FDA-Software-Validation软件验证指南

GeneralPrinciplesofSoftwareValidation;FinalGuidanceforIndustryandFDAStaff软件验证的基本原理；企业和FDA人员的最终指导准则Documentissuedon发布日期:January11,2002Thisdocumentsupersedesthedraftdocument,GeneralPrinciplesofSoftwareValidation,Version1.1,datedJune9,1997.本文件取代之前的草案“1997年6月9日的1.1版软件验证的基本原理”U.S.DepartmentOfHealthandHumanServicesFoodandDrugAdministrationCenterforDevicesandRadiologicalHealthCenterforBiologicsEvaluationandResearchPreface前言PublicComment公众评论（意见/问题）CommentsandsuggestionsmaybesubmittedatanytimeforAgencyconsiderationtoDocketsManagementBranch,DivisionofManagementSystemsandPolicy,OfficeofHumanResourcesandManagementServices,FoodandDrugAdministration,5630FishersLane,Room1061,(HFA-305),Rockville,MD,20852.Whensubmittingcomments,pleaserefertotheexacttitleofthisguidancedocument.CommentsmaynotbeacteduponbytheAgencyuntilthedocumentisnextrevisedorupdated.ForquestionsregardingtheuseorinterpretationofthisguidancewhichinvolvetheCenterforDevicesandRadiologicalHealth(CDRH),contactJohnF.Murrayat(301)[e-mail]theuseorinterpretationofthisguidancewhichinvolvetheCenterforBiologicsEvaluationandResearch(CBER)contactJeromeDavisat(301)[e-mail].（略）AdditionalCopies额外话题CDRHAdditionalcopiesareavailablefromtheInternetat:@fda.hhs.govtoreceiveanelectroniccopyoftheguidanceorsendafaxrequestto301-847-8149toreceiveahardcopy.Pleaseusethedocumentnumber(938)toidentifytheguidanceyouarerequesting.CBERAdditionalcopiesareavailablefromtheInternetat:(HFM40),1401RockvillePike,Rockville,Maryland20852-1448,orbytelephonerequestat1800-835-5709or301-827-1800.（略）TableofContents目录SECTION1.PURPOSE第1部分目的....................................................................................................................................4SECTION2.SCOPE第2部分范围.........................................................................................................................................42.1.APPLICABILITY适用范围..............................................................................................................................................52.2.AUDIENCE公众.............................................................................................................................................................52.3.THELEASTBURDENSOMEAPPROACH最简便的方法.................................................................................................52.4.REGULATORYREQUIREMENTSFORSOFTWAREVALIDATION软件验证的监管要求..................................................62.5.QUALITYSYSTEMREGULATIONVSPRE-MARKETSUBMISSIONS质量系统法规VS上市前申请...............................7SECTION3.CONTEXTFORSOFTWAREVALIDATION软件验证的背景.........................................................................83.1.DEFINITIONSANDTERMINOLOGY定义和术语...........................................................................................................83.1.1RequirementsandSpecifications法规要求和标准规范..................................................................................83.1.2VerificationandValidation软件确认和验证.....................................................................................................93.1.3IQ/OQ/PQ..........................................................................................................................................................103.2.SOFTWAREDEVELOPMENTASPARTOFSYSTEMDESIGN软件设计--软件开发.......................................................113.3.SOFTWAREISDIFFERENTFROMHARDWARE软件不同于硬件.................................................................................113.4.BENEFITSOFSOFTWAREVALIDATION软件验证的益处...........................................................................................133.5DESIGNREVIEW设计评审..........................................................................................................................................13SECTION4.PRINCIPLESOFSOFTWAREVALIDATION软件验证的法则......................................................................144.1.REQUIREMENTS法规要求.........................................................................................................................................144.2.DEFECTPREVENTION缺陷预防.................................................................................................................................144.3.TIMEANDEFFORT时间和尝试..................................................................................................................................144.4.SOFTWARELIFECYCLE软件生命周期.......................................................................................................................154.5.PLANS计划.................................................................................................................................................................154.6.PROCEDURES规程.......................