Software automates event lifecycle of medical devices.
Press Release Summary:
CATSWeb Complaints Management & Regulatory Reporting system helps manage event lifecycle from event intake through investigation, root cause analysis, and reporting to regulatory agencies. With built-in management dashboards and metrics, system allows integration and cross-querying with quality processes. Audit trail and electronic signatures are compliant with FDA's 21 CFR Part 11 regulations, while decision-tree process generates electronic forms and supplemental reports.
Original Press Release:
Assurx Announces Next Generation Complaints Management & Regulatory Reporting System for Medical Device Manufacturers
o Automates the entire event lifecycle from events intake through regulatory reporting
o Facilitates reporting to US, Canadian, Australian & European regulatory bodies
MORGAN HILL CA USA -- OCT 19 2006 -- AssurX, Inc, the leader in quality and regulatory compliance management systems, today announced the release of its next generation Complaints Management & 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.
As 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 provides 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 nonreportable. 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 queryable.
REPORTABILITY EVALUATION & 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:
http://sacserv.com/tracking.jsp?linkid=39990&subid=3839298&campid=2000879&type=0
or by calling 408-778-1376 ext 705 phone.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Janet Worthen
Marketing Communications Manager
AssurX Inc
305 Vineyard Town Ctr Ste 374
Morgan Hill CA USA 95037
408-778-1376 ext 707 phone
408-776-1267 fax
jworthen@assurx.com
http://sacserv.com/tracking.jsp?linkid=39991&subid=3839298&campid=2000879&type=0
