From: "Sale, Mark" <ms93267@GlaxoWellcome.com>
Subject: NONMEM compliance
Date: Fri, 4 May 2001 12:39:59 -0400
In our current merger process we are evaluating how we use NONMEM. Our IT/compliance group is very concerned about the "open source" nature of NONMEM. They have requested that I post the following question to the user group.
Has anyone ever had an FDA audit of their NONMEM installation for compliance with GLP, or a data audit?