WorkFlow
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.
Events
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