English (Original Text)

A General Provisions

§ 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 § 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.

§ 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.

§ 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.

Subpart B Electronic Records

B §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:

11.10 (a) Validation of systems to ensure

accuracy, reliability, consistent intended

performance, and the ability to discern invalid or

altered records.

11.10 (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.

11.10 (c) Protection of records to enable their

accurate and ready retrieval throughout the

records retention period

11.10 (d) Limiting system access to authorized

individuals.

11.10 (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.

11.10 (f) Use of operational system checks to

enforce permitted sequencing of steps and events,

as appropriate.

11.10 (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.

11.10 (h) Use of device (e.g., terminal) checks to

determine, as appropriate, the validity of the

source of data input or operational instruction.

11.10 (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.

11.10 (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.

11.10 (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.

B §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 §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.

B §11.50 Signature manifestations.

11.50 (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.

11.50 (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).

B §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.

Subpart C Electronic signatures

C §11.100 General requirements.

11.100 (a) Each electronic signature shall be

unique to one individual and shall not be reused

by, or reassigned to, anyone else.

11.100 (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.

11.100 (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

20857,0

(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.

C §11.200 Electronic signature components

and controls.

11.200 (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.

11.200 (a)(1)(i) When an individual executes a

series of signings during a single, continuous

period of controlled system access, the firs

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.

11.200 (a)(1)(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.

11.200 (a)(2) Electronic signatures that are not

based upon biometrics shall be used only by their

genuine owners.

11.200 (a)(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.

11.200 (b) Electronic signatures based upon

biometrics shall be designed to ensure that they

cannot be used by anyone other than their

genuine owners.

C §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:

11.300 (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.

11.300 (b) Ensuring that identification code and

password issuances are periodically checked,

recalled, or revised (e.g., to cover such events as

password aging).

11.300 (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.

11.300 (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.

11.300 (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.