Quality Review

The Trail Interactive’s Quality Review module allows users to conduct an audit/quality review of document filed within eTMF. The functionality includes:

• Audit Profile Creation
• Configuration of Audit Parameters
• Assignment of Audit Roles
• Document Review
• Rectification of Failed Documents

To access the Quality Review module, follow the steps below:

1. Click the waffle menu (navigation grid).
2. Select the Quality Review module.
   
   
   
3. Ensure the user has the necessary role assigned (Auditor, Audit Responder or Audit Manager role) to access the Quality Review module.
4. The Quality Review module displays the following tabs within the left-hand navigation pane.
   • Quality Review: This section allows users to choose the audit profile within which a they are either assigned either as an Auditor, Audit Responder, or Manager and view documents associated to that audit
   • Documents: The section allows users to add documents and perform all other document related actions.
   • Quality Review Settings: This section allows users to configure the audit profile settings.
   • Audit Trail: This section allows users to retrieve an audit trail log based on certain parameters.