SmartSolve Complaint Management
Complaint Management Software – 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.
Let Complaint Management take the guesswork out of your investigations. Our 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. This comes in handy when submitting electronic Medical Device Reports (eMDRs) for adverse events, and when your complaint handling system is audited during an FDA inspection.
- Streamline complaint intake for quick response.
Once you’re aware of a complaint, the clock starts ticking. Complaint Management’s flexible intake options provide the fastest path from incident awareness to action. 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.
Intake data automatically drives your investigation and resolution workflow. High-severity issues and adverse events are instantly escalated to the right personnel for investigation.
- Simplify global adverse event reporting.
Complaint Management helps you understand your reporting requirements throughout the global marketplace. Our complaint management 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.
For medical device manufactures and importers submitting eMDRs in the United States, Complaint Management automatically creates, validates, and formats the XML file for submission to the FDA. To further streamline compliance, when implementing in the Pilgrim Cloud, Complaint Management automatically submits the eMDR file and receives and attaches the appropriate acknowledgement files (ACKs) from the FDA.
- Increase management oversight.
Do you know how many complaints you receive for each of your products? With our configurable reporting and quality intelligence tools, you can easily monitor and explore your complaint data, including due dates, critical tasks, recurring failure modes, and more. You’ll be able to resolve issues quickly and make effective decisions based on actionable insight from your reports.
Complaint Management is an integrated part of our SmartSolve quality management software.