traceable calibrations, FDA regulations, FDA regulation training, FDA pharmaceutical regulation, 21 CFR Part 820, calibration standards, ISO calibration, FDA cGMP regulations, FDA compliance, FDA cGMP, paperless records, 21 CFR Part 11, calibration procedures, calibration traceability, quality calibration program, a paperless calibration department that meets biotech, pharmaceutical, and medical device reqirements, paperless calibration compliance for national and international standards and regulations, virtual calibration workshops

Learn

Paperless Calibration Compliance

two ways:

By the book, or virtual workshop

 

Paperless Cal Dept.      Virtual Workshop

Our next workshop entitled:

Unravel the mystery of paperless calibration compliance for ISO standards & FDA regulations 

will be held during the fall/winter time frame, more information to come.

For information on the workshop Click Me

Welcome to Bucherview Metrology Services

The mission of Bucherview Metrology Services is to help companies achieve a quality calibration program, either in developing a new system, implementing one that is in progress, or helping to manage and/or improve your current calibration program. Please refer to our services section to see how we might be able to help you. Our consulting services include how to meet the calibration requirements needed within Biotech, Pharmaceutical, Medical Device, and Healthcare companies. In-house calibrations are easily accomplished by calibration/metrology departments and can be highly self-sufficient with the proper quality calibration program in place.

 

We specialize in helping companies to meet ISO 9001:2008 and ISO 13485:2003 standards for calibration compliance; and the following calibration requirements for FDA regulations:

  • 21 CFR Part 58 (GLP for Nonclinical Laboratory Studies),

  • 21 CFR Part 110 (cGMP in Manufacturing...human food equipment),

  • 21 CFR Part 211 (cGMP for Finished Pharmaceuticals),

  • 21 CFR Part 606 (cGMP for Blood and Blood Components),

  • 21 CFR Part 820 (the Quality System Regulation - QSR - cGMP for Medical Devices)

Our paperless calibration record system also meets 21 CFR Part 11 (electronic records and electronic signatures) requirements.

 

Two books that may be of interest are Paperless Calibration Compliance for National and International Standards & Regulations; and

A Paperless Calibration Department That Meets Biotech, Pharmaceutical, & Medical Device Requirements.