The validity of a result depends on the equipment producing it being in working order at that moment. Therefore, equipment management is an integral part of laboratory management.
Scope
Device inventory: Brand, model, serial number, location, responsible personnel, supplier, and warranty information.
Calibration plan: Period, responsible party, internal or external calibration, reference used and traceability chain; storage of certificates attached to the device.
Validation lock: The system prevents the entry of results with a device whose calibration period has expired. This single check prevents a significant portion of the audit findings.
Qualification records: Installation, operation, and performance qualification documents must be linked to the device registration.
Maintenance and repairs: Periodic maintenance plan, fault records, service reports, and downtime tracking.
Usage log: A record of which sample and for which analysis the device was used, and by whom.
Identifying affected results: When a problem is identified retrospectively on a device, it's possible to list all results generated with that device.
Critical ability
"The last calibration of this device was invalid; which results were affected?" The goal is to be able to answer this question within minutes. In paper-based systems, this question takes weeks and is often answered incompletely.