Streamline Complaint Handling and Regulatory Reporting

Complaint handling and regulatory reporting are an inescapable part of the Life Sciences industry. Our SmartSolve® Complaint Management software makes these processes easier to handle in a timely and compliant manner. With SmartSolve Complaint Management you can:

  • Demonstrate regulatory compliance.
    Configurable intake decision trees help you consistently differentiate complaints from other customer interactions. You can also capture key product information like market approval date, product classification, unique device identifier (UDI), and license numbers. Then use our built-in reports and complaint history to show that specific products and failures were investigated consistently every time.
  • Streamline complaint intake for quick response.
    Incidents are quickly recorded using our simple, configurable intake forms. Plus, our Quality Intake Portal enables members of your extended demand chain – including field personnel and healthcare professionals - to quickly and securely record incidents.
  • Simplify global adverse event reporting. 
    This system streamlines your submissions with standard reporting for the FDA, EU, Health Canada, Japan, and Australia. Are you expanding into additional countries? You can easily configure decision trees or add regulatory reports for any country in the world.
  • Increase management oversight with reporting and tools that allow you to easily monitor and explore your complaint data, including due dates, critical tasks, recurring failure modes, and more.
  • Tailor, extend, and integrate your quality processes as the demands on your quality management system grow.

See how we can help you streamline complaint handling and regulatory reporting.