Systematically Manage the Entire Complaint Lifecycle

Manage risk, ensure patient safety and improve product quality with data-driven insights.

Complaint Management Software for Regulated Industries

Your postmarket surveillance process should ensure that all complaints are processed in a timely manner and in alignment with industry regulations. AssurX Complaint Management Software is designed for industries that require a robust system to document, review, and report applicable adverse events to the FDA and other international bodies.

While most applicable to the postmarket surveillance demands of the life sciences industry, quality-centric organizations across markets are electing to implement a strong complaint management system to protect consumer confidence and health, pinpoint where incidents are occurring, and make continual product improvements.

AssurX helps organizations meet compliance with regulations including:

Standards for Medical Device Quality Systems

Postmarket Surveillance

Guidelines for Complaints Handling

Standards for Application of Risk Management to Medical Devices

Quality Risk Management Guidance for drugs and biologics

to Support Regulatory Decisions

AssurX Complaint Management Software is designed for industries that require a robust system to document, review, and report applicable adverse events to the FDA and other international bodies.


Automation of the process and use of standardized forms help avoid errors common in manual intake of information. Intuitive workflows with clear selection criteria make triage and routing easier. Pre-configured complaint categorization helps prioritize event severity for timely response.


Prioritize complaints based on risk and objectives. Analysis of data collected will help you determine whether a complaint or quality issue is valid and/or reportable. Verified adverse events can be electronically reported within specific deadlines to FDA, the European Union, as well as other regional regulatory bodies globally.


Complaints deemed valid during the review stage are categorized according to risk to prioritize investigations. Robust workflow rules move the complaint through a task and sub-task cycle to manage deviations and nonconformances.

Moving from paper processes to an automated enterprise quality and compliance system, the AssurX platform enables the medical device manufacturer to improve the speed of investigations by integrating directly with Salesforce to automatically create records for complaints without data re-entry.

AssurX enables cardiovascular device company to automate their complaint handling process

Integrated Complaint Management for a Modern Quality Management Software System

AssurX seamlessly integrates complaint handling to improve quality and compliance, minimize recalls, and present data for continuous improvement. The system clearly identifies where events are occurring and trends are happening, allowing you to make data-driven, risk-based decisions to prevent future incidents and demonstrate compliance.

AssurX CAPA Management Dashboards and Analytics
  • Unmatched Configurability

    AssurX’s Complaint Management Solution is highly configurable to meet the unique demands of our customer. Scale the complaint management solution to align with your company’s needs in both clinical and commercial phases. Guided workflows navigate users through the right documentation and reporting for each complaint from intake to closure.

  • A True QMS Platform

    AssurX provides a single, closed-loop system of processes that can integrate from day one to close the loop on complaints including Deviation Management, Audit Management, Risk Management, Document Management, Training Management, Supply Chain Quality, and Change Control Management.

  • Enterprise System Integration

    Integrate enterprise systems including MES, LIMS, PLM, ERP, and others to extend your quality ecosystem for downstream activities such as post-market investigations and reporting. Harmonize collaboration between R&D, manufacturing, suppliers, and all areas of the business responsible for outputting high quality products. Achieve unmatched visibility into the device history.

  • Greater Compliance Control

    Dashboards, analytics, and reports indicate the state of compliance based on trending issues and associated risks. Configurable decision trees determine rule enforcement paths, including launching corrective actions and report submission for regulatory requirements. Built-in performance metrics enable oversight of KPIs to enable a perpetual state of compliance. AssurX provides full traceability through audit trails and electronic signatures as required for 21 CFR Part 11 compliance.

AssurX Complaint Management Demo Video

Watch a 10 Minute Video of the AssurX Complaint Management Solution Now

See how the AssurX Complaint Management Sofware provides the most efficient path from complaint intake to resolution. It is easy to deploy with the flexibility to adapt to your unique business requirements.

“We have been using AssurX for over 14 years now to manage some of our critical quality processes. The configurable nature of the software allows us to adapt quickly to changing requirements and continuously deliver new features.”

AssurX: Quality & Compliance Systems for Every Enterprise

When you choose AssurX, you’re choosing decades of expertise in regulatory environments and innovation in quality management. Our unwavering focus on quality management means you’re getting a best-of-class solution, not a scaled-down or inflexible software solution.

One Platform. Every Solution.

Seamlessly integrate all quality management and regulatory compliance management processes with one software system. AssurX provides all core quality and compliance processes within the software system, eliminating the need to budget for and install individual quality “modules.” Pre-configured workflows are available to you from day one.

First, implement the solutions you need now, then seamlessly connect more as you are ready. No other system is easier to deploy, configure, and modify.

Audit Management

CAPA Management

Calibration Management

Change Management

Complaint Management

Customer Quality Management

Deviation Management

Document Management

EHS Incident Management

Nonconformance Management

Quality Management Review

Risk Management

Supplier Quality Management

Training Management

Validation Management Solution