Camstar Extends Life Science Manufacturing Execution System To Pharmaceutical Industry; Camstar to Provide Fully Electronic Batch History Record and Integrated Quality Management.Business Editors/Health/Medical Writers/High-Tech Writers CAMPBELL, Calif.--(BUSINESS WIRE)--Dec. 3, 2003 Camstar, a 20-year industry veteran in enterprise manufacturing execution systems (MES (Manufacturing Execution Software) Software that provides real time access to plant activities that include equipment, labor, orders and inventory. An MES integrates the data with enterprise resource planning (ERP) systems so that management has complete control of ), today announced an edition of its integrated manufacturing and quality solution specifically designed for global pharmaceutical companies. Camstar's entrance into the market is bolstered by a formal partnership with IBM (International Business Machines Corporation, Armonk, NY, www.ibm.com) The world's largest computer company. IBM's product lines include the S/390 mainframes (zSeries), AS/400 midrange business systems (iSeries), RS/6000 workstations and servers (pSeries), Intel-based servers (xSeries) Life Sciences and enthusiastic customer references in the medical device, combination device, semiconductor, metals and electronics markets. Recent customer wins for Camstar in 2003 have included a rapidly growing $1.6B manufacturer of combination medical devices whose processes include both discrete and pharmaceutical components. "The same factors that have propelled Camstar to success in the medical device industry will serve them well in pharmaceuticals," says Jim Bradburn, from IBM Life Sciences. "They have taken the most flexible and configurable FDA-compliant MES and brought it to the pharmaceutical industry. The ability to rapidly deploy an enterprise-wide manufacturing system has been sorely missing in other MES systems currently present in this industry." Camstar's InSite Pharmaceutical Edition includes a visual Master Batch Record (MBR (Master Boot Record) See boot sector. ) process modeling environment that allows process specialists to rapidly create, easily modify, and swiftly validate new process specifications in single or multi-plant environments. Camstar's patented revision management capability allows multiple revisions of a single base MBR to be simultaneously active in production. In addition, the system automatically compiles an Electronic Batch Record (EBR EBR East Baton Rouge EBR Environmental Bill of Rights (Ontario, Canada) EBR European Business Register (European Economic Interest Group) EBR Established Business Relationship EBR Experimental Breeder Reactor ) that provides traceability of the final product back to every plant, machine, batch, order, operator, supplier, ingredient, and operating condition encountered or consumed in production. The integration of Camstar's enterprise corrective and preventive action Corrective and Preventive Action (CAPA) is a concept within Good Manufacturing Practice (GMP). CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their reoccurrence. (CAPA CAPA California Alternate Performance Assessment CAPA Captaris, Inc (stock symbol) CAPA Confederation of Asian and Pacific Accountants CAPA Creative and Performing Arts (school) ) functionality coordinates the company's response to deviations and insures that a fully auditable record of corrective actions is also included in the EBR. In addition, Camstar provides pre-built integration adapters for SAP, JD Edwards, Oracle and PeopleSoft ERP (Enterprise Resource Planning) An integrated information system that serves all departments within an enterprise. Evolving out of the manufacturing industry, ERP implies the use of packaged software rather than proprietary software written by or for one customer. systems for rapid implementation and return on investment. About Camstar Systems, Inc. Camstar is a leading provider of enterprise manufacturing performance management systems for life sciences, semiconductor, electronics, and other global industrial manufacturers. More than 100 leading companies including IBM, Corning, Kodak, Zeiss Meditec, Hitachi and ZOLL Medical rely on Camstar as a trusted software partner. Camstar's solutions for the life sciences industry support FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Regulation 21 CFR CFR See: Cost and Freight Part 11 requirements such as Electronic Records and Electronic Signatures as well as the Good Manufacturing Practices outlined by FDA Regulation 21 CFR Part 820. For more information about Camstar and its InSite product solution, call 1-408-559-5700 or visit www.camstar.com. |
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