NONMEM Users Network Archive

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RE: 21 CFR Part 11

From: tjfisher
Date: Thu, 19 Apr 2007 13:54:00 -0700

If you're looking to add Part 11 compliance to your NONMEM environment, =
check out the benefits of SmartPK at the following links: =
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 =
* 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 =
* View INTER files while runs are in progress
* Email notification of run completion
* Diagnostic plots and parameter comparisons at your fingertips

Terri Fisher
Clinapps, Inc.


From: owner-nmusers
On Behalf Of nonmem
Sent: Thursday, April 19, 2007 12:57 PM
To: Steve Chapel
Cc: nmusers
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,

----- Original Message -----
From: Steve Chapel
Date: Thursday, April 19, 2007 12:07 pm
Subject: [NMusers] 21 CFR Part 11
To: nmusers

> 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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Received on Thu Apr 19 2007 - 16:54:00 EDT

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