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| Market Strategy
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| Manufacturing Execution System for Pharmaceutical and Biotech Industries |
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Werum's area of expertise are Manufacturing Execution Systems (MES) deployed in the pharmaceutical and biotech industries. Thanks to our PAS-X product, we are the industry's top MES supplier.
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MES software is IT software for production management; which is used to plan, control, and optimize production processes.
In the manufacturing industry, MES constitutes the link between corporate management and the automation level. |
Nowadays, it is impossible to imagine a comprehensive IT strategy of manufacturing
companies that does not include MES. In conjunction with Enterprise Resource Planning (ERP) software for business management and by interacting with process control systems (DCS/SCADA), Programmable Logic Controllers (PLC), or process visualization systems at automation level, PAS-X facilitates integrated management of all manufacturing processes, as well as all associated material movements.
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| PAS-X: Standard Software for Special Requirements |
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PAS-X has been designed to provide standard software for the regulated, batch-oriented process industry. Our MES product PAS-X focuses specifically on manufacturing processes in the pharmaceutical and biotech industry. As a standard product, PAS-X provides maximum standard functionality for applications in the pharmaceutical sector out-of-the-box. PAS-X has not been designed as a tool set - on the contrary, it constitutes a qualified standard system, which is ready for validation and covers all essential business processes in the pharmaceutical industry. When the functions of an independent, yet integrated MES are designed in such a way that they ensure the optimum performance of the manufacturing process, this offers considerable technical advantages and significantly reduces the cost of implementation, validation, and maintenance.
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| Particular Requirements for Regulated Industries |
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Specific legal rules regulate the pharmaceutical and biotech industries. MES installations
in Life Science Industries have to comply with worldwide manufacturing standards, following
regulatory statutory provisions, e.g., by the U.S. Food and Drug Administration (FDA), by the European Medicines Agency (EMEA),
and other standards set forth by the authorities of different countries. Furthermore, companies have to comply
with the "Good Manufacturing Practices" (GMP) guidelines.
The functions provided by PAS-X functions and the offered associated services are specifically
tailored to meet the requirements of Regulatory Compliance.
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| The Road to Market Leadership |
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Since the first version of the production came on the market in 1994, PAS-X has developed into the leading MES product in the pharmaceutical and biotech industries.
 PAS-X: Development milestones
Today, PAS-X is used in over 420 installations in more than 30
countries. A large number of these installations have been
validated by the FDA or other local authorities.
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MES for Pharma & Biotech