(21 CFR Part 11)
The checklist below has been adapted from our reprint On Complying with 21 CFR Part 11. This article originally appeared in BioPharm Magazine in August 2000, with permission to reprint given by the publisher, Advanstar Communications.
Electronic Records (21 CFR Part 11) Implementation Checklist
FDA is in the process of revising the Part 11 regulation.
Their current thinking about the rule, including their approach to
enforcing the regulation, is defined in their guidance, Guidance for Industry: Part 11, Electronic
Records, Electronic Signatures -- Scope and Application.
In January 2004, we were asked to write an article explaining the
agency's new approach, as well as to provide practical tips on how to
comply with the regulation, for Medical
Device & Diagnostic Industry. That article, Part 11:
New Guidance Provides Little Guidance, is available on
Three of our favorite Part 11 resources were published by the Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineers (ISPE). This Good Practice and Compliance for Electronic Records series has three volumes:
* Part 1, Good Electronic Records Management
Although Part 1 was published before the agency began
approach to Part 11, these guides contain useful information, and are
highly recommended. They may
be purchased online via the PDA
The following checklist is not an all-inclusive list, nor is
it the only approach
implementing Part 11. Your approach may vary.
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