药品经营企业计算机系统质量控制功能的场景化设计与实现OA
Scenario-based design and implementation of quality control function of computer system in pharmaceutical enterprises
随着我国医药物流行业信息化进程的发展,药品经营企业信息化应用手段丰富多样.《药品经营质量管理规范》(GSP)在附录2中明确了对计算机系统的要求,对系统在各环节实操中应具备的质量控制功能做了要求,但在实际检查过程中发现,部分企业对具体的控制功能尚不明确,个别功能的应用没有达到要求.本文通过借鉴相关文献,系统归纳GSP、《药品经营质量管理规范现场检查指导原则》和GSP附录2:药品经营企业计算机系统中的相应内容,结合计算机系统的运行特点,联系检查工作实际,运用场景式思维,分析计算机系统在药品经营全环节各关键场景(采购、储存、销售、运输)应采取的质量控制措施,明确系统中在各场景应设置的各项判断、识别和控制功能,为药品检查部门提供有益参考,向药品经营企业提供信息化建设的合规依据,助力医药物流行业信息化建设高质量发展.
Along with the development of our country's pharmaceutical logistics industry informationization process,the application means of pharmaceutical management enterprise informationization are rich and varied.In the appendices,the requirements of the computer system and the quality control function of the computer system are clearly defined in the code for the quality management of drug operation(hereinafter referred to as GSP),the specific control function of some enterprises is not yet clear,the application of individual functions did not meet the requirements.Based on the relevant literature,this paper systematically summarized the relevant contents in GSP,the Guiding Principles for On-site Inspection of Drug Quality Management Norms and GSP Appendix 2:Computer System for Drug Enterprises,according to the running characteristics of the computer system,the quality control measures of the computer system in drug purchase,storage,sale and transportation are analyzed by using the scene thinking and combining with the actual inspection work,to define the functions of judgment,identification and control that should be set up in each scene in the system,so as to provide useful reference for drug inspection departments and compliance basis for information construction of drug distribution enterprises,to promote the development of high-quality medical logistics industry information construction.
林晓明;李海峰;聂娇龙;赵彩虹;陈雨洁;尚京迎
山东省食品药品审评查验中心,山东济南 250014山东省食品药品审评查验中心,山东济南 250014山东省食品药品审评查验中心,山东济南 250014山东省食品药品审评查验中心,山东济南 250014山东省食品药品审评查验中心,山东济南 250014山东省食品药品审评查验中心,山东济南 250014
医药卫生
药品经营企业计算机系统质量控制功能场景化
Drug distribution enterprisesComputer systemsQuality control functionScenario-based
《药学研究》 2026 (3)
350-355,6
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