The traceability of the whole process of drug production is an important means to ensure the quality of drugs. In August 2023, the local standard of “Construction and Operation Specification for the Whole Process Digital Traceability System of Drug Production” (DB31/T 1400-2012) organized and drafted by Shanghai Pharmaceutical Administration, Shanghai Pharmaceutical Quality Association and Shanghai Pharmaceutical Industry Association was formally implemented, which also clarified the construction of a digital traceability system covering the drug production process. Help enterprises to promote digital development. In the same year, Rockwell joined hands with Daiichi Sankyo Pharmaceutical (Shanghai) Co., LTD. (referred to as Daiichi

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Sankyo) to create a full-life cycle digital management and manufacturing management system (MES) through advanced cloud deployment. Daiichi Sankyo is an original research and development multinational group with more than 120 years of history. As early as the 1980s, Daiichi Sankyo began to introduce many excellent original research products into China, and continue to expand its business in China, and now has successfully established a business organization in China, including research and development, production and sales.
Rockwell’s mature pharmaceutical MES suite PharmaSuite helps Daiichi Sankyo realize the full life cycle traceability of materials and control of key production links; Establish a new management model suitable for the development of Daiichi Sankyo; To realize digital and fine production management, visual and intelligent production decision-making; Promote enterprises to reduce costs and increase efficiency, and constantly improve the industrial level. The quality of drugs needs to be reflected by design, production process assurance and inspection results. Quality is not tested out, but designed and produced. Therefore, the pharmaceutical factory not only needs the test results to meet the requirements, but also needs the production process to meet the design and specification requirements. Through PharmaSuite MES system, Rockwell provides the first Sankyo with work order management, label material management and equipment management, and quality control of the production process. The system will automatically collect key operating parameters of the equipment in the future, and electronic records will efficiently collect production process data.