From: "Kimko, Hui [PRDUS]" HKimko@prdus.jnj.com
Subject:[NMusers] Software: regulatory compliance
Date: Fri, July 9, 2004 5:10 pm 
 
Dear all, 

We're interested in the ways in which pharmaceutical companies
deal with regulatory compliance issues (e.g., 21 CFR Part 11)
surrounding NONMEM and potential tools like Wings for NONMEM.

Since NONMEM-output is GXP-critical (GCP - GLP mainly, I assume),
we need to comply with, among other things, regulations governing
audit trail and security requirements. A DOS environment is not
easily adaptable to current FDA expectations, but maybe some of
you have found a more "compliant" solution.

We look forward to getting your perspectives and strategies in
establishing "controls" over this environment. 

Regards, 
Hui 
************************************************************************************** 
Hui C. Kimko, PhD
Advanced Pharmacokinetic/Pharmacodynamic Modeling & Simulation, GCPCP 
Johnson & Johnson Pharmaceutical Research & Development 
920 Route 202, Raritan, NJ 08869 
PRD Bldg. Rm 2423   TEL: + 908 704 5577    FAX: + 908 203 1527  HKimko@prdus.jnj.com 
_______________________________________________________

From:Immanuel Freedman, PhD, MIEEE drfreedman@drfreedmaninc.com
Subject: RE:[NMusers] Software: regulatory compliance
Date: Fri, July 9, 2004 6:43 pm

Colleagues

ClinApps (http://www.clinapps.com) has a multi-CPU compliant 
solution.  I would be happy to provide PK/PD modeling 
expertise based on this toolset.

Immanuel Freedman, PhD, MIEEE
(619) 884-1347
_______________________________________________________

From: "Joel S. Owen" joel@cognigencorp.com
Subject: RE:[NMusers] Software: regulatory compliance
Date: Wednesday, July 14, 2004 4:51 PM

Dear Hui,

Some of these issues were discussed at the ECPAG meeting in April of 
this year.  In a preceding workshop on model qualification and software 
validation Joga Gobburu and Jill Fiedler-Kelly presented software 
validation issues which should be addressed whether the validation is of 
NONMEM or other off the shelf vendor software.  Slides of the speakers 
presentations are still available at:

http://www.ecpag.org/presentations.php?year=2004w&session=2.

Some examples of documentation materials worth considering are contained 
in Jill's presentation.

Best regards,

Joel S. Owen
_______________________________________________________