Risk Score

This section explains how to upload a document, assign a Risk Score through a configured Document Type, and display Risk Level and Risk Score in the document grid for monitoring and classification.

Overview

The Risk Score functionality allows users to classify documents based on predefined risk parameters. Before assigning a risk score to a document, the required configurations must be completed in the Document Settings and Document Type configuration.

To configure Risk Score settings, refer to the section:

Risk Score Configuration – Click here

To configure Risk Score at the Document Type level, refer to:

Document Type Configuration – Click here

Upload a Document with Risk Score Configuration

  1. Enter the required eTMF Room and click on the Documents module from the left-hand navigation panel.
  2. Click the View by index drop-down and select the Index view.
  3. Select the folder from the Index panel.

  4. Click the Document dropdown from the top toolbar and Select + Add Document.

  5. The New Document window will appear. Click Browse and upload the required file.

  6. Fill in the remaining mandatory metadata fields. Navigate to the Document Type field and select a Document Type that has a Risk Score configured.

  7. Click the Next and Finish buttons to complete the document upload.
  8. The document is now successfully uploaded with the associated Risk Score configuration.
  9. Please Note:
  • The Safety Management Plan Document type is already configured in settings.
  • The Risk score can be applied to an existing document; the user needs to change the configured document type.

View Documents by Risk Level

  1. Click the View By dropdown located above the folder panel.
  2. Select By Risk Level and click Select to apply the view.

The left panel now groups documents based on their assigned Risk Level categories such as:

  • High
  • Medium
  • Low
  • No Score

Configure Grid View to Display Risk Score and Risk Level

To display Risk information in the document list:

  1. Click Manage Columns from the toolbar.

  2. In the Available Columns panel, search for Risk.

    Select:

    • Risk Level
    • Risk Score
  1. Click the + icon to move them into the Selected Columns section.
  2. Click Set View and Click Save Changes.

  3. The document grid will now display Risk Level and Risk Score for each document.

  4. Select the document from the list. Open the Metadata panel on the right-hand side. Scroll to view the Risk fields where the assigned Risk Score and Risk Level are displayed.

Please Note that updated risk information is visible both in the grid and within the document metadata.