Bookshelf Home | Contents | Index | PDF |
Siebel Life Sciences Guide > Capturing Adverse Events and Complaints > About Adverse Events and Complaints ManagementAdverse 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 ManagementSiebel 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 28 illustrates such a life cycle. Each step in the process represents a chapter in this book. Related TopicsIntegration with Other Siebel Business ApplicationsSiebel 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. |
Siebel Life Sciences Guide | Copyright © 2013, Oracle and/or its affiliates. All rights reserved. Legal Notices. | |