Part 11 Compliance Policy Guide

WITHDRAWN BY FDA Feb 2003 as not representative of their current thinking

FDA’s Office of Regulatory Affairs updated their compliance policy guide to include guidance for enforcement of 21 CFR Part 11 Electronic Records;Electronic Signatures. This together with the transfer of Paul Motise (the lead author and advocate of this regulation) from CDER to ORA and news of a training program for a large group of inspectors indicate enforcement activity for this regulation is ramping up.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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