[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: 21CFR11.1]
[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.
(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]
[[Page 111]]
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