Software: regulatory compliance
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
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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