Electronic signature

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

Overview

The e-signature feature enforces standardized status transitions for project entities and requires approval before further actions are taken. It applies to requirements, test cases, test plans, test run documents, and defects. The feature also provides audit logs for compliance tracking. 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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Prerequisites

To use e-signatures, ensure that the following prerequisites are met.

  • You have a valid e-signature license. For details on licenses, see Editions.

  • Your site administrator has enabled the ALM E-signature Extension for your project. For details on enabling extensions, see Manage projects.

  • Desktop Client only: Your site administrator has enabled the product e-signature solution by setting the site parameter ENABLE_ESIGN = Y (Default = N)

  • Your site administrator has disabled any previous e-signature solution. Entities in projects that used a previous solution must be in an initial state such as Draft or already be in a final workflow state such as Approved or Rejected. For more known issues when moving from a previous solution, see Known issues.

  • To view and configure e-signature settings, users must belong to a group with Approval Settings permissions or must have a TD_Admin role.

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User roles

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

User role Details
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. If an approver rejects or cancels a request, the entity returns to the author for revision and the workflow restarts. 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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The e-signature approval process

After the project administrator configures the approval settings, the e-signature process follows these 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 project administrator configures the field value that triggers the workflow and defines which users can initiate the process.

  2. Route approval requests.

    If the new status requires e-signature approval, the request is routed to the approvers defined in 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: