e-Signature approval of entities

The e-signature feature enables the configuration and management of controlled workflows for various entities.

Overview

The e-signature feature enforces standardized status transitions for project entities. The e-signature approval process applies to entities such as requirements, test cases, test plans, test run documents, and defects, necessitating approval before further actions can be taken. It also offers logs to produce a comprehensive and tamper-proof audit trail. The feature is useful for any organization that requires controlled workflows. This includes pharma, healthcare, and medical equipment manufacturers that must follow a formal approval process for electronic records to comply with FDA 21 CFR Part 11 regulations.

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User roles

The e-signature approval process supports the following user roles:

  • Project admin: Configures approval settings and manages project teams. The project administrator can also view the detailed audit trails. For details, see Configure approval settings.

  • Author: Creates entities and submits them for approval. For details, see Submit entities for approval.

  • Approver: Reviews and approves or rejects approval requests. For details, see Review and approve requests.

  • Auditor: Checks compliance.

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Approval settings overview

The e-signature approval process involves multiple levels and teams. Any rejection or cancellation sends the entity back to the author for revisions, restarting the entire workflow, and approved entities become immutable electronic records.

Approval settings are configured by the administrator and are built on the following hierarchical structure:

  1. Users form Teams.

  2. Teams and Users form Approval Levels.

  3. Approval Levels form Approval Routes.

  4. Approval Routes and Conditions form Approval Policies.

For details, see Configure approval settings.

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How the e-signature approval process works

After the project administrator configures the approval settings, the e-signature process proceeds through the following steps.

  1. Initiate entity status updates and submit approval requests.

    A project user authorized to initiate the approval process updates the status of an entity and submits the entity for approval. The field value used for triggering the workflow process, as well as the individuals who can initiate the process, is configured by the project admin.

  2. Route approval requests.

    If the new status requires e-signature approval, the request is routed to the appropriate approvers, predefined by the approval settings.

    If the new status does not require e-signature approval, it is saved immediately.

  3. Notify approvers.

    The designated approvers receive the request via email.

  4. Review and act on approval requests.

    Approvers log in to the system and review the request. They then approve or reject it while providing credentials for audit trail purposes.

  5. Track updates and log actions.

    All actions are logged in the system for compliance and audit purposes.

  6. Finalize updates.

    When all required approvals are collected, the entity is saved with the new status.

To use the e-signature approval process: