NONMEM Users Network Archive

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Re: 21 CFR Part 11

From: Steve Chapel <steven.chapel>
Date: Thu, 19 Apr 2007 17:55:37 -0400

No, part 11 doesn't seem to say anything about file formats, predefined
analyses, or which documents fall under its regulations. Instead, it
establishes the equivalence of electronic documents to paper documents.
It says the electronic copies are equivalent to the paper copies as long
as the regulations in 21 CFR part 11 are followed. To summarize the
basic requirements, any operation that creates or changes a document
must be logged. The closest equivalent I can think of is a wiki, where
you can view the history of a document to see each edit of a file, and
who performed the edit and when, as in
Another example might be a version control system such as CVS
<>. That's not to
say that you'd want to actually use a standard wiki or version control
system to attempt to meet 21 CFR part 11 requirements, but that might be
a simple way of thinking about a system that you could use to log
changes. 21 CFR part 11 also contains requirements for ensuring the
system is secured against unauthorized use and for electronic signatures
that are equivalent to handwritten signatures.

-- Steve

> 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
Received on Thu Apr 19 2007 - 17:55:37 EDT

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