Document Approval Workflows & e-Signatures

Transcript: Document Approval Workflows and E-Signatures

Introduction

Hello and welcome to eLeaP. In this tutorial, we are looking at Document Approval Workflows and Electronic Signatures (e-signatures) within the eLeaP QMS. This is a critical area for meeting FDA, ISO, and internal audit requirements.

The Importance of Controlled Workflows

Approval workflows ensure that the right subject matter experts review and authorize documents before they become official, controlled records. In the eLeaP QMS, these workflows are enforced by the system—not left to memory or buried in email chains—ensuring a compliant and repeatable process.

Setting Up the Workflow

Once your document content is finalized in the Draft stage, you can configure your approval path:

Assign Reviewers and Approvers: Select the specific individuals or groups required for the document.
Set Timelines: Assign the number of days each person has to complete their task to keep the process moving.
Advanced Settings: Click the Settings (ellipsis icon) to access powerful automation options:
Request Training: Automatically push the document to the eLeaP LMS once it becomes effective.
Auto-Effective: Set the document to transition to “Effective” status immediately upon final approval.
Periodic Review: Set an annual or biennial review period (e.g., 12 months) to ensure the document remains current.

The Review and Approval Process

When you kick off the workflow, the system takes over:

Notifications: Reviewers receive both an email and an in-app notification (the red bell icon) alerting them that their action is required.
Review Actions: Reviewers can mark the document as Approved, Rejected, or Return to Draft for further edits.
E-Signatures: In compliance with 21 CFR Part 11, users must provide an electronic signature to confirm their identity and intent when approving or marking a document as effective.

Finalizing the Document

Once the reviewers have signed off, the document moves to the Approver. After the final signature is captured:

The document moves to the Effective status.
Depending on your settings, a “Send to Training” track is created, closing the loop between document control and employee competency.
The system maintains a full, time-stamped history of every signature and comment, providing the defensible evidence needed for any audit.

Conclusion

By automating the signature and approval process, eLeaP ensures that your document control is secure, transparent, and always audit-ready.

As usual, if you have any questions about approval workflows, e-signatures, or any other features, please do not hesitate to contact us.