制药企业实验室信息管理系统的设计及应用  

Design and application of laboratory information management system in pharmaceutical enterprise

作　　者：舒泽柳 江虎 潘其麟 SHU Zeliu;JIANG Hu;PAN Qilin(Sichuan Institute for Drug Control(Sichuan Testing Center of Medical Devices),NMPA Key Laboratory for Quality Control and Evaluation of Vaccines and Biological Products,Ministry of Industry and Information Technology Industrial Technology Basic Public Service Platform,Chengdu Sichuan,611731,China;Chengdu Kanghua Biological Products Co.,Ltd.;Sichuan Center for Medical Product Technical Inspection)

机构地区：[1]四川省药品检验研究院(四川省医疗器械检测中心)、国家药品监督管理局疫苗及生物制品质量控制与评价重点实验室、工业和信息化部产业技术基础公共服务平台,四川成都611731 [2]成都康华生物制品股份有限公司 [3]四川省药品技术检查中心

出　　处：《质量安全与检验检测》2024年第5期79-83,共5页QUALITY SAFETY INSPECTION AND TESTING

摘　　要：为实现制药企业实验室业务的规范化、自动化、数字化管理,进一步提升实验室的管理水平,本文对制药企业实验室信息管理系统(LIMS)进行研究。LIMS基于完善的检验检测质量管理体系,按照标准化的实验室管理理念,系统包含了检验管理、实验室管理、实验用品管理、质量管理、统计分析及公共信息6大模块,对传统的实验室业务管理模式进行了多角度的升级和改造。通过统计并分析制药企业LIMS的应用数据,总结其优缺点,以提升制药企业实验室的管理水平。制药企业通过LIMS的应用,规范了检验业务流程,实现检验的标准化和自动化,有效提升了实验室的管理水平和工作效率。In order to realize the standardization,automation and digital management of laboratory business in pharmaceutical enterprises,and further improve the management level of laboratory,this paper studies the laboratory information management system(LIMS)of pharmaceutical enterprises.LIMS of pharmaceutical enterprises is based on perfect inspection and testing quality management system,and according to standardized laboratory management concept,the system includes six modules:inspection management,laboratory management,laboratory supplies management,quality management,statistical analysis and public information.The traditional laboratory business management mode was upgraded and reformed from multiple angles.Through the application of LIMS in pharmaceutical enterprises,its advantages and disadvantages are summarized.To improve the management level of LIMS in pharmaceutical enterprises.Through the application of LIMS,pharmaceutical enterprises can standardize the inspection business process,realize the standardization and automation of the inspection,and effectively improve the management level and work efficiency of the laboratory.

关 键 词：制药企业 实验室信息管理系统 LIMS应用 

分 类 号：TP315[自动化与计算机技术—计算机软件与理论] R954[自动化与计算机技术—计算机科学与技术]