[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]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 11_ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
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.
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.
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[62 FR 13464, Mar. 20, 1997, as amended at 69 FR 71655, Dec. 9, 2004]
Sec. 11.2 Implementation.
(a) For records required to be maintained but not submitted to the
agency, persons may use electronic records in lieu of paper records or
electronic signatures in lieu of traditional signatures, in whole or in
part, provided that the requirements of this part are met.
(b) For records submitted to the agency, persons may use electronic
records in lieu of paper records or electronic signatures in lieu of
traditional signatures, in whole or in part, provided that:
(1) The requirements of this part are met; and
(2) The document or parts of a document to be submitted have been
identified in public docket No. 92S-0251 as being the type of submission
the agency accepts in electronic form. This docket will identify
specifically what types of documents or parts of documents are
acceptable for submission in electronic form without paper records and
the agency receiving unit(s) (e.g., specific center, office, division,
branch) to which such submissions may be made. Documents to agency
receiving unit(s) not specified in the public docket will not be
considered as official if they are submitted in electronic form; paper
forms of such documents will be considered as official and must
accompany any electronic records. Persons are expected to consult with
the intended agency receiving unit for details on how (e.g., method of
transmission, media, file formats, and technical protocols) and whether
to proceed with the electronic submission.
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Sec. 11.3 Definitions.
(a) The definitions and interpretations of terms contained in
section 201 of the act apply to those terms when used in this part.
(b) The following definitions of terms also apply to this part:
(1) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-
903 (21 U.S.C. 321-393)).
(2) Agency means the Food and Drug Administration.
(3) Biometrics means a method of verifying an individual's identity
based on measurement of the individual's physical feature(s) or
repeatable action(s) where those features and/or actions are both unique
to that individual and measurable.
(4) Closed system means an environment in which system access is
controlled by persons who are responsible for the content of electronic
records that are on the system.
(5) Digital signature means an electronic signature based upon
cryptographic methods of originator authentication, computed by using a
set of rules and a set of parameters such that the identity of the
signer and the integrity of the data can be verified.
(6) Electronic record means any combination of text, graphics, data,
audio, pictorial, or other information representation in digital form
that is created, modified, maintained, archived, retrieved, or
distributed by a computer system.
(7) Electronic signature means a computer data compilation of any
symbol or series of symbols executed, adopted, or authorized by an
individual to be the legally binding equivalent of the individual's
handwritten signature.
(8) Handwritten signature means the scripted name or legal mark of
an individual handwritten by that individual and executed or adopted
with the present intention to authenticate a writing in a permanent
form. The act of signing with a writing or marking instrument such as a
pen or stylus is preserved. The scripted name or legal mark, while
conventionally applied to paper, may also be applied to other devices
that capture the name or mark.
(9) Open system means an environment in which system access is not
controlled by persons who are responsible for the content of electronic
records that are on the system.
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Subpart B_Electronic Records
Sec. 11.10 Controls for closed systems.
Persons who use closed systems to create, modify, maintain, or
transmit electronic records shall employ procedures and controls
designed to ensure the authenticity, integrity, and, when appropriate,
the confidentiality of electronic records, and to ensure that the signer
cannot readily repudiate the
signed record as not genuine. Such procedures and controls shall include
the following:
(a) Validation of systems to ensure accuracy, reliability,
consistent intended performance, and the ability to discern invalid or
altered records.
(b) The ability to generate accurate and complete copies of records
in both human readable and electronic form suitable for inspection,
review, and copying by the agency. Persons should contact the agency if
there are any questions regarding the ability of the agency to perform
such review and copying of the electronic records.
(c) Protection of records to enable their accurate and ready
retrieval throughout the records retention period.
(d) Limiting system access to authorized individuals.
(e) Use of secure, computer-generated, time-stamped audit trails to
independently record the date and time of operator entries and actions
that create, modify, or delete electronic records. Record changes shall
not obscure previously recorded information. Such audit trail
documentation shall be retained for a period at least as long as that
required for the subject electronic records and shall be available for
agency review and copying.
(f) Use of operational system checks to enforce permitted sequencing
of steps and events, as appropriate.
(g) Use of authority checks to ensure that only authorized
individuals can use the system, electronically sign a record, access the
operation or computer system input or output device, alter a record, or
perform the operation at hand.
(h) Use of device (e.g., terminal) checks to determine, as
appropriate, the validity of the source of data input or operational
instruction.
(i) Determination that persons who develop, maintain, or use
electronic record/electronic signature systems have the education,
training, and experience to perform their assigned tasks.
(j) The establishment of, and adherence to, written policies that
hold individuals accountable and responsible for actions initiated under
their electronic signatures, in order to deter record and signature
falsification.
(k) Use of appropriate controls over systems documentation
including:
(1) Adequate controls over the distribution of, access to, and use
of documentation for system operation and maintenance.
(2) Revision and change control procedures to maintain an audit
trail that documents time-sequenced development and modification of
systems documentation.
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Sec. 11.30 Controls for open systems.
Persons who use open systems to create, modify, maintain, or
transmit electronic records shall employ procedures and controls
designed to ensure the authenticity, integrity, and, as appropriate, the
confidentiality of electronic records from the point of their creation
to the point of their receipt. Such procedures and controls shall
include those identified in Sec. 11.10, as appropriate, and additional
measures such as document encryption and use of appropriate digital
signature standards to ensure, as necessary under the circumstances,
record authenticity, integrity, and confidentiality.
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Sec. 11.50 Signature manifestations.
(a) Signed electronic records shall contain information associated
with the signing that clearly indicates all of the following:
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or
authorship) associated with the signature.
(b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of
this section shall be subject to the same controls as for electronic
records and shall be included as part of any human readable form of the
electronic record (such as electronic display or printout).
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Sec. 11.70 Signature/record linking.
Electronic signatures and handwritten signatures executed to
electronic records shall be linked to their respective electronic
records to ensure that the signatures cannot be excised, copied, or
otherwise transferred to falsify an electronic record by ordinary means.
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Subpart C_Electronic Signatures
Sec. 11.100 General requirements.
(a) Each electronic signature shall be unique to one individual and
shall not be reused by, or reassigned to, anyone else.
(b) Before an organization establishes, assigns, certifies, or
otherwise sanctions an individual's electronic signature, or any element
of such electronic signature, the organization shall verify the identity
of the individual.
(c) Persons using electronic signatures shall, prior to or at the
time of such use, certify to the agency that the electronic signatures
in their system, used on or after August 20, 1997, are intended to be
the legally binding equivalent of traditional handwritten signatures.
(1) The certification shall be submitted in paper form and signed
with a traditional handwritten signature, to the Office of Regional
Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.
(2) Persons using electronic signatures shall, upon agency request,
provide additional certification or testimony that a specific electronic
signature is the legally binding equivalent of the signer's handwritten
signature.
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Sec. 11.200 Electronic signature components and controls.
(a) Electronic signatures that are not based upon biometrics shall:
(1) Employ at least two distinct identification components such as
an identification code and password.
(i) When an individual executes a series of signings during a
single, continuous period of controlled system access, the first signing
shall be executed using all electronic signature components; subsequent
signings shall be executed using at least one electronic signature
component that is only executable by, and designed to be used only by,
the individual.
(ii) When an individual executes one or more signings not performed
during a single, continuous period of controlled system access, each
signing shall be executed using all of the electronic signature
components.
(2) Be used only by their genuine owners; and
(3) Be administered and executed to ensure that attempted use of an
individual's electronic signature by anyone other than its genuine owner
requires collaboration of two or more individuals.
(b) Electronic signatures based upon biometrics shall be designed to
ensure that they cannot be used by anyone other than their genuine
owners.
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Sec. 11.300 Controls for identification codes/passwords.
Persons who use electronic signatures based upon use of
identification codes in combination with passwords shall employ controls
to ensure their security and integrity. Such controls shall include:
(a) Maintaining the uniqueness of each combined identification code
and password, such that no two individuals have the same combination of
identification code and password.
(b) Ensuring that identification code and password issuances are
periodically checked, recalled, or revised (e.g., to cover such events
as password aging).
(c) Following loss management procedures to electronically
deauthorize lost, stolen, missing, or otherwise potentially compromised
tokens, cards, and other devices that bear or generate identification
code or password information, and to issue temporary or permanent
replacements using suitable, rigorous controls.
(d) Use of transaction safeguards to prevent unauthorized use of
passwords and/or identification codes, and to detect and report in an
immediate and urgent manner any attempts at their unauthorized use to
the system security unit, and, as appropriate, to organizational
management.
(e) Initial and periodic testing of devices, such as tokens or
cards, that bear or generate identification code or password information
to ensure that they function properly and have not been altered in an
unauthorized manner.
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