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 risk man-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.