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About Regulatory Reporting

This chapter describes how to use the Siebel application to create and manage regulatory reports for product complaints and adverse events. The reports are generated with unique and sequential numbers and formatted ready for submission to the FDA or other regulatory agencies.

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
• Communicating with Customers for AECM
• Closing Adverse Events and Complaints