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Bio-Design and Manufacturing  2016 Vol.-1 No.-1 P.

http://doi.org/10.1007/s42242-023-00037-X


Pharmaceutical digital transformation in China: Digital Quality Assurance Takes the Driver’s Seat


Author(s):  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

Affiliation(s):  Shenyang Pharmaceutical University, Shenyang 110016, China; more

Corresponding email(s):   yuanhm612@163.com, chenguiliang@smda.sh.cn

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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. Pharmaceutical digital transformation in China: Digital Quality Assurance Takes the Driver’s Seat[J]. Journal of Zhejiang University Science D, 2016, -1(-1): .

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Abstract: 
The development of automation, the Internet of Things (IoT), artificial intelligence (AI), big data, and other digital 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 risk management 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.

Darkslateblue:Affiliate; Royal Blue:Author; Turquoise:Article

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