• Product Nonconformance Software Solutions (NCMR)

    TrackWise can be used as nonconformance software (NCMR) to ensure that product and process issues are properly and efficiently handled through an integrated process that tracks and manages the complete lifecycle from the initial report through investigation, root cause analysis, any resulting actions and follow- up verification of effectiveness.  

    TrackWise provides a fully configurable automated nonconformance software process with the flexibility to address the specific needs of your corporate processes while providing a rigorous controlled environment to facilitate compliance and regulatory conformance and mitigate risk. 

    Benefits of Nonconformance (NCMR) Software:

    • Reduce the risk of lost or incomplete data through closed-loop nonconformance software management  
    • Decrease time to market and production/operation costs by increasing nonconformance process efficiency
    • Increase customer safety and reduce the risk of damage to your company’s brand and corporate image by improving product quality  
    • Improve operational efficiency by integrating your product nonconformance process with other quality and operating processes, most commonly ERP systems 
    • Increase organizational transparency through automated alerts and extensive reporting capabilities of NCMR software featuring dashboards and executive overviews  
    • Increase accountability through assignments, process step approvals and audit trails  
    • Decrease the risks of repeat errors or issues by improving root cause analysis using built-in decision trees and drill-down selection lists with NCMR software 
    • Facilitate compliance with medical device industry regulations including 21 CFR Part 11, 21 CFR Part 803 and 21 CFR Part 820; ISO 9001, 13485, 13488, 14001, 14791; EN 46001 and 46002; GMP #40 and #63 ordinances and other international standards 
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