Sparta Systems, Inc.

Dec 01, 2005
By BioPharm International Editors
Volume 18, Issue 12

Company Description

Founded in 1994, Sparta Systems, Inc. is an enterprise software manufacturer that has developed innovative, 21 CFR Part 11 compliant Quality Management System (QMS) software for logging, tracking, reporting, and trending of quality and regulatory areas. Sparta has pioneered QMS and has provided cGxP solutions since 1998. Its product, TrackWise, is a leading QMS solution in the highly regulated life sciences industry, with over 115 accounts, over 250 implementations, and more than 200,000 end-users.

cGxP Solutions For:

  • Deviations
  • Nonconformities
  • Investigations
  • Customer complaints
  • Audits and audit observations
  • Change requests
  • Regulatory commitments
  • Root cause analysis
  • Corrective actions and preventive actions (CAPA)
  • Calibrations
  • Preventive maintenance
  • Clinical trials
  • Environmental health and safety
  • Sarbanes-Oxley

In addition to US corporate, sales and service operations in Holmdel, NJ, Sparta Systems, Inc. provides sales and services to Europe, Asia, and Australia through its subsidiary, Sparta Systems Europe, Ltd.

TrackWise is an off-the-shelf QMS enterprise software, which is 100% configurable and requires no customization of code. TrackWise delivers modularity and scalability "out-of-the-box" where "modules" (i.e., work areas and applications) can be defined and configured by the customer independently of the vendor. Configuration includes the ability to define web-based data-entry forms, user defined fields, workflows, business rules, and permissions, as well as any other configuration areas.

TrackWise's workflow tools manage the life cycle of all quality issues and related corrective and preventive actions. The Ad Hoc Query Builder and Full Text search tools enable users to find-up-to-date information in seconds. Integrated reporting via Crystal Reports allows users to generate customized trends, distribution metrics, and cycle time reports. TrackWise also has user-configurable dashboards and drill-down reports for further, detailed analysis.

TrackWise Coordinator, a built-in 24/7 business rule engine, enforces SOPs, eliminates user errors, and reduces training costs. Coordinator provides for automated routing, notifications, escalations, automated execution and distribution of management reports, as well as automated trending and alerts.

TrackWise is equipped with record locking, Universal Time Code (UTC), support of multi-languages, and a comprehensive security model to enforce access restrictions by site, work area, and user profile. The system comes with a suite of integration tools, such as open API (through Web Services) and external fields for linking to data including lot numbers, product codes and material numbers that reside in external databases. Utilizing a best-of-breed approach, TrackWise integrates seamlessly to complimentary systems like Documentum and Livelink. Additionally, TrackWise supports NT and LDAP user authentication.

Sparta's professional services and implementation teams facilitate all project phases, from requirements analysis, through installation, configuration, validation, and training. Sparta delivers a complete IQ/OQ validation package as well as TrackWise Certification Courses for administrators and power users.

Sparta Systems is a quality-driven organization financially backed by AIG Healthcare Partners.

Holmdel Corporate Plaza 2137 Highway 35 Holmdel, NJ 07733

Toll Free in the US 888.261.5948 Tel 732.203.0400





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