Guidance

Title 21--Food and Drugs – Part 11 – Electronic Records, Electronic Signatures

Background
21 CFR 11 (Part 11) is the regulation that sets forth the criteria under which the Food and Drug Administration (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. This regulation, which applies to all FDA program areas, was intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health.

Human Subject Research Application (eResearch)

  1. Electronic Signature Certification letter dated July 15, 2008 PDF
  2. Self-Assessment of eResearch Compliance with 21 CFR Part 11, Electronic Record; Electronic Signatures PDF

Electronic Records Closed Systems and Electronic Signature Standards (e.g., CareWeb)

  1. Electronic Signature Certification Statement letter dated May 22, 2008 PDF
  2. Compliance checklist for 21 CFR Part 11 – FDA Electronic Records Closed Systems and Electronic Signatures Standards PDF

Resources
Title 21--Food and Drugs – Part 11 – Electronic Records, Electronic Signatures http://www.access.gpo.gov/nara/cfr/waisidx_10/21cfr11_10.html

Updated 2/1/11