CVM CVM Computer System Validation & Software Testing

Question 1

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

Accepted Answer

Electronic records and electronic signatures to ensure their trustworthiness and reliability

Answer

Good Manufacturing Practices for sterile drug products

Answer

Validation of process equipment

Answer

Good Laboratory Practices for non-clinical studies

Question 2

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

Accepted Answer

A risk-based approach to CSV, categorizing software by complexity to scale validation effort appropriately

Answer

A mandatory FDA regulation for software testing

Answer

A European directive for medical device software

Answer

A testing standard for cybersecurity of clinical systems

Question 3

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

Accepted Answer

Validation Plan (VP) or System Validation Plan

Answer

Installation Qualification (IQ) Protocol

Answer

User Requirement Specification (URS)

Answer

Traceability Matrix

Question 4

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

Accepted Answer

To define what the system must do from the user's perspective, forming the basis for testing

Answer

To document the vendor's software architecture design

Answer

To record the results of operational qualification testing

Answer

To list all hardware components in the system

Question 5

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

Accepted Answer

Testing phases that verify and validate the design and requirements documents on the left side

Answer

Requirements gathering and design phases

Answer

Post-market surveillance activities

Answer

Risk assessment documentation

Question 6

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

Accepted Answer

Category 4 (Configured Products)

Answer

Category 1 (Infrastructure Software)

Answer

Category 3 (Non-Configured Products)

Answer

Category 5 (Custom Applications)