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Manufacturing Execution Management

Manufacturing Execution Management

Manufacturing Execution Systems are critical to guaranteeing overall process compliance, ensuring maximum quality, and production optimization across all global facilities and all phases of the product lifecycle. Our MES capabilities were among the first to address the challenges facing various manufacturing sectors, including the medical devices and pharmaceuticals industries.

Our manufacturing solutions comprise a highly sophisticated, scalable, digital suite that delivers exceptional functionality and allows your med-tech organization to combine production efficiency with quality and visibility, as well as production optimization.  This ultimately results in greater manufacturing responsiveness and better, safer, more cost effective products.

Manufacturing Execution Systems are critical to guaranteeing overall process compliance, ensuring maximum quality, and production optimization across all global facilities and all phases of the product lifecycle. Our MES capabilities were among the first to address the challenges facing various manufacturing sectors, including the medical devices and pharmaceuticals industries.

Our manufacturing solutions comprise a highly sophisticated, scalable, digital suite that delivers exceptional functionality and allows your med-tech organization to combine production efficiency with quality and visibility, as well as production optimization.  This ultimately results in greater manufacturing responsiveness and better, safer, more cost effective products.

Manufacturing Execution Management

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Our manufacturing solutions provide unparalleled access to controlled information on-demand to safely store critical data as part of eDHR best practices. In addition, we help define and manage programs in production areas to enforce mandates that only skilled, trained operators are completing the correct activities, at the correct time, and at the correct place.

Our maintenance management requirements are usage and time based, thus ensuring only qualified machinery is being utilized. We provide the ability to define and manage storage locations for material tracking and further enforce time limits on stored materials for the utmost safety and quality practices, while also implementing tracking tools which are required for production and quality inspections.

Data management and collection for incoming, in process, and final inspection processes help accurately interpret critical information in the final determination of inspection results. Our authoring tools for manufacturing processes ensure the proper eDMR in production, while supporting reworks and alternative product paths based on branching logic to serve as added reinforcement. Finally, imagine accomplishing all this while also tracking production and inspection activities for a work order – lots, batches, and serial numbers - all to help ensure a self-auditing eDHR.

All of these core capabilities help manage manufacturing and operational KPI’s in real-time, including yield, throughput, fulfillment, and cycle time, along with failure causes, pending quality actions, and other potentially costly occurrences to help medical device and pharmaceutical companies establish long-term success and the best possible products.

Manufacturing Execution Management

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Excelencia en la calidad de los productos fabricados: la colaboración entre la FDA y Edwards Lifesciences

Descubra cómo los programas de calidad de la FDA impulsan el cambio en las prácticas regulatorias de los dispositivos médicos del futuro.

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