Siebel Life Sciences Guide > Closing Adverse Events and Complaints >

About Closing Adverse Events and Complaints

This chapter describes the closing of a product issue.

A product issue has come to a conclusion and no new activity or information is anticipated: quality manager closes the product issue record.

When the status of a product issue is changed to Closed, many of the fields in the product issue record become read-only or are locked down to maintain data integrity.

Where to Find More Information

The following chapters describe other aspects of the complaints and adverse events management process:

• Capturing Adverse Events and Complaints
• Investigating Adverse Events and Complaints
• Recording Product Analysis for AECM
• Managing CAPAs
• Regulatory Reporting
• Communicating with Customers for AECM