NONMEM Users Network Archive

Hosted by Cognigen

Re: 21 CFR Part 11

From: Steve Chapel <steven.chapel>
Date: Thu, 19 Apr 2007 12:41:13 -0400

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. 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
Several people pointed me to the sites and even the specific document I
found and printed; finding those sites and even that specific document
was relatively easy. The problem was that when I read that document, I
found it referred to certain sections of the rule, but I could not find
the sections themselves. In desperation, I turned to the back thinking
there might be some information about where to find the sections, and
there they were on the last three pages! I would not have thought to
look for them there. Is that normal in federal regulations to put the
meat of the material in the back? I'm not complaining, just asking so
I'll know where to find the regulations in the future.

-- Steve
Received on Thu Apr 19 2007 - 12:41:13 EDT

The NONMEM Users Network is maintained by ICON plc. Requests to subscribe to the network should be sent to:

Once subscribed, you may contribute to the discussion by emailing: