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Compliance to Regulations, PAT Initiative Remain Top Market Drivers in European Market

Tue, 04/22/2008 - 22:00
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(Research and Markets: Dublin, Ireland) – A Frost & Sullivan research service titled “Automation and Control Solutions in the European Pharmaceutical Market” provides an analysis of the various factors driving and restraining the market, revenue forecasts, geographic trends and competitive structure. In this research, Frost & Sullivan’s expert analysts thoroughly examine the following markets: programmable logic controllers (PLC), distributed control systems, supervisory control and data acquisition (SCADA), manufacturing execution systems (MES), human machine interface (HMI), and advanced process control in the European region.

The 21 CFR Part 11 regulation stipulated by the Food and Drug Administration was introduced in 1997. Implemented across Europe through the European Medicines Agency, this regulation requires pharmaceutical companies to increase transparency in their production processes through audit trails and access control functions. By accepting electronic records and electronic signatures as equivalent to paper-based records and handwritten signatures, the FDA paved the way for significant changes in the way that the pharmaceutical industry maintained its records and allowed the industry to leverage technology to keep pace with the fast growth of the industry.

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