Manage, track, and report on complaints, corrective actions, and regulatory reporting. Ensure that the reporting complaints are systematically captured, investigated, analyzed and properly communicated to customers, authorities, suppliers and employees.
An out of the box ready to use module, the Dot Compliance Solution includes a built-in incident and complaints management solution that tracks incoming complaints, manages assessments, determines reporting requirements, investigates and carries through any Corrective action and preventive actions required
Industry best practices pre-configured workflow – reliable and compliant
Integrated processes with investigations and impact/risk assessments
Traceability to Corrective and Preventive Action Plans (CAPA)
Association to impacted batch records and related product registration.
Integrations with external CRM applications, ERP systems or websites
Tracking of communication and correspondence with regulatory agencies.
Data Trend Reports and KPIs for measurable data and indicators
Avoid lengthy design and configuration processes with our core QMS processes