Femto Scientific runs a single, ISO/IEC 17025 accredited calibration program across your whole laboratory — pipettes, balances, thermometers, temperature-controlled equipment, and HPLC — built for FDA 21 CFR Part 211 and Part 58 GLP. Every certificate carries documented measurement uncertainty, as-found/as-left data, and unbroken NIST traceability, so the instruments behind your batch records and stability data hold up under inspection.
- FDA 21 CFR Part 211 & Part 58 aligned records
- Documented measurement uncertainty (k=2)
- As-found & as-left data for change control
- One accredited program for the whole lab
- Data-integrity / ALCOA+ ready documentation
- NIST-traceable references for every instrument
- Onsite service with zero shipping downtime
- Electronic certificates for QMS / LIMS
One accredited calibration program your quality unit can defend against a data-integrity finding.
Why Pharmaceutical & GMP Laboratories Require ISO 17025 Accredited Calibration
In a cGMP environment every pipette, balance, thermometer, and analyzer is a measuring device whose accuracy flows directly into in-process results, batch records, stability data, and release decisions. FDA 21 CFR Part 211 sets the calibration expectations; ISO/IEC 17025 accreditation provides the documented uncertainty and NIST traceability that prove the calibration can actually demonstrate compliance.
FDA 21 CFR Part 211 & Part 58
21 CFR 211.68 and 211.160 require automatic, mechanical, and electronic equipment and laboratory instruments to be calibrated on a written schedule with established limits, and results and remedial action recorded. Our certificates capture the calibration date, results, NIST traceability, and as-found/as-left data your quality unit needs for Part 211 cGMP and Part 58 GLP calibration programs.
Data Integrity & Measurement Uncertainty
Without a reported measurement uncertainty, a certificate cannot demonstrate fitness for purpose. Accredited calibration with expanded uncertainty (k=2, 95%) gives you the attributable, accurate, and complete measurement evidence auditors expect under ALCOA+ and 21 CFR Part 11 — the difference between a calibration and an in-house verification an investigator can challenge.
Qualification & Change Control
As-found data lets an out-of-tolerance result be impact-assessed under change control before the instrument is adjusted, and supports the calibration element of IQ/OQ/PQ equipment qualification. We document every point with reported uncertainty and NIST-traceable references so your qualification and periodic-review records stay audit-ready.
One Accredited Program Across Every GMP Instrument
Instead of managing a different vendor for every instrument class, put your whole regulated fleet on a single ISO/IEC 17025 accredited calibration schedule — with consistent documentation, reported uncertainty, and NIST traceability across all of it.
- Pipettes & automated liquid handlers (ISO 8655, gravimetric)
- Analytical & precision balances (ASTM E617, OIML weights)
- Thermometers, RTDs, probes & temperature data loggers
- Incubators, ovens, autoclaves, refrigerators & freezers
- HPLC / UHPLC preventative maintenance & IQ/OQ/PQ
- As-found & as-left data with expanded uncertainty (k=2)
Start with the instruments driving your batch and stability data — pipette calibration, balance calibration, thermometer calibration, temperature calibration, and HPLC preventative maintenance — or see every service on the calibration services hub.
Pharmaceutical & GMP Laboratory Calibration FAQs
ISO/IEC 17025 laboratory calibration is performed by a laboratory that has been independently assessed and accredited as technically competent by a recognized accreditation body such as A2LA or NVLAP. An ISO 17025 accredited calibration certificate includes documented measurement uncertainty — a mandatory requirement for instrument qualification under GMP, GLP, FDA, CAP, and CLIA compliance programs. Without accreditation, a calibration certificate cannot demonstrate that the laboratory’s reference standards and measurement processes meet the technical competency requirements of these regulatory frameworks. Femto Scientific’s ISO/IEC 17025 accredited certificates are accepted by FDA inspectors, CAP surveyors, and international quality auditors as evidence of instrument performance and regulatory compliance.
A NIST traceable calibration certificate documents that the calibration results were obtained using measurement standards with an unbroken chain of comparisons to the National Institute of Standards and Technology (NIST) national measurement standards. For each instrument type, traceability is established through the appropriate measurement quantity: mass (OIML weights) for balances, volume (gravimetry) for pipettes, rotational frequency for centrifuges, and temperature (ITS-90) for thermometers. Femto Scientific uses NIST-traceable reference instruments with current calibration certificates maintained on a documented recertification schedule — ensuring your calibration documentation satisfies FDA, CAP, CLIA, and ISO requirements for measurement traceability.
Measurement uncertainty is a quantitative estimate of the doubt associated with a calibration result — the range within which the true value of the measured quantity is expected to lie, usually reported at a 95% confidence level (a coverage factor of k = 2). Every measurement carries some uncertainty arising from the reference standard, the instrument under test, the environment, and the method. An ISO/IEC 17025 accredited calibration certificate must state the expanded measurement uncertainty for each measured point, so you can judge whether the instrument’s accuracy is adequate for its application and whether it meets the tolerance required by your quality system. Documented uncertainty is a mandatory element of instrument qualification under GMP, GLP, FDA, CAP, and CLIA programs — a calibration certificate without it cannot support a defensible tolerance decision.
Calibration is the process of comparing an instrument’s measurement output against certified reference standards to determine its accuracy, document the deviation, and adjust the instrument if necessary. A calibration produces a formal certificate documenting as-found and as-left data with NIST traceability and measurement uncertainty. Verification is a check to confirm that an instrument continues to meet a specified performance criterion, typically using in-house standards or daily performance checks — it is not a calibration and does not produce an accredited certificate. Regulatory programs (GMP, CAP, CLIA) require formal calibration, not just verification, for instrument qualification and compliance documentation.
Calibration frequency depends on regulatory requirements, instrument criticality, usage intensity, and environmental conditions. As a general guideline: pipettes are typically calibrated every 3–6 months in GMP environments and every 6–12 months in research labs; balances are calibrated every 6–12 months; centrifuges are calibrated annually; and thermometers are calibrated every 6–12 months. CAP and CLIA require calibration per the manufacturer’s instructions, with CLIA calibration verification at least every 6 months for many quantitative test systems (and after reagent-lot or major-maintenance changes). GMP and GxP programs require calibration intervals to be justified in instrument qualification documentation. Femto Scientific can help you establish and document calibration intervals appropriate for your specific regulatory environment and instrument usage patterns.
Put Your Whole GMP Lab on a Defensible Calibration Program
Send us your instrument list, types, and required service level — we’ll return a quote with turnaround options and a recommended calibration interval for each instrument class in your compliance program.