ASTM E1578-2006 实验室信息管理系统(LIMS)的标准指南

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【英文标准名称】:StandardGuideforLaboratoryInformationManagementSystems(LIMS)
【原文标准名称】:实验室信息管理系统(LIMS)的标准指南
【标准号】:ASTME1578-2006
【标准状态】:现行
【国别】:
【发布日期】:2006
【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】:指南;信息处理;情报系统;实验室;管理
【英文主题词】:
【摘要】:Relevance8212;ThisguideisintendedtoeducatethoseintheintendedaudienceonmanyaspectsofLIMS.Specifically,theguidemay:4.1.1HelpeducatenewusersofLIMS;4.1.2HelpeducategeneralaudiencesinlaboratoriesandotherorganizationsthatuseLIMS;4.1.3Helpeducateinstrumentmanufacturesandproducersofothercommonlyinterfacedsystems;4.1.4ProvidestandardterminologythatcanbeusedbyLIMSvendorsandendusers;4.1.5EstablishaminimumsetofrequirementsforprimaryLIMSfunctions;4.1.6Provideguidanceonthetasksperformedanddocumentationcreatedinthespecification,evaluation,costjustification,implementation,projectmanagement,training,anddocumentationofLIMS;and4.1.7Providehigh-levelguidancefortheintegrationofLIMSwiththemostcommonlyintegratedsystemssuchaslaboratoryinstruments,CDS,ERP,ELN,SDMSandsoforth.HowUsed8212;ThisguideisintendedtobeusedbyallstakeholdersinvolvedinanyaspectofLIMSimplementationormaintenance.4.2.1ItisintendedtobeusedthroughouttheLIMSlifecyclebyindividualsorgroupsresponsibleforLIMSincludingspecification,build/configuration,validation,use,upgrades,retirement/decommissioning.4.2.2ItisalsointendedtoprovideanexampleofaLIMSfunctionchecklist.1.1ThisguidecoversissuescommonlyencounteredatallstagesinthelifecycleofLaboratoryInformationManagementSystemsfrominceptiontoretirement.Thesub-sectionsthatfollowdescribedetailsofscopeofthisdocumentinspecificareas.1.2HighLevelPurposeThepurposeofthisguideincludes:(1)helpeducatenewusersofLaboratoryInformationManagementSystems(LIMS),(2)providestandardterminologythatcanbeusedbyLIMSvendorsandendusers,(3)establishminimumrequirementsforprimaryLIMSfunctions,(4)provideguidanceforthespecification,evaluation,costjustification,implementation,projectmanagement,training,anddocumentation,and(5)provideanexampleofaLIMSfunctionchecklist.1.3LIMSDefinitionThetermLaboratoryInformationManagementSystems(LIMS)describestheclassofcomputersystemsdesignedtomanagelaboratoryinformation.1.4LaboratoryCategoriesThespectrumoflaboratoriesthatemployLIMSiswidespread.ThefollowingbreakdownprovidesanoverviewofthelaboratorycategoriesthatuseLIMSaswellasexamplesoflaboratoriesineachcategory.1.4.1GeneralLaboratoriesStandards(ASTM,IEEE,ISO),andGovernment(EPA,FDA,JPL,NASA,NRC,USDA,FERC).1.4.2EnvironmentalEnvironmentalMonitoring.1.4.3LifeScienceLaboratoriesBiotechnology,Diagnostic,HealthcareMedical,Devices,andPharmaceuticalsVet/Animal.1.4.4HeavyIndustryLaboratoriesEnergyResources,ManufacturingConstruction,MaterialsChemicals,andTransportationShipping.1.4.5FoodBeverageLaboratoriesAgriculture,Beverages,Food,andFoodServiceHospitality.1.4.6PublicSectorLaboratoriesLawEnforcement,StateLocalGovernment,Education,andPublicUtilities(Water,Electric,WasteTreatment).1.4.7LaboratorySizeThisguidecoverstopicsregardingLIMSforarangeoflaboratorysizesrangingfromsmallwithsimplerequirementstolargemulti-site/globallaboratorieswithcomplexrequirements.AlthoughtheguideaddressescomplexissuesthatimpactprimarilylargeLIMSimplementations,laboratoriesofallsizeswillfindthisguideuseful.Theimplementationtimesandrecommendationslistedin......
【中国标准分类号】:N04
【国际标准分类号】:35_240_80
【页数】:39P.;A4
【正文语种】: