CVM Computer System Validation & Software Testing Flashcards

What does 21 CFR Part 11 regulate in the pharmaceutical industry?

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.

In Computer System Validation (CSV), what does the GAMP 5 framework primarily provide?

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.

Which validation document defines the overall strategy, scope, and responsibilities for validating a computerized system?

Answer: Validation Plan (VP) or System Validation Plan

The Validation Plan defines the scope, approach, responsibilities, and schedule for validating a specific computerized system.

What is the purpose of a User Requirement Specification (URS) in CSV?

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.

In the V-Model for Computer System Validation, what does the right side of the 'V' represent?

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.

Which GAMP 5 software category applies to standard, commercially available, configurable software such as an ERP or LIMS system?

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.