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Electronic Code of Federal Regulations

e-CFR data is current as of January 23, 2020

Title 21Chapter ISubchapter APart 11


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A—GENERAL

PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

rule

Subpart A—GENERAL PROVISIONS

§11.1
Scope.
§11.2
Implementation.
§11.3
Definitions.
rule

Subpart B—ELECTRONIC RECORDS

§11.10
Controls for closed systems.
§11.30
Controls for open systems.
§11.50
Signature manifestations.
§11.70
Signature/record linking.
rule

Subpart C—ELECTRONIC SIGNATURES

§11.100
General requirements.
§11.200
Electronic signature components and controls.
§11.300
Controls for identification codes/passwords.

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