Selection of authorship, review, or approval in the Part 11 Module

During system validation testing of DocuSign, we observed that a single signer is able to select different roles within the same document. In other words, when the signer has more than one signature field in the document, they can choose to act as "author," "reviewer," and "approver" using the Part 11 Module. I suggest adjusting the module configuration so that once a role (authorship, review, or approval) has been selected, the same signer cannot select another role within the same document.

Additionally, we opened a support ticket (16067933), and the feedback received indicated that this configuration is currently not possible. The recommendation was to submit an idea (improvement opportunity) through the platform.

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It is important to highlight that, at a minimum, the system should include a configuration preventing a single signer from completing the entire approval workflow by selecting all three roles – authorship, review, and approval – within the same document. Allowing this practice, as currently not restricted in DocuSign, contradicts life sciences GxP good practices, since one individual must not be solely responsible for authoring, reviewing, and approving a document. The approval workflow must necessarily involve at least two distinct individuals for authorship, review, and approval, and preferably three.

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