Siebel Life Sciences Guide > Closing Adverse Events and Complaints >

Scenario for Closing Adverse Events and Complaints

This scenario is an example process performed by the quality manager. Your company may follow a different process according to its business requirements.

This scenario is designed to illustrate the functionality of Siebel AECM.

The Quality Manager

In the course of this scenario, the quality manager closes the product issue, reopens it, reviews its history and finally closes it for good.

Closing

A product issue is ready for closure when:

• The activities associated with the product issue have been completed and closed.
• Product analysis has been carried out.
• The product issue was assessed as reportable and the report sent to the regulatory agency.
• The customer has been informed about the status of the product issue.
• A CAPA record has been created.

The quality manager, who is the owner of the product issue, changes the status of the product issue to closed.

Reopening

Some months later, new information resulting from the CAPA work is reported. A new quality manager needs to reopen and revise the product issue based on this new information.

Reviewing History

The new quality manager acquaints himself with the product issue.

He reviews the approval history for the issue, noting who approved the initial product issue review, and who approved the closure.

He also reviews the lockdown fields. This tells him that the name of the account has changed since the product issue was closed.

After updating the fields, the quality manager uses audit trail to review all changes that were made to product issue since reopening. Then he closes the product issue.