With a proven track record over the last decade, now Argus EasyTrak™ is the industry standard solution for medical product complaints. Integrated with Argus Safety™, Argus EasyTrak™ can be implemented stand alone for processing of product complaints or as part of an integrated solution with Argus EasyTrak™ handling product complaints and Argus Safety™ handling adverse events, with cross-linked workflows and triage.

The Argus EasyTrak™ user interface has been optimized to provide ease of entry of complaints of both high and low complexity. Flexible workflow, configurable screens, and user-defined decision trees are a few of the features available to tailor Argus EasyTrak™ to fit your business process. Product complaints are managed from origination, to investigation, laboratory analysis, corrective action, summary, regulatory reporting, and closure. Management tools support monitoring of the workflow real-time as well as identification of trends, increased frequency of complaints, or new problem areas.

Features and Benefits

• Full lifecycle product complaint processing
• Complaint investigation and results tracking
• Sample tracking with laboratory analysis actions and results
• Reimbursement and replacement tracking including RGAs
• Flexible configurable workflow with group and user security
• Configurable decision trees to support key process decisions
• Global regulatory reporting
• Automated letter generation
• Corrective Action and Preventive Action (CAPA) module
• Claims and Legal module
• Seamless integration with Argus Safety for adverse event processing
• Multiple types of automated alerts and notifications
• Reporting, trending and statistical analysis
• Management monitoring tools and reports
• 21 CFR Part 11 Compliant
• Meets FDA complaint handling requirements
• Integrated adverse-event reporting for FDA and EU Device Vigilance Reporting
• Return Goods Authorization
• Alternate Summary Report
• Configurable workflow, group and user security levels
• Automated letter generation for contact management
• Extensive reporting & trending capabilities
• Spell check capabilities for regulatory reports
• Extensive lab analysis
• Claims/legal module
• Root Cause Analysis & Corrective Actions
• Intuitive Graphical User Interface
• Oracle 8i, Sybase 7.0 & MS SQL 2000 compatible