R&D and Clinical Quality
Bringing digital excellence to GCP/GLP
Confidence in quality from lab to patient
R&D and clinical teams face many challenges such as the increasing pace of innovation and focus on patient centricity, all while meeting strict regulatory requirements. We offer the most advanced quality management solutions to help companies bring products to market faster while maintaining compliance and ensuring patient safety.
TrackWise Digital R&D and Clinical Quality
With TrackWise Digital, identify quality issues, find root causes and take corrective action to ensure only safe and effective product is delivered to the customer.
With processes such as audit management and CAPA, continuous improvement is integrated throughout R&D and clinical activities.
Enable faster scale-up and technology transfer from the laboratory to manufacturing.
Key Capabilities Available for R&D and Clinical Quality
Manage and trend quality events, root cause investigations and approval of resulting actions.
Manage deviations in a centralized location, along with associated investigations, approvals and resulting records (e.g. CAPA and change control).
Fully integrated CAPA system with automated routing, notification, delivery, escalation and approval capabilities.
An integrated tracking system and a powerful workflow engine that automates audit findings, responses, corrective actions, approval and reporting.
Manage changes from request, through pre-approvals, change execution, follow-up approvals and implementation.
Centralized document and training management that ensures compliance, streamlines approvals and tracks employee training.