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
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.
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.
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
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 and compliance management processes with one software system. First, implement the solutions you need now, then easily connect more as you are ready. No other system is easier to deploy, configure, and modify.