RE: 21 CFR part 11 certified FDA

, Peter L. Tarver, PE Product Safety Manager Sanmina-SCI Homologation Services San Jose, CA peter.tar...@sanmina-sci.com -Original Message- From: Terry Meck Sent: Wednesday, July 03, 2002 11:22 AM To: emc-p...@majordomo.ieee.org Subject: 21 CFR part 11 certified FDA Hello again, Does

21 CFR part 11 certified FDA

Hello again, Does anyone in this forum have any knowledge about United States FDA 21 CFR part 11 certification. What is the process? Are there independent labs that test or witness test software? I have been asked these questions and have no experience in this direction. This may not be the