Gamp5 Category ★ Tested & Top-Rated

Auditors (like the FDA or EMA) expect to see a rationale for why you tested a system the way you did. The GAMP categories provide that rationale. Summary Table Complexity Validation Effort 1 Infrastructure Record version/Installation 3 Non-Configured Verify against URS 4 Configured Test configurations & workflows 5 Full lifecycle (Design + Code + Test) Conclusion

Code written specifically for you. This is the highest risk. gamp5 category

Using GAMP 5 categories allows companies to follow a . Auditors (like the FDA or EMA) expect to