Electronic Batch Records and Enforced Compliance are Critical for Commercialization of Stirling’s Leading Edge Test Strip for Cardiac Testing
Charlotte, NC (July 12, 2007) - Camstar Systems, Inc, a leading provider of Enterprise Manufacturing Execution and Quality Systems, announced today that Stirling Medical Innovations, Ltd. (SMI), a developer of advanced medical devices for the diagnosis and management of chronic cardiovascular conditions, has selected Camstar’s Medical Device Suite™ to replace their paper batch records, ensure compliance and streamline processes at their Stirling, Scotland manufacturing plant.
“It is important to Stirling Medical to rapidly ramp up new products; time to volume is crucial,” said Robert Hutchison, Managing Director, for Stirling Medical. “Commercializing an innovative product like NT Pro BNP, a test strip for cardiac testing developed to enhance the lives of people suffering from chronic heart disease, requires a manufacturing process with an extensive batch record,” said Hutchison.
“Camstar’s Medical Device Suite has a compelling track record in the industry for its ability to streamline the collection and management of data that we can use to improve processes and quickly ramp up NT Pro BNP and other products under development,” said Barry Slater, QA and Quality Systems Manager for Stirling. “Camstar’s advanced technology and proven integration experience with our SAP, CAPA, and document management systems will give us real-time production information, traceability and control.”
Camstar’s SwifTrack™ Implementation Methodology, which enables rapid deployment, a phased approach, and a foundation for future expansion as they grow, was important for Stirling. The solution comprises the Medical Device Suite, a flexible and configurable architecture, and a proven implementation methodology, that together drive the shortest time to value and significant competitive value for Stirling. Camstar’s strategic business partner, Seabrook Research Ltd., will lead the implementation.
“We are delighted to be working with Seabrook Research Ltd. whose successful track record of implementing Camstar’s Medical Device Suite ensures we will be leveraging the local knowledge and technical expertise for our Manufacturing Execution System (MES) implementation at SMI,” says Colin Boyd, SMI MES Project Manager.
Camstar’s Medical Device Suite is a highly configurable, best-in-class Manufacturing Execution System (MES) created to meet the specific needs of Life Sciences Manufacturers. The system will provide a production and quality management framework that includes self-auditing electronic Batch Records (eBR), process enforcement, complete manufacturing traceability and audit trail, comprehensive data analysis and production visibility.
“We are very pleased to be working with Stirling Medical and Seabrook Research on this project,” said Jason Adams, Vice President of North American Sales for Camstar. “Medical Device and Biotechnology manufacturers are embracing Camstar technology and the SwifTrack Methodology for their manufacturing operations. They realize that their ability to grow while increasing efficiencies and improving quality is possible only with accessible, actionable real-time data. Camstar’s Medical Device Suite and SwifTrack help them rapidly ramp and launch the highest quality products.”
About Camstar Systems, Inc.
Camstar’s Enterprise Manufacturing and Quality Solutions help manufacturers rapidly boost the performance of their distributed manufacturing operations by delivering complete visibility and by providing the flexibility required for rapid growth and change. Camstar’s unparalleled solution monitors, controls and synchronizes global manufacturing, delivering process interoperability and best practices – resulting in maximum agility, the highest quality products, and leaner, more efficient operations.
Designed for ultimate configurability and built on services oriented architecture, Camstar’s tightly integrated solution set encompasses a manufacturing execution system (MES), quality management system (QMS), business process interoperability (BPI), and manufacturing business intelligence (MBI). Industry-specific, out-of-the box applications and a proven implementation methodology ensure successful deployment and rapid time to benefit.
More than 100 leading companies, including AMD, Amkor, ASAT, Corning, dpiX, GEM Services, Genesis Microchip, Hitachi, IBM, Kodak, NXP (Philips Semiconductors), SanDisk, SCHOTT, Sony Ericsson, Renesas, Spansion, Xilinx, Roche, Tyco Healthcare, CIBA Vision, Favrille and Zeiss, rely on Camstar as a trusted software partner.
For more information, please visit www.camstar.com.
About Seabrook Research, Ltd.
Seabrook Research Ltd. is a leading specialist software company servicing the Life Science industries. Established in 1989, Seabrook Research focuses on speedy effective implementations, using predetermined methodologies and experienced staff. Compliance with ISO 9002 proves organization wide commitment to high standards of quality. Based at the Camstar European Support Center at the Business and Technology Park, Model Farm Road in Cork, Ireland Seabrook provides fully trained InSite consultancy services, integration and automation expertise as well as process and computer systems validation services to companies in Ireland and Europe. For more information about Seabrook Research Limited, visit www.seabrook.ie .
About Stirling Medical Innovations, Ltd.
Stirling Medical Innovations, Ltd. will be a world leader in research and development of advanced medical devices for the diagnosis and management primarily of chronic cardiovascular conditions. The company is a subsidiary of the Massachusetts based Inverness Medical Innovations (IMI) group, a global leader in the development, manufacture and marketing of over-the-counter healthcare and rapid diagnostic products. IMI has facilities in more than 20 countries and employs around 2000 people worldwide. With plans for a state-of-the-art facility on the campus of Stirling University Innovation Park, SMI is IMI group's global centre of excellence in cardio care. .
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