Siebel Adverse Events and Complaints Management

Siebel Adverse Events and Complaints Management (Siebel AECM) is designed to manage the life cycle of an adverse event or a medical product complaint. Users collaborate and capture all of the necessary data to track the complaint through investigation to corrective action and generate the required regulatory reports. The following table outlines such a life cycle, where each step in the process represents a chapter in this book.

Process	Roles	Typical Activities
1. Capture adverse event or complaint	Call Center Agent	Capture and verify customer contact information Identify whether service request is potential adverse event or complaint Capture adverse event and patient consequences; identify devices Diagnose and solve problem Assess the problem Dispatch Field Engineer Create RMA and replacement orders
2. Investigate adverse event or complaint	Quality or Regulatory Agency	Review information for correctness Identify FDA codes, other similar agencies codes, and internal codes to label the problem Assess whether reportable Perform trend analysis Contacts customer for information Coordinate investigation
3. Manage product analysis and CAPA	Product Analysis and CAPA Team	Make sure receipt of product Decontaminate devices Ship devices to manufacturing or third party for analysis Review complaints Analyze the devices and records results Approve analysis Submit requests for CAPA
4. Report to regulatory agency	Quality or Regulatory Agency	Verify and approve analysis Assess whether problem is reportable Complete information for regulatory reports Generate and submit reports Submit supplemental and annual reports
5. Manage customer communication	Call Center Agent or Quality or Regulatory Agency	Notify customer about investigation Identify all customers with potentially defective devices Execute product recalls Create communication materials for sales and regional offices
6. Close adverse event or complaint	Quality or Regulatory Agency	Verify that all necessary activities are completed Initiate complaint closure approval Close complaint