CVM CVM Computer System Validation & Software Testing 1 — Questions and Answers
Question 1: What does 21 CFR Part 11 regulate in the pharmaceutical industry?
- Good Manufacturing Practices for sterile drug products
- Electronic records and electronic signatures to ensure their trustworthiness and reliability (Correct answer)
- Validation of process equipment
- Good Laboratory Practices for non-clinical studies
Correct answer: Electronic records and electronic signatures to ensure their trustworthiness and reliability
21 CFR Part 11 establishes criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
Question 2: In Computer System Validation (CSV), what does the GAMP 5 framework primarily provide?
- A mandatory FDA regulation for software testing
- A risk-based approach to CSV, categorizing software by complexity to scale validation effort appropriately (Correct answer)
- A European directive for medical device software
- A testing standard for cybersecurity of clinical systems
Correct answer: A risk-based approach to CSV, categorizing software by complexity to scale validation effort appropriately
GAMP 5 (Good Automated Manufacturing Practice) provides a risk-based framework that categorizes software into types (1–5) to help determine the appropriate level of validation effort.
Question 3: Which validation document defines the overall strategy, scope, and responsibilities for validating a computerized system?
- Installation Qualification (IQ) Protocol
- Validation Plan (VP) or System Validation Plan (Correct answer)
- User Requirement Specification (URS)
- Traceability Matrix
Correct answer: Validation Plan (VP) or System Validation Plan
The Validation Plan defines the scope, approach, responsibilities, and schedule for validating a specific computerized system.
Question 4: What is the purpose of a User Requirement Specification (URS) in CSV?
- To document the vendor's software architecture design
- To define what the system must do from the user's perspective, forming the basis for testing (Correct answer)
- To record the results of operational qualification testing
- To list all hardware components in the system
Correct answer: To define what the system must do from the user's perspective, forming the basis for testing
The URS captures the user's needs and intended uses for the system, providing the foundation against which the system's compliance and performance are validated.
Question 5: In the V-Model for Computer System Validation, what does the right side of the 'V' represent?
- Requirements gathering and design phases
- Testing phases that verify and validate the design and requirements documents on the left side (Correct answer)
- Post-market surveillance activities
- Risk assessment documentation
Correct answer: Testing phases that verify and validate the design and requirements documents on the left side
The right side of the V-Model represents the testing phases (IQ, OQ, PQ) that verify each corresponding specification document created on the left side of the V.
Question 6: Which GAMP 5 software category applies to standard, commercially available, configurable software such as an ERP or LIMS system?
- Category 1 (Infrastructure Software)
- Category 3 (Non-Configured Products)
- Category 4 (Configured Products) (Correct answer)
- Category 5 (Custom Applications)
Correct answer: Category 4 (Configured Products)
GAMP 5 Category 4 covers configurable off-the-shelf software products where vendor testing is supplemented by configuration and user acceptance testing.
CVM CVM Computer System Validation & Software Testing 1
What does 21 CFR Part 11 regulate in the pharmaceutical industry?