Siebel Life Sciences Guide > Investigating Adverse Events and Complaints >

Creating Multiple Product Issues Related to One Service Request (End User)

Only one product issue can be created directly from a service request (using the Create Product Issue button on the Service Requests screen). However, in the Product Issues screen, the quality manager can create additional product issues related to the service request and the original product issue.

Here are some examples where multiple product issue records are needed:

• A medical kit contains a drug and a device. The drug and the device may have caused the event. Separate adverse event and product complaint investigations have to be completed.
• There are several products involved with the adverse event or complaint and the quality manager wants a unique product issue for each product.

To create a new product issue

1. Navigate to Product Issues screen > Product Issue List view.
2. Drill down on a product issue.
3. Click Create Related PI.

   This starts a workflow (LS Medical Product Issue Create Related PI), which creates a new product issue record, copying fields from the current product issue.

   For more information about the workflow, see About Configuring Create Related PI and Review Complete Buttons.

4. Edit fields in the Event Detail form as required.
5. Enter information about the products associated with the issue in the Products list.