Configuring Quality Issues (eTMF & Study Startup)

With the standard Quality Issue object, users can track, manage, and report on quality issues via a user action on document lifecycle states.

Configuration Overview

1. Add the # of Open Issues, # of Closed Issues, and # of Total Issues document fields to document types that need quality issue tracking.
2. Add the Create Related Record user action to document lifecycle states where you want quality issues available. Enter an Action Label and select Quality Issue as the Object, and Related Document as the Field to Default.
3. Add Read permission for the Quality Issues object on relevant permission sets.
4. Optional: Set the Disable Document Requiredness on Quality Issues setting to true to make the Related Document field optional. If selected, when users delete a document referenced by a Quality Issue, Vault allows the deletion and updates the Related Document field to be blank on the Quality Issue.
5. Optional: Adjust the Default Value for the Due Date field on the Quality Issue object.
6. Optional: Secure the Study and Blinding fields.

Securing the Study & Content Fields

You can enable study and blinding security to automatically populate the Study and Content (blinding__v) fields on Quality Issues.

1. Navigate to Admin > Settings > Application Settings > Edit. Set the Enable Study and Blinding Security on Quality Issues checkbox and click Save.
2. Add the Securing Study and Securing Content fields to the Quality Issue page layout.
3. If there are existing Study and Content fields, remove them from the Quality Issue page layout.

Once enabled, you can configure Dynamic Access Control for the Study and Content fields.