Bookshelf v7.7: About Adverse Events and Complaints Management

Adverse events and complaints management (AECM) is an important process in the regulated medical device and pharmaceutical industries. The FDA in the USA and similar agencies in other countries have specific requirements for capturing, investigating, reporting, and resolving adverse events and complaints on medical devices and drugs.

Poor handling of adverse events and complaints can lead to non-compliance penalties such as warning letters, restrictions, fines, and recalls.

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. Table 38 illustrates such a life cycle. Each step in the process represents a chapter in this book.

Table 38. Complaints Process Flow
Process	Roles	Typical Activities
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
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
Manage product analysis and CAPA	Product Analysis and CAPA Team	Ensure 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
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
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
Close adverse event or complaint	Quality or Regulatory Agency	Verify that all necessary activities are completed Initiate complaint closure approval Close complaint

Where to Find More Information

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

Integration with Other Siebel Applications

Siebel AECM is integrated with Siebel Call Center, Siebel Sales, Siebel Field Service, and Siebel Clinical. This allows the flexibility to share varying levels of visibility to adverse event or complaint details, investigation status, and corrective action across different users and functions within the organization. The Siebel Audit Trail functionality keeps a record of changes made to records throughout the course of the investigation.