CMMS

A computerised maintenance management system schedules, dispatches and records maintenance and calibration against an asset register. In a regulated plant that makes it a quality record system whether or not anyone has classified it as one: the evidence that a critical instrument was calibrated before the batch it measured, and that a qualified system was maintained in its qualified state, lives here rather than in the quality system.

The consequences follow. Calibration status has to be trustworthy and current, because an out-of-tolerance result found at the next calibration puts every measurement since the last one in question — and answering that question requires knowing exactly which batches the instrument touched. An asset register that is incomplete, or whose criticality flags are stale, makes that impact assessment an estimate.

Because it holds GxP-relevant records, the system itself carries the expectations any such system does: attributable entries, a protected audit trail, controlled access, and change control over the schedules and tolerances it enforces. A CMMS administered informally by the maintenance group is a common and invisible gap.

• —Holds the evidence that qualified systems stayed qualified and critical instruments stayed calibrated.
• —Out-of-tolerance at calibration triggers impact assessment over every measurement since the last one.
• —The asset register and its criticality flags determine whether that assessment is defensible.
• —A GxP record system in practice: attributable entries, protected audit trail, controlled access.
• —Schedules and tolerances are configuration and belong under change control.

EU GMP Annex 11; EU GMP Part I Chapter 3 (equipment maintenance); 21 CFR 211.67 and 211.68; ISPE GAMP 5 (2nd ed., 2022).