[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR11.100]
[Page 113]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES--Table of Contents
Subpart C Electronic Signatures
Sec. 11.100 General requirements.
(a) Each electronic signature shall be unique to one individual and
shall not be reused by, or reassigned to, anyone else.
(b) Before an organization establishes, assigns, certifies, or
otherwise sanctions an individual's electronic signature, or any element
of such electronic signature, the organization shall verify the identity
of the individual.
(c) Persons using electronic signatures shall, 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.
(1) The certification shall be submitted in paper form and signed
with a traditional handwritten signature, to the Office of Regional
Operations (HFC.100), 5600 Fishers Lane, Rockville, MD 20857.
(2) Persons using electronic signatures shall, upon agency request,
provide additional certification or testimony that a specific electronic
signature is the legally binding equivalent of the signer's handwritten
signature.
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