ES - 21 CFR 11 Validation report

Title 21 CFR Part 11 is the FDA's regulations for electronic documentation and electronic signatures. It outlines the administration of electronic records in FDA-regulated industries and defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. 21 CFR 11 is important for those FDA-regulated companies that want to use electronic records and electronic signatures instead of their paper signatures to comply with FDA regulations more quickly and effectively. To view the full text of the Part 11 regulation, click here.

This page describes how Electronic Signatures add-on that build in electronic signatures into your workflow with custom field validation, helps to compliance FDA 21 CFR Part 11. Below you can find a detailed match of sections 21 CFR 11 to the characteristics of the Electronic Signatures app.

Please see the detailed report attached Electronic Signatures FDA CFR 21 part 11.

Subpart A - General Provisions

(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.

....

Electronic Signatures add-on enables you to check user credentials and meets the requirements of technical elements of 21 CFR Part 11 that define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. According to this part, electronic signatures can be equivalent to full handwritten signatures.

(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.

In accordance with Subpart A, section 11.2, persons may use Electronic Signatures add-on for both submitted and non-submitted records.

(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.

According to definition of electronic signature, User Validator Field and Logged User Validator Field which use username and password, as well as PIN in case of using Jira cloud, can be considered electronic signatures because they are data compilation of series of symbols executed, adopted, or authorized by an individual.

Subpart B - Electronic Records

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.

Electronic Signatures app prevents unauthorized actions on Jira tickets. The add-on contains custom fields for checking user credentials. To execute transition or edit issues the users have to type valid credentials to proceed. In compliance with 21 CFR 11.10, only a Jira Administrator, a person with appropriate knowledge, authority and permission is able to install and configure Electronic Signatures plugin. In addition to this, on the configuration page you are able to set up 'Username check' sensitivity and count of invalid login attempts.

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.

Using either the User Validator Field or the Logged User Validator within Electronic Signatures add-on, the user password is invisible and is not disclosed for security reasons and to ensure the authenticity, integrity, and the confidentiality.

Information about username of the signer, date, time and meaning of signature you can find within ticket. To do this, go to Issue Sign Information tab in Jira server platform and to E-Signatures tab if you use Jira cloud platform.

Electronic Signatures add-on automatically links signatures to issues and does not allow further modification to be tampered to ensure 21 CFR Part 11 compliance.

Subpart C - Electronic Signatures

Both the User Validator Field and the Logged User Validator Field use username and password of the Jira user profile, reconciling of them is unique to each Jira account and cannot be reused by, or reassigned to, anyone else. In case of using Electronic Signatures for Jira cloud, apart from login and password, special PIN is verified, which is personal for each Jira user and, as well as cannot be transferred or disclosed to third parties.

Because the Electronic Signatures add-on is not based upon biometric data, identification always involves the use of mandatory authentication components, such as a username and password. If you use Electronic Signatures for Jira cloud, identification components includes verification of username and password when logging in and checking your personal PIN when signing.

Existence of two or more users with the same combination of login and password is impossible and contradicts the Atlassian Password policies. As an organization admin, you can use a password policy to require all of your managed users to meet a minimum password strength or set a password expiration period. Apart from this, you can set up count of invalid login attempts during signing the issue and sensitivity check on Electronic Signatures configuration page.

If you have any questions, contact the appfire Products team at support@appfire.com or visit our Support Desk to request support or suggest a feature.