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About Recording Product Analysis for AECM

This chapter describes how to use the Siebel application during the product analysis phase of an adverse events and complaints investigation.

When a faulty product is returned to the manufacturer for study, a product analysis record is opened. This record documents details of the analysis. When the analysis is complete, root cause and corrective action information are added and the record is submitted for approval.

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
• Managing CAPAs
• Regulatory Reporting
• Communicating with Customers for AECM
• Closing Adverse Events and Complaints