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Teva Analysis

In: Business and Management

Submitted By legion17
Words 1059
Pages 5
Case Study

TEVA Strengthens Security for Software Assets with MKS Integrity
“One of the main measures for success in the implementation of the MKS Integrity Suite was the reduction in the amount of paper and forms that get manually pushed from person to person. By simply automating service request forms and routing them via electronic workflows we have become much more effective, and dramatically reduced our time spent managing projects.”
Tom Loane, Chief Information Officer , TEVA Pharmaceuticals

Company Overview
TEVA USA is a wholly-owned subsidiary of TEVA Pharmaceutical Industries Ltd., Israel’s largest pharmaceutical manufacturer operating globally in 30 countries on 5 continents. TEVA is among the top 20 pharmaceutical companies and the largest generic pharmaceutical companies in the world. The company has approximately 14,000 employees worldwide with production facilities in Israel, North America, Europe and Mexico. TEVA USA has an aggressive Research & Development effort and one of the best overall ANDA approval records in the industry. The company’s mission is to play a leading role in the transformation of the U.S. healthcare system through its preeminence in the development, manufacturing and marketing of pharmaceuticals.

The Challenge
As a pharmaceutical company operating in the U.S., TEVA must comply with Food and Drug Administration (FDA) regulations. The FDA requires stringent application development and change control practices surrounding software registration, phlebotomy, component processing, testing, and distribution of applications. A particular compliance challenge is FDA 21 CFR Part 11, concerning electronic records and electronic signatures. All pharmaceutical companies are subject to audit by the FDA and face scrutiny with respect to their systems and processes, including computer systems. A pharmaceutical company is obligated to...

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