Read the FDA Guidance Document at: http://www.21cfrpart11.com/files/fda_docs/part11_final_guidanceSep2003.pdf Regards, Ron Wellman
From: [email protected] [mailto:[email protected]]On Behalf Of John Kretsch Sent: Tuesday, March 07, 2006 11:54 AM To: [email protected] Subject: 21 CFR 11 Electronic Signatures and Records Hello Everyone: One of my clients came to me asking about 21 CFR 11. They manufacture lasers as part of their products. They said that one of their customers is concerned about electronic traceability. However, upon reading the scope, I don’t see how this fits…meaning, is my client really supposed to comply with this standard? Does anyone have experience with this? Thanks for your help. Regards, John R. Kretsch, P.E., NCE Principal Interpro Consulting Engineering, LLC http://www.ip-ce.com - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas [email protected] Mike Cantwell [email protected] For policy questions, send mail to: Jim Bacher: [email protected] David Heald: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas [email protected] Mike Cantwell [email protected] For policy questions, send mail to: Jim Bacher: [email protected] David Heald: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
