CMMS for GMP maintenance: assets, preventive plans, work orders and reliability
The QLogix CMMS is a computerized maintenance management system built on the same audited, signed records as the quality system. Every asset carries its criticality, GxP impact, qualified state and preventive maintenance plan; every work order is requested, planned, assigned, executed with its tasks, labour, parts, downtime and findings, assessed for GxP impact and verified for return to service with electronic signatures. From that history the module computes each asset's reliability and lifecycle stage and predicts when it will fail next.
What the module does
- An asset register with tag, type, location, system, criticality, GxP impact, qualification reference and requalification date, commissioning date, operating hours and run-hour counter.
- Preventive maintenance plans per asset, drafted by the AI from the manual and the maintenance procedure, with tasks, intervals and the rationale; each task raises its work order when due.
- Work orders of six types: preventive, corrective, calibration, inspection, emergency and modification, with priority and target response, assignment, tasks with acceptance criteria, labour, parts, downtime and findings.
- Completion verification: the GxP impact assessed, requalification or a deviation raised where needed, and the verifier's signature on the return to service.
- A maintenance dashboard: PM compliance, the state of every preventive cycle, work by type, status and priority, completed work with downtime and labour, failure codes and requalifications due.
- Reliability and lifecycle per asset from the work orders: mean time between failures, mean time to repair, availability, the failure trend, a Weibull fit once there are enough failures, the predicted next failure and the preventive interval that would catch it.
- Alerts for overdue work and preventive tasks, assets predicted to fail, and preventive tasks scheduled after the predicted failure; an AI advisory that drafts the plan changes and the replacement cases.
- Decommissioning under change control: the close-out withdraws the asset's documents, deactivates its plan, cancels its open work orders, retires its instruments' calibration records and lists the controlled documents to obsolete, each step audited with the change control's reference.
How it fits the platform
A work order that finds a failure opens a deviation investigation with the findings already written. A modification goes through change control, and a change that affects the qualified state links to the validation project that requalifies it. The instruments and gauges mounted on an asset keep their calibration records in the calibration module, linked to the asset both ways, so an out-of-tolerance calibration counts toward the asset's reliability. Run-hour counters can be sent from a PLC, SCADA or MES through the REST API, so operating time is measured rather than estimated.
Everything is one record graph: the inspector follows the link from the work order to the deviation to the change control to the requalification, and back to the asset, without a spreadsheet.
Where people decide
The AI proposes maintenance plans, classifies work and drafts the advisory; the maintenance engineer sets the plan, the technician records the work, and the verifier signs the return to service. Nothing changes an interval, closes a work order or returns an asset to service without a named person and a reason.
Questions about CMMS
Does the CMMS replace our existing maintenance system?
It can, or it can run alongside it. Assets and work orders live in QLogix as audited records; a run-hour counter or a work order feed from another system comes in through the REST API with the source named in the audit trail.
How does predictive maintenance work without sensors?
From the work orders: corrective and emergency work counts as failures, their downtime as unavailability. With operating hours per day or a counter reading the figures are in operating time; with four failures the Weibull fit says whether the asset is wearing out and where the preventive interval should sit.
Is the return to service signed?
Yes. Completion verification is a review and approval cycle with electronic signatures under 21 CFR Part 11: the verifier records the outcome, the GxP impact and any requalification, and signs.
What happens when an asset is decommissioned?
It leaves service only under an approved change control. The close-out withdraws every document on the asset and on its open work orders, deactivates the preventive plan, cancels the open work orders, retires the linked calibration records and lists the controlled documents to obsolete. Nothing is deleted: the records and their audit trails stay, and verified work orders keep their documents as evidence.
How is it licensed?
Per user per month, on its own or with other modules, ordered by purchase order from the client portal. There is no card payment or self-serve plan.
Reading
Other modules
- Calibration managementEvery instrument, tool and gauge: an approved requirement, readings judged by the system and reviewed by a second person, out-of-tolerance impact signed by QA.
- Project managementPrograms and projects on audited records: AI-drafted plans with work breakdown, resources, risks, baseline, critical path and earned value, signed at approval.