The TrackWise® Validation Package streamlines validation activities for user of the TrackWise® Quality Management System. The package allows for, not only rapid validation for initial deployment, but also minimizes validation activities with future enhancements and configuration changes. The package encompasses; functional requirements specification for the software applications, step-by-step installation manual, installation qualification protocols and scripts for proper installation, operational qualification protocol and scripts to certify that the QMS meets expected functional requirements (including 21 CFR Part 11 and ER/ES), operational qualification results to document each functional requirement, a traceability matrix which visually links specific functional to specific operational qualification scripts, configuration standard operating procedure that specifies steps for configuring TrackWise, as well as document configuration, using best practices procedures, TrackWise administration standard operating procedure which follows "best practices" steps for administering TrackWise and a Validation summary that summarizes results of all activities of the Validation Package. Sparta Systems, Inc.

Sparta Systems, Inc.
Holmdel Corporate Plaza, 2137 Highway 35
Holmdel, NJ, 07733