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:
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.
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.
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: Quality & Compliance Systems for Every Enterprise
The quality and compliance journey can be an obstacle course of changing regulations and standards in a dynamic global market. The AssurX enterprise quality management system (EQMS) and the AssurX Energy Compliance System (ECOS) help guide organizations through the complexities of any regulatory landscape.
Our dynamic, connected quality and compliance management solutions help guide your journey by automating processes to streamline event management, minimize risk, measure performance and facilitate change. The result is a proactive system that improves efficiency, compliance readiness, product quality, and customer satisfaction.
One Platform. Every Solution.
AssurX centralizes quality management and regulatory compliance processes within a single, configurable software platform. The system includes core quality and compliance workflows out of the box, eliminating the need for separate modules and reducing reliance on paper-based or disconnected systems.
Organizations can deploy the solutions they need today and add additional capabilities as requirements evolve. With pre-configured workflows, searchable data, and flexible integration options, AssurX supports efficient deployment, configuration, and long-term scalability across the enterprise.
