Tracking Solution

Relsys International, Inc.k from <%=company%> helps manufacturers of devices, drugs and biologics respond to customer complaints, but also assists in the proactive development of corrective action plans. With a keystroke, it can provide data to help the user analyze trends and identify the root cause of an event.

Adverse event and MDR report generation, including FDA-approved MEdWatch, Baseline and Annual Certification forms with the ability to electroincally transmit reports directly to the FDA International reporting features including Vigilance, CIOMS-I, CIOMS-II, and Japan's Ministry of Health and Welfare Scalable from single-user to multiple site worldwide Provides the means to comply with GMP and adverse event reporting regulations Executive summary reports communicate information and monitor progress of complaints Automated Root Cause Analysis Wizard constantly searches for potential problem areas Complies with FDA-recommended guidelines for software development and validation Remote log-in capability A customizable multi-level security system controls access to information

Fully customizable system COSTART, WHOART, and ICD-9 coding dictionaries available Support for Sybase, Oracle and Microsoft SQL Server databases Global connectivity via corporate WAN, Lotus Notes, modem and Internet.

Relsys International Inc., 2 Venture, Ste. 400, Irvine, California 92718. Phone: 714-453-1715; Fax: 714-453-1817.