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 and Pharmaceutical 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 - Medical Devices)

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

Three books that may be of interest are The Quality Calibration Handbook; Paperless Records: Designing and Creating Your Own Electronic Forms; and Ethics - The Final Frontier.

Coming soon: Paperless Calibration Compliance for National and International Standards & Regulations.(click to view book cover)