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. Sparta Systems offers 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

 
 
Ensure the highest level of 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.

 
 
Continuous Quality Improvement

With processes such as audit management and CAPA, continuous improvement is integrated throughout R&D and clinical activities.

 
 
Streamline Technology Transfer

Enable faster scale-up and technology transfer from the laboratory to manufacturing.

Key Capabilities Available for R&D and Clinical Quality

 
 
Incident Management

Manage and trend quality events, root cause investigations and approval of resulting actions.

Deviations

Manage deviations in a centralized location, along with associated investigations, approvals and resulting records (e.g. CAPA and change control).

Corrective and Preventive Action (CAPA)

Fully integrated CAPA system with automated routing, notification, delivery, escalation and approval capabilities.

Audit Management

An integrated tracking system and a powerful workflow engine that automates audit findings, responses, corrective actions, approval and reporting.

Change Control

Manage changes from request, through pre-approvals, change execution, follow-up approvals and implementation.

Quality Content Management

Centralized document and training management that ensures compliance, streamlines approvals and tracks employee training.

Let’s talk about how our digital quality solutions can work for you

Request a demo to learn more about how TrackWise Digital’s R&D and clinical quality solutions can meet your organization’s needs.