[Federal Register Volume 66, Number 185 (Monday, September 24, 2001)]
[Notices]
[Page 48886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23698]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1538]


Draft Guidance for Industry; Electronic Records; Electronic 
Signatures, Validation; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Guidance for 
Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, 
Validation.'' The draft guidance describes the agency's current 
thinking on issues pertaining to validating computer systems subject to 
part 11 (21 CFR part 11) requirements, to ensure that electronic 
records and electronic signatures are trustworthy, reliable, and 
compatible with FDA's public health responsibilities. Such validation 
is a requirement of part 11 of title 21 of the Code of Federal 
Regulations.

DATES: Submit written or electronic comments on the draft guidance by 
Decmeber 24, 2001. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Compliance Information and Quality 
Assurance (HFC-240), Office of Enforcement, 5600 Fishers Lane, 
Rockville, MD 20857. Send one self-addressed adhesive label to assist 
that office in processing your requests. Submit written comments on the 
draft guidance document to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, room 1060, Rockville, 
MD 20852. Submit electronic comments to http://www.FDA.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Paul J. Motise, Office of Enforcement 
(HFC-240), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-0383, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic 
Signatures, Validation.'' In the Federal Register of March 20, 1997 (62 
FR 13430), FDA published a regulation providing criteria under which 
the agency considers electronic records and electronic signatures to be 
trustworthy, reliable, and generally equivalent to paper records and 
handwritten signatures executed on paper (``part 11''). The preamble to 
part 11 stated that the agency anticipated issuing supplemental 
guidance documents and would afford all interested parties the 
opportunity to comment on draft guidance documents. Therefore, FDA is 
making this draft guidance available for public comment.
    The draft guidance addresses issues pertaining to the validation of 
computer systems used to create, modify, maintain, archive, retrieve, 
or transmit electronic records and electronic signatures subject to 
part 11. Part 11 requires such validation, and the guidance is intended 
to assist people who must meet this requirement; it may also assist FDA 
staff who apply part 11 to persons subject to the regulation.
    The draft guidance provides specific information on key validation 
principles, and it addresses some frequently asked questions. However, 
it is not intended to cover everything that computer systems validation 
should encompass in the context of electronic record/signature systems. 
In addition to addressing key validation principles, the draft document 
discusses considerations regarding off the shelf software and the 
Internet.
    By direct reference, this draft guidance incorporates definitions 
of terms contained in a companion draft guidance, ``Guidance for 
Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, 
Glossary of Terms.'' Elsewhere in this issue of the Federal Register, 
FDA is announcing the availability of that companion draft document, 
and is offering the opportunity to comment on it, as well.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). This draft 
guidance, when finalized, will represent the agency's current thinking 
on validating computerized systems subject to part 11. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments on the draft guidance. 
Two copies of any comments are to be submitted, except that individuals 
may submit one copy. Comments are to be identified with the docket 
number found in brackets in the heading of this document. A copy of the 
draft guidance and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/ora/compliance_ref/Part11.

    Dated: August 23, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-23698 Filed 9-21-01; 8:45 am]
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