Software validation checklist MCQs With Answer

Introduction

This blog presents a focused set of Software Validation Checklist MCQs with answers tailored for M.Pharm students studying Good Regulatory Practices. The questions cover critical areas such as User Requirements Specification (URS), Computerized System Validation (CSV), IQ/OQ/PQ phases, traceability, risk assessment, data integrity, 21 CFR Part 11, change control, vendor qualification, and validation deliverables. Each MCQ is designed to deepen understanding of practical validation checklists and regulatory expectations encountered in pharmaceutical computerized systems. Use these questions to test knowledge, identify gaps, and reinforce concepts necessary for designing, executing, documenting, and maintaining validated software systems in a GxP environment.

Q1. What is the primary purpose of a software validation checklist in a GxP environment?

• To ensure the computerized system meets its intended use and regulatory requirements
• To provide a user manual for end users
• To document marketing claims about the software
• To reduce the cost of software licensing

Correct Answer: To ensure the computerized system meets its intended use and regulatory requirements

Q2. Which document captures the high-level functions and constraints that users expect from a validated system?

• Functional Requirements Specification (FRS)
• User Requirements Specification (URS)
• Design Qualification (DQ)
• Quality Risk Assessment (QRA)

Correct Answer: User Requirements Specification (URS)

Q3. Which validation activity confirms that hardware and software are installed according to manufacturer and design specifications?

• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Installation Qualification (IQ)
• Design Qualification (DQ)

Correct Answer: Installation Qualification (IQ)

Q4. During which phase are functional tests executed to verify the system operates as intended under controlled conditions?

• Installation Qualification (IQ)
• Performance Qualification (PQ)
• Operational Qualification (OQ)
• Design Review

Correct Answer: Operational Qualification (OQ)

Q5. Performance Qualification (PQ) primarily demonstrates what aspect of a validated system?

• That the system was installed correctly
• That the system performs reliably in the simulated development environment only
• That the system performs consistently under actual production conditions
• That user training materials are complete

Correct Answer: That the system performs consistently under actual production conditions

Q6. CSV in pharmaceutical regulation commonly stands for which term?

• Computer Software Specification
• Computerized System Validation
• Clinical System Verification
• Continuous Software Verification

Correct Answer: Computerized System Validation

Q7. What is the primary purpose of a requirements traceability matrix in software validation?

• To track project budget and timelines
• To map user requirements to design elements, test cases, and test results
• To provide training schedules for users
• To document vendor financial stability

Correct Answer: To map user requirements to design elements, test cases, and test results

Q8. Which regulation specifically addresses the controls for electronic records and electronic signatures in FDA-regulated environments?

• ICH Q7
• 21 CFR Part 11
• EU Annex 11
• GMP Chapter 1

Correct Answer: 21 CFR Part 11

Q9. Which of the following is a key control to support data integrity in validated computerized systems?

• Audit trails and access controls
• Graphical user interface themes
• Screen resolution settings
• Unrestricted file downloads

Correct Answer: Audit trails and access controls

Q10. Which risk assessment technique is most commonly used in validation planning to identify and prioritize potential system failures?

• SWOT analysis
• Failure Mode and Effects Analysis (FMEA)
• Key Performance Indicator (KPI) tracking
• Cost-benefit analysis

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q11. Which documents are essential validation deliverables that demonstrate testing and acceptance of a computerized system?

• Marketing authorization dossier and promotional materials
• Validation protocols, test scripts, and validation summary reports
• Only the system user manual
• Vendor sales brochures and price lists

Correct Answer: Validation protocols, test scripts, and validation summary reports

Q12. Who is typically responsible for the final approval to release a validated system into production?

• Information Technology (IT) only
• Quality Assurance (QA)
• Marketing department
• External vendor sales representative

Correct Answer: Quality Assurance (QA)

Q13. Change control in the context of validated software is primarily used to:

• Approve marketing campaigns for the software
• Manage and document modifications to a validated system to maintain compliance
• Replace training needs assessment
• Track software license renewals only

Correct Answer: Manage and document modifications to a validated system to maintain compliance

Q14. Which event typically requires re-validation or partial requalification of a computerized system?

• Minor cosmetic changes to screen color
• Major software upgrade or change in system function affecting GxP data
• Routine user password expiration
• Change in office furniture layout

Correct Answer: Major software upgrade or change in system function affecting GxP data

Q15. Best practice for backups in a validated system includes which approach?

• Performing regular backups and periodic restore testing to verify recoverability
• Backing up only when the system administrator remembers
• Storing backups on the same physical disk as the production data only
• Never testing restores to avoid downtime

Correct Answer: Performing regular backups and periodic restore testing to verify recoverability

Q16. A vendor audit for a software supplier should primarily evaluate:

• The supplier’s advertising reach
• The supplier’s quality management system, development lifecycle, and support for validation
• Only the supplier’s price competitiveness
• The supplier’s office interior design

Correct Answer: The supplier’s quality management system, development lifecycle, and support for validation

Q17. Which statement correctly reflects an expectation for electronic signatures under regulatory controls?

• Electronic signatures can be shared among multiple users to simplify access
• Electronic signatures must be uniquely linked to their electronic records and attributable to an individual
• Electronic signatures do not need to be traceable
• Electronic signatures are optional for audit trail purposes

Correct Answer: Electronic signatures must be uniquely linked to their electronic records and attributable to an individual

Q18. What should a validation protocol include to ensure objective evaluation of system readiness?

• A list of preferred vendors and their logos
• Clear objectives, acceptance criteria, test cases, and responsibilities
• Only a project timeline without tests
• Budget estimates for support services

Correct Answer: Clear objectives, acceptance criteria, test cases, and responsibilities

Q19. Which life-cycle model is commonly endorsed for computerized system validation to ensure traceability between requirements and testing?

• V-model
• Ad-hoc model
• Marketing-driven model
• Decorative design model

Correct Answer: V-model

Q20. Which of the following is NOT part of the IQ/OQ/PQ qualification activities?

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Marketing approval for product advertising

Correct Answer: Marketing approval for product advertising

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