Equipment
When equipment goes out of tolerance, you already know what to review.
Know at any moment whether equipment is fit for use: calibrated, clean, maintained and qualified. And when it isn’t, which results and batches it may have affected.
What it does
The whole life of your equipment, in one place.
Measuring equipment gets calibrated, production equipment gets maintained, and everything goes into a logbook that can’t be rewritten.
Calibration
- Plan per equipment with frequency, standard and points with tolerance
- Record with certificate, per-point deviation and calculated due date
- Signed approval and due-date alerts
- Retroactive impact frozen at signature
Logbook and status
- Immutable logbook of use, cleaning and out-of-service events
- Mistakes are corrected with a new entry, never by deleting
- Clean, dirty, in use or out of service status, with cleaning expiry
Maintenance and reliability
- Preventive maintenance by calendar, measured usage or variable condition
- Work orders with spare parts and signed closure
- Corrective work requires a root cause
- MTBF, MTTR and reject rate per equipment
Qualification
- IQ, OQ and PQ stages with protocols linked to an effective document
- Requalification alerts
Connected
It shares the record with the rest of the suite.
Modules aren’t integrated through exports: they work on the same batch data.
An instrument with expired calibration accepts no results.
MTMaterialsAn uncalibrated scale can’t be used for weighing.
QMSQuality managementOut of tolerance opens a quality event, linked both ways.
OEEOEE and plant monitoringPlant downtime feeds reliability and usage-based maintenance.
Compliance
Regulations it supports.
Electronic signatures and the audit trail are the same across the suite.
See the compliance matrix- GMP
- Equipment calibrated, maintained and fit for intended use.
- IQ · OQ · PQ
- Installation, operational and performance qualification, linked to the DMS.
- 21 CFR Part 11
- E-signatures on calibrations, work orders and qualifications.
See the impact of an out-of-tolerance event.
We’ll walk you through the module with a case like yours and show how it connects to what you already use.