Engineering evidence, audit ready.
Preventive maintenance, calibration, SOP execution and audit logs in one controlled system.
One controlled engineering system.
Pharma engineering
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Preventive maintenance, Calibration, SOP execution, Deviations and CAPA, Electronic logbooks, Audit trail.
Held together by people and paper.
A formulation facility
- PAPERSOP sign-off sheets, two signatures each
- EXCELCalibration due dates
- LOGBOOKEquipment usage, by hand
- EMAILVendor service reports as PDFs
- BINDERDeviation records
- MEMORY“I think B-07 is due next month”
- PRINTERBatch records printed to be signed
Three causes behind the daily firefighting.
Due dates lived in a spreadsheet and in memory.
Calibration and maintenance could lapse without anyone noticing until an auditor did.
Second signatures were chased by hand.
SOP steps waited on paper sheets moving between desks.
Audit evidence took a day a week.
QA assembled the pack from logbooks, binders and emailed PDFs before every inspection.
One controlled engineering system.
Preventive maintenance
Schedules per asset, work orders on the technician’s device, history in one place.
Calibration
Every instrument, its due date, its certificate and its out-of-tolerance history.
SOP execution
Steps completed and signed in order, with the second signature requested automatically.
Deviations and CAPA
Raised where they happen, investigated, closed and linked to the asset.
Electronic logbooks
Equipment usage and cleaning logs recorded as the work is done.
Audit trail
Who did what, when and why, for every record, protected from edits.
AI drafts. Their people decide.
- Schedules calibration before it expires. The engineering head approves the schedule.
- Chases the missing second signature. The named reviewer still signs it themselves.
- Builds the audit pack on request. QA reviews it before it leaves the building.
Inspection ready, with a complete trail for every action.
Every engagement begins with a two-week diagnosis.
One workflow, two weeks. You keep the map either way.