Automate Complaint Management Software
AssurX’s Complaint Management solution enables an automated approach to a customer’s product complaint process. Streamline the complaint lifecycle from intake through investigation, root cause analysis, corrective action and regulatory reporting throughout the product lifecycle. Reinforce accountability and speed to action through task management and dashboards. Minimize the risk of complaint mismanagement and maximize efficiency in complaint resolution.
Configurable and Intuitive Complaint Management
- AssurX’s configurable Complaint Management solution adapts to any industry requiring greater control of complaint handling with expanded visibility into the state of compliance. Scale the complaint management solution to align with your company’s need in both clinical and commercial phases.
- Guided workflow navigates users through the right documentation and reporting for each complaint from intake to closure.
- Configurable decision trees determine rule enforcement paths, including launching corrective actions and report submission for regulatory requirements. The ability to produce reports with a mouse click enables audit-readiness and compliance with FDA, EU MDR, ISO, GMP and other industry regulations.
- Built-in performance metrics provide full visibility and oversight of KPIs and help enable a perpetual state of compliance.
- Notifications, escalations, rules and reminders drive complaints down the most efficient path to closure.
- AssurX Complaint Management comes with fully compliant audit trail and electronic signature functionality for total enterprise accountability.
The AssurX Complaint Management solution efficiently processes complaints across operations: reporting assessment, root cause analysis, corrective action and regulatory actions.
- Compliance : Closed-loop complaint handling with built-in audit trail and electronic signature functionality helps your organization stay audit-ready and compliant with FDA, ISO, GMP and other regulatory bodies
- Streamline : Streamline and control the entire complaint lifecycle by automatically linking related processes, product issues/events and information throughout operations.
- Centralize : Automatically collect detailed product event data from across the organization into a single repository.
- Automated : Increase processing consistency while reducing errors and cycle times. Automatically capture detailed data about product issues, events and complaints.
- Visibility : Instantly access real-time status, analytics and performance metrics so you KNOW all products events, tasks and approvals are being properly handled, and all trends are identified quickly.
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