As an important component of life sciences and an extension of the value chain, as well as one of the direct ways for pharmaceutical research achievements to be applied to consumers, the in vitro diagnostic industry requires enterprises to have higher technological innovation capabilities, utilize their digital capabilities to deeply integrate with enterprise operations and production manufacturing, and enhance the agility and flexibility of factory building and product production. On the basis of rich technical reserves and industry practical experience, Schneider Electric assists in the digital transformation of in vitro diagnostic industry enterprises with a complete solution that runs through four layers of applications:
The production process of diagnostic reagents is a complex process, including manual mixing, liquid preparation, online cleaning, weighing instruments, laboratory calibration equipment, pure water system, filling, and other links. Enterprises need to strictly control each link to ensure product quality and safety. From the device access layer, to the production control layer, data center, production operation application layer, and management analysis layer, Schneider Electric can provide complete digital solutions to help achieve digital control throughout the entire process.
At the production control level, the FMCS factory management and control system can integrate a series of systems such as high and low voltage distribution, air compression, air conditioning, and water treatment that are integrated into the factory, improving the operational efficiency and optimizing control of factory equipment through full lifecycle management, providing support for enterprise energy management and production environment certification compliance; The SCADA system based on production lines can collect relevant data on machine operation, timely grasp production dynamics, and provide a foundation for data analysis and decision-making. The ESOP workflow management system can effectively guide employees to execute the correct processes in the correct order, while fully recording manual operations

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to achieve data integrity of manual operations. The building management system BMS achieves stable control of the entire pharmaceutical storage environment and pharmaceutical production environment by controlling industrial air conditioning units. The environmental monitoring system EMS monitors the key production areas and equipment environment, and real-time views the environmental temperature, humidity, and pressure difference in the drug production area, achieving data integrity of production environment records.
In the data center, through the AVEVA AIM digital delivery system and AVEVA PI System big data management platform, Schneider Electric can help achieve enterprise level information integration and management covering GMP and Non GMP, and build an enterprise level industrial data dual base.
At the production operation application layer, the MES system and warehouse management system WMS can help comprehensively standardize the production execution process and achieve lean warehouse management; The laboratory management system LIMS can uniformly store experimental data and literature, helping the laboratory achieve digital management; There are also equipment management systems such as EAM, AVEVA UOC integrated operation center, EMS+energy efficiency management and control system, which enable the visualization of factory equipment, energy consumption and other information and break away from the “black box” state.
At the management analysis level, a series of enterprise management system software such as supplier management system, business process management software, and quality management system are utilized to improve the efficiency of business management and achieve unified management from decentralization to centralization.
Merier Bio is a leader in the in vitro diagnostic industry. In the construction of its Suzhou base, Schneider Electric has adopted a complete set of power distribution, automation, and information technology solutions, including EMS environmental monitoring system, PO power monitoring system, EBO building operation system, and production process automation system PAS based on AVEVA system platform. With more advanced management and control technology and more efficient energy efficiency strategies, Promote the construction of automated production lines and improve user management of the environment and production data, reduce costs, improve efficiency, and help them achieve sustainable development goals, creating a benchmark for the biopharmaceutical industry.
The changes in social environment and policies have brought many opportunities and challenges to the medical device industry. How to improve efficiency through comprehensive digitization of production and management work has become an industry consensus. Schneider Electric has been deeply involved in the life science industry for a long time, combining its own technical expertise and industry experience to provide digital solutions covering the entire lifecycle for medical device and diagnostic reagent enterprises, assisting in production and operation safety compliance, ensuring strict quality control, accelerating digital transformation, and thus maintaining a leading position in the new round of market competition.