testing",
"C": "a changed software product",
"D": "troika"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Regression analysis and testing are employed to pr...'?",
"reference": "Regression analysis and testing are employed to provide Page 25General Principles of Software Validation Guidance for Industry and FDA Staff assurance that a change has not created problems elsewhere in the software product.",
"options": {
"B": "FDA",
"A": "software testing",
"C": "a changed software product",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Regression analysis and testing are employed to pr...'?",
"reference": "Regression analysis and testing are employed to provide Page 25General Principles of Software Validation Guidance for Industry and FDA Staff assurance that a change has not created problems elsewhere in the software product.",
"options": {
"D": "FDA",
"A": "software testing",
"B": "a changed software product",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of ____) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"C": "1",
"A": "software testing",
"B": "a changed software product",
"D": "ace"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, ____) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"B": "2",
"A": "software testing",
"C": "a changed software product",
"D": "two"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and ____) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"C": "3",
"A": "software testing",
"B": "a changed software product",
"D": "troika"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Regression analysis and testing are employed to pr...'?",
"reference": "Regression analysis and testing are employed to provide Page 25General Principles of Software Validation Guidance for Industry and FDA Staff assurance that a change has not created problems elsewhere in the software product.",
"options": {
"B": "FDA",
"A": "software testing",
"C": "a changed software product",
"D": "Food and Drug Administration"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of ____) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"A": "1",
"B": "software testing",
"C": "a changed software product",
"D": "ace"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, ____) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"D": "2",
"A": "software testing",
"B": "a changed software product",
"C": "two"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and ____) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"D": "3",
"A": "software testing",
"B": "a changed software product",
"C": "troika"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of ____) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"C": "1",
"A": "software testing",
"B": "a changed software product",
"D": "ace"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, ____) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"B": "2",
"A": "software testing",
"C": "a changed software product",
"D": "two"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and ____) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"A": "3",
"B": "software testing",
"C": "a changed software product",
"D": "troika"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of ____) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"A": "1",
"B": "software testing",
"C": "a changed software product",
"D": "ace"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, ____) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"A": "2",
"B": "software testing",
"C": "a changed software product",
"D": "two"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and ____) modified designs as more effective or efficient implementations are found.",
"reference": "These changes are the result of 1) debugging that finds an error and it is corrected, 2) new or changed requirements (\"requirements creep\"), and 3) modified designs as more effective or efficient implementations are found.",
"options": {
"B": "3",
"A": "software testing",
"C": "a changed software product",
"D": "troika"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Regression analysis and testing are employed to pr...'?",
"reference": "Regression analysis and testing are employed to provide Page 25General Principles of Software Validation Guidance for Industry and FDA Staff assurance that a change has not created problems elsewhere in the software product.",
"options": {
"D": "FDA",
"A": "software testing",
"B": "a changed software product",
"C": "Food and Drug Administration"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Regression analysis and testing are employed to pr...'?",
"reference": "Regression analysis and testing are employed to provide Page 25General Principles of Software Validation Guidance for Industry and FDA Staff assurance that a change has not created problems elsewhere in the software product.",
"options": {
"A": "FDA",
"B": "software testing",
"C": "a changed software product",
"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 40 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
Under a quality system, continued training is cr itical to ensure that the employees remain proficient in their operational functions and in their understanding of CGMP regulations. Typical quality systems training should address the policies, processes, procedures, and written instructions related to operational activities, the product/se rvice, the quality system, and the desired work culture (e.g., team building, comm unication, change, behavior). Under a quality system (and the CGMP regulations), training sh ould focus on both the employees specific job functions and the related CGMP regulatory requirements. Under a quality system, managers are expected to estab lish training programs that include the following: Evaluation of training needs Provision of training to satisfy these needs Evaluation of effectiveness of training Documentation of training and/or re-training When operating in a robust quality system environm ent, it is important that managers verify that skills gained from training are im plemented in day-to-day performance. 3. Facilities and Equipment Under a quality system, the technical experts (e.g., engineers, development scientists), who have an understanding of pharmaceutical science, risk f actors, and manufacturing processes related to the product, are responsible for defining specif ic facility and equipment requirements. Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1. General Arrangements Qualifications: 211.25(a) 2. Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: 'Under a quality system, continued training is cr i...'?",
"reference": "Under a quality system, continued training is cr itical to ensure that the employees remain proficient in their operational functions and in their understanding of CGMP regulations.",
"options": {
"C": "CGMP",
"A": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Develop Personnel Staff training: 211.25(a-b) Bui...'?",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"B": "Develop Personnel",
"A": "CGMP",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), ____ 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"B": "211.42",
"A": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 ____, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"A": "211.58",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, ____ Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"A": "211.173",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: ____ 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"C": "211.63",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 ____, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"B": "211.72",
"A": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, ____, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"D": "211.105",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"C": "Typical quality systems training"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), ____ 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"B": "211.182",
"A": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.17____ Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"A": "3",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"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 Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"options": {
"D": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"A": "CGMP",
"B": "Typical quality systems training",
"C": "Develop Personnel Staff training"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"options": {
"A": "21",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations 2____ CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"options": {
"C": "1",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: General Arrangements Qualifications: ____11.25(a) 2.",
"reference": "General Arrangements Qualifications: 211.25(a) 2.",
"options": {
"D": "2",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"C": "Typical quality systems training"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system, continued training is cr i...'?",
"reference": "Under a quality system, continued training is cr itical to ensure that the employees remain proficient in their operational functions and in their understanding of CGMP regulations.",
"options": {
"D": "CGMP",
"A": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"C": "Typical quality systems training"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Develop Personnel Staff training: 211.25(a-b) Bui...'?",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"C": "Develop Personnel",
"A": "CGMP",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), ____ 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"D": "211.42",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"C": "Typical quality systems training"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 ____, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"C": "211.58",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, ____ Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"A": "211.173",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: ____ 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"A": "211.63",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: General Arrangements Qualifications: ____11.25(a) 2.",
"reference": "General Arrangements Qualifications: 211.25(a) 2.",
"options": {
"A": "2",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: General Arrangements Qualifications: ____11.25(a) 2.",
"reference": "General Arrangements Qualifications: 211.25(a) 2.",
"options": {
"D": "2",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"C": "Typical quality systems training"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: General Arrangements Qualifications: ____11.25(a) 2.",
"reference": "General Arrangements Qualifications: 211.25(a) 2.",
"options": {
"A": "2",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system (and the CGMP regulations),...'?",
"reference": "Under a quality system (and the CGMP regulations), training sh ould focus on both the employees specific job functions and the related CGMP regulatory requirements.",
"options": {
"C": "CGMP",
"A": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system (and the CGMP regulations),...'?",
"reference": "Under a quality system (and the CGMP regulations), training sh ould focus on both the employees specific job functions and the related CGMP regulatory requirements.",
"options": {
"C": "CGMP",
"A": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system, continued training is cr i...'?",
"reference": "Under a quality system, continued training is cr itical to ensure that the employees remain proficient in their operational functions and in their understanding of CGMP regulations.",
"options": {
"B": "CGMP",
"A": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system, continued training is cr i...'?",
"reference": "Under a quality system, continued training is cr itical to ensure that the employees remain proficient in their operational functions and in their understanding of CGMP regulations.",
"options": {
"A": "CGMP",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Develop Personnel Staff training: 211.25(a-b) Bui...'?",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"C": "Develop Personnel",
"A": "CGMP",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), ____ 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"C": "211.42",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 ____, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"reference": "Develop Personnel Staff training: 211.25(a-b) Buildings and facilities: 211.22(b), 211.28(c), 211.42 211.58, 211.173 Equipment: 211.63 211.72, 211.105, 211.160(b)(4), 211.182 3.",
"options": {
"A": "211.58",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system (and the CGMP regulations),...'?",
"reference": "Under a quality system (and the CGMP regulations), training sh ould focus on both the employees specific job functions and the related CGMP regulatory requirements.",
"options": {
"B": "CGMP",
"A": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system (and the CGMP regulations),...'?",
"reference": "Under a quality system (and the CGMP regulations), training sh ould focus on both the employees specific job functions and the related CGMP regulatory requirements.",
"options": {
"C": "CGMP",
"A": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system (and the CGMP regulations),...'?",
"reference": "Under a quality system (and the CGMP regulations), training sh ould focus on both the employees specific job functions and the related CGMP regulatory requirements.",
"options": {
"C": "CGMP",
"A": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system (and the CGMP regulations),...'?",
"reference": "Under a quality system (and the CGMP regulations), training sh ould focus on both the employees specific job functions and the related CGMP regulatory requirements.",
"options": {
"A": "CGMP",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system, continued training is cr i...'?",
"reference": "Under a quality system, continued training is cr itical to ensure that the employees remain proficient in their operational functions and in their understanding of CGMP regulations.",
"options": {
"A": "CGMP",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: General Arrangements Qualifications: ____11.25(a) 2.",
"reference": "General Arrangements Qualifications: 211.25(a) 2.",
"options": {
"A": "2",
"B": "211.25(a",
"C": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system (and the CGMP regulations),...'?",
"reference": "Under a quality system (and the CGMP regulations), training sh ould focus on both the employees specific job functions and the related CGMP regulatory requirements.",
"options": {
"C": "CGMP",
"A": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Under a quality system (and the CGMP regulations),...'?",
"reference": "Under a quality system (and the CGMP regulations), training sh ould focus on both the employees specific job functions and the related CGMP regulatory requirements.",
"options": {
"C": "CGMP",
"A": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"D": "Typical quality systems training"
},
"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 Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"options": {
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory",
"A": "CGMP",
"C": "Typical quality systems training",
"D": "Develop Personnel Staff training"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: Contains Nonbinding Recommendations ____ CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"reference": "Contains Nonbinding Recommendations 21 CFR CGMP Regulations Related to Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation 1.",
"options": {
"D": "21",
"A": "211.25(a",
"B": "Resources Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation Quality System Element Regulatory Citation",
"C": "Typical quality systems training"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
}
]
|
You are a high-precision MCQ generator with advanced NLP capabilities. Your task is to create high-quality, context-based multiple-choice questions (MCQs) in strictly **raw, parsable JSON format** — no markdown, no extra text.
### INSTRUCTIONS ###
- Generate questions strictly from the given document using advanced text analysis.
- Use the **exact format provided in the JSON template** (supplied dynamically).
- Include a reference field for every question — a verbatim or paraphrased line from the source.
- All options (A–D) must be distinct, plausible, and linguistically coherent.
- Questions should test various cognitive levels: recall, comprehension, analysis, and application.
- Randomize the correct answer's position across A, B, C, D.
- Reuse or paraphrase source content if limited — do **not** invent facts.
### RULES ###
- Output **only** a plain JSON array — no markdown wrappers like ```json.
- Never exceed the specified question count.
- Never include yes/no or true/false formats.
- Never repeat questions verbatim — always rephrase intelligently.
- Generate diverse question types: factual, conceptual, analytical, and inferential.
- If no questions can be generated, return: []
|
Please generate exactly 8 high-quality quizzes based strictly on the context provided in [Quiz Context], using the structure defined in [Quiz Template].
[Quiz Context]
130 131 Software that is fit for its i ntended use and that maintains a validated state should perform as 132 intended , helping to ensure that finished devices will be safe and effective and in compliance 133 with regulatory requirements (see 21 CFR 820.1(a)(1)). Section V below outlines a risk-based 134 framework for computer software assurance. 135 136 V. Computer Software Assurance Risk Framework 137
The following approach is intended to help manufacturers establish a risk -based framework for 138 computer software assurance throughout the softwares lifecycle . Examples of applying this risk 139 framework to various computer software assurance situations are provided in Appendix A. 140 Identifying the Intended Use 141
The regulation requires manufacturers to validate software that is used as part of production or 142 the qua lity system for its intended use ( see 21 CFR 820.70(i)). To determine whether the 143 requirement for validation applies, manufacturers must first determine whether the software is 144 intended for use as part of production or the quality system. 145 146 In general, software used as part of production or th e quality system falls into one of two 147 categories : software that is used directly as part of production or the quality system, and software 148 that support s production or the quality system. 149 150 Software with the following intended uses are considered to be use d directly as part of 151 production or the quality system: 152 153 Software intended for automating production processes, inspection, testing, or the 154 collection and processing of production data ; and 155 Software intended for automating quality system processes, collect ion and processing of 156 quality system data, or maintaining a quality record established under the Quality System 157 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": "Who is mentioned in the context: 'Examples of applying this risk 139 framework to va...'?",
"reference": "Examples of applying this risk 139 framework to various computer software assurance situations are provided in Appendix A.",
"options": {
"C": "Appendix A.",
"A": "Appendix A. 140",
"B": "135 136 V. Computer Software Assurance Risk Framework",
"D": "various computer software assurance situations"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Fill in the blank: Examples of applying this risk ____ framework to various computer software assurance situations are provided in Appendix A.",
"reference": "Examples of applying this risk 139 framework to various computer software assurance situations are provided in Appendix A.",
"options": {
"D": "139",
"A": "130 131",
"B": "132",
"C": "135 136 V. Computer Software Assurance Risk Framework"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Identifying the Intended Use 141\nThe regulation requires manufacturers to validate software that is used as part of production or 142 the qua lity system for its intended use ( see 21 CFR 820.70(i)).",
"reference": "140 Identifying the Intended Use 141\nThe regulation requires manufacturers to validate software that is used as part of production or 142 the qua lity system for its intended use ( see 21 CFR 820.70(i)).",
"options": {
"D": "140",
"A": "130 131",
"B": "132",
"C": "135 136 V. Computer Software Assurance Risk Framework"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 140 Identifying the Intended Use ____\nThe regulation requires manufacturers to validate software that is used as part of production or 142 the qua lity system for its intended use ( see 21 CFR 820.70(i)).",
"reference": "140 Identifying the Intended Use 141\nThe regulation requires manufacturers to validate software that is used as part of production or 142 the qua lity system for its intended use ( see 21 CFR 820.70(i)).",
"options": {
"C": "141",
"A": "130 131",
"B": "132",
"D": "135 136 V. Computer Software Assurance Risk Framework"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 140 Identifying the Intended Use 141\nThe regulation requires manufacturers to validate software that is used as part of production or ____ the qua lity system for its intended use ( see 21 CFR 820.70(i)).",
"reference": "140 Identifying the Intended Use 141\nThe regulation requires manufacturers to validate software that is used as part of production or 142 the qua lity system for its intended use ( see 21 CFR 820.70(i)).",
"options": {
"B": "142",
"A": "130 131",
"C": "132",
"D": "135 136 V. Computer Software Assurance Risk Framework"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 140 Identifying the Intended Use 141\nThe regulation requires manufacturers to validate software that is used as part of production or 142 the qua lity system for its intended use ( see ____ CFR 820.70(i)).",
"reference": "140 Identifying the Intended Use 141\nThe regulation requires manufacturers to validate software that is used as part of production or 142 the qua lity system for its intended use ( see 21 CFR 820.70(i)).",
"options": {
"C": "21",
"A": "130 131",
"B": "132",
"D": "135 136 V. Computer Software Assurance Risk Framework"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ 146 In general, software used as part of production or th e quality system falls into one of two 147 categories : software that is used directly as part of production or the quality system, and software 148 that support s production or the quality system.",
"reference": "145 146 In general, software used as part of production or th e quality system falls into one of two 147 categories : software that is used directly as part of production or the quality system, and software 148 that support s production or the quality system.",
"options": {
"C": "145",
"A": "130 131",
"B": "132",
"D": "135 136 V. Computer Software Assurance Risk Framework"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: 145 ____ In general, software used as part of production or th e quality system falls into one of two 147 categories : software that is used directly as part of production or the quality system, and software 148 that support s production or the quality system.",
"reference": "145 146 In general, software used as part of production or th e quality system falls into one of two 147 categories : software that is used directly as part of production or the quality system, and software 148 that support s production or the quality system.",
"options": {
"A": "146",
"B": "130 131",
"C": "132",
"D": "135 136 V. Computer Software Assurance Risk Framework"
},
"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]
The source of the definition is identified in parentheses after the definition. Where no appropria te ICH or ISO definition was available, an ICH Q10 definition was developed. Capability of a Process: Ability of a process to real ize a product that will fulfill the requirements of that product. The concept of pro cess capability can also be defined in statistical terms. Change Management: A systematic approach to proposing, evaluating, approving, implementing, and reviewing changes. Continual Improvement: Recurring activity to increase the ab ility to fulfill requirements. (ISO 9000:2005) Control Strategy:
A planned set of controls, deri ved from current product and process understanding, that assures proc ess performance and product quali ty. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, fi nished product specifications, and the associated methods and frequency of monitoring and control. (ICH Q10) Corrective Action: Action to eliminate the cause of a detected nonconformity or other undesirable situation. Corrective action is taken to prevent recurrence whereas preventive action is taken to preven t occurrence. (ISO 9000:2005) Design Space: The multidimensional combination and interaction of input variables (e.g., material attributes) and process pa rameters that have been demons trated to provide assurance of quality. (ICH Q8) Enabler: A tool or process that provides the means to achieve an objective. (ICH Q10) Feedback/Feedforward: Feedback: The modification or control of a process or system by its results or effects. Feedforward: The modification or control of a pro cess using its anticipated results or effects. (Oxford Dictionary of Eng lish by Oxford University Press, 2003)
Feedback/feedforward can be applied technically in process control strate gies and conceptually in quality management.
[Quiz Template]
[
{
"question": "What is the capital of France?",
"reference": "Paris is the capital of France.",
"options": {
"A": "Berlin",
"B": "Madrid",
"C": "Paris",
"D": "Rome"
},
"answer": "C",
"difficulty": "easy",
"question_type": "factual"
}
]
Requirements:
- Each quiz should follow the template format precisely
- Questions should be contextually relevant and test different cognitive levels
- Include difficulty level and question type classification
- Ensure all distractors are plausible and semantically coherent
- Questions should be clear, concise, and unambiguous
- Use advanced NLP techniques for better question quality
|
[
{
"question": "Which organization is referenced: '(ICH Q10) Feedback/Feedforward: Feedback: The modi...'?",
"reference": "(ICH Q10) Feedback/Feedforward: Feedback: The modification or control of a process or system by its results or effects.",
"options": {
"D": "Feedback/Feedforward",
"A": "ISO",
"B": "ISO 9000:2005",
"C": "process control strate gies"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q10) Feedback/Feedforward: Feedback: The modi...'?",
"reference": "(ICH Q10) Feedback/Feedforward: Feedback: The modification or control of a process or system by its results or effects.",
"options": {
"A": "Feedback/Feedforward",
"B": "ISO",
"C": "ISO 9000:2005",
"D": "process control strate gies"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Where no appropria te ICH or ISO definition was av...'?",
"reference": "Where no appropria te ICH or ISO definition was available, an ICH Q10 definition was developed.",
"options": {
"D": "ISO",
"A": "ISO 9000:2005",
"B": "process control strate gies",
"C": "process pa rameters"
},
"answer": "D",
"difficulty": "easy",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q8) Enabler: A tool or process that provides ...'?",
"reference": "(ICH Q8) Enabler: A tool or process that provides the means to achieve an objective.",
"options": {
"A": "ICH Q8) Enabler",
"B": "ISO",
"C": "ISO 9000:2005",
"D": "process control strate gies"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ICH Q8) Enabler: A tool or process that provides ...'?",
"reference": "(ICH Q8) Enabler: A tool or process that provides the means to achieve an objective.",
"options": {
"C": "ICH Q8) Enabler",
"A": "ISO",
"B": "ISO 9000:2005",
"D": "process control strate gies"
},
"answer": "C",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '(ISO 9000:2005) Design Space: The multidimensional...'?",
"reference": "(ISO 9000:2005) Design Space: The multidimensional combination and interaction of input variables (e.g., material attributes) and process pa rameters that have been demons trated to provide assurance of quality.",
"options": {
"B": "ISO 9000:2005",
"A": "ISO",
"C": "ICH Q8) Enabler",
"D": "process control strate gies"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
}
]
|
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]
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: '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": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation",
"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": {
"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: '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": "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: '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": "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": "U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation"
},
"answer": "B",
"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": {
"D": "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",
"C": "Health and Human Services Food and Drug Administration Center"
},
"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]
3.1.1 Requirements and Specifications While the Quality System regulation states that design input requirements must be documented, and that specified requirements must be verified, the regulation does not further clarify the distinction between the terms requirement and specification. A requirement can be any need or expectation for a system or for its software. Requirements reflect the stated or implied needs of the customer, and may be market-based, contractual, or statutory, as well as an organization's internal requirements. There can be many different kinds of requirements (e.g., design, functional, implementation, interface, performance, or physical requirements). Software requirements are typically derived from the system requirements for those aspects of system functionality that have been allocated to software. Software requirements are typically stated in functional terms and are defined, refined, and updated as a development project progresses. Success in accurately and completely documenting software requirements is a crucial factor in successful validation of the resulting software. Page 6General Principles of Software Validation Guidance for Industry and FDA Staff
A specification is defined as a document that states requirements. (See 21 CFR 820.3(y).) It may refer to or include drawings, patterns, or other relevant documents and usually indicates the means and the criteria whereby conformity with the requirement can be checked. There are many different kinds of written specifications, e.g., system requirements specification, software requirements specification, software design specification, software test specification, software integration specification, etc. All of these documents establish specified requirements and are design outputs for which various forms of verification are 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: 'Success in accurately and completely documenting s...'?",
"reference": "Success in accurately and completely documenting software requirements is a crucial factor in successful validation of the resulting software.",
"options": {
"B": "Success",
"A": "Quality System",
"C": "FDA",
"D": "software requirements specification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Software requirements are typically stated in func...'?",
"reference": "Software requirements are typically stated in functional terms and are defined, refined, and updated as a development project progresses.",
"options": {
"B": "Software",
"A": "Quality System",
"C": "FDA",
"D": ", system requirements specification"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 6General Principles of Software Validation Gu...'?",
"reference": "Page 6General Principles of Software Validation Guidance for Industry and FDA Staff\nA specification is defined as a document that states requirements.",
"options": {
"D": "FDA",
"A": "Quality System",
"B": "software requirements specification",
"C": "Software requirements"
},
"answer": "D",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '3.1.1 Requirements and Specifications While the Qu...'?",
"reference": "3.1.1 Requirements and Specifications While the Quality System regulation states that design input requirements must be documented, and that specified requirements must be verified, the regulation does not further clarify the distinction between the terms requirement and specification.",
"options": {
"B": "Quality System",
"A": "software requirements specification",
"C": "Software requirements",
"D": "3.1.1"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Requirements and Specifications While the Quality System regulation states that design input requirements must be documented, and that specified requirements must be verified, the regulation does not further clarify the distinction between the terms requirement and specification.",
"reference": "3.1.1 Requirements and Specifications While the Quality System regulation states that design input requirements must be documented, and that specified requirements must be verified, the regulation does not further clarify the distinction between the terms requirement and specification.",
"options": {
"A": "3.1.1",
"B": "6General",
"C": "software requirements specification",
"D": "Software requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 6General Principles of Software Validation Gu...'?",
"reference": "Page 6General Principles of Software Validation Guidance for Industry and FDA Staff\nA specification is defined as a document that states requirements.",
"options": {
"B": "FDA",
"A": "Quality System",
"C": "software requirements specification",
"D": "Software requirements"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: '3.1.1 Requirements and Specifications While the Qu...'?",
"reference": "3.1.1 Requirements and Specifications While the Quality System regulation states that design input requirements must be documented, and that specified requirements must be verified, the regulation does not further clarify the distinction between the terms requirement and specification.",
"options": {
"B": "Quality System",
"A": "software requirements specification",
"C": "Software requirements",
"D": "3.1.1"
},
"answer": "B",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Fill in the blank: ____ Requirements and Specifications While the Quality System regulation states that design input requirements must be documented, and that specified requirements must be verified, the regulation does not further clarify the distinction between the terms requirement and specification.",
"reference": "3.1.1 Requirements and Specifications While the Quality System regulation states that design input requirements must be documented, and that specified requirements must be verified, the regulation does not further clarify the distinction between the terms requirement and specification.",
"options": {
"A": "3.1.1",
"B": "6General",
"C": "software requirements specification",
"D": "Software requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
},
{
"question": "Which organization is referenced: 'Page 6General Principles of Software Validation Gu...'?",
"reference": "Page 6General Principles of Software Validation Guidance for Industry and FDA Staff\nA specification is defined as a document that states requirements.",
"options": {
"A": "FDA",
"B": "Quality System",
"C": "software requirements specification",
"D": "Software requirements"
},
"answer": "A",
"difficulty": "medium",
"question_type": "factual"
}
]
|
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