In this article, you will learn when is necessary an instrument calibration according to the ISO/IEC 17025 Testing and Calibration Laboratories and FDA requirements. Calibration is needed whenever an instrument is added or modified in the manufacturing process, procedures, batch record instructions, specifications, equipment settings, validated process, material, product, etc. More specifically, a calibration must be considered if you add, modify, or impact any instrument or equipment related to the measurement in the following areas:
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httpss://www.law.cornell.edu/cfr/text/21/58.63 40 CFR § 160.63 – Maintenance and calibration of equipment.
httpss://www.law.cornell.edu/cfr/text/40/160.63 For more information about when is necessary an instrument calibration, refer to:httpss://whatis.techtarget.com/definition/calibration-management-software |