Pharmaceutical digital transformation in China:digital quality assurance takes the driver’s seat  

作　　者：Yuanyuan Ge Meng Cao Hui Cao Bin Han Jingchen Zhang Zhengyu Yi Yaowei Wu Beifen Zhu Keping Ruan Yiyi Pu Yi Zeng Tongjing Tao Zhenzhong Lyu Hongmei Yuan Guiliang Chen 

机构地区：[1]School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China [2]Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China [3]Shanghai Pharmaceutical Profession Association,Shanghai 200003,China [4]Sanofi(China)Investment Co.,Ltd.,Shanghai 200040,China [5]Shanghai Dendreon Biopharmaceuticals,Shanghai 201203,China [6]Shanghai Cellular Biomedicine Group,Shanghai 201203,China [7]Fosun Kite Biotechnology,Shanghai 201203,China [8]Merck Pharmaceuticals,Nantong 226000,China

出　　处：《Bio-Design and Manufacturing》2023年第5期609-615,共7页生物设计与制造（英文）

摘　　要：The development of automation,the Internet of Things(IoT),artificial intelligence(AI),big data,and other digi-tal technologies has made it imperative for pharmaceutical companies to undergo digital transformation to improve their research and development capabilities,increase the quality of their products,lower operating costs,and gain a competitive edge.One of the most crucial steps in the life-cycle riskman-agement chain for drugs is digital quality assurance(DQA).Based on a literature review,questionnaire survey,and expert consensus,a panel of experts was convened in Shanghai to generate a set of conceptual,pharmaceutical manufacturing-specific DQA specifications.The goal of the consensus is to advance common practices that use digital tools to quickly collect,record,evaluate,and review particular forms of data to enhance the automation of quality assurance and make drug quality activities more efficient.

关 键 词：IoT TRANSFORMATION COMPANIES 

分 类 号：TB472[一般工业技术—工业设计]