Electronic records and electronic signatures (21 CFR 11.1-11.300).

Part 11 of Title 21 of the Federal Code of Regulations defines the rules governing the electronic data (records) and related electronic signatures in administrative and technical practice and manner in food safety related procedures.
This Regulation set forth the criteria under which the Food and drug 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.