[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

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.