Product/Service

Complaint Management Software

Source: Sparta Systems, Inc.
TrackWise Complaint Management and Regulatory Reporting Solutions enable medical device manufacturers to effectively implement a global and consolidated approach to managing customer complaints and medical device reporting.

Click Here To Visit Sparta Systems Web Site

Click Here To Download:
•White Paper: Issues Facing Device Manufacturers As F.D.A. Moves Closer To Mandating Electronic Reporting (eMDR)

TrackWise Complaint Management and Regulatory Reporting Solutions enable medical device manufacturers to effectively implement a global and consolidated approach to managing customer complaints and medical device reporting. TrackWise ensures compliance, reduces product safety risk, and streamlines workflow processes. The system integrates complaint handling and medical device reporting into the overall quality management system, allowing users to benefit from a single interface and eliminating the need for complex and costly custom integration.

Medical Device manufacturers must record, track, and trend customer complaints according to the Quality System Regulation (QSR) defined in 21 CFR Parts 820. In addition, FDA regulations require firms who 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 require scalable and flexible complaint management systems that enable them to implement enterprise complaint handling coupled with medical device reporting processes.

Benefits

  • Complying with federal government regulations, ensuring good standing with the regulating agencies
  • Provide an electronic MedWatch form, with Electronic Medical Device Report (eMDR)
  • Increased data entry accuracy by requiring fields and limiting choices, data sent to the MDR form will strictly comply with regulations
  • Eliminates manual process and increase in productivity and decrease in cost using an automated versus manual system
  • Centralized storage for global usage; global divisions within the organization can have access to similar events and the ability to track reporting
  • Consolidate and improve regulatory assessments and medical device reporting with integrated decision trees and direct regulatory report generation
  • Increase compliance, eliminate lost records, and ensure on-time reporting of adverse events
  • Automate the process of assigning complaints and related investigations based on manufacturing location and product type
  • Reduce administrative costs with integrated letter generation, product return tracking, and improved workflow management
  • Improve management of the complaint lifecycle with real-time trending and escalation of issues
  • Provide a validated environment compliant with FDA, EMEA and other regulatory authority requirements

Click Here To Download:
•White Paper: Issues Facing Device Manufacturers As F.D.A. Moves Closer To Mandating Electronic Reporting (eMDR)