Electronic records and electronic signatures (21 CFR 11.1-11.300)

170 21 CFR Ch. I (4–1–16 Edition) Pt. 11 necessitated such an action within 24 hours or sooner if requested by the Deputy Commissioner. In the absence or unavailability of the Deputy Com missioner, the presiding officer shall notify the Associate Commissioner for Regulatory Affairs. (h) A decision by a presiding officer, made either before the proceeding or during the course of a proceeding, to establish requirements in addition to the minimum standards set forth in this guideline may be appealed by any adversely affected person who intends to record the proceeding electronically. Appeals may be made in writing or by phone to the Deputy Commissioner or, in his or her absence, to the Associate Commissioner for Regulatory Affairs. The filing of an appeal, whether before or during a proceeding, does not re quire the presiding officer to interrupt the proceeding. However, the Deputy Commissioner or, in his or her absence, the Associate Commissioner for Regu latory Affairs will resolve an appeal as expeditiously as possible so as to pre serve, to the extent possible, the re porters’ opportunity to record the pro ceedings. [49 FR 14726, Apr. 13, 1984, as amended at 54 FR 9035, Mar. 3, 1989] 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/pass words. 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 § 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, modi fied, maintained, archived, retrieved, or transmitted, under any records re quirements set forth in agency regula tions. This part also applies to elec tronic 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 sig natures to be equivalent to full hand written signatures, initials, and other general signings as required by agency regulations, unless specifically ex cepted 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 spe cifically required. (e) Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily avail able for, and subject to, FDA inspec tion. (f) This part does not apply to records required to be established or maintained by §§ 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 provi sions or regulations, remain subject to this part. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00180 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 171 Food and Drug Administration, HHS § 11.3 (g) This part does not apply to elec tronic signatures obtained under § 101.11(d) of this chapter. (h) [Reserved] (i) This part does not apply to records required to be established or maintained by part 117 of this chapter. Records that satisfy the requirements of part 117 of this chapter, but that also are required under other applicable statutory provisions or regulations, re main subject to this part. (j) This part does not apply to records required to be established or maintained by part 507 of this chapter. Records that satisfy the requirements of part 507 of this chapter, but that also are required under other applicable statutory provisions or regulations, re main subject to this part. (k) This part does not apply to records required to be established or maintained by part 112 of this chapter. Records that satisfy the requirements of part 112 of this chapter, but that also are required under other applicable statutory provisions or regulations, re main subject to this part. (l) This part does not apply to records required to be established or maintained by subpart L of part 1 of this chapter. Records that satisfy the requirements of subpart L of part 1 of this chapter, but that also are required under other applicable statutory provi sions or regulations, remain subject to this part. (m) This part does not apply to records required to be established or maintained by subpart M of part 1 of this chapter. Records that satisfy the requirements of subpart M of part 1 of this chapter, but that also are required under other applicable statutory provi sions or regulations, remain subject to this part. [62 FR 13464, Mar. 20, 1997, as amended at 69 FR 71655, Dec. 9, 2004; 79 FR 71253, Dec. 1, 2014; 80 FR 71253, June 19, 2015; 80 FR 56144, 56336, Sept. 17, 2015; 80 FR 74352, 74547, 74667, Nov. 27, 2015] EFFECTIVE DATE NOTE: At 79 FR 71291, Dec. 1, 2014,§ 11.1 was amended by adding para graph (h), effective Dec. 1, 2016. For the con venience of the user, the revised text is set forth as follows: § 11.1 Scope. * * * * * (h) This part does not apply to electronic signatures obtained under § 101.8(d) of this chapter. § 11.2 Implementation. (a) For records required to be main tained but not submitted to the agen cy, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signa tures, 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 elec tronic signatures in lieu of traditional signatures, in whole or in part, pro vided that: (1) The requirements of this part are met; and (2) The document or parts of a docu ment to be submitted have been identi fied in public docket No. 92S–0251 as being the type of submission the agen cy accepts in electronic form. This docket will identify specifically what types of documents or parts of docu ments 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 dock et 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 accom pany any electronic records. Persons are expected to consult with the in tended agency receiving unit for de tails on how (e.g., method of trans mission, media, file formats, and tech nical protocols) and whether to proceed with the electronic submission. § 11.3 Definitions. (a) The definitions and interpreta tions 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. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00181 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 172 21 CFR Ch. I (4–1–16 Edition) § 11.10 (3) Biometrics means a method of verifying an individual’s identity based on measurement of the individual’s physical feature(s) or repeatable ac tion(s) where those features and/or ac tions are both unique to that indi vidual and measurable. (4) Closed system means an environ ment in which system access is con trolled by persons who are responsible for the content of electronic records that are on the system. (5) Digital signature means an elec tronic signature based upon cryp tographic methods of originator au thentication, 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 com bination of text, graphics, data, audio, pictorial, or other information rep resentation in digital form that is cre ated, modified, maintained, archived, retrieved, or distributed by a computer system. (7) Electronic signature means a com puter 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 indi vidual 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 de vices that capture the name or mark. (9) Open system means an environ ment in which system access is not controlled by persons who are respon sible for the content of electronic records that are on the system. Subpart B—Electronic Records § 11.10 Controls for closed systems. Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ proce dures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of elec tronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such pro cedures and controls shall include the following: (a) Validation of systems to ensure accuracy, reliability, consistent in tended 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 pe riod. (d) Limiting system access to author ized individuals. (e) Use of secure, computer-gen erated, 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 ob scure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject elec tronic 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 com puter 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 expe rience to perform their assigned tasks. (j) The establishment of, and adher ence to, written policies that hold indi viduals accountable and responsible for actions initiated under their electronic VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00182 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 173 Food and Drug Administration, HHS § 11.200 signatures, in order to deter record and signature falsification. (k) Use of appropriate controls over systems documentation including: (1) Adequate controls over the dis tribution of, access to, and use of docu mentation for system operation and maintenance. (2) Revision and change control pro cedures to maintain an audit trail that documents time-sequenced develop ment and modification of systems doc umentation. § 11.30 Controls for open systems. Persons who use open systems to cre ate, modify, maintain, or transmit electronic records shall employ proce dures and controls designed to ensure the authenticity, integrity, and, as ap propriate, the confidentiality of elec tronic records from the point of their creation to the point of their receipt. Such procedures and controls shall in clude those identified in § 11.10, as ap propriate, and additional measures such as document encryption and use of appropriate digital signature stand ards to ensure, as necessary under the circumstances, record authenticity, in tegrity, and confidentiality. § 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 signa ture was executed; and (3) The meaning (such as review, ap proval, responsibility, or authorship) associated with the signature. (b) The items identified in para graphs (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). § 11.70 Signature/record linking. Electronic signatures and hand written signatures executed to elec tronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to fal sify an electronic record by ordinary means. Subpart C—Electronic Signatures § 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 estab lishes, assigns, certifies, or otherwise sanctions an individual’s electronic signature, or any element of such elec tronic signature, the organization shall verify the identity of the individual. (c) Persons using electronic signa tures 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 in tended to be the legally binding equiv alent of traditional handwritten signa tures. (1) The certification shall be sub mitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC–100), 5600 Fishers Lane, Rock ville, MD 20857. (2) Persons using electronic signa tures shall, upon agency request, pro vide additional certification or testi mony that a specific electronic signa ture is the legally binding equivalent of the signer’s handwritten signature. § 11.200 Electronic signature compo nents and controls. (a) Electronic signatures that are not based upon biometrics shall: (1) Employ at least two distinct iden tification components such as an iden tification code and password. (i) When an individual executes a se ries of signings during a single, contin uous period of controlled system ac cess, the first signing shall be executed using all electronic signature compo nents; subsequent signings shall be exe cuted using at least one electronic sig nature component that is only execut able 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 con trolled system access, each signing VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00183 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 174 21 CFR Ch. I (4–1–16 Edition) § 11.300 shall be executed using all of the elec tronic signature components. (2) Be used only by their genuine owners; and (3) Be administered and executed to ensure that attempted use of an indi vidual’s electronic signature by anyone other than its genuine owner requires collaboration of two or more individ uals. (b) Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners. § 11.300 Controls for identification codes/passwords. Persons who use electronic signa tures 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 identi fication 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 pro cedures to electronically deauthorize lost, stolen, missing, or otherwise po tentially compromised tokens, cards, and other devices that bear or generate identification code or password infor mation, and to issue temporary or per manent replacements using suitable, rigorous controls. (d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to de tect and report in an immediate and urgent manner any attempts at their unauthorized use to the system secu rity unit, and, as appropriate, to orga nizational management. (e) Initial and periodic testing of de vices, 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 man ner. PART 12—FORMAL EVIDENTIARY PUBLIC HEARING Subpart A—General Provisions Sec. 12.1 Scope. Subpart B—Initiation of Proceedings 12.20 Initiation of a hearing involving the issuance, amendment, or revocation of a regulation. 12.21 Initiation of a hearing involving the issuance, amendment, or revocation of an order. 12.22 Filing objections and requests for a hearing on a regulation or order. 12.23 Notice of filing of objections. 12.24 Ruling on objections and requests for hearing. 12.26 Modification or revocation of regula tion or order. 12.28 Denial of hearing in whole or in part. 12.30 Judicial review after waiver of hearing on a regulation. 12.32 Request for alternative form of hear ing. 12.35 Notice of hearing; stay of action. 12.37 Effective date of a regulation. 12.38 Effective date of an order. Subpart C—Appearance and Participation 12.40 Appearance. 12.45 Notice of participation. 12.50 Advice on public participation in hear ings. Subpart D—Presiding Officer 12.60 Presiding officer. 12.62 Commencement of functions. 12.70 Authority of presiding officer. 12.75 Disqualification of presiding officer. 12.78 Unavailability of presiding officer. Subpart E—Hearing Procedures 12.80 Filing and service of submissions. 12.82 Petition to participate in forma pauperis. 12.83 Advisory opinions. 12.85 Disclosure of data and information by the participants. 12.87 Purpose; oral and written testimony; burden of proof. 12.89 Participation of nonparties. 12.90 Conduct at oral hearings or con ferences. 12.91 Time and place of prehearing con ference. 12.92 Prehearing conference procedure. 12.93 Summary decisions. 12.94 Receipt of evidence. 12.95 Official notice. 12.96 Briefs and argument. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00184 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B