Completing Adverse Events and Complaints Reviews

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, then the Product Issue List view.

2. In the Product Issues list, drill down on 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, Device Type, and Part #.

   • Makes these fields read-only: Account, Account Address, Date of Event, Summary, All patient information (on Patient view), and 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.