Quality Management

TrackWise enterprise quality management software

Hundreds of pharmaceutical and biotechnology companies have turned to Sparta Systems’ TrackWise software as their solution for enterprise quality management. TrackWise enables your organisation to ensure compliance, improve quality and reduce costs by centralising and integrating all quality processes, including management and reporting of deviations, 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.

TrackWise has been validated in over 100 pharmaceutical and biotechnology companies as a 21 CFR Part 11 compliant solution, and has enabled many of these companies to remediate quality system deficiencies cited in 483s, warning letters, and consent decrees.

Benefits

• Ensure compliance with 21 CFR Part 11, 21 CFR Part 210, 211, and ISO standards
• Implement a closed-loop quality system consistent with FDA thinking and industry best practices
• Implement best-of-breed quality management while integrating to ERP and MES systems
• Maintain high quality levels while conducting manufacturing 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