Terry - Part 11 of 21CFR is related to electronic reporting and electronic signatures for submittals to the FDA; I don't believe there's any "certification" program for Part 11, just a process/procedure to follow. Refer to
http://www.fda.gov/ora/compliance_ref/part11/ for details. Regards, Peter L. Tarver, PE Product Safety Manager Sanmina-SCI Homologation Services San Jose, CA [email protected] -----Original Message----- From: Terry Meck Sent: Wednesday, July 03, 2002 11:22 AM To: [email protected] Subject: 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 forum to ask. If so please ignore this message. Thanks! Best regards, Terry J. Meck Senior Compliance Engineer ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
