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Siebel Life Sciences Guide > Closing Adverse Events and Complaints > Scenario for Closing Adverse Events and ComplaintsThis scenario is an example process performed by the quality manager. Your company might follow a different process according to its business requirements. This scenario is designed to illustrate the functionality of Siebel AECM. The Quality ManagerIn the course of this scenario, the quality manager closes the product issue, reopens it, reviews its history and finally closes it for good. ClosingA product issue is ready for closure when:
The quality manager, who is the owner of the product issue, changes the status of the product issue to closed. ReopeningSome 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 HistoryThe 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. |
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