Camstar Introduces First Integrated Paperless Manufacturing System Designed for Small and Mid-Sized Medical Device Manufacturers.CAMPBELL, Calif. -- Camstar's Rapid eDHR to Accelerate Time to Compliance and Quality Camstar Systems, Inc., a leading provider of enterprise manufacturing and quality systems for life sciences and other global manufacturers, announced today that it is offering the first integrated paperless device history record (eDHR) system designed specifically for small and mid-sized medical device manufacturers. Camstar's Rapid eDHR(TM) will be generally available in 60 days. "Small and mid-sized medical device manufacturers are subject to the same regulatory oversight as larger companies in the industry. However, until now, they could not take advantage of the technologies the larger players use to manage their manufacturing operations Manufacturing operations concern the operation of a facility, as opposed to maintenance, supply and distribution, health, and safety, emergency response, human resources, security, information technology and other infrastructural support organizations. ," said Greg Gorbach, Research Director, ARC Advisory Group. "By lowering the total cost of ownership of manufacturing systems for the small to mid-sized business (SMB (1) (Small to Medium-sized Business) Also called "SME" (small to medium-sized enterprise), it refers to companies that are larger than the small office/home office (SOHO), but not huge. ) marketplace, Camstar's Rapid eDHR allows these manufacturers to use the same proven approach to reduce their costs of compliance and improve quality." Powered by Camstar's widely-used InSite application, Rapid eDHR establishes an electronically-enforced manufacturing process that captures the required data to ensure compliance and construct the audit trail. Interactive Web-based forms direct operators and capture critical manufacturing data. Built-in security and electronic signatures ensure that manufacturers comply with 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. In addition, managers can access the online DHR DHR De Heer (Dutch: Mister) DHR Department of Human Resources DHR Department of Historic Resources (Virginia) DHR Dihydrorhodamine DHR Device History Record DHR Director of Human Resources information to query, sort and analyze collected data to ensure they are continuously and rapidly resolving problems, and improving processes. The rapid results are possible because of InSite's architecture, which allows manufacturers to configure their manufacturing model and data collection requirements without programming. "Camstar's 'configure versus code' methodology is ideal for small and mid-sized manufacturers to jumpstart their manufacturing and regulatory performance," said Camstar customer Larry Dube, Director of Manufacturing Engineering Manufacturing engineering Engineering activities involved in the creation and operation of the technical and economic processes that convert raw materials, energy, and purchased items into components for sale to other manufacturers or into end products for at ZOLL Medical Corporation. "Rapid eDHR will give smaller companies the same opportunity as large corporations to increase yields and streamline manufacturing, both of which ZOLL has found essential in competing in a regulated environment." Camstar leverages more than 20 years of Manufacturing Execution System – Manufacturing execution system (MES) describes a set of integrated functions within a packaged software system or it can also describe the accumulated functionality within the production management infrastructure of a manufacturing or production company. (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 ) experience and best-of-breed technologies that have helped manufacturers improve operations performance, shorten manufacturing cycle times and reduce the cost of compliance. "The majority of small and mid-sized manufacturers rely on paper logbooks to complete device history records because implementing an automated system has been time consuming and cost-prohibitive," said Dave Cone, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Camstar. "Camstar has designed an affordable, easy-to-implement, easy-to-validate system that meets the pressing needs of this growing marketplace." About Camstar Systems, Inc. Camstar is a leading provider of enterprise manufacturing execution and quality management systems for life sciences, semiconductor, electronics, and other global industrial manufacturers. Camstar's InSite product line manages, monitors, and synchronizes manufacturing activities across globally distributed plants and integrates them in real-time with core business processes. The system enables customers to respond rapidly to changing demand, optimize the use of production assets, and quickly ramp the production of new products. More than 100 leading companies, including Johnson & Johnson, Boston Scientific, Roche, ZOLL, Zeiss, 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) , Kodak, AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. , Philips, Corning, Lexmark and Hitachi rely on Camstar as a trusted software partner. For more information about Camstar and its InSite product, call 1-408-559-5700 or 1-800-237-2841, or visit www.camstar.com. |
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