Software solution
CMMS for Pharma Plants: Built for GAMP 5 Compliance
Equipment maintenance management per PIC/S GMP & GAMP 5
Paper logs and spreadsheets no longer hold up for pharma equipment maintenance. Here's how a GAMP 5-validated CMMS removes audit findings at the root.
Read the full articlePillar outline
- 1Regulatory baseline: why Annex 11 & GAMP 5 require validated CMMS
- 2CMMS for pharma: 3 real audit-finding scenarios
- 3Auditor lens: what inspectors check in maintenance history
- 4Case study: CMMS rollout at a tableting plant
- 5Reference table: item — requirement — evidence — system link
- 6Conclusion + 4 action items this week
In-cluster deep dives
Cluster articles that link up to this pillar (in editing).
audit trail bảo trì thiết bị 21 CFR Part 11
Exactly what FDA checks in tableting-machine repair logs
Coming soonhiệu chuẩn thiết bị GxP tự động
Prevent cold-storage temperature drift with auto calibration scheduling
Coming sooneLogbook điện tử ALCOA+
Contemporaneous recording replacing paper logs
Coming soonthẩm định CMMS GAMP 5 Category 4
URS → IQ/OQ/PQ for a Configured Product
Coming soon