Oracle® AERS version 4.5.2/4.6 includes many powerful, new features not available in previous versions, such as dynamic labeling, support for multi-lingual implementations, including Japanese data capture and reporting, built-in document management, enhanced workflow, a personalizable web interface and support for collecting product complaints. These features offer companies the opportunity to re-evaluate and optimize their use of the system to implement a more efficient, effective and compliant regulatory process.

Our short, one week readiness assessment project assists companies in understanding the technical, functional and regulatory implications of moving to the new version.

Our consultants will review the usage and configuration of the current AERS version, the structure of the safety organization and the corresponding system workflow, and the company's safety and regulatory objectives and standard operating procedures. The deliverable for the project is an Assessment Report describing the required or recommended changes to your infrastructure, configuration and organization for getting the most value from the new version.