# Calibration management software for instruments, tools and gauges
QLogix calibration management keeps one audited record per instrument, equipment, tool, gauge, test equipment, sensor or reference standard under calibration. The calibration requirement, drafted by the AI from the manual and previous certificates, is approved with electronic signatures before the asset is relied on. Each calibration is recorded with as-found and as-left readings judged against the tolerances as they are entered, reviewed and signed by a second person, and kept with its certificate; an out-of-tolerance reading opens the impact assessment and QA signs the decision.
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## What the module does
- An asset record with identification, criticality (GMP critical, GMP, Non-GMP), location, responsible person, description and use, and the maintenance asset it belongs to.
- A calibration requirement per asset: interval and its basis, procedure or method, test points with nominal values and tolerances over the range of use, traceability of the standards, provider, acceptance criteria, the out-of-tolerance rule and the rationale; AI-drafted, edited by the metrologist, approved in review and approval.
- Calibrations recorded with who, when, procedure, standards used, environment, the as-found and as-left reading at every test point judged by the system, the result, the certificate number and file, the work order, and the next due date kept by the system.
- Second-person review of each calibration, signed with the reviewer's password; only a reviewed calibration counts for the asset's due date and service.
- Out-of-tolerance handling: the impact assessment drafted by the AI from the readings, the earlier calibrations and the linked records; QA's decision signed; the investigation linked.
- Service status with a reasoned history, retirement as the final approval, locked PDF exports, and a dashboard with compliance, the state of every calibration cycle and what falls due each month.
- Alerts for assets due, overdue or failed, calibrations awaiting review, and out-of-tolerance results without a decision.

## How it fits the platform
A calibration record belongs to a CMMS asset when the site keeps one, so the instrument's calibrations and the equipment's work orders read as one file, and a calibration work order records its calibration once. An out-of-tolerance result opens an investigation in the quality system with the impact assessment attached. The LIMS locks out an instrument whose calibration has expired. The tolerances the AI proposes come from the process tolerance the reading serves, which it reads from the asset's description and the linked records.

## Where people decide
The AI drafts the requirement and the impact assessment; the metrologist approves the requirement, the technician records the calibration, a second person reviews and signs it, and QA signs the out-of-tolerance decision. The asset's due date is computed by the system from reviewed calibrations and never typed.

## Where people decide
- The calibration requirement is approved in review and approval before any calibration is recorded against it; changes afterwards need a reason.
- Each calibration is reviewed and signed by a person other than the one who recorded it.
- The out-of-tolerance decision is taken and signed by a person other than the recorder, with the impact assessment on record.

## Built to
- 21 CFR 211.68 and 211.160(b)(4)
- 21 CFR 820.72
- EU GMP Chapter 3
- ISO/IEC 17025 for the laboratories used
- ISO 10012 measurement management
- 21 CFR Part 11 and EU GMP Annex 11

## Licensing
Per user per month, on its own or with other modules, ordered by purchase order from the client portal. Every module writes to the same audited records.
[Ask for a quote](https://qlogix.ai/contact)

## Questions about Calibration management

### How are tolerances judged?

As the readings are entered, against the point's tolerance written as ±x, ±x % or +a/-b, in the point's unit or a convertible one. An as-found reading out of tolerance can only be recorded as a pass after adjustment or a fail; an as-left reading out of tolerance as a fail or a pass with limitation.

### What happens when a reading is out of tolerance?

The calibration appears under out-of-tolerance results with the decision pending. The AI drafts the impact assessment for the period since the last good calibration; the assessor edits it, QA signs the decision with a reason, and an investigation is linked where a result, a batch or a validated state may be affected.

### Can calibrations come from an external laboratory's certificate?

Yes. The certificate is attached to the record and linked to the calibration; the readings are entered from it and judged by the system; a second person reviews them against the certificate and signs.

### How is it licensed?

Per user per month, on its own or with other modules, ordered by purchase order from the client portal.

## Reading
- [Predictive maintenance in GMP: how CMMS, calibration and reliability data decide when equipment is serviced, calibrated and replacedA preventive interval copied from a manual is a guess. The work orders, downtime and calibration results a site already records contain the answer: mean time between failures, avai…](https://qlogix.ai/blog/predictive-maintenance-cmms-calibration-gmp)
- [Connecting LIMS to investigations and CAPA: how AI speeds up OOS investigations and strengthens complianceMost OOS investigations lose their first days to gathering: the result, the raw data, the instrument's calibration, the standard's expiry, the analyst's history, the trend. When th…](https://qlogix.ai/blog/lims-investigation-capa-integration-ai)

## Other modules
- [CMMSA GMP CMMS on audited records: assets with preventive plans, work orders verified for return to service, and reliability and predicted failures from the history.](https://qlogix.ai/products/cmms)
- [Project managementPrograms and projects on audited records: AI-drafted plans with work breakdown, resources, risks, baseline, critical path and earned value, signed at approval.](https://qlogix.ai/products/project-management)

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Source: https://qlogix.ai/products/calibration-management
QLogix · contact@qlogix.ai · +17146639012