CVM CVM Computer System Validation & Software Testing 2 — Questions and Answers
Question 1: What is the primary objective of Installation Qualification (IQ) for a computerized system?
- To verify the system performs as intended under normal operating conditions
- To confirm the system is installed correctly according to vendor and site specifications (Correct answer)
- To demonstrate the system meets user requirements in the production environment
- To evaluate vendor qualifications and regulatory compliance
Correct answer: To confirm the system is installed correctly according to vendor and site specifications
IQ verifies that the hardware, software, and infrastructure are installed correctly, documented, and consistent with approved specifications.
Question 2: Operational Qualification (OQ) for a computerized system is designed to verify that:
- The system is physically installed as per vendor drawings
- The system operates correctly throughout its specified operating range and handles edge cases appropriately (Correct answer)
- The system produces acceptable product quality data under actual production conditions
- Vendor training on the system has been completed
Correct answer: The system operates correctly throughout its specified operating range and handles edge cases appropriately
OQ tests system functionality across its operating range, including normal conditions, edge cases, and error handling, to confirm it operates as designed.
Question 3: What is the purpose of a Traceability Matrix in CSV?
- To track project timelines and milestones
- To demonstrate that each user requirement is addressed by a design specification and verified by a test (Correct answer)
- To record calibration intervals for instruments
- To map process flow between manufacturing steps
Correct answer: To demonstrate that each user requirement is addressed by a design specification and verified by a test
A Traceability Matrix links each user requirement to its corresponding design specification and test script, ensuring complete test coverage and providing a clear audit trail.
Question 4: Under 21 CFR Part 11, which control is required for electronic records to prevent unauthorized alteration?
- Color-coded access badges for all personnel
- Audit trails that capture date, time, operator, and what was changed for any record modification (Correct answer)
- Monthly paper printouts of all electronic records
- Mandatory two-day waiting period before any record is finalized
Correct answer: Audit trails that capture date, time, operator, and what was changed for any record modification
21 CFR Part 11 requires secure, computer-generated audit trails that record the date and time of operator entries and actions that create, modify, or delete electronic records.
Question 5: What is 'periodic review' in the context of Computer System Validation?
- Annual review of employee training records
- A scheduled reassessment of a validated system to confirm it remains in a validated state over time (Correct answer)
- Quarterly financial audits of the IT department
- Review of vendor invoices for software licenses
Correct answer: A scheduled reassessment of a validated system to confirm it remains in a validated state over time
Periodic review is a planned assessment (typically annual) of a validated computerized system to confirm its validated status is maintained through change control, incidents, and use history.
Question 6: Which term describes the process of systematically confirming that a software vendor's development practices and quality system are adequate for GxP purposes?
- Software Acceptance Testing
- Vendor Audit / Supplier Qualification (Correct answer)
- System Decommissioning
- Functional Specification Review
Correct answer: Vendor Audit / Supplier Qualification
Vendor audits and supplier qualification assess a software vendor's development processes, testing practices, and quality system to determine how much reliance can be placed on their testing in CSV.
CVM CVM Computer System Validation & Software Testing 2
What is the primary objective of Installation Qualification (IQ) for a computerized system?