Document Management

Transcript: Document Control 101 – Creating and Managing Controlled Documents | Document Approvals | Revising Effective Documents | Assigning Effective Documents for Training

Introduction

Hello and welcome to eLeaP. In this tutorial, we are exploring Document Control 101: the process of creating and managing controlled documents. In highly regulated industries, document control is the backbone of any Quality Management System (QMS). We will walk through how eLeaP allows you to manage these critical assets seamlessly.

The Document Lifecycle

In eLeaP, documents move through a controlled lifecycle to ensure compliance. The typical stages include:

Draft: Initial creation and editing.
Review: Subject matter experts evaluate the content.
Approved/Declined: Stakeholders finalize or reject the document.
Effective: The document is active and ready for use.
Obsolete/Expired/Canceled: The document is retired based on your pre-set parameters.

Creating a New Document

To begin, navigate to the Documents module on the left-hand menu. (Tip: You can collapse the side menu to provide a wider viewport for your work.)

Click Add Document.
Define the Basics: Enter the document name and select the type (e.g., SOP, Form, etc.).
Details: Add a description, assign authors, and link workgroups or tags.
Version Control: The eLeaP QMS includes a built-in versioning system. It automatically starts at version 1.0 and will incrementally increase the version number every time a revision is made, ensuring an airtight audit trail.

Management and Collaboration Tools

Within the document viewport, you have several powerful tools at your disposal:

Content Management: This is the primary area for adding and editing the document text.
Traceability: Link the document to other related items in the QMS. This creates the two-way traceability required for validated systems and regulatory compliance.
Task List: Use this built-in project management feature to assign actions to team members and collaborate during the creation phase.
Comments: A space for internal stakeholders to provide feedback and discuss the document.
Approval Workflow: This is the “workhorse” of the system. You can assign specific reviewers and approvers and set deadlines (number of days) for their tasks.
Activity History: This section is automatically updated by the system, recording every action taken for full transparency without manual entry.

Effective Documents and Training Integration

Once a document completes the approval process, it transitions to the Effective status.

One of the most powerful features of eLeaP is the deep integration between the QMS and the LMS (Learning Management System).

Once a document is Effective, you will see the option to Send to Training.
Clicking this automatically creates a training track in the eLeaP LMS.
From there, you can review the content and assign it to the relevant personnel. This ensures the loop is closed—not only is the document controlled, but your team is verified as trained on the latest version.

Conclusion

This overview covers the essential foundations of document management in eLeaP. We will explore more advanced components in future videos. If you have any questions about these features, please do not hesitate to contact us.