Enables complaint documentation, investigation, regulatory evaluation and submission process to ensure adherence to regulatory and international standards.

Complaint sources can be monitored and linked to associated complaints and quality events to allow early detection of potential problems and alert appropriate individuals.

Complaints and associated quality events can be scanned for highest risk items to correctly set resolution priorities.

With complete electronic traceability from product to component to raw materials, quality issues can be rapidly contained to limit the scope and impact of potential quality incidents.

Rapid identification of root causes by leveraging a growing knowledge base of Product Design, Process Design, Manufacturing (As-Built and Inspection), Complaint, Service and Quality Event data.

Use out-of-the-box methods, modify them, or define your own, the process is completely configurable to adapt to your business.

Intuitive page flows and user interfaces speed user adoption and expand business value.

Flexible organizational structures and security frameworks support scaling from local to global, in-sourced to outsourced, onshore to offshore implementations.

Interoperates seamlessly with quality and manufacturing products to enable closed-loop quality.

eMDR capabilities are fully compliant with FDA requirements.