TrackWise® by Sparta Systems for the Medical Device Industry
TrackWise is a web-based enterprise quality management software solution that enables your organization to comply with government regulations, regulatory guidelines, ISO and industry standards. For more than 15 years TrackWise holistic EQMS has been successfully enabling companies both big and small to streamline quality processes, consolidate redundant systems and reduce manual operations to generate top-line revenue. TrackWise is the only solution that provides centralized and consolidated tracking, workflow management, and reporting for all critical business processes. TrackWise enables medical device manufacturers to achieve unprecedented compliance results by consolidating redundant systems, reducing manual operations, and implementing best-of-breed technology.
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.
The TrackWise Nonconformance solution ensures product non-conformances are properly and efficiently handled through an integrated process that tracks and manages the complete process from the initial report, to the investigation process and root cause analysis to any resulting actions and follow up verification of effectiveness.
The TrackWise corrective action and preventative action (CAPA) solution automates CAPAs generated independently or through other quality processes. TrackWise tracks and manages the process of generating and carrying out CAPA plans, verifies completion, automates follow-up effectiveness tasks, and, when applicable, closes the loop with the incident record for which the CAPA was created.
The TrackWise Supplier Quality Management solution increases quality throughout the supply chain by managing the process of qualifying, selecting, and monitoring suppliers and supply chain partners by offering features such as supplier scorecards, supplier qualification workflows, and tracking systems for supplier non-conformances and resulting actions.
TrackWise software empowers medical device manufacturers with the tools to improve quality, reduce costs and identify operational and compliance risks by managing the full audit lifecycle and helping to ensure that findings are resolved in a timely and effective manner. TrackWise enables your organization to take a best practices approach to compliance and risk management and support all audit programs using an enterprise system.
TrackWise risk management functionalities enable companies to integrate risk management processes across their entire quality management system. This ensures that nonconformities, regardless of source, are evaluated using consistent criteria to determine risk using standards such as ISO 14971 – the international standard recognized as the best process to ensure that all aspects of risk management are considered throughout the product lifecycle for medical devices. Additionally, this can trigger updates to review the product risk register to have a truly closed-loop process.