“AssurX provided a fully configurable solution that no other Quality Management System provider has been able to match.”

immunogen selects assurx Complaint Management Software

“Our AssurX eMDR system works great! With just two clicks, MedWatch reports are submitted and all acknowledgments from the FDA are received in real time. Consistently.”

Senior Analyst
Medical Device Manufacturer

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Automate Complaint Management

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 needs 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 a fully compliant audit trail and electronic signature functionality for total enterprise accountability.

Extend Complaint Handling Across the Enterprise

Create an ironclad closed-loop system that ensures all product issues are correctly handled and reported promptly. Integrate other AssurX processes or connect with external systems (CRM, PLM, vendor management, case management, and others) to create a fully collaborative supply chain by connecting quality, customer, and product records.

Download the AssurX Complaint Management Product Brochure for more information.

The AssurX Complaint Management solution efficiently processes complaints across operations: reporting assessment,
root cause analysis, corrective action, and regulatory actions.

AssurX Complaint Management Software Features

COMPLIANCE

Closed-loop complaint handling with built-in audit trail and electronic signature functionality help 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 product events, tasks, and approvals are being correctly handled, and all trends are identified quickly.

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