GAMP 5, “A Risk-Based Approach to Compliant GxP Computerized Systems”, is guidance published by ISPE (the International Society for Pharmaceutical Engineering). It is the most widely used framework for planning computer system validation in pharma, and its Second Edition, published in 2022, strengthens the emphasis on critical thinking, agile development and leveraging supplier activities.
GAMP 5 groups software into categories that indicate how much specification and testing is typically needed: infrastructure software (category 1), non-configured products (category 3), configured products (category 4) and custom applications (category 5). It describes a system lifecycle from concept through project and operation to retirement, with quality risk management applied throughout.
Why it matters in GMP
Regulations such as 21 CFR Part 11 and EU GMP Annex 11 say that computerised systems must be validated but do not prescribe how. GAMP 5 fills that gap with a recognised, proportionate approach that inspectors understand. It is good practice guidance: neither a product nor a company can be certified against it, and a claim that software is “GAMP 5 validated” misunderstands its purpose.
- Classify the system and its components, then scale effort accordingly.
- Use supplier documentation and testing where it is good enough.
- Keep the system in a validated state through change control and periodic review.
How Swat iQua Suite supports a GAMP 5 approach
Swat iQua Suite supports a GAMP 5 risk-based approach with its computerised system assurance register — requirements with risk levels, traced to test executions with a coverage report — together with built-in Part 11 controls and validation support from our implementation team. Your validation team decides the category and the testing strategy for your intended use.