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Press Release |
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Competing in the Pharmaceutical Industry: the Importance of Integrated Quality Control
Competitiveness among companies in the pharmaceutical industry depends on an ability to transform raw materials into finished products with maximum efficiency and minimal cost, while meeting strict regulations and varying customer demands. A solution designed to help companies improve their competitive edge must integrate various business processes,combine the best supply chain management/reporting tools with industry-specific tools(multi-site management, lot traceability, quality control, etc.), and provide real-time access to strategic information. AX for Pharma is the ERP system developed by New Strategies in response to the specific needs of the pharmaceutical industry. Based on the Microsoft Dynamics AX ERP platform,AX for Pharma is a flexible and integrated solution designed to support advanced quality management. Flexibility, integration, and easeof-use are some of the terms used to describe AX for Pharma, a solution that merges the key functions of a complex industry into a comprehensive, centralized, and manageable system. It provides tools for the management of batch formulations. Different formula versions, batch size,units of measure and substitute, and alternative work centers can be managed directly, providing optimal flexibility if production needs change. Integrated scheduling features provide rule-based planning and programming tailored to different sites, warehouses, items, etc. Cleaning and equipment maintenance activities can also be scheduled in the same system, reducing the risk of miscommunication and production down time. Developed largely in response to the need for an ERP system that could support the level of quality management required by the pharmaceutical industry, Ax for Pharma Critical has such functions as non-compliance controls, quarantine management, automated quality control orders, sampling, testing, acceptance criteria, and certificate of analysis that are streamlined into the system, guarding against errors and providing clear documentation for critical steps. It provides comprehensive lot tracking, which ensures immediate retrieval of information for raw materials, semi-finished and finished products, and supports compliance with GxP and FDA regulations (i.e., 21 CFR Part 11), among others. It is implemented using the Microsoft SureStep methodology that, with the help of support materials, significantly reduces the time and effort required to validate the solution, leaving the pharmaceutical company and its partner free to focus on company-specific details. Successfully implemented in key Italian pharmaceutical companies and international companies with offices in Italy, Europe, and North America, it is an innovative and unique solution that integrates all business processes to meet the dynamic needs of companies in the pharmaceutical sector. The solution allows process management in accordance with critical regulations as well as industry standards and simplified access to information without limiting the flexibility to adapt to new market opportunities and growth. Pharmaceutical companies now have an alternative to complex, demanding, and oversized ERP systems that are often unable to provide definitive response to the needs of the industry. Visit New Strategies at Stand 3B28. Download PDF |
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