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1、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.DepartmentOfHealthandH
2、umanServicesFoodandDrugAdministrationCenterforDevicesandRadiologicalHealthCenterforBiologicsEvaluationandResearchPreface前言PublicComment公众评论（意见/问题）CommentsandsuggestionsmaybesubmittedatanytimeforAgencyconsiderationtoDocketsManagementBranch,DivisionofManagementSystemsandPolicy,OfficeofHumanResourcesa
3、ndManagementServices,FoodandDrugAdministration,5630FishersLane,Room1061,(HFA-305),Rockville,MD,20852.Whensubmittingcomments,pleaserefertotheexacttitleofthisguidancedocument.CommentsmaynotbeacteduponbytheAgencyuntilthedocumentisnextrevisedorupdated.Forquestionsregardingtheuseorinterpretationofthisgu
4、idancewhichinvolvetheCenterforDevicesandRadiologicalHealth(CDRH),contactJohnF.Murrayat(301)594-4659oremailjfm@cdrh.fda.govForquestionsregardingtheuseorinterpretationofthisguidancewhichinvolvetheCenterforBiologicsEvaluationandResearch(CBER)contactJeromeDavisat(301)827-6220oremaildavis@cber.fda.gov.（
5、略）AdditionalCopies额外话题CDRHAdditionalcopiesareavailablefromtheInternetat:www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM085281.htm.Youmayalsosendane-mailrequesttodsmica@fda.hhs.govtoreceiveanelectroniccopyoftheguidanceorsendafaxrequestto301-847-8149toreceiveahardcopy.Ple
6、aseusethedocumentnumber(938)toidentifytheguidanceyouarerequesting.CBERAdditionalcopiesareavailablefromtheInternetat:http://www.fda.gov/cber/guidelines.htm,bywritingtoCBER,OfficeofCommunication,Training,andManufacturers'Assistance(HFM40),1401RockvillePike,Rockville,Maryland20852-1448,orbytelephonere
7、questat1800-835-5709or301-827-1800.（略）TableofContents目录SECTION1.PURPOSE第1部分目的.................................................................................................................................
