[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: 21CFR11.1]



[Page 110]

 

                        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.  11.1  Scope.









                      Subpart A_General Provisions



Sec.

11.1 Scope.

11.2 Implementation.

11.3 Definitions.



                      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.



                     Subpart C_Electronic Signatures



11.100 General requirements.

11.200 Electronic signature components and controls.

11.300 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.







    (a) The regulations in this part set forth the criteria under which 

the agency considers electronic records, electronic signatures, and 

handwritten signatures executed to electronic records to be trustworthy, 

reliable, and generally equivalent to paper records and handwritten 

signatures executed on paper.

    (b) This part applies to records in electronic form that are 

created, modified, maintained, archived, retrieved, or transmitted, 

under any records requirements set forth in agency regulations. This 

part also applies to electronic records submitted to the agency under 

requirements of the Federal Food, Drug, and Cosmetic Act and the Public 

Health Service Act, even if such records are not specifically identified 

in agency regulations. However, this part does not apply to paper 

records that are, or have been, transmitted by electronic means.

    (c) Where electronic signatures and their associated electronic 

records meet the requirements of this part, the agency will consider the 

electronic signatures to be equivalent to full handwritten signatures, 

initials, and other general signings as required by agency regulations, 

unless specifically excepted by regulation(s) effective on or after 

August 20, 1997.

    (d) Electronic records that meet the requirements of this part may 

be used in lieu of paper records, in accordance with Sec.  11.2, unless 

paper records are specifically required.

    (e) Computer systems (including hardware and software), controls, 

and attendant documentation maintained under this part shall be readily 

available for, and subject to, FDA inspection.

    (f) This part does not apply to records required to be established 

or maintained by Sec. Sec.  1.326 through 1.368 of this chapter. Records 

that satisfy the requirements of part 1, subpart J of this chapter, but 

that also are required under other applicable statutory provisions or 

regulations, remain subject to this part.



[62 FR 13464, Mar. 20, 1997, as amended at 69 FR 71655, Dec. 9, 2004]



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