FDA 21 CFR Part 11 Part11.100: Electronic signatures - general requirements (21 CFR §11.100)

Section 11.100 establishes the general requirements for electronic signatures: (a) UNIQUENESS - each electronic signature must be UNIQUE TO ONE INDIVIDUAL + must not be reused by + or reassigned to anyone else. (b) IDENTITY VERIFICATION - before an organisation establishes + assigns + certifies + or otherwise sanctions an individual's electronic signature + or any element of such electronic signature + the organisation must verify the identity of the individual. (c) FDA CERTIFICATION - persons using electronic signatures must, prior to + or at the time of + such use, certify to the agency that the electronic signatures in their system, used on or after August 20 1997, are intended to be the legally binding equivalent of traditional handwritten signatures. The CERTIFICATION must be SUBMITTED IN PAPER FORM SIGNED WITH A TRADITIONAL HANDWRITTEN SIGNATURE to: Food and Drug Administration, Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857. Persons using electronic signatures must, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature.