Re: 21 CFR Part 11
Hello Steve,
It seems like NONMEM jobs are not part 11 compliant, are they? Also, PK
analyses are exploratory and cannot be predefined. The FDA asks for SAS files
and NONMEM works with text files. This also makes Part 11 less related.
Thank you,
Pavel
Quoted reply history
----- Original Message -----
From: Steve Chapel
Date: Thursday, April 19, 2007 12:07 pm
Subject: [NMusers] 21 CFR Part 11
To: [email protected]
> 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
>