Gamp 5 Categories |best|

| GAMP Category | URS | Supplier Assessment | IQ | OQ (Config/Function) | PQ | Code Review | |---------------|-----|---------------------|----|----------------------|----|--------------| | 1 (Infra) | No | No | Basic IT | No | No | No | | 3 (Non-Config)| Yes (simple) | Minimal (certificate) | Yes | Limited (core functions) | No | No | | 4 (Configured)| Yes | Required | Yes | Yes (config-focused) | Yes | No | | 5 (Custom) | Yes | Full audit | Yes | Yes (full functional) | Yes | Yes |

GAMP 5 introduces a risk-based approach to validation. Instead of validating every system with the same heavy documentation, GAMP 5 categories help you: gamp 5 categories

This is the foundational software that isn't specific to your business process but is required to run your applications. | GAMP Category | URS | Supplier Assessment