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I摘要研究背景：随着信息技术（IT）的发展，实验室信息管理系统（简称LIMS）取得了显著的发展，为实验室提供了强有力的平台，降低运营成本，提高工作效率。国外LIMS发展已经非常成熟，而在国内，特别是制药企业，还处于起步阶段。大多数制药企业还采用传统的人工方法对实验室进行管理，但是随着样品量的增加、实验室规模的扩大以及实验室要求的不断提高，传统的管理方法面临很多挑战。同时，随着新版《药品生产质量管理规范》的推行及管理理念提升与国际化进程的加快，实施LIMS已是制药企业实验室的必然趋势。研究目的：本文通过文献回顾，了解国内外LIMS的发展以及应用情况，并结合国内制药企业的特点，通过对比分析LIMS系统与传统实验室管理模式的特点，研究适合不同规模的实验室的管理方案。本文重点介绍LIMS在不同规模实验室的建立和实施，为国内企业LIMS的实施提供一个可行的方案。研究方法：本文首先通过文献回顾和市场调研，比较了国外主要LIMS和国内LIMS系统的主要特点，包括供应商、价格、成熟度、应用支持等方面。其次从实验室的规模及管理要素、技术要求以及法律法规等方面评估分析不同管理系统的优缺点。最后结合大型实验室，并以市售的LIMS为例，说明LIMS实施的方案、流程、难点以及策略。研究结论：随着我国GMP及管理理念与国际的逐步接轨，企业对在质量体系建设的投入不断加大，实施LIMS已是制药企业检验实验室的必然趋势。选择与实验室规模相适应的LIMS系统是成功实施的前提。软件的结构和功能及复杂程度，应和实验室规模相适应。企业内部管理模式的转变及后续维护，是LIMS成功实施的关键。关键词：制药企业；实验室；信息化管理；LIMSIIStudyonlaboratoryinformationmanagementsystemforChinesepharmaceuticalcompanyBackground:WiththedevelopmentofITtechnology,LaboratoryInformationManagementSystem(LIMS)hasachievedstrikingdevelopment,whichprovidesastrongplatformforlabsandhelpstoreduceoperatingcostandimproveworkefficiency.LIMSisverymatureabroad,butitstartedlateinourcountry,especiallyinthepharmaceuticalenterprises.Thelaboratoriesofmostdomesticpharmaceuticalenterpirsesweretraditionallymanagedinanartificialway.However,withtheincreasingofthesamplesize,expansionoflabscaleandcontinuousdemandonlabs,agreatmanychallengeslieintraditionallabmanagementmethods.Meanwhile,duetotheimplementationofnew-versionGMP,theadvanceofmanagementconceptandtheacceleratingdevelopmentofinternationalization,it’sinevitableforpharmaceuticallabstoadoptLIMS.Purpose:ThisarticleaimsatmakingthedevelopmentandapplicationsoftheLIMSathomeandaboardunderstoodthroughliteraturereview.Besides,combiningthecharacteristicsofdomesticpharmaceuticalenterprises,thisarticleprovidesafeasiblesolutionfortheimplementationofLIMSindomesticenterprisesbycomparingandanalyzingthefeaturesofLIMSandtraditionallabmanagementmode,studyingthemanagementschemesapplicabletothelabsofdifferentscalesandfocusingontheestablishmentandintroduceofsuchasysteminthoselabs.Method:ThisarticlestartswiththecomparisonofmainfeaturesoftheforeignanddomesticLIMSthroughliteraturereviewandmarketresearch,includingtheaspectsofsupplier,price,technologicalmaturity,applicationsupport,etc.;thenitfocusesonanalyzingandevaluatingthemeritsanddemeritsofdifferentmanagementsystemsfromtheperspectivesoflabscale,essentialsofmanagements,technicalrequirements,regulations,etc.;intheend,theLIMSinthemarketistakenasanexampletoillustratetheprotocol,procedure,difficultiesandstrategiesforLIMSimplementationwiththecombinationoflargelab.Conclusion:ImplementationofLIMSinthelaboratoriesofpharmaceuticalenterprisesisaninevitabletrendalongwiththeGMPandmanagementconceptofourcountryintegratingwithinternationalstandardsandtheincreasinginvestmentintheestablishmentofIIItheenterprise’squalitysystem.SelectionofaLIMSmatchingwiththelabscaleisthepremiseofsuccess.Thestructure,functionsandcomplexityofthesoftwareshouldaccordwiththelabscale.ThetransformationofinternalmanagementmodeandfollowingmaintenanceisthekeytosuccessfulimplementationofLIMS.Keywords:pharmaceuticalenterprises;lab;informationmanagement;LIMSIV目录第一章引言.................................................................................................................1第二章LIMS简介......................................................................................................22.1LIMS概念及发展历史.......................................................................................22.2LIMS的功能......................................................................................................32.3国内外LIMS......................................................................................................5第三章实施前评估分析.............................................................................................83.1实验室现状概述.................................................................................................83.2实验室评估分析.................................................................................................93.3实施LIMS的可行性分析...............................................................................113.4用户需求（URS）建立...................................................................................12第四章LIMS实施方案和步骤.................................................................................134.1方案一：办公软件管理...................................................................................134.2方案二：部分模块功能管理...........................................................................134.3方案三：LIMS管理........................................................................................144.3.1组建项目实施小组......................................................................................154.3.2确定用户需求（URS）..............................................................................154.3.3LIMS的选择...............................................................................................164.3.4实验室硬件准备及网络支持......................................................................184.3.5仪器数据采集及接口................................................