TrackWise by Sparta Systems for the Blood and Tissue Industries

Blood centers and blood and tissue manufacturers are regulated by strict quality requirements to ensure the safety of our blood supply. Blood centers and blood and tissue manufacturers are challenged with implementing effective quality management systems while balancing constrained budgets and limited resources.

Sparta Systems' TrackWise Enterprise Quality Management Solutions is software that enables blood centers to ensure compliance, improve quality and reduce costs by centralizing and integrating all quality processes, including customer complaints, supplier quality, internal and external audits, change control, corrective and preventive actions (CAPA), preventive maintenance and calibration, training management and document management.

TrackWise EQMS best practices enables organizations to efficiently manage and enforce current Good Manufacturing/Laboratory/Clinical Practices (cGxPs), compliance guidelines for FDA and AABB (American Association of Blood Banks) and organizational SOPs. All issues, actions and changes reside in a single, easy-to-configure, web-based system that integrates quality information between QA, donor collections, hospital services, laboratory services and other departments.

• Higher ROI and improved efficiency as a result of improved user proficiency and streamlined processes
• Adhere to and ensure compliance to FDA and AABB
• Provide Biological Product Deviation Reporting (BPDRs) to the FDA on a timely basis
• Provide centralized data management through consolidated tracking, workflow management and reporting
• Ensure workflow management and SOP enforcement
• Rapid deployment enables small and medium size organizations to rapidly migrate from paper-based systems and spreadsheets to an automated, electronic system
• Electronic Reporting generates reports in electronic format from structured audit-trailed data fields to meet CBER’s guidelines for Biological Product Deviation Reporting (BPDR)
• Increase visibility and transparency through dashboards and reports, using a powerful reporting interface provides up-to-date information for compliance health and open record status