• Corrective Action and Preventive Action (CAPA) for Medical Device

    The TrackWise corrective action and preventive action (CAPA) software 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.  

    TrackWise is the only enterprise quality and compliance software system that makes it possible for your company to implement a holistic approach to your CAPA software activities. The flexible TrackWise architecture grants your organization the power to log and manage quality issues originating from any source, while its automated workflow engine routes records through the appropriate investigation, root cause analysis, planning, verification and effectiveness steps. With TrackWise, your organization is assured a repeatable, compliant, and 100% closed-loop CAPA process. 

    Benefits:

      • Ensures compliance with industry and government regulations and ISO standards  
      • Decreases cycle time and production/operation costs by increasing quality and process efficiency  
      • Escalates the issues of highest risk to the change control process, ultimately leading to next-generation design changes 
      • Reduces risks of repeated issues and problems by ensuring CAPA processes are followed-up as defined by SOPs  
      • Promotes consistent and harmonized processes throughout the company through an enterprise-level CAPA solution 
      • Incorporates the use of CAPA review boards as appropriate in your organization  
      • Reduces risk of lost or incomplete data through closed-loop CAPA management process  
      • 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 ERPs and MESs, batch release systems and regulatory reporting systems  
      • 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  
      • Facilitate compliance with medical device industry regulations including 21 CFR parts 11, 803 and 820; ISO 9001, 13485, 13488, 14001, 14791; EN 46001 and 46002; GMP #40 and #63 ordinances and other international standards