TrackWise, a 21 CFR Part 11 compliant solution enables your organization to ensure compliance, improve quality and reduce costs by centralising and integrating all quality processes, including management and reporting of nonconformance, customer complaints, supplier quality, internal and external audits, change control, corrective and preventive actions (CAPA), preventive maintenance and calibration, training management, document management and others.
TrackWise provides the unique capability to manage all issues, actions, and changes in a centralised and integrated system. Automated workflow and configurable business rules ensure processes are followed, while enterprise reporting provides reliable information upon request to support decision-making and improve cycle times.
Medical device manufacturers have turned to Sparta Systems’ TrackWise CAPA software as their solution for enterprise quality management. Customers have consistently passed FDA audits and the European Medicines Agency (EMEA) has selected and implemented TrackWise as its own QMS.
• Ensure compliance with 21 CFR Part 11, 21 CFR Part 820, and ISO standards 9001 and 13485.
• Integrate complaint handling, root cause analysis and CAPA into a closed-loop quality system consistent with FDA thinking and industry best practices
• Implement a best-of-breed quality management that integrates with ERP and MES systems
• Maintain high quality levels while conducting operations across outsourced sites and supply chain partners
• Reduce costs incurred by re-works, scrap, and process down times
• Increase product quality and support efforts to enhance brand equity
• Reduce cycle time and increase time to market
• Adapt quickly to manufacturing changes and reduce time-to-market