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Industries

Calibration management for your industry

Every regulated industry answers to different auditors, but the calibration work is the same: traceability, status, records, and acting when something drifts. See how Axiospec maps to yours.

For medical device manufacturers

Medical Device Manufacturing

In medical device manufacturing, a single measurement can decide whether a product is safe to ship, so your calibration records have to satisfy a notified body and an FDA investigator alike. ISO 13485 clause 7.6 and FDA's Quality Management System Regulation (QMSR) under 21 CFR 820 both require you to control measuring equipment, keep it traceable, and prove that a drifted instrument did not send suspect product into the field. Axiospec gives device manufacturers documented, attributable calibration records, a tamper-evident audit ledger, and reverse traceability from any instrument to the measurements and product it touched, so those records exist by default instead of getting rebuilt the week before an audit.

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For aerospace and defense suppliers

Aerospace & Defense

In aerospace and defense, one out-of-tolerance gage can put suspect parts on a flight-critical assembly. Primes and defense customers expect calibration records that trace back to national standards, survive AS9100 and Nadcap audits, and show exactly which parts each instrument measured. Axiospec is cloud calibration management software that keeps that history in one place. You log as-found and as-left readings with automatic pass/fail, issue PDF certificates, and keep a tamper-evident ledger you can hand an auditor in one click. Axiospec documents and organizes the work. Your registrar or auditor decides conformance.

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For automotive suppliers

Automotive Manufacturing

In automotive manufacturing, every gauge in your control plan feeds a dimension a customer will hold you to, and IATF 16949 section 7.1.5 expects calibration and verification against traceable standards, measurement systems analysis on those gauges, and records that show the status of each one. When a gauge drifts, the question is not only what to recalibrate but which parts it measured. Axiospec gives automotive suppliers one system to keep measuring resources under control, capture the data behind every calibration and MSA study, and produce records a customer or IATF third-party auditor can follow from the instrument back to the reference standard.

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For pharma and life sciences quality teams

Pharmaceutical & Life Sciences

In pharmaceutical and life sciences manufacturing, the instruments that measure temperature, pressure, weight, and pH sit directly on top of product quality and patient safety. Regulators expect that equipment to be calibrated, traceable, and backed by records that hold up under GMP inspection and 21 CFR Part 11 scrutiny, where attributable, tamper-evident data integrity is the whole point. Axiospec gives you one system to schedule calibrations, capture as-found and as-left readings with automatic pass or fail, and keep every event on a tamper-evident ledger you can hand to an inspector. It is a documentation and workflow tool, so the conformance call stays with your quality unit and your inspectors.

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