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Sparta Systems Inc.
2137 Highway 35
Holmdel, NJ 07733
Tel: 732/203-0400
Fax: 732/203-0375
Web: http://www.sparta-systems.com
E-mail: info@sparta-systems.com
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Founded in 1994 Sparta Systems is the industry leader for global quality and compliance management systems. Its TrackWise product is a web-based software application used by quality, manufacturing, and regulatory affairs professionals to manage quality and compliance issues across the enterprise. The company has provided solutions to the medical device industry since 1998.
In addition to its U.S. operations, the company provides sales and services to Europe, Asia and Australia through its subsidiary, Sparta Systems Europe, Ltd.
Reducing risk, complying with industry regulations and lowering costs are just a few of the challenges that companies face today. While these pressures continue to grow, many organizations still rely on legacy data silos and paper-based systems to manage their critical business processes.
TrackWise® manages quality and regulatory compliance requirements, issues and related actions. TrackWise enables medical device organizations to cost-effectively maintain compliance with 21 CFR Parts 808, 812 and 820, and other quality standards and regulations.
TrackWise is a 100% configurable application that allows companies to custom-configure and manage an unlimited number of business processes on a standard architecture without the need to purchase, install, and validate numerous application modules. The web-based system manages and tracks Nonconformance, Deviations/Incidents, Investigations, Complaints, Calibrations, Audits, CAPA, Change Control, Supplier Quality, MDR (3500A), Training Management, Vigilance reporting, and other compliance requirements.
TrackWise streamlines and enforces SOPs through automated workflow, business rules and integrated report generation. The system provides ad hoc query capabilities as well as dynamic reporting to provide up-to-date information. TrackWise's built-in 24/7 business rule engine provides automated routing, notification, escalation, execution and distribution of reports and automated alerts based on developing trends. TrackWise interfaces seamlessly with best of breed data management systems including EDMS, ERP, CRM and MES.
TrackWise also enables organizations to manage controlled documents in a secure repository and reduce costs involved in document life cycle and retention management. SOPs, engineering specifications, device history records, investigation and lab documents, supplier quality records and other objects may be maintained and versioned electronically in accordance with industry best practices.
Sparta has established an experienced professional services group that provides extensive integration services ranging from pre-sale consulting, to implementation, validation assistance, and training.
TrackWise is the only solution that provides centralized and consolidated tracking, workflow management, and reporting for all critical business processes. TrackWise enables medical device manufacturers to achieve unprecedented compliance results by consolidating redundant systems, reducing manual operations, and implementing best-of-breed technology.
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