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 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

作者机构：School of Business AdministrationShenyang Pharmaceutical UniversityShenyang 110016China Shanghai Center for Drug Evaluation and InspectionShanghai 201203China Shanghai Pharmaceutical Profession AssociationShanghai 200003China Sanofi(China)Investment Co.Ltd.Shanghai 200040China Shanghai Dendreon BiopharmaceuticalsShanghai 201203China Shanghai Cellular Biomedicine GroupShanghai 201203China Fosun Kite BiotechnologyShanghai 201203China Merck PharmaceuticalsNantong 226000China 

基　　金：Sanofi (Hangzhou) Pharmaceuticals, Shanghai Cellular Biomedicine Group Shanghai Center for Drug Evaluation and Inspection Shanghai Dendreon Biopharmaceuticals Shanghai Yaozhi Tech Shenzhen Sanofi Pasteur Biological 

出 版 物：《生物设计与制造(英文)》 (Bio-Design and Manufacturing)

年 卷 期：2023年第6卷第5期

页      码：609-615页

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 *** 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 *** 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.

主 题 词：IoT transformation companies 

学科分类：0831[工学-公安技术类] 1305[艺术学-设计学类] 13[艺术学] 

核心收录：

D　O　I：10.1007/s42242-023-00248-0

馆 藏 号：203123520...