• TrackWise Supplier Quality & Vendor Management System 

    For Medical Device manufacturers, having visibility into the critical supply chain processes, starting with the raw material suppliers and vendors through point-of-sale is a major factor to success.  Producing poor products or wrong products that require repair or replacement erodes customer sentiment and customer satisfaction levels go down. 

    Sparta Systems’ vendor management system for medical device manufacturers offers features such as supplier scorecards, supplier qualification best practices, manage the approved supplier list (ASL), and tracking systems for supplier non-conformances and resulting CAPA.  

    The TrackWise supplier qualification and vendor tracking software for medical device manufacturers increases the efficiency of supplier and vendor selection by both tracking and managing the qualification and approval process for new potential vendors and parts while avoiding redundant evaluations.  TrackWise enables complete maintenance and transparency of all previous vendor records, making them available  for reference across the enterprise. Supplier qualification is further enhanced by our advanced auditing capabilities to allow offline execution of audits and generation of audit reports and seamless integration back into corporate TrackWise. 

    Whitepaper - A Business Case for an Enterprise Quality Management System - Download Now

    Addressing Nonconformance and Risk in Real-time using TrackWise 

    The TrackWise supplier nonconformance process ensures all supplier non conformances are addressed and appropriate actions are taken by tracking and managing all reported non-conformances, their subsequent investigations, and any resulting CAPA in a timely and harmonized manner. Efficiency gains are achieved through effective workflow progression and appropriate risk management. 

    Supplier scorecards are the real-time view into the health of your supply chain. These scorecards pull information from all TrackWise processes and activities such as new supplier qualification, incoming inspections, non-conformance , SCARs, supplier actions and audit results, as well as ERP data such as quantity delivered and on-time delivery statistics. This truly holistic view helps highlight areas of greatest risk in your supply chain to make appropriate supplier development, supply usage and spend decisions. 

    Four Best Practices to Improve Quality in the Supply Chain - Download eBook Now

    Benefits of TrackWise Supplier and Vendor Management System for Healthcare and Medical Device Manufacturers 

    • Facilitate compliance with medical device industry regulations including 21 CFR parts 11, 803 and 820;; EN 46001 and 46002; GMP #40 and #63 ordinances and other international standards, including EU GMP Annex 11. 
    • Ensures compliance with medical industry and government regulations and ISO standards, ISO 9001, 13485, 13488, 14001, 14791  
    • Reduces risks of medical device and healthcare product deviations and other quality incidents by ensuring supplier and vendor non-conformances are addressed before using materials in product  
    • Increases supplier selection efficiency by eliminating redundant supplier evaluations across departments using a standardized, centralized supplier evaluation process  
    • Provides seamless integration into Quality Management System functionality such as non-conformances, CAPA, and other quality activities  
    • Fosters collaboration with key suppliers through effective communications and visibility of supplier performance 
    • Reduces risk of lost or incomplete data through a closed-loop supplier process  
    • Reduces costs of supplier evaluation driven by multiple redundant, siloed systems  
    • Provides flexible yet controlled environments through fully configurable process workflows  
    • Improves other quality and operating processes by integrating with other enterprise-level control systems such as PLMs, ERPs, and MESs  
    • Increases operational transparency through automated alerts, overview views using dashboard functionality, and extensive reporting capabilities  
    • Increases accountability through assignments, process step sign-offs, and automated audit trails 
    • Provides a global platform to manage ASL, a key challenge in many device companies with fragmented ERP systems 
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