From: "Phil Jackson"
Subject: [NMusers] Part 11 compliance
Date: Mon, 08 Aug 2005 00:56:49 +0000

Anybody have any opinions on how to achieve 21 CFR Part 11 compliance for NONMEM?



From: "Simon Davis"
Subject: RE: [NMusers] Part 11 compliance
Date: Mon, 8 Aug 2005 06:52:58 -0700

Pharsight has addressed the 21 CFR Part 11 issue for NONMEM (and SAS and WinNonlin)
using its commercial product PKS, a regulatory-compliant data repository.  In short, PKS
connects to underlying lab and other data systems using compliant Connectors.  PKS
distributes data to analytical applications including NONMEM using a regulatory-compliant
NONMEM Client.  NONMEM analyses are linked to the source data, and flagged as out of date
when the source data change.  One can store scripts and other analysis files as PKS
libraries to share them across studies and analyses. 

There is more information available at

Best regards,
Simon Davis
Senior Scientific Consultant
Mobile       : +44 7980 832 666
Facsimile    : +1  801 991 7145
Home Office  : +44 113 274 1198.

From: "Terri J. Fisher"
Subject: RE: [NMusers] Part 11 compliance
Date: Mon, 8 Aug 2005 09:30:09 -0700

Hi Phil,

Without a doubt, the most advanced choice for this is a product called SmartPK developed
by Clinapps, Inc.  This web-based software brings 21 CFR Part 11 compliant, electronic
recordkeeping to your NONMEM environment.  All input and output files are stored electronically
in read-only format, including the data and control stream files used to produce the results.
Full audit trail capability captures a record of each transaction in a relational database.

In addition to being able to create user accounts and assign roles to control project/study
level access, Smart PK v2.0 allows you to move your NONMEM analysis from the desktop to a
clustered server environment, allowing you to execute multiple runs simultaneously, accelerating
your modeling and analysis process.  This is similar to GRID computing, but at a fraction of
the cost with an advanced user interface that is specific to NONMEM.

Here are just a few of the other advanced features that Smart PK v2.0 provides:
 - Batch load thousands of NONMEM runs at a time
 - Non-parametric bootstrapping
 - View INTER files while NONMEM runs are in progress
 - Email notification of completion
 - Easy to use, web-based interface
 - Diagnostic plots and parameter comparisons at your fingertips

You can go to the Clinapps web site at and download a data sheet for
Smart PK v2.0 that outlines this popular new software or request a demonstration by calling
(805) 494-1777, ext. 3.

Kind Regards,
Terri Fisher
Pharmaceutical Projects Director
Clinapps, Inc.
(805) 494-1777