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Maintenance module — live

Preventive maintenance connected to the same quality record as the batches it touches.

Maintenance Management schedules preventive maintenance by equipment criticality, logs every work order and downtime event against the asset's full history, and can automatically flag a piece of equipment for re-qualification after major maintenance is performed.

21 CFR §211.67 21 CFR §211.68 EU GMP Annex 15
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Regulatory basis

Maintenance history is part of the equipment's quality record — not a separate facilities log.

An investigator tracing a deviation back to equipment will ask for maintenance history in the same breath as calibration history — this module keeps both on the same asset record.

21 CFR §211.67

Equipment Cleaning and Maintenance

Requires written procedures for the cleaning and maintenance of equipment, at appropriate intervals, to prevent malfunctions or contamination.

21 CFR §211.68

Automatic, Mechanical & Electronic Equipment

Extends the same expectation of routine maintenance and inspection to automated and computerised equipment, with maintained records.

EU GMP Annex 15

Qualification & Validation

Major maintenance or repair of a qualified system can require re-qualification — a link this module flags automatically rather than relying on someone to remember.

NOTE The module tracks schedules, work orders and re-qualification flags. Determining whether a specific repair requires re-qualification remains an engineering and QA judgment.
Why teams use GxP Technology

Maintenance history that's part of the quality record, not next to it.

When equipment is implicated in an investigation, the question is always the same: what was its condition, and when was it last worked on. This module answers that in seconds.

Preventive schedules by criticality

Maintenance intervals are set based on how critical each asset is to product quality — not a flat calendar reminder for everything.

Every work order tied to the asset record

Work orders, parts used and technician notes log directly against the equipment's permanent history — visible alongside its calibration and qualification status.

Downtime tracked by cause

Downtime events roll up by asset and by cause, so a recurring failure pattern is visible before it causes a batch impact.

Re-qualification flagged automatically

Major maintenance or a repair above a defined threshold can automatically flag the asset for re-qualification review.

See maintenance history on a live equipment record.

We'll show preventive scheduling, work order logging and the automatic re-qualification flag, using an equipment type from your own facility.

hr@gxptechnology.com