“AssurX has helped tremendously in assuring that manufacturing related complaints are addressed in a timely fashion.”

– Regulatory & Compliance Auditor

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Complaint Management Software

Automate and streamline the complaint lifecycle from product event intake through investigation, root cause analysis, corrective action and reporting to regulatory agencies. Based on compliant industry best practices for complaint handling, AssurX’s complaint management software guides users through proper processing, documenting and reporting of every complaint. The software logs product events from all sources (CRM, phone, email, website, internal, etc.) then centrally manages the process as reporting requirements are assessed; investigations conducted, and follow-up activities are assigned and tracked. When required, the system can automatically launch corrective actions and electronic regulatory reporting. The software comes with fully compliant audit trail and electronic signature functionality. Using automatic task assignment, escalation, and notifications to keep the process efficiently moving, AssurX complaint management software creates an ironclad closed-loop system that ensures all product issues are properly handled and reported in a timely manner.

FEATURES

The AssurX Complaint Management solution efficiently processes complaints across operations: reporting assessment, root cause analysis, corrective action and regulatory actions.

COMPLIANCE

Closed-loop complaint handling with built-in audit trail and electronic signature functionality helps your organization stay audit-ready and compliant with FDA, ISO, GMP and other regulatory bodies

STREAMLINE

Streamline and control the entire complaint lifecycle by automatically linking related processes, product issues/events and information throughout operations.

CENTRALIZE

Automatically collect detailed product event data from across the organization into a single repository.

AUTOMATED

Increase processing consistency while reducing errors and cycle times. Automatically capture detailed data about product issues, events and complaints.

VISIBILITY

Instantly access real-time status, analytics and performance metrics so you KNOW all products events, tasks and approvals are being properly handled, and all trends are identified quickly.

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Software Name
Assurx - Quality and Regulatory Compliance Solution
Operating System
Windows, MacOSx, Linux
Software Category
Business