The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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

Subpart A–General Provisions 
   – Scope. 
   – Implementation. 
   – Definitions.
Subpart B–Electronic Records 
   – Controls for closed systems. 
   – Controls for open systems. 
   – Signature manifestations. 
   – Signature/record linking.
Subpart C–Electronic Signatures 
   – General requirements. 
   – Electronic signature components and controls. 
   – Controls for identification codes/passwords.

Authority: 21 U.S.C. 321-393; 42 U.S.C. 262. 
Source: 62 FR 13464, Mar. 20, 1997, unless otherwise noted.

 

Page Last Updated: 09/04/2018
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