Guidance

Electronic Records and Electronic Signatures (21 CFR Part 11)

IRBMED
Mar 8, 2013 10:30 am

The regulations in 21 CFR Part 11 set forth the criteria under which FDA 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.

Created 4/8/2013

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Edited By: mhayward@umich.edu
Last Updated: May 31, 2018 1:00 PM