Siebel Life Sciences Guide > Investigating Adverse Events and Complaints >

Completing Adverse Events and Complaints Reviews (End User)

The exact meaning of the adverse event or complaint review status depends upon your business process. For example, it could indicate that there is sufficient data to begin a second phase of the investigation (trend analysis and recreation of the problem in the lab).

As part of the review process, the quality manager changes the status the record to Review Complete. An important effect of changing the status of a product issue to Review Complete is that a number of key fields are locked down and others are made read-only.

This task is a step in Process of Adverse Events and Complaints Investigation.

To complete a review of a product issue

1. Navigate to Product Issues screen > Product Issue List view.
2. Select a product issue.
3. Click Review Complete.

   This starts a workflow (LS Medical Product Issue Review Complete) that:

   • Changes the status of the product issue to Review Complete
   • Authenticates the user
   • Locks down these fields:

     Primary Contact first and last names	Contact work phone #
     Reported By	Account Name
     Account Address	Product
     Common Device Name	Part #

   • Makes these fields read-only:

     Account	Account Address
     Date of Event	Summary
     All patient information (on Patient view)	Description

     For more information about the workflow, see About Configuring Create Related PI and Review Complete Buttons. For more information about field lockdown, see Closing Adverse Events and Complaints.