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【英文标准名称】:StandardGuideforValidationofLaboratoryInformationManagementSystems
【原文标准名称】:实验室信息管理系统的鉴定标准导则
【标准号】:ASTME2066-2000(2007)
【标准状态】:现行
【国别】:
【发布日期】:2000
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:E13.15
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:Validationisanimportantandmandatoryactivityforlaboratoriesthatfallunderregulatoryagencyreview.Suchlaboratoriesproducedatauponwhichthegovernmentdependstoenforcelawsandmakedecisionsinthepublicinterest.Examplesincludedatatosupportapprovalofnewdrugs,provemarketeddrugsmeetspecifications,enforceenvironmentallaws,anddevelopforensicevidencefortrial.ThisalsoextendstoLIMSusedinenvironmentallaboratories.InsomecasesthesesystemsmayneedtobeinteroperablewithCLIMSandcomputer-basedpatientrecords(CPR)forreportingenvironmentalexposuresandclinicallaboratorytestingforbiologicmeasureofstressorexposure.Theenormousfinancial,legal,andsocialimpactofthesedecisionsrequiresgovernmentandpublicconfidenceinlaboratorydata.Toensurethisconfidence,governmentagenciesregularlyreviewlaboratoriesoperatingundertheirrulestoconfirmthattheyareproducingvaliddata.Computersystemvalidationisapartofthisreview.ThisguideisdesignedtoaidusersvalidatingLIMSandincorporatingthevalidationprocessintotheirLIMSlifecycle.Validationmustprovideevidenceoftesting,training,auditandreview,managementresponsibility,designcontrol,anddocumentcontrol,bothduringthedevelopmentofthesystemanditsoperationlife(2).1.1ThisguidedescribesanapproachtothevalidationprocessforaLaboratoryInformationManagementSystem(LIMS).1.2ThisguideisforvalidationofacommercialLIMSpurchasedfromavendor.Theproceduresmayapplytoothertypesofsystems,butthisguidemakesnoclaimtoaddressallissuesforothertypesofsystems.Further,in-housedevelopedLIMS,thatis,thosedevelopedbyinternalorexternalprogrammersspecificallyforanorganization,canutilizethisguide.Itshouldbenotedthatthereareanumberofrelatedsoftwaredevelopmentissuesthatthisguidedoesnotaddress.UserswhoembarkondevelopingaLIMSeitherinternallyorwithexternalprogrammersalsoshouldconsulttheappropriateASTM,ISO,andIEEEsoftwaredevelopmentstandards.1.3ThisguideisintendedtoeducateindividualsonLIMSvalidation,toprovidestandardterminologyusefulindiscussionswithindependentvalidationconsultants,andtoprovideguidancefordevelopmentofvalidationplans,testplans,requiredstandardoperatingprocedures,andthefinalvalidationreport.
【中国标准分类号】:N07
【国际标准分类号】:35_240_80
【页数】:25P.;A4
【正文语种】: