RE: 21 CFR Part 11
If you're looking to add Part 11 compliance to your NONMEM environment, check
out the benefits of SmartPK at the following links:
http://www.clinapps.com/Products/Products_clinapps.html
http://mail1.clinapps.com/Products/Products_clinapps.html
http://www.clinapps.com/Brochure/SmartPK_Benefits.pdf
Some of the regulatory benefits include:
* Tracking and storage of all input/output files in a hierarchical model
* Database auditing of all activities for improved regulatory compliance
* Mulitple levels of security, including LDAP and project/study-level
blinding
* Configurable for use with electronic signature
Other features:
* Easy-to-use, web-based, graphical user interface
* Free up your desktop CPU
* Batch load hundreds of NONMEM runs at a time
* Create and run non-parametric bootstrap data sets at the touch of a
button
* View INTER files while runs are in progress
* Email notification of run completion
* Diagnostic plots and parameter comparisons at your fingertips
-Terri
Terri Fisher
Clinapps, Inc.
www.clinapps.com
mailto:[EMAIL PROTECTED]
_____
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
>
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