News & Events

Sparta Systems, Inc. Successfully Completes Third PDA Software Supplier Quality Audit

Holmdel, NJ - January 11, 2006 – Sparta Systems, Inc., (Sparta) the maker of TrackWise®, the leading product for Quality Management Systems (QMS) software for life science and other highly regulated industries, announced today that it has successfully completed its third Parenteral Drug Association (PDA) Software Supplier Quality Audit.

The Pharmaceutical Industry Software Supplier Quality Audit, conducted by SynTegra, an independent, PDA-approved auditor, allows Sparta's customers to meet federal government auditing requirements for companies that supply software solutions to the pharmaceutical industry. Following the PDA audit process, the auditors reviewed documented evidence of ten key areas: Quality System, Project Management, Software Methodology, Testing, Configuration Management, Manufacturing, Documentation & Records Management, Security, Training & Education and Maintenance. An excerpt from the final audit summary noted: "Sparta Systems has an extremely comprehensive documented quality system. This is not surprising given that its business is writing software for structuring quality systems."

"Participating in PDA Audits is a respected way for Sparta Systems to demonstrate its compliance with industry standards for developing software," said Charles Steiniger, Manager of Quality Assurance at Sparta Systems. "Completing this audit helps our customers and prospective customers reduce risk and save significant cost and time commitments in lieu of conducting their own audits. The audit provides out clients assurance that Sparta Systems' TrackWise software is in compliance with the PDA's established Supplier Audit Process Model, which includes 21 CFR Part 11 requirements."

Sparta completes a PDA Software Supplier Quality Audit every two years, and has passed both previous audits in 2001 and 2003.

The PDA designed the Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations (TR-32) after the U.S. Food and Drug Administration (FDA) appealed to the regulated industry to standardize the auditing process for computer software and service suppliers and establish a global repository for the audit information.

Sparta Systems' completed audit report will be available at SynTegra's Audit Resource Center, which provides online access to a secure audit data repository. Through a partnership with PDA (Parenteral Drug Association), the Center is designed to enable secure sharing of completed computer products and service audits used by FDA-regulated pharmaceutical and biotechnology manufacturers.

About SynTegra

Syntegra, a wholly owned subsidiary of Health Pathways, Inc., is a trusted third-party pharmaceutical supply chain operations auditor. Through experience and intensive market research, the division has created contemporary knowledge of industry standards, guidelines, business transactions, and regulations to allow insightful consulting and solutions development. Further, the division has created unique training and audit procedures and standards-based infrastructure to implement these procedures. For more information, please visit www.syntegrallc.com.

About PDA

PDA is a nonprofit global association recognized as the authoritative voice and leading technical organization in the fields of pharmaceutical and biopharmaceutical science and technology. PDA has a membership of over 10,000 individual scientists involved in the development, manufacture, quality control and regulation of pharmaceuticals/biopharmaceuticals and related products. It is dedicated to promoting scientifically sound and practical technical information and Career-long Learning® for industry and regulatory agencies worldwide. More information is available at www.pda.org.

Sparta Systems Inc. and the Sparta Systems, Inc. logo, TrackWise and the TrackWise logo are trademarks or registered trademarks of Sparta Systems, Inc. SynTegra is a registered trademark of Health Pathways, Inc. Parenteral Drug Association and PDA are registered trademarks of PDA. All other company and product names are used for identification purposes only and may be trademarks of their respective owners.

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.

Media Contact:
Jon Rabinowitz
Director of Marketing
Sparta Systems, Inc.
Phone: (732) 203-0400 x121
Email: jon.rabinowitz@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.