Gather actionable insights to ensure a high level of product quality and patient safety
Insights to reduce product safety risk and ensure regulatory compliance
Improve the efficiency and effectiveness of post-market surveillance processes, including complaint handling and regulatory reporting. Take complaint handling capabilities to the next level with AI-augmented decisions using QualityWise.ai.
TrackWise Digital Post-Market Surveillance
Rapidly triage, investigate root causes and resolve complaints for continuous product quality improvements.
Stay on top of regulatory reporting requirements to ensure timeliness and accuracy of submissions.
Identify quality issues, find root causes and take corrective action to ensure safe and effective product is delivered to the customer and patient.
Key Capabilities for Post-Market Surveillance
Empower employees with a simple, intuitive interface to raise quality events anytime, anywhere – from their computer, tablet or smartphone.
Manage the entire complaint lifecycle—from investigation to resolution, and gain insights for continuous improvement.
Submit information to appropriate regulatory bodies with regulatory reporting capabilities like eMDR, EU MIR and adverse events.
View suggestions on type, reportability and severity, to help teams quickly triage and ensure timely action.
Identify related quality events and avoid repeating the same investigation multiple times.
Auto-categorization of complaints and quality event severity ensure timely action.
Check Out Other Sparta Solutions
The complaint handling QPA provides the ability to log, respond to and investigate complaints.
The supplier quality management QPA enables organizations to manage and collaborate with suppliers and contract manufacturers across your supply chain.
Risk Management enables companies to seamlessly link the risk process to other quality management processes.
The audit management QPA helps companies monitor critical processes, identify gaps and improve quality.
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.
The nonconformance QPA records data about situations in which a product or device has not conformed to standards.
Access, edit, approve, store and share the latest version of quality documents throughout the value chain
With training management, automate company-wide training policies and regulatory requirements, where training activities are scheduled and tracked through completion
Document and track results of in-process or finished product testing falling out of specified limits using the Out of Specification (OOS) QPA.
The change management QPA manages change at every level of the supply chain to ensure quality and compliance requirements are not affected.
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.