Electronic Records: Electronic Signatures

This information collection supports Food and Drug Administration (FDA) regulations. Specifically, the regulations found at 21 CFR Part 11: Electronic Records; Electronic Signatures provide criteria for acceptance of electronic records, electronic signatures, and handwritten signatures serving to legally bind subsequent electronic submissions and verify electronic records. Under the regulations, records and reports may be submitted to FDA electronically, with certain provisions.

The latest form for Electronic Records: Electronic Signatures expires 2021-01-31 and can be found here.

General Requirements - 11.100

Federal Enterprise Architecture: Health - Public Health Monitoring