Systems & integration
Asset lifecycle management
alm · equipment lifecycle management
TL;DR
End-to-end management of regulated equipment from procurement and qualification through calibration, PM, change control, retirement and disposal.
ALM treats every piece of GMP-relevant equipment as a regulated asset with a lifecycle file: URS, FAT/SAT, IQ/OQ/PQ, calibration history, PM history, change control log, deviations, requalification events, and end-of-life decommissioning record. EU GMP Chapter 3 and 21 CFR 211.63–211.72 are the regulatory anchors.
In V5 the equipment record threads through dispense, batch records, calibration, deviations and audits — pulling an equipment ID returns the full lifecycle in one view.
Regulatory anchors
- 21 CFR 211.63–211.72
- EU GMP Chapter 3
- ISO 13485 §6.3
Related terms
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