| Pitfall | Fix | |---------|-----| | | Use vendor docs, templates, reduce non-value add tests. | | Ignoring supplier assessment | Perform vendor audit or use questionnaire (GAMP 5 Good Practice Guide: Supplier). | | Testing everything | Use risk-based testing – don't test dropdown menus, test critical data flows. | | No audit trail review | Add an SOP for periodic audit trail review. | | Treating Excel like a category 5 system | Use GAMP 5 "Appendix D3 – End-User Computing" for spreadsheets. |
| Aspect | Traditional CSV (pre-GAMP) | GAMP 5 Approach | |--------|----------------------------|------------------| | Documentation | Heavy, one-size-fits-all | Lean, risk-based, scalable | | Testing | Test everything possible | Test only high-risk areas | | Supplier role | Ignored | Leverage supplier documentation | | Change control | Rigid, slow | Risk-based change assessment | | Data integrity | Separate exercise | Built into validation |
GAMP 5 is based on several key principles: