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White Papers for Food and Drug Administration (FDA)MKS Case Study TEVATEVA USA is a wholly-owned subsidiary of TEVA Pharmaceutical Industries Ltd., Israel's largest pharmaceutical manufacturer operating globally in 30 countries on 5 continents with 2004 sales of US$4.8 billion. The goal for TEVA is to reduce the burden and cost associated with compliance to FDA regulations. In 2003 TEVA's IT department identified requirements for a change control process that is more efficient and compliant with Good Manufacturing Processes (GMP). Following a thorough evaluation process, MKS Integrity Manager and MKS Source Integrity Enterprise, key components of the MKS Integrity Suite, were selected.
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