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21 CFR Part 11

From: Steve Chapel <steven.chapel>
Date: Thu, 19 Apr 2007 10:45:20 -0400

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!

Received on Thu Apr 19 2007 - 10:45:20 EDT

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