FDA 21 CFR Part 11 Compliance and Validation of Titrator Software

In food and drug labs analytical devices, such a titrators, typically work with software and computers. In most cases the titration software is part of the device and produces so called “electronic records”. These records are subject to FDA regulations. As a result, software in a FDA compliant lab has to be 21 CFR part 11 compliant. This publication explains the important requirements and practical validation process for titrator software.

FDA 21 CFR Part 11 compliance and validation of titrator software

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