NONMEM Users Network Archive

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Re: 21 CFR Part 11

From: Steve Chapel <steven.chapel>
Date: Thu, 19 Apr 2007 13:51:57 -0400

I've received a request to post the URL of this document, as others are
also apparently having trouble finding it.

Here's the main FDA page where I found the document:
http://www.fda.gov/ora/compliance_ref/part11/
On that page, the document is listed under the link "Final Rule" (in the
Background section).

The document itself comes in different formats:
HTML:
http://www.fda.gov/ora/compliance_ref/part11/frs/background/11cfr-fr.htm
PDF:
http://www.fda.gov/ora/compliance_ref/part11/FRs/background/pt11finr.pdf

Note that the majority of this document is clarification on the
regulations. The regulations themselves are found at the very end. If
you can find section 11.10k(2) "Revision and change control procedures
to maintain an audit trail...", you've found it!

-- Steve


Steve Chapel wrote:
> I'm looking for the document from the FDA called the "21 CFR Part 11,"
> which are the regulations for the handling of electronic records and
> signatures required by the FDA.
Received on Thu Apr 19 2007 - 13:51:57 EDT

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