21 CFR Part 11

From: Steve Chapel Date: April 19, 2007 technical Source: mail-archive.com
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. I've found numerous references to this document, but I cannot seem to locate where I can obtain a copy of that document itself. It is available on the web? If so, could someone provide a direct link to the document itself? Do I need to order a copy? If so, can someone provide the details of ordering it? On a related note, where can I find the FDA regulations on software validation for drug development? I found a very useful document from the FDA, but it is only a set of general principles and not the regulations themselves, and they apply to medical devices instead of drug development. I'm a software engineer relatively new to the field of drug development, and I find many instances of people referring to "validation" and "audit trails", but mysteriously I cannot find the actual FDA regulations I'm supposed to be following. Any help would be greatly appreciated! Thanks, Steve
Apr 19, 2007 Steve Chapel 21 CFR Part 11
Apr 19, 2007 Anthony J. Rossini Re: 21 CFR Part 11
Apr 19, 2007 NONMEM Re: 21 CFR Part 11
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Apr 19, 2007 Tjfisher RE: 21 CFR Part 11
Apr 20, 2007 Anthony J. Rossini Re: 21 CFR Part 11
May 06, 2007 David Garbutt Re: 21 CFR Part 11
May 09, 2007 Andreas Krause RE: 21 CFR Part 11
May 09, 2007 Anthony J. Rossini Re: 21 CFR Part 11