[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: 21CFR11.3]



[Page 111]

 

                        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 A_General Provisions

 

Sec.  11.3  Definitions.



    (a) The definitions and interpretations of terms contained in 

section 201 of the act apply to those terms when used in this part.

    (b) The following definitions of terms also apply to this part:

    (1) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-

903 (21 U.S.C. 321-393)).

    (2) Agency means the Food and Drug Administration.

    (3) Biometrics means a method of verifying an individual's identity 

based on measurement of the individual's physical feature(s) or 

repeatable action(s) where those features and/or actions are both unique 

to that individual and measurable.

    (4) Closed system means an environment in which system access is 

controlled by persons who are responsible for the content of electronic 

records that are on the system.

    (5) Digital signature means an electronic signature based upon 

cryptographic methods of originator authentication, computed by using a 

set of rules and a set of parameters such that the identity of the 

signer and the integrity of the data can be verified.

    (6) Electronic record means any combination of text, graphics, data, 

audio, pictorial, or other information representation in digital form 

that is created, modified, maintained, archived, retrieved, or 

distributed by a computer system.

    (7) Electronic signature means a computer data compilation of any 

symbol or series of symbols executed, adopted, or authorized by an 

individual to be the legally binding equivalent of the individual's 

handwritten signature.

    (8) Handwritten signature means the scripted name or legal mark of 

an individual handwritten by that individual and executed or adopted 

with the present intention to authenticate a writing in a permanent 

form. The act of signing with a writing or marking instrument such as a 

pen or stylus is preserved. The scripted name or legal mark, while 

conventionally applied to paper, may also be applied to other devices 

that capture the name or mark.

    (9) Open system means an environment in which system access is not 

controlled by persons who are responsible for the content of electronic 

records that are on the system.