Q

Where to find resources on 21CFR11

Where can I find more information regarding The Code of Federal Regulations, Title 21, Part 11 (21CFR11). This regulation talks about digital signitures. I need to know if the USB token (eToken) I have developed complies with these standards. Any suggestions?

21CFR11 is an FDA regulation dealing with data handling. It handles "criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper."

Here are some sources on 21CFR11:
Information on 21CFR11
Compliance with 21CFR11


For more information on this topic, visit these other SearchSecurity.com resources:
SearchSecurity.com Search Results: 21CFR11
Best Web Links: Law, Public Policy and Standards


This was first published in November 2002

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