Risks are identified and mitigated using data.
| | GAMP 4 | GAMP 5 | |------------|-------------|---------------| | Approach | One-size-fits-all | Scalable, risk-driven | | Mindset | “Validate everything” | “Validate what matters” | | Key driver | Compliance checklists | Product quality & patient safety | gamp 4 vs gamp 5
Best for a detailed comparison or educational context. Risks are identified and mitigated using data
Example: User access review, audit trail verification, and backup validation are now explicit requirements, not afterthoughts. audit trail verification