AssurX's Complaint Management software automates the intake, review, and resolution of complaints, ensuring compliance with industry regulations. It enhances efficiency, reduces risks, and supports continuous improvement by providing real-time insights and streamlined workflows.
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AssurX
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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:
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.
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.