📍 GAMP 5 removed Category 2, merging many of those elements into Category 1 or 3 to simplify the validation path for hardware-linked software. Why the Change Matters
Viewed validation as a "one size fits all" checklist. gamp 4 vs gamp 5 difference
Treated suppliers as external entities to be audited. 📍 GAMP 5 removed Category 2, merging many
| Aspect | GAMP 4 | GAMP 5 | |--------|--------|--------| | | Validation as a linear phase | Risk-based lifecycle management | | Software categories | 5 (including Category 2 Firmware) | 4 (Category 2 removed) | | Documentation | Prescriptive, heavy | Scalable, lean, risk-based | | Data integrity | Implicit | Explicit (ALCOA+) | | Development model | Waterfall-centric | Agile, iterative friendly | | Supplier docs usage | Limited | Encouraged (leveraging) | | Mindset | Compliance-driven | Critical thinking & risk-driven | | Aspect | GAMP 4 | GAMP 5