RE: 21 CFR Part 11
Here is the link to the FDA guidance. Note that it does not
differentiate between SAS files or any other software. Nor does exclude
analyses that are not predefined. I think this is something we will all
need to deal with.
thanks
mike
www.fda.gov/cder/guidance/5505dft.pdf
Quoted reply history
________________________________
From: [EMAIL PROTECTED] [mailto:[EMAIL PROTECTED]
On Behalf Of [EMAIL PROTECTED]
Sent: Thursday, April 19, 2007 12:57 PM
To: Steve Chapel
Cc: [email protected]
Subject: Re: [NMusers] 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
----- 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
>
______________________________________________________________________
This email transmission and any documents, files or previous email
messages attached to it may contain information that is confidential or
legally privileged. If you are not the intended recipient or a person
responsible for delivering this transmission to the intended recipient,
you are hereby notified that you must not read this transmission and
that any disclosure, copying, printing, distribution or use of this
transmission is strictly prohibited. If you have received this transmission
in error, please immediately notify the sender by telephone or return email
and delete the original transmission and its attachments without reading
or saving in any manner.