GAMP guidelines for computerized systems MCQs With Answer

Introduction: GAMP guidelines for computerized systems MCQs With Answer is a focused practice resource tailored for M.Pharm students studying Pharmaceutical Validation. This blog introduces core GAMP principles—risk-based validation, life-cycle management, supplier assessment, and documentation expectations—through concise multiple-choice questions with answers. The quiz emphasizes practical aspects of Computerized System Validation (CSV) used in regulated pharmaceutical environments, including requirement specifications, testing strategies (IQ/OQ/PQ), software categorization, and data integrity (ALCOA+). Each question challenges students to apply GAMP concepts to real-world scenarios encountered during commissioning, qualification, and operation of computerized systems to prepare for exams and professional responsibilities in quality assurance and regulatory compliance.

Q1. What is the primary philosophical approach promoted by GAMP for validating computerized systems?

• Zero-tolerance validation for all systems regardless of risk
• A risk-based, scalable life-cycle approach
• Testing only final outputs without documentation
• Outsourcing all validation activities to vendors

Correct Answer: A risk-based, scalable life-cycle approach

Q2. In GAMP 5, which document typically captures what the user needs the system to do?

• Functional Specification (FS)
• Validation Plan
• User Requirements Specification (URS)
• Configuration Specification

Correct Answer: User Requirements Specification (URS)

Q3. Which GAMP software category describes bespoke or custom-developed software?

• Category 3 — Non-configurable packaged software
• Category 5 — Custom (bespoke) software
• Category 1 — Infrastructure software
• Category 4 — Configurable packaged software

Correct Answer: Category 5 — Custom (bespoke) software

Q4. Which of the following is NOT one of the ALCOA principles extended by GAMP and regulators (ALCOA+)?

• Accurate
• Legible
• Ambiguous
• Contemporaneous

Correct Answer: Ambiguous

Q5. During validation, traceability matrix is used primarily to:

• List vendor contact details
• Map user requirements to design, configuration, and test cases
• Document system passwords
• Record daily operational logs

Correct Answer: Map user requirements to design, configuration, and test cases

Q6. Which GAMP deliverable defines how the system will be tested to demonstrate it meets requirements?

• Validation Plan
• Test Plan/Test Scripts
• Risk Assessment Summary
• Supplier Audit Report

Correct Answer: Test Plan/Test Scripts

Q7. What is the main purpose of a supplier/vendor assessment under GAMP?

• To negotiate pricing and delivery schedules
• To evaluate supplier capability to provide quality products and support for GxP systems
• To certify the vendor as compliant with ISO 9001 only
• To replace internal validation activities entirely

Correct Answer: To evaluate supplier capability to provide quality products and support for GxP systems

Q8. Which testing phase is primarily concerned with verifying installation and environment setup?

• System Integration Testing (SIT)
• Operational Qualification (OQ)
• Installation Qualification (IQ)
• Performance Qualification (PQ)

Correct Answer: Installation Qualification (IQ)

Q9. GAMP recommends focusing validation effort based on:

• System complexity only
• Regulatory agency of origin
• Patient risk and product quality impact determined by risk assessment
• Whether the software vendor is large or small

Correct Answer: Patient risk and product quality impact determined by risk assessment

Q10. Which term best describes a packaged software product that is used without customization?

• Category 4 — Configurable packaged software
• Category 3 — Non-configurable packaged software
• Category 5 — Bespoke software
• Category 1 — Infrastructure software

Correct Answer: Category 3 — Non-configurable packaged software

Q11. A GAMP-compliant periodic review should primarily address:

• Only software version upgrades
• Ongoing suitability for intended use, considering change, risk, and performance
• Marketing strategy for the system
• Employee satisfaction surveys

Correct Answer: Ongoing suitability for intended use, considering change, risk, and performance

Q12. In GAMP 5, the term “fit-for-purpose” most closely means:

• The system is certified by the vendor
• The system adequately supports the intended GxP processes and associated risk control
• The system has the latest user interface
• The system uses open-source components

Correct Answer: The system adequately supports the intended GxP processes and associated risk control

Q13. Which document records the planned validation approach, responsibilities, scope, and deliverables?

• Change Control Log
• Validation Plan
• Installation Qualification Report
• Training Matrix

Correct Answer: Validation Plan

Q14. Which activity is a key part of configuration management in GAMP?

• Identifying and controlling system versions, changes, and baselines
• Removing user access controls to speed testing
• Only documenting vendor emails
• Performing PQ without documented procedures

Correct Answer: Identifying and controlling system versions, changes, and baselines

Q15. Which of the following is a GAMP recommendation for electronic signatures and records?

• Ignore 21 CFR Part 11 requirements if using cloud systems
• Implement controls to ensure integrity, authenticity, and non-repudiation of electronic records/signatures
• Use unencrypted email for all record transmission
• Rely solely on paper backups without controls

Correct Answer: Implement controls to ensure integrity, authenticity, and non-repudiation of electronic records/signatures

Q16. What is the role of a User Requirements Specification (URS) traceability to tests?

• It is optional and rarely used
• To ensure each user requirement is verified by one or more test cases
• To reduce the number of test cases regardless of coverage
• To document vendor training sessions only

Correct Answer: To ensure each user requirement is verified by one or more test cases

Q17. According to GAMP, which team is typically accountable for accepting computerized system validation deliverables?

• Vendor technical support only
• Cross-functional team including QA, IT, and process owners
• Marketing department
• External auditors exclusively

Correct Answer: Cross-functional team including QA, IT, and process owners

Q18. Which GAMP concept helps determine the depth and extent of verification activities?

• Fixed test scripts applied to all systems equally
• Risk-based assessment of system impact and complexity
• Length of vendor history only
• Number of users logged into the system

Correct Answer: Risk-based assessment of system impact and complexity

Q19. What is an appropriate GAMP approach when implementing a widely used, validated, configurable pharmaceutical LIMS?

• Treat it as bespoke software requiring full custom development lifecycle
• Apply a scaled validation strategy emphasizing configuration testing and vendor assurance
• Skip validation because it is a commercial product
• Only perform IQ and ignore OQ/PQ

Correct Answer: Apply a scaled validation strategy emphasizing configuration testing and vendor assurance

Q20. Change control in GAMP should ensure that:

• Changes are implemented without evaluation to save time
• All changes are assessed for risk, authorized, tested, documented, and reviewed before release
• Only cosmetic changes are recorded
• Changes are only communicated verbally

Correct Answer: All changes are assessed for risk, authorized, tested, documented, and reviewed before release

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