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Carl Zeiss Meditec Selects Camstar's Software to Manage Production of Ophthalmic Solutions.


Business Editors/Health/Medical Writers/High-Tech Writers

CAMPBELL, Calif.--(BUSINESS WIRE)--Oct. 9, 2003

Integrated Quality Management and Device History Record

Software Streamlines Demand Flow Technology Deployment

Camstar, the leader in providing solutions for enterprise manufacturing performance and compliance management, today announced that Carl Zeiss Meditec Inc, one of the world's leading suppliers of complete system solutions for ophthalmology, has chosen Camstar's InSite Medical Device Edition(TM) software. The software will be utilized to help Carl Zeiss monitor quality and manufacturing performance, compliance to regulatory requirements in manufacturing, and support the roll out of its Demand Flow Technology and GMP GMP (guanosine monophosphate): see guanine.  initiatives.

"We conducted a thorough evaluation of both Quality and Manufacturing Solutions, and selected Camstar as the best-in-class for combined functionality and ease of deployment," said Keith Hunt, Vice President of Worldwide Operations, Carl Zeiss Meditec. "At Zeiss, we are committed to providing the highest level of product quality. The Camstar solution seamlessly coordinates our major quality and manufacturing activities, further enhancing our efforts in achieving our aggressive quality goals."

Carl Zeiss Meditec designs, manufactures and markets medical instruments for the four main ophthalmic disease clusters (refractive refractive

capacity to refract light.


refractive error
a difference between the focal length of the cornea and lens, and the length of the eye, resulting in myopia or hyperopia.
, cataract, glaucoma, and retinal disorders) - from diagnosis to surgery and follow-up treatment.

Camstar's InSite Medical Device Edition provides an out-of-the-box software solution to rapidly enable compliance 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.
 Regulations 21 CFR CFR

See: Cost and Freight
 Part 11 and 820. InSite provides the comprehensive enterprise data infrastructure that manufacturers need to achieve and maintain regulatory compliance, operational excellence, supply chain optimization Supply Chain Optimization is the application of processes and tools to ensure the optimal operation of a manufacturing and distribution supply chain. This includes the optimal placement of inventory within the supply chain, minimizing operating costs (including manufacturing costs, , and continuous product lifecycle improvements through repair and post-sale operations.

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. Camstar's InSite product manages, monitors, and synchronizes manufacturing activities across globally distributed plants, and integrates them in real-time with core business processes. It automates the task of creating and managing paperless device, lot, and batch history records. 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 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) , Corning, Kodak, Hitachi, ZOLL Medical, ALZ Steel and La-Z-Boy, rely on Camstar as a trusted software partner.

Camstar's solutions for the life sciences industry support FDA Regulation 21 CFR 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. The software system simplifies the process of collecting and maintaining device history records (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
), and includes tightly integrated 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.

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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Publication:Business Wire
Geographic Code:1USA
Date:Oct 9, 2003
Words:443
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