• Complaint Management Software & Regulatory Reporting

    TrackWise complaint management software and regulatory reporting compliance software enables your organization to implement an effective, consolidated, global approach to managing customer complaints and regulatory reporting, including electronic reporting methods such as eMDR and eMDV. 

    Medical device manufacturers must record, track and trend customer complaints according to the Quality System Regulation (QSR) defined in 21 CFR Part 820. In addition, FDA Part 803 regulations require firms that have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify the FDA of the incident. As a result, companies must implement best-of-breed complaint handling systems that enable them to implement enterprise complaint management coupled with medical device complaint reporting processes. 

    TrackWise regulatory reporting and complaint management software facilitates compliance, reduces product safety risk and streamlines workflow processes. TrackWise integrates complaint handling and medical device reporting into the overall quality management system, giving users the benefit of a single, familiar interface and eliminating the need for complex and costly custom complaints software integration. 

    Whitepaper - The Challenges of Complaint Handling, Investigations and Adverse Event Reporting - Download Now

    Benefits of TrackWise Complaint Management & Regulatory Reporting Software:

      • Improve management of the complaint handling lifecycle with real-time trending and escalation of customer complaints  
      • Automate the process of assigning complaints and related investigations based on manufacturing location, product type or other established customer complaint criteria
      • Error-proof processes by utilizing decision trees, specific to your products, to help drive complaint management investigations and determine regulatory requirements around the world  
      • Provide a validated environment compliant with FDA, European Medicines Agency and other regulatory authority requirements  
      • Automate the eMDR and eMDV process by leveraging industry-standard EDI technology and reduce effort to comply with government mandates 
      • Integrate with existing Customer Relationship Management (CRM) systems, globally, to ensure automatic generation of complaints and feedback of investigation status to regional complaints software systems 
      • Consolidate and improve regulatory assessments and medical device reporting with integrated decision trees and the ability to generate and submit MedWatch forms electronically using electronic medical device report (eMDR) functionality 
      • Reduce administrative costs with integrated letter generation, product return tracking and improved complaints software workflow management 
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