Who are Unlicensed Users?

Unlicensed users are external users, such as CRO or vendor personnel, who review assigned Risk Alerts and respond to assigned Risk Signals and Issues.

Unlicensed users can:

• Review assigned Risk Alerts, Risk Signals, and Issues.
• Add comments to assigned items.
• Answer assigned Risk Signals and Issues.

Risk Alerts can be reviewed and commented on, but cannot be answered.

Note: Unlicensed users can only view and act on assigned items. Access to other modules and underlying data is not available.

Access Risk Signals in elluminate

An elluminate administrator must create an account for each unlicensed user. The user receives an email with a URL, username, and temporary password, which must be updated at first login. If Single Sign-On is enabled, the process may differ.

Unlicensed users receive an email notification when a Risk Alert, Risk Signal, or Issue is assigned.

1. Open the email notification.
2. Click View Risk Alerts / Risk Signals / Issues.
3. Log in using the provided credentials.

The Risk Signals listing opens automatically and includes assigned Risk Alerts, Risk Signals, and RBQM Issues. Only items assigned to the user with a status of Open or Answered display.

Note: The Risk Signals listing includes Risk Alerts, Risk Signals, and RBQM Issues. If an unlicensed user is also assigned Issues from other elluminate modules, both a Risk Signals listing and an Issues listing may be available.

Understand Risk Alerts, Risk Signals, and Issues

The Risk Signals listing includes three types of items:

• Risk Alerts: Generated automatically when a Key Risk Indicator (KRI) or Quality Tolerance Limit (QTL) exceeds a configured threshold.
• Risk Signals: Created by users to evaluate and investigate potential risks.
• Issues: Created by users to track and manage confirmed risks requiring action.

Risk items can progress through the following workflow:

• Risk Alerts can be promoted to Risk Signals or Issues.
• Risk Signals can be promoted to Issues.

Unlicensed users may be assigned any of these item types and can view them together in the same listing.

Review Assigned Risk Alerts, Risk Signals, and Issues

By default, the listing displays:

• Items assigned to the user
• Statuses: Open and Answered

Each row represents a Risk Alert, Risk Signal, or Issue requiring review or action. Use the columns to identify priority, status, and required action.

Tip: Use the horizontal scrollbar to view all columns.

Work in the Risk Signals Listing

Use the listing to locate, filter, and manage assigned items.

• Sort: Select a column header and choose Sort Ascending or Sort Descending.
• Filter: Select a column header, choose Filter, and enter criteria.
• Clear filters: Click the Filters icon and select Clear Filters.
• Search: Click the Search icon to open a popout listing all available columns. Begin typing to filter the list. Select a column name to navigate directly to that column.
• Previous and Next Page: Use the Previous and Next icons to navigate between pages. By default, 20 rows display per page.

View and Add Comments from the Listing

1. Click the number in the Comments column.
   
2. View existing comments.
   
3. Enter a comment.
4. Click Add.

View Details and Add Comments

Use the Details panel to review context and manage comments. The panel provides additional context and available actions for the selected record.

1. Select a record.
2. Click the Details icon in the toolbar.
   
3. Expand Comments to: 
   • View existing comments
   • Add a new comment

Comments support communication with assigned users.

Answer Risk Signals or Issues

Answer Risk Signals or Issues using one of the following methods:

From the Listing

1. Select one or more records.
2. Click the Action icon.
3. Select Answer.
   
4. Enter a Response.
5. Click Save.

From the Details Panel

1. Select a Risk Signal or Issue from the listing.
2. Click the Details icon in the toolbar. The Details panel opens.
3. Click the Action icon.
4. Select Answer.
5. Enter a Response.
6. Click Save.

Note: Risk Alerts do not support answering.

Export Risk Signals

The export includes only records currently displayed in the listing, including any applied filters.

1. From the listing, click the Export icon in the toolbar.
2. Select Export Risk Signals or Export Risk Signals with Comments.

The file downloads.