Since 1994, Sparta Systems has addressed the need for accountability and control of workflow processes, along with visibility and transparency, in the medical device industry.
Medical enterprise quality management systems (EQMS)
Sparta Systems is the recognised leader in providing enterprise quality management systems for global organisations in the medical device industry. Sparta’s TrackWise® software provides unmatched benefits for these companies, including consolidation of redundant systems, reduction of manual operations, and streamlined quality processes that result in greater efficiencies and tangible revenue gains.
TrackWise is the only solution that leverages best-of-breed technology to provide centralised and consolidated tracking, workflow management and regulatory reporting for all critical business processes affecting medical device companies. With over 150 life sciences customers, TrackWise is the de facto standard in quality and regulatory compliance management in FDA-regulated industries.
Web-based enterprise quality management
TrackWise is a web-based enterprise quality management system that enables your organisation to comply with 21 CFR 11, 21 CFR 820, GMP, ISO13485, ISO 9000 and many other industry standards. It allows medical device companies to improve control, reduce risk and lower costs by consolidating management of issues and actions, automating workflow, and facilitating trending and reporting.
TrackWise is the only solution that provides centralised and consolidated tracking, workflow management and reporting for all critical business processes.
Nonconformance management, audit preparation, and corrective and preventative actions (CAPAs)
Sparta Systems has designed TrackWise to offer dedicated functionality that empowers device manufacturers to take control of their quality operations. The software includes capabilities for managing nonconformance, preparing for internal and external audits, complaints, corrective and preventative actions (CAPAs) and other enterprise-wide processes.
Web-service integrated enterprise quality management system
With revolutionary new web services integration features, TrackWise works with leading software solutions including enterprise resource planning (ERP), customer relationship management (CRM), laboratory information management systems (LIMS) and manufacturing execution systems (MES), providing a seamless transition to a dedicated quality management solution that complements these existing systems without overlap.
Enterprise quality management system benefits
Features of Sparta Systems’ enterprise quality management system include:
- Quality management: nonconformance management, customer complaint management and medical device reporting, supplier quality, internal and external audits, change control, CAPAs, calibration and preventive maintenance
- Training management and employee qualifications
- Electronic reporting
- Document management and changes
- Clinical trials management