Training Features for the Controlled Document Management Application

Overview

The Controlled Document Management application now includes an optional training module. You can now create training assignments for the effective and future effective documents available in the Controlled Document Management application by using training features. 

 

When the training features are turned on for the Controlled Document Management application, it will allow:

• The Category Managers/Controlled Document Management application admin to initiate a training assignment by assigning a document to individual users or groups of users with a set due date. 
• The training assignee to view the document and acknowledge the completion of the training assignment by providing a 21 CFR Part 11 compliant  Digital signature.
• The application to send automated email notifications to the training assignees and training assigners.
• The application to capture complete audit trails on all the actions performed related to the training assignments.

Accessing the Training Features

The training features are accessed through the Controlled Document Management application. There are two additional sections available in the Controlled Document Management application when training features are turned on.

• My Training Assignments
• Trainings I Manage
  

 

My Training Assignments is available to all the users of the Controlled Document Management application.  This page shows the user all of their current and previous training assignments. By default, the page shows Pending and Overdue assignments, but completed or canceled assignments can be shown by changing the Status filter.

 

Training I Manage is available to:

• Domain administrators
• Users with a role that grants the "can manage Controlled Documents" capability
• Users who are added as a Category Manager to one or more Document Categories

This page allows these users to view and manage the training assignments for categories that they manage. By default, the page shows Pending and Overdue assignments, but completed or canceled assignments can be shown by changing the Status filter.  Additional filters are available to show only assignments for specific users or documents.

How to Assign a Document for Training?

1. Open a document with effective or future effective status from the Documents page.
2. A Category Manager or Controlled Document Management application Admin user role will see an option Manage Trainings at the top of the document preview.
3. Clicking on Manage Training displays the training records screen for this specific document. Click the Assign New Training button on this screen.
4. Assign New Training dialog will be shown with a form. All fields are required.
   
   
   
5. The document's name is displayed on the form. By default, the Version field will show the current version of the document the user is viewing in the preview screen. If there is any other effective or future effective version available for the same document, then the user can select the other version of the document.
6. The Due Date defines when the Training Assignment for this document is due. You can choose the current day or any date in the future, but not the previous days.
7. Search and enter the names of an individual user(s) or group(s) in the Training Assignee(s) field.
8. Click “Assign training” to assign the training on this document to the user(s)/group(s) entered into the previous step.

How to View Training Records?

1. Navigate to Trainings I Manage page.
2. The training records for all the training assignments on all of the documents are displayed in a table format. You can only view the documents from the Categories you manage.
3. By default, it displays the training assignments with Pending and Overdue training status but you can change it to any other training status by using the Status filter.
4. You can filter the training records based on the Category, specific document, specific user, and training status. 
5. You can sort the training records based on your need and then export the same data into CSV format by clicking the Download CSV button.
6. For any Overdue and Pending training assignment, the user can perform the following actions by clicking on the three vertical dots menu icon:
   -Modify the training due date by clicking Edit
   -Send a reminder to complete the training to the assignee by clicking Send Reminder
   -Cancel the training assignment by clicking on Cancel training