• Audit Management Software for Medical Device

    TrackWise audit management 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. Medical device manufacturers must comply with a wide range of regulations like 21 CFR Part 820, as well as medical device reporting, premarket notification 510-(k), investigational device exemption and quality system (QS) regulations. TrackWise audit management software allows manufacturers to take a best practices approach to compliance and risk management and support all audit programs using an enterprise system. 

    TrackWise assists auditors to plan and execute audits more efficiently by providing an integrated tracking system and a powerful workflow engine that automates all steps in the audit lifecycle, including scheduling, preparation, auditing, report approval, report issuance, response and corrective action (CAPA) tracking. In addition, the audit management software delivers audit reports that can be generated as needed, thereby eliminating time consuming paper-based processes. TrackWise can also be utilized to manage the responses of audits conducted of your facility, such as regulatory or customer audits, to ensure audit findings are resolved in a timely fashion.

    Benefits of TrackWise Audit Management Software

      • Reduce risk and increase audit efficiency and visibility by enforcing consistent and harmonized processes and procedures across the organization  
      • Securely manage all information in a centralized, scalable and reliable closed-loop CAPA system   
      • Facilitate compliance with 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 
      • Reduces risk of lost or incomplete data through a centralized, scalable auditing system  
      • Provide flexible, yet controlled functionality to allow the co-location of multiple diverse auditing groups and processes   
      • Increase operational transparency through automated alerts, overview views using dashboard functionality, and extensive reporting capabilities 
      • Increase accountability through assignments, process step sign-offs, and automated audit trails 
      • Feed information to supplier oversight processes to enable truly integrated supplier oversight 
    "Audit Process Medical Device"


    TrackWise Audit Execution Package

    The TrackWise Audit Execution Package is an additional offering that can be utilized to generate even higher levels of efficiency and consistency in your audit programs. This package changes the audit paradigm by enabling auditors to document results in real time and eliminating the error-prone and time-consuming copy/paste steps found in most audit programs. A new offline tool gives auditors the ability to conduct the audit and document results, including any associated observations, whether signed into TrackWise or not. The TrackWise Audit Execution Package bridges the gap between the needs of your management team and your auditors, providing management the consistent data needed to evaluate audit program effectiveness while providing auditors the flexibility and authoring tools they need to be successful in the field. 

    Additional benefits:  

      • Save time and ensure consistency by creating audit templates with as little or as much flexibility as standards and corporate policy dictate  
      • Improve auditor efficiency by enabling them to document results and create offline observations which then automatically create the records in TrackWise when imported back into the system 
      • Improve supply chain collaboration by enabling suppliers to respond electronically, in your company’s format, to audit observations  

    Click here to read more on our Audit Execution Package 

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