AssurX Announces Next Generation Complaints Management And Regulatory Reporting System For Medical Device Manufacturers
•Brochure: CATSWeb Enterprise Quality Tracking System
Morgan Hill, CA — AssurX, Inc., a leading developer of quality and regulatory compliance management systems, has 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."
SOURCE: AssurX, Inc.
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•Brochure: CATSWeb Enterprise Quality Tracking System