CVM Computer System Validation & Software Testing Flashcards

What is the primary objective of Installation Qualification (IQ) for a computerized system?

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.

Operational Qualification (OQ) for a computerized system is designed to verify that:

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.

What is the purpose of a Traceability Matrix in CSV?

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.

Under 21 CFR Part 11, which control is required for electronic records to prevent unauthorized alteration?

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.

What is 'periodic review' in the context of Computer System Validation?

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.

Which term describes the process of systematically confirming that a software vendor's development practices and quality system are adequate for GxP purposes?

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.