POST-MARKET SURVEILLANCE
Gather actionable insights to ensure a high level of product quality and patient safety
TrackWise Digital Post-Market Surveillance
Quote: Awesome Complaint Management Solution
Phay Lee
Senior Manager Quality Systems, TG Therapeutics
Key Capabilities for Post-Market Surveillance
INTAKE
Empower employees with a simple, intuitive interface to raise quality events anytime, anywhere – from their computer, tablet or smartphone.
COMPLAINT HANDLING
Manage the entire complaint lifecycle—from investigation to resolution, and gain insights for continuous improvement.
REGULATORY REPORTING
Submit information to appropriate regulatory bodies with regulatory reporting capabilities like eMDR, EU MIR and adverse events.
AI-ENABLED COMPLAINT CATEGORIZATION
An integrated tracking system and a powerful workflow engine that automates audit findings, responses, corrective actions, approval, and reporting.
AI INSIGHTS
Identify related quality events and avoid repeating the same investigation multiple times.
EARLY RISK DETECTION
Auto-categorization of complaints and quality event severity ensure timely action.
Check Out Other Honeywell Solutions
COMPLAINT MANAGEMENT SOFTWARE
The complaint handling QPA provides the ability to log, respond to and investigate complaints.
SUPPLIER QUALITY MANAGEMENT (SQM)
The supplier quality management QPA enables organizations to manage and collaborate with suppliers and contract manufacturers across your supply chain.
QUALITY RISK MANAGEMENT
Risk Management enables companies to seamlessly link the risk process to other quality management processes.
AUDIT MANAGEMEMT
The audit management QPA helps companies monitor critical processes, identify gaps and improve quality.
CORRECTIVE AND PREVENTIVE ACTION (CAPA)
The CAPA QPA enables organizations to track and manage the process of carrying out CAPA plans, automate verification of effectiveness over time, and provide seamless traceability to related quality processes, including change control and training.
NONCONFORMANCES
The nonconformance QPA records data about situations in which a product or device has not conformed to standards.
DOCUMENT MANAGEMENT
Access, edit, approve, store and share the latest version of quality documents throughout the value chain
TRAINING MANAGEMENT
With training management, automate company-wide training policies and regulatory requirements, where training activities are scheduled and tracked through completion
OUT OF SPECIFICATION
Document and track results of in-process or finished product testing falling out of specified limits using the Out of Specification (OOS) QPA.
CHANGE MANAGEMENT
The change management QPA manages change at every level of the supply chain to ensure quality and compliance requirements are not affected.
DEVIATIONS AND QUALITY EVENTS
Respond to adverse events faster with the quality events QPA and reduce the amount of time it takes to act on quality and safety issues.
