[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: 21CFR11.200]
[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. 11.200 Electronic signature components and controls.
(a) Electronic signatures that are not based upon biometrics shall:
(1) Employ at least two distinct identification components such as
an identification code and password.
(i) When an individual executes a series of signings during a
single, continuous period of controlled system access, the first signing
shall be executed using all electronic signature components; subsequent
signings shall be executed using at least one electronic signature
component that is only executable by, and designed to be used only by,
the individual.
(ii) When an individual executes one or more signings not performed
during a single, continuous period of controlled system access, each
signing shall be executed using all of the electronic signature
components.
(2) Be used only by their genuine owners; and
(3) Be administered and executed to ensure that attempted use of an
individual's electronic signature by anyone other than its genuine owner
requires collaboration of two or more individuals.
(b) Electronic signatures based upon biometrics shall be designed to
ensure that they cannot be used by anyone other than their genuine
owners.
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