US FDA Part 11 Electronic Signature Assessment

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 … (abbreviated, see CFR)

Atlassian Jira with eSign can be considered generally equivalent to paper records and handwritten signatures executed on paper, with adequate assessment and validation.

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 … (abbreviated, see CFR)

Electronic records and signatures may be used for both submitted and non-submitted records.

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 … (abbreviated, see CFR)

General definitions. It will be important to identify and justify the classification of Atlassian Jira as either Open or Closed system. Typically customers will assess Atlassian Jira as a closed system because user account access is controlled by the customer’s administrators.

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 …

( see CFR for full text )

In general, using Atlassian Jira and the eSign add-on for electronic records and electronic signatures will require validation for an organization's intended use along with and adequate documentation and user training.

For security purposes, only users with edit access to a specific Atlassian JIRA project may execute signatures on issues within.

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.

All data transferred communication between users and the Atlassian Jira system and the eSign Add-on is encrypted (i.e. HTTP/TLS) to ensure authenticity, confidentiality and integrity.

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).

eSign signature manifestations include:

1. full name of the signee

2. signee title (if provided)

3. date and time (including timezone)

4. meaning

5. issue status at time of signing

6. issue key

Each signature is immutable once captured; re-signing of the same issue by the same user will void (but not obscure) the previous signature.

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.

eSign signatures are stored within the customer’s Atlassian Jira cloud instance as an extended property of the Jira issue. Signature integrity is protected with cryptographic encoding to ensure that contents can not be falsified by ordinary means.

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.

With eSign each signature is traced to the unique identifying account ID assigned by Atlassian for the user profile.

The eSign signature dialog includes user instructions that the electronic signatures are intended to be legally equivalent to handwritten signatures.

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.

Atlassian Jira requires two identifiers (username and password) to initially authenticate any user. Jira optionally offers Two Step Verification for additional security.

After Atlassian Jira authentication, eSign requires an additional identification component.

1. Atlassian Jira username

2. Atlassian Jira password

3. eSign Signature Pin

Subsequent signings within the same JIra authenticated session requires the eSign Signature Pin.

For security purposes, reset of the Signature Pin requires access to both an authenticated Atlassian Jira session AND the user’s associated e-mail account.

Atlassian security controls also permit adjusting the maximum session duration. This can be configured if required to meet internal regulatory requirements. See Session Duration Management.

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.

Atlassian Jira cloud provides requires each user to have a unique account identifier.

Assign a password policy as part of configuring the managed Atlassian Jira instance to satisfy password controls and aging. See Password Policies.