New Validation Package Streamlines the Validation Process for TrackWise®

Holmdel, NJ - September 27, 2004 – Sparta Systems has announced its release of the TrackWise® Validation Package. This comprehensive set of documents streamlines validation activities for users of the TrackWise Quality Management System (QMS). The validation package allows for rapid validation for initial deployment. It is also structured to minimize validation activities associated with future enhancements and configuration changes.

"The TrackWise Validation Package is based on the classic V-Model and offers an overall approach to validation, validation activities and validation deliverables," stated Charlie Steiniger, Sparta's QA Manager.

The package encompasses: (1) Functional Requirements Specification for the software application, (2) Step-by-step Installation Manual, (3) Installation Qualification Protocols & Scripts for proper installation of the TrackWise system, (4) Operational Qualification Protocol & Scripts to certify that the QMS meets expected functional requirements (including 21 CFR Part 11 and ER/ES), (5) Operational Qualification Results to document each functional requirement, (6) a Traceability Matrix which visually links specific functional to specific operational qualification scripts, (7) Configuration Standard Operating Procedure that specifies steps for configuring TrackWise, as well as document the configuration, using "best practices" procedures, (8) TrackWise Administration Standard Operating Procedure which follows "best practices" steps for administering TrackWise® and (9) a Validation Summary that summarizes results of all activities of the Validation Package.

"The TrackWise validation package has been more than popular. Customers are using this package to complete their validation in a matter of a few weeks, with minimal resources. This saves them a substantial amount of time in what is normally the toughest part of the project (validation). It also and saves them tens of thousands of dollars in associated costs, and at the same time provides them a more thorough set of validation documents than they could have provided on their own," indicated Al Seden, Manager of Product Support and Customer Satisfaction for Sparta Systems.

To ensure quality of the TrackWise IQ/OQ Validation Package, Sparta has partnered with one of its premier validation services partner, who has extensive experience in the FDA-regulated industries and has performed several TrackWise validations. This partner spent several months with Sparta to write the package, as well as successfully execute the IQ/OQ protocols. "Sparta felt that proven experience in computer validation was the key to success of the project and the execution of the IQ/OQ protocols by a third party is very important for our customers," said Ran Flam, Founder and CEO of Sparta Systems.

The TrackWise Validation Package is a supplemental set of documentation that accompanies a suite of patent-pending software tools that includes the TrackWise Web TeamAccess, the TrackWise Coordinator®, the TrackWise Audit Manager™, the TrackWise Configuration Migrator™, and the TrackWise Integration Manager™. Professional services are available from the company to assist with implementation and validation.

About Sparta Systems

Sparta Systems, Inc. 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 more than 12 years of experience and an extensive customer base in the life sciences and other highly regulated industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle. More information about Sparta Systems and TrackWise® can be found at www.sparta-systems.com.

Sparta Systems Inc. and the Sparta Systems, Inc. logo, TrackWise and the TrackWise logo are trademarks or registered trademarks of Sparta Systems, Inc.

All other company and product names are used for identification purposes only and may be trademarks of their respective owners. Sparta Systems, Inc. cannot guarantee completion of any of the aforementioned products or product features, and no reliance should be placed on their availability. Sparta Systems does not undertake an obligation to update the forward-looking information contained herein.