Never miss a calibration. Never question your data.
Automated schedules with drift detection. Out-of-tolerance events open impact assessments on every result the instrument touched.
Calibration tracked in a spreadsheet fails on the same two days: the day a due date silently passes, and the day a calibration comes back out of tolerance. The first puts an overdue instrument in service. The second demands an answer — what did this instrument measure since its last good calibration? — that spreadsheets cannot give.
Part 820.72 makes the second failure explicit: out-of-specification equipment requires documented remedial action, including assessment of product already measured. That assessment is only fast if the linkage already exists.
Part 820.72 requires calibration per documented procedures with specified accuracy limits, records of the calibrator and date, and remedial action on out-of-specification findings. ISO 17025 requires metrological traceability to reference standards. CAP checklists require calibration verification at defined intervals and after major maintenance.
The requirement is not just doing calibrations — it is proving schedule discipline and reacting to failures with documented impact assessment. Kintavo does both: schedules escalate, and an out-of-tolerance result opens the assessment workflow your team configures — impact review, disposition, signature.
A pipette calibration comes back out of tolerance at the 10 µL point. Kintavo opens a remedial event and quarantines the pipette; the configured impact-assessment workflow routes the review to the supervisor. The disposition is documented: three runs repeated, results confirmed, no patient impact. The interval on that pipette model is shortened based on history — with the rationale on the record.
Calibration Tracking shares the same data model, AI engine, and audit trail as the other eighteen modules — so its records see, and are seen by, everything else in your quality system.
The owner is alerted before the due date, the quality manager is escalated after it, and — if you configure it — the instrument quarantines so results cannot be recorded against it.
An out-of-tolerance finding opens a remedial event automatically: impact assessment is assigned per the workflow your team configures, and disposition requires a signature. That is Part 820.72 as a workflow, not a memo.
Yes — attach the certificate to the asset with calibrator, standards used, and as-found/as-left values, keeping the traceability chain reviewable.
Yes, with the rationale documented on the asset — tightened after failures, extended with justification from history.