SIMATIC IT EBR is an Electronic Batch Records (EBR) and Manufacturing Execution System (MES) platform from Siemens, focused specifically on Life Science manufacturing.
More than 120 plants worldwide have utilized SIMATIC IT EBR to improve efficiency, quality and visibility in Life Science production processes including Bio-technologies, Blood Fractionation, Chemical API, Drug Manufacturing, Vaccine Manufacturing, Cosmetics and Neutraceuticals.
As a fully functional MES platform, SIMATIC IT EBR provides many of the functions you would expect from a traditional MES including:
Additionally, since SIMATIC IT EBR is specifically optimized for Life Science manufacturing, it goes a step further by providing a host of features geared towards this challenging industry. SIMATIC IT EBR is fully compliant with ISA-95 regulations and the core software comes pre-validated to GAMP 5 standards.
The key functionality for Life Science manufacturing is Electronic Batch Records (EBR), and SIMATIC IT EBR delivers a powerful and intuitive EBR engine that enables a more streamlined, paperless and automated process while ensuring full compliance with FDA and international regulations. SIMATIC IT EBR's engine enables exciting features, including:
This fusion of out-of-the-box MES and EBR functionalities creates an impressive array of benefits that should appeal to any Life Science manufacturer. By utilizing the key features of SIMATIC IT EBR to help drive your manufacturing process while tracking and collecting critical process data in real-time, you can increase quality and productivity while simultaneously reducing cycle times and increasing process visibility. Benefits of a MES/EBR system include:
Hyla Soft has executed SIMATIC IT EBR projects of all sizes, from a pre-weighing system for an over-the-counter pharmaceutical manufacturer to the development and qualification of a full Electronic Batch Record, Equipment Management and Stock Management system for one of the largest vaccine producers in North America.
As Siemens’ preferred integration partner, Hyla Soft consultants are the leading functional experts on SIMATIC IT EBR in North America and have participated in and led implementations all over the world. Our deep product knowledge combined with our Life Science sector experience gives us insight into the specific needs and requirements of companies in this challenging industry.
From solution design and quality planning, to project management and execution, to system integration and validation, Hyla Soft has the SIMATIC IT EBR experience to make your MES/EBR implementation a success.
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