[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR11.3]

[Page 122-123]
 
                        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

[[Page 123]]

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.