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SoftwareCPR has prepared an audit checklist for assessing compliance with 21 CFR Part 11 Electronic Records and Electronic Signatures regulation. The checklist is intended for use by expert assessors knowledgeable in the regulation, its preamble, history, and current enforcement practices. The checklist was modified March 2003 to reflect issues related to Part 11 redirection issued in Feb 2003. View the checklist at . . .
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