GAMP 5 categorizes systems into four categories based on their impact on product quality, patient safety, and data integrity:
| Aspect | GAMP 5 (1st Ed.) | GAMP 5 (2nd Ed.) | |--------|------------------|------------------| | | Waterfall, sequential | Agile, iterative, DevOps | | Software delivery | On-premise only | Cloud, SaaS, hybrid | | Validation evidence | Heavy paper documentation | Electronic, automated testing | | Data integrity | Addressed separately (DI guidelines) | Integrated throughout | | Critical thinking | Implied | Explicit requirement – avoid checkbox mentality | gamp 5