GxP calibration · ISO/IEC 17025 traceable · 21 CFR 211.68
Calibration management software that flags out-of-tolerance instruments and the batches they touched — with every reading on record.
Every regulated plant runs on measurements — balances, thermometers, pressure gauges, pH meters, torque wrenches, HPLC detectors. When an instrument drifts out of tolerance, the batches it touched since its last good calibration are suspect. V5 replaces the calibration spreadsheet plus the paper certificates plus the OOT investigation folder with one live register that schedules, records, investigates and impact-assesses in one file.
Instrument Register with Criticality & Tolerance
As-found / as-left readings with signed capture
Traceability to National Standards
External vendor certificates as first-class records
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You're shopping because calibrations are tracked in a spreadsheet, OOT events don't trigger a batch impact review, and inspectors keep finding overdue instruments in use.
The calibration schedule lives in a spreadsheet — nobody knows it's overdue until QA finds it during a walk-through
External certificates are PDFs in a folder — no as-found data, no traceability to the standard used
An out-of-tolerance reading gets a sticker change but no impact assessment on batches released since the last good cal
Instruments in use without a current calibration sticker are a repeat 483 / Form 8 observation
You can't answer 'which batches did instrument X touch between date A and date B?' without a database dive
Calibration technicians re-key readings from a certificate — transcription errors show up during audit
Calibration, run as one live register.
Instrument Register with Criticality & Tolerance
Every instrument carries make/model/serial, location, GxP criticality, calibration frequency, acceptance tolerance, measurement range, and the standard(s) it must be checked against. The register is the source of truth for the schedule, the batch record, and the audit.
As-found / as-left readings with signed capture
Calibration events capture as-found (before adjustment) and as-left (after adjustment) readings at each check point, with the reference standard's cert number and expiry. Readings are entered directly against the record — no transcription from a paper certificate.
Traceability to National Standards
Every calibration links to the reference standard used (in-house or external) and that standard's chain of traceability to a national metrology institute (NIST, NPL, PTB).
External vendor certificates as first-class records
When a vendor performs the calibration, their certificate is attached as a controlled record — but the as-found/as-left numbers are still entered as structured data, not left as a PDF. The register stays queryable, the certificate stays defensible.
What changes the day this goes live.
- Every measurement is traceable to the reference standard used and that standard's chain to a national institute
- Inspector asks for the last five calibrations of balance BAL-042 and gets them with as-found/as-left data
- Vendor certificates are structured records, not PDFs in a folder
The frameworks a calibration owner has to satisfy.
21 CFR 211.68 · EU GMP Ch.3
EU GMP Chapter 3 equipment requirements.
ISO/IEC 17025:2017 §6.4 · §6.5
Equipment used for testing that has significant influence on results shall be calibrated when measurement accuracy or uncertainty affects validity, or before being placed in service; metrological traceability established via an unbroken chain to the SI.
USP <41>, <1251> · Ph.Eur. 2.1.7
Balances used for materials to be accurately weighed require calibration with appropriate references; repeatability and accuracy against defined criteria; procedures for daily performance checks and periodic calibration by qualified personnel.
Calibration management software, answered.
How does V5 stop an out-of-cal instrument from being used?
The batch record and LIMS test entry reference instruments by ID. When a step or test is opened, V5 checks the instrument's current calibration status. Operators can't override without a documented deviation and QA release — the sticker is no longer the enforcement mechanism.
How does V5 handle out-of-tolerance investigations?
QA sees the impact scope immediately — every potentially affected batch, test result, and released lot — and can decide on quarantine, retest, or investigation without a manual database dive.
Does V5 handle both in-house and external calibrations?
Yes. In-house calibrations are performed against reference standards in your register, with as-found/as-left data entered directly. External calibrations attach the vendor certificate as a controlled record, but the as-found/as-left readings and reference standard traceability are still captured as structured data. Both paths produce the same queryable record — you don't lose fidelity when a vendor touches the instrument.
How does V5 handle reference standard traceability to the SI?
Every reference standard in the register carries its issuing lab, certificate number, expiry, and the national metrology institute that anchors its chain (NIST, NPL, PTB, etc.). When you calibrate a working instrument against that standard, the traceability chain is captured on the calibration record — so an auditor asking 'trace this measurement back to a national standard' sees the chain without a document hunt.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
Run GxP calibration on one live register.
Free trial. Real instrument register, real OOT engine, real batch impact scope.