Datasweep Extends Further Support for Life Sciences in Datasweep Advantage Suite.

Business Editors

SAN JOSE, Calif.--(BUSINESS WIRE)--Feb. 19, 2003

Best-in-Class Solution for Medical Device Manufacturing

Drives Profitability and Predictable Quality across Product Lifecycle 

Datasweep, Inc., the leader in operations performance management solutions for manufacturers, today announced further support for the Life Sciences market with comprehensive functionality to help global medical device manufacturers significantly increase operational profitability, efficiency and predictable quality across the product lifecycle.

Features in the Datasweep(R) Advantage(TM) suite specifically targeted to Life Sciences currently include integrated quality and corrective/preventive action (Datasweep CAPA(TM) solution), electronic device history records (eDHR) and support for 21 CFR Part 11 and Part 820 regulations. New to the Datasweep Advantage suite are operator certification, ANSI-standard sampling plans and industry-specific key performance indicators (KPI) with supporting analytics designed to generate roles-based visibility, root-cause analysis and fact-based decision-making. Datasweep's market-leading analytics help medical device manufacturers identify and eliminate deviations and non-conformance from their product lifecycles and extended supply chain. Datasweep's new KPIs will include roles-based metrics on areas such as corrective/preventive actions, complaint tracking, non-conformance, operator management and capacity utilization to enable rapid decision-making and enforce corrective actions, resulting in superior quality, efficiency and reduced costs.

Industry experts recognize the value of integrated quality management and recommend that manufacturers adopt systems that support consolidated visibility and data management across the product lifecycle in order to reduce variability and increase product quality. According to an AMR Research Alert, "Companies are now required to have a comprehensive integrated quality management strategy in place that encompasses the maze of quality management islands across all areas of manufacturing operations." CAPA: A Platform for Top-Down Quality Management, AMR Research, April 2002.

"Life Sciences manufacturers face the dual challenge of profitably competing in a challenging global marketplace, while simultaneously reducing risk and complying with regulatory requirements. Datasweep has consistently focused on providing the operations execution and decision-support tools to enable better management and overall product success," said Vladimir Preysman, president and CEO of Datasweep. "According to the FDA, the top five areas found to be deficient in quality upon inspection at medical device manufacturers are CAPA, complaint handling, non-conformance, test procedures and device history record tracking and management. We continue to support the needs of medical device manufacturers through solutions that address these FDA requirements while helping them drive down cost, improve efficiencies and realize higher yield in critical product deliveries."

Many industry leaders are leveraging the Datasweep Advantage suite to build global visibility, collaboration and data analysis among their plants and suppliers. The Datasweep Advantage suite is recognized in multiple industries for its superior data management infrastructure, modern architecture and analytics capabilities to drive closed-loop quality assurance and traceability across product cycles. Companies such as Johnson & Johnson, Siemens Medical and SonoSite have chosen Datasweep to help them achieve predictable quality and significant manufacturing performance across their organizations.

About Datasweep

Datasweep is the leader in operations performance management solutions for manufacturers. Datasweep solutions uniquely enable companies to collect, aggregate, analyze and act on product and operational data from their enterprise and supply chain, improving process efficiencies and product quality, reducing product lifecycle costs, and ensuring regulatory compliance. Datasweep customers are achieving fast time-to-benefit and lower cost of ownership, deploying in as few as eight weeks. Headquartered in San Jose, California, Datasweep serves customers in high-tech, life sciences, automotive, telecommunications and other industries, including Flextronics International, Ltd. (FLEX), General Electric (GE), Harris Corporation (HRS), Johnson & Johnson (JNJ), KLA-Tencor Corporation (KLAC), Lucent (LU), Siemens Medical Solutions USA, Inc. (SI) and SonoSite (SONO). Additional information can be found on the Internet at www.datasweep.com.

The determination of when the Datasweep Advantage suite features will be made available, if ever, remains at the sole discretion of Datasweep.

Note to Editors: Datasweep is a registered trademark of Datasweep, Inc. Advantage and CAPA are trademarks of Datasweep, Inc. All other trademarks are the property of their respective owners.