RE: Software: regulatory compliance

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 _______________________________________________________