Press Releases
Camstar to Provide Fully Electronic Batch History Record and Integrated Quality
Management
CAMPBELL, Calif. (December 3, 2003) - Camstar, a 20-year industry
veteran in enterprise manufacturing execution systems (MES), 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
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)
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) 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 (CAPA) 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 systems for rapid implementation and return on investment.
About Camstar Systems, Inc.
Camstar is a leading provider of enterprise Manufacturing Execution and Quality
Systems. Camstar’s InSite and Medical Device Suite applications manage, monitor,
and synchronize manufacturing activities across globally distributed plants, and
integrates them in real-time with core business processes. Rapid to implement, they
provide the manufacturing control needed to help eliminate scrap, rework, paperwork
errors and redundant checks. As a result, manufacturers improve yields and product
quality, shorten lead times and reach volumes quickly, respond to changing demand,
and reduce the cost of compliance. More than 100 leading companies, including Johnson
& Johnson, Roche, Tyco, ZOLL, CIBA Vision, Zeiss, Kinetic Concepts, BIOTRONIK,
IBM, Kodak, AMD, Philips, Hitachi, SCHOTT, Amkor, ASAT, Renesas, Arcelor and Industeel
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.
For more information about Camstar and its InSite product, call us toll free at
1-800-588-0030, or visit at www.camstar.com.
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