11/8/2021: This page has been archived. UMMS Regulatory Affairs maintains documentation regarding FDA Part 11 compliance at Data Integrity and Sharing (level-2 login required).
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
