RE: Part 11 compliance

From: "Simon Davis" sdavis@pharsight.com 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 NONMEM analyses are linked to the source data, and flagged as out of date when the source data change.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 www.pharsight.com. Best regards, Simon. ___________________________________ Simon Davis Senior Scientific Consultant Mobile : +44 7980 832 666 Facsimile : +1 801 991 7145 Home Office : +44 113 274 1198.