Title21 Complaint Handling Solution is easy-to-use complaint management software built for healthcare and life sciences organizations to support the complete documentation, investigation and resolution of customer feedback and complaints while ensuring compliance to FDA and GMP guidelines.
Intuitive complaint intake forms facilitate accurate documentation of complaints through required fields and automated workflows.
Flexible drop-down options and data lists enable the collection of serial number, lot number or other product identifiers, facilitating traceability.
Standardized risk assessment tools configured to your organization’s risk profile enable consistent categorization of the severity of complaints.
Automated Escalations ensure proper managerial notification and prioritization of critical complaints.
Electronic workflows and task generation accelerate complaint response time and reduce investigation bottlenecks.
Coding and categorization tools enable tracking and trend analysis on historical complaints, facilitating continuous quality and safety monitoring.
Permission-based reporting on real-time and historical complaint data keeps you inspection-ready and supports overall quality improvement efforts.
Generate a CAPA form from a high risk complaint right from the complaint form or from an adverse trend identified by recurring complaints.
Automated workflows ensure complaints are recorded, assessed and resolved in a timely manner.
Management can track, trend, and report on complaint data through a centralized system at leach location and across the enterprise.
Built-in risk assessment tools ensure threats to patient safety are escalated and quickly acted upon.