Complaint Handling

Timely complaint handling in accordance with the applicable regulatory requirements is vital for your company compliance and product quality. Disposition events in an effective and rigorous manner by tracking: receiving and recording information, complaint evaluation and investigation, reporting requirements, product disposition, and connection with the ClearMark CAPA module.

Complaint Handling Feature List

Complaint files are easy to generate and maintain with full traceability to product, vigilance or reporting, and corrective actions.


Record events and document complaint determinations

Regulatory impact and reporting assessments

Vigilance and reporting assessments and approvals

Manage approvals

Fully customized approval workflows

Risk-based Framework

Manage complaints from a risk-based perspective

Root Cause Analysis

Root cause analysis records and attachments

Tracking and Trending Exports

Automatic tracking for export and analysis

Real Time Information

Process and documentation visibility in real-time