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 Complaint Handling Solution

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AssurX helps organizations meet compliance with regulations including:

ISO13485

Standards for Medical Device Quality Systems

21 CFR Part 822

Postmarket Surveillance

ISO10002

Guidelines for Complaints Handling

EU MDR

Standards for Application of Risk Management to Medical Devices

EU IVDR

Quality Risk Management Guidance for drugs and biologics

Real World Evidence

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.

Complaint Management Brochure

Electronic Medical Device Reporting (eMDR)

EU Manufacturer Incident Reporting (MIR)

INTAKE

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.

REVIEW

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.

INVESTIGATION

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.

CASE STUDY
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.

“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 more than two decades of expertise in regulated environments and continuous 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 and compliance processes with one software system. Start by using just the solutions you need now, then easily add more as you are ready. No other system is easier to deploy, configure, and modify.

CAPA Management

Training Management

Validation Management Solution

Document Management

Supplier Quality Management

Customer Quality Management

Complaint Management

Change Management

Risk Management

Audit Management

Quality Management Review

Deviation Management

EHS Incident Management

Calibration Management