Corrective Action and Preventative Action (CAPA) for Medical Device 

The HDL Systems Corrective Action and Preventative Action (CAPA) solution automates CAPAs generated independently or through other quality processes. HDL Systems 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. 

HDL Systems is the only enterprise quality and compliance software system that makes it possible for your company to implement a holistic approach to its CAPA system. The flexible HDL Systems 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. 

Benefits: 

  • Ensures compliance with industry and government regulations and ISO standards
  • Decreases cycle time and production/operation costs by increasing quality and process efficiency 
  • 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
  • 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 EPRs 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 though assignments, process step sign-offs, and automated audit trails 
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