Page Comparison

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 Confluence 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 Confluence as either Open or Closed system. Typically customers will assess Atlassian Confluence 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 Confluence and the eSign app 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 Atlassian Confluence users with access to the target content to be signed may execute signatures on that content.

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 Confluence 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

Each signature is electronically linked to the content it was signed on and is immutable once captured;

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 cloud environment as an extended property of the Confluence content. Signature integrity is protected with cryptographic encoding to ensure that signature data can not be modified by ordinary means.