bioMérieux Launches
VITEK^® Validation Package Version 3.0

Marcy l’Etoile, France - October 31, 2003 bioMérieux announced the release of the VITEK Validation Package Version 3.0 for the industrial microbiology market.

bioMérieux has already developed a strong leadership in this market with their wide range of products. From prepared media to automated identification systems, bioMérieux offers complete solutions to the pharmaceutical and cosmetic industries. The VITEK System is used worldwide today in these companies to identify a wide range of bacteria and yeast. The VITEK Validation package was specifically designed to meet the needs of the INDUSTRY customer validating their VITEK system.

This package is being launched concurrently with the latest version of VITEK software, VTK-R09.01, featuring 21 CFR, Part 11 compliance. bioMérieux took a “users approach” in gathering system requirements for this important regulation by interviewing groups of existing clients. The VITEK Validation Package allows customers to validate the new functionality of this software.

The VITEK Validation Package also includes informational references and templates for a Validation Plan, Installation Qualification, Operational Qualification, Performance Qualification and Validation Report for use by the customer.

About bioMérieux INDUSTRY

bioMérieux INDUSTRY provides product solutions to quality control and research microbiology laboratories. Applications served include environmental monitoring, sterility testing, pathogen screening, quality indicators, microbial identification, quality control organisms, microbial limits and Preservative Effectiveness Testing.

About bioMérieux

A global leader in disease prevention and management, bioMérieux provides assays, reagents and instrumentation for clinical microbiology, coagulation, immunoassay, and nucleic acid diagnostics; and also for product quality control in the agri-food, cosmetics and pharmaceutical industries. Based in Marcy-l’Etoile, France, the company’s U.S. headquarters is in Durham, North Carolina.

With sales of 950 million Euros in 2002, bioMérieux ranks as the eighth largest
biological diagnostics company worldwide. Over 81% of its activity takes place on an
international level. Investment in research and development represents 13% of sales.

bioMérieux, employs 5400 people throughout the world, including 3200 in Europe and 1500 in the US. The group has 15 production sites distributed in France, the United States, Brazil, Italy and the Netherlands, as well as a European logistics center in France.

Already present in over 130 countries, with more than 110 distributors and 32 subsidiaries, bioMérieux continues its international development by strengthening its presence in Latin America and Asia.

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