AssurX Announces Next Generation Complaints Management and Regulatory Reporting System for Medical Device Manufacturers

October 17, 2006

AssurX Announces Next Generation Complaints Management and Regulatory Reporting System for Medical Device Manufacturers

-- Automates the entire event lifecycle from events intake through regulatory reporting.
-- Facilitates reporting to United States, Canadian, Australian and European regulatory bodies.

MORGAN HILL, CA (October 17, 2006) AssurX, Inc, the leader in quality and regulatory compliance management systems, today announced the release of its next generation Complaints Management and Regulatory Reporting system. The CATSWeb Complaints Management & Regulatory Reporting system provides a best practices process for managing the entire event lifecycle from event intake through investigation, root cause analysis and reporting to regulatory agencies.

A comprehensive solution, CATSWeb Complaints Management & Regulatory Reporting system offers the following key features that are built-in, right out of the box such as:

Built-in Business Performance Metrics/Management Dashboards: Unlike other systems that rely on third party tools to generate reports and metrics, CATSWeb provide built-in management dashboards and metrics to easily monitor status and performance at any level of the organization; enterprise, division, functional or departmental.

Best Practices Workflow: AssurX has simplified and streamlined an end-to-end workflow for processing all events intake, reportable and non-reportable. In addition, unlimited best practices workflows may be added, and modifications to existing template workflows can be easily done with point-and-click configuration.

Integration with other Processes: The Complaints Management system can also be integrated and cross-queried with many of the other built-in quality processes that come with CATSWeb such as audits, CAPAs, issue tracking and change management.

Audit Trail, Electronic Signatures: Audit trail and electronic signatures are compliant with the FDA’s 21 CFR Part 11 regulations. Edit changes to entire records, not just the field changes, are viewable and fully query-able.

Report-ability Evaluation and Regulatory Reports: Decision-tree process automates the evaluation requirements for the United States, Canada, Europe and Australian regulatory bodies and generates the appropriate electronic forms (MedWatch 3500s, etc.) and follow-up/supplemental reports as well.

According to Eric Cooper, Director of Business Development, AssurX, Inc., “We designed the complaint handling and regulatory reporting system in a way to help medical device companies streamline their process. By using the decision-tree methodology, we are providing a system that not only automates the intake events through regulatory reporting process, but also provides ease of use at all levels of the organization.”

About AssurX, Inc.
AssurX, Inc. provides organizations with enterprise-wide solutions for their quality management and regulatory compliance needs. CATSWeb is a proven leader as the industry’s enterprise system of choice at FDA-regulated companies around the world. CATSWeb is a zero-client application available as an on-premise or on-demand system. FDA-regulated companies around the world, including Alcon Labs, Siemens Medical Systems, Genzyme, Bausch & Lomb, and Guidant Corporation use CATSWeb. AssurX is headquartered in Morgan Hill, CA. More information about CATSWeb and AssurX can be found at www.assurx.com or by calling 1-408-778-1376, ext. 705.