计算机系统验证主计划(中英文对照)

MasterPlan计算机系统验证主计划ComputerSystemValidationJune20122012年6月ThisisanexampleofaMasterPlan.Itisaproposalandstartingpointonly.Thetypeandextentofdocumentationdependsontheprocessenvironment.Theproposeddocumentationshouldbeadaptedaccordinglyandshouldbebasedonindividualriskassessments.Thereisnoguaranteethatthisdocumentwillpassaregulatoryinspection.这是一份主计划的样板。它只是一份建议和起点而已。本文件的程度及类型取决于工艺环境。本文件应做相应的改编并基于一些单独的风险评估。本文件并不保证可以通过法规机构的检查。Publicationfrom出版，全球在线验证及合规性资源。CopyrightbyLabcompliance.Thisdocumentmayonlybesavedandviewedorprintedforpersonaluse.Usersmaynottransmitorduplicatethisdocumentinwholeorinpart,inanymedium.Additionalcopiesandlicensesfordepartment,siteorcorporateusecanbeorderedfrom版权属于Labcompliance。本文件只可以用于个人用途的保存、查看或印刷。用户不允许通过任何媒体传播或复制本文件的全部或部分内容。需要额外的拷贝和许可的部门、网站或公司可以在预定。Whileeveryefforthasbeenmadetoensuretheaccuracyofinformationcontainedinthisdocument,Labcomplianceacceptsnoresponsibilityforerrorsoromissions.Noliabilitycanbeacceptedinanyway.MasterPlanPage2of89DocumentNumber:M-173ComputerSystemValidation(Replacewithyourcompany’sname)FORINTERNALUSE尽管Labcompliance尽可能的去确保此文件中信息的准确性，但无论以哪种方式，不会为其中的错误或疏漏而承担任何责任。Labcomplianceoffersbooks,masterplans,completeQualityPackageswithvalidationprocedures,scriptsandexamples,SOPs,publications,trainingandpresentationmaterial,userclubmembershipwithmorethan500downloadsandaudio/webseminars.Formoreinformationandordering,visit可以为用户俱乐部的会员提供超过300份的书籍、主计划、完整的验证程序质量包、脚本及模版、SOP、出版物、培训和介绍材料的下载和音频/网路研讨会。访问以获得更多的信息。MasterPlanPage3of89DocumentNumber:M-173ComputerSystemValidation(Replacewithyourcompany’sname)FORINTERNALUSECompanyName公司名称:Controls受控信息:SupersededDocument取代的文件N/A,new新文件ReasonforRevision修订原因N/AEffectiveDate生效日期June1,2012Signatures签名:Author起草人IindicatethatIhaveauthoredorupdatedthisMasterPlanaccordingtoapplicablebusinessrequirementsandourcompanystandards.本人声明我已根据适用的商业需求和本公司标准起草或升版此主计划文件Name姓名:________________________________Signature签名:________________________________Date日期:________________________________Approver批准人IindicatethatIhavereviewedthisMasterPlan,andfinditmeetsallapplicablebusinessrequirementsandthatitreflectstheproceduredescribed.Iapproveitforuse.本人声明我已经审核此主计划，并认为其符合所有的适用的的商业需求并在程序中描述。我同意此主计划可以使用Name姓名:________________________________Signature签名:________________________________Date日期:________________________________Reviewer复核人IindicatethatIhavereviewedthisMasterPlanandfindthatitmeetsallapplicablequalityrequirementsandcompanystandards.Iapproveitforuse.本人声明我已复核此主计划并认为其符合所有的适用的质量需求和公司标准。我同意此主计划可以使用MasterPlanPage4of89DocumentNumber:M-173ComputerSystemValidation(Replacewithyourcompany’sname)FORINTERNALUSEName姓名:________________________________Signature签名:________________________________Date日期:________________________________MasterPlanPage5of89DocumentNumber:M-173ComputerSystemValidation(Replacewithyourcompany’sname)FORINTERNALUSETableofContents1.Introduction,ScopeandObjectivesofthisDocument简介，范围和目的...........91.1Introduction简介..................................................................................................91.2Scope范围............................................................................................................91.2.1EnterpriseLevel企业水平..........................................................................................91.2.2SystemLevel系统水平..............................................................................................101.3Objectives目的...................................................................................................102.Policy方针.............................................................................................................113.RelatedDocumentsandActivities相关文件及活动..............................................113.1OtherMasterPlans其他主计划..........................................................................113.1.1RiskManagementMasterPlan风险管理主计划(17.1).........................................123.1.2NetworkQualificationMasterPlan网络确认主计划(17.2)..................................123.1.321CFRPart11ComplianceMasterPlan21CFRPart11符合性主计划(17.3)..123.1.4SecurityMasterPlan安全主计划(17.4)..................................................................133.1.5TrainingMasterPlan培训主计划(17.5).................................................................133.2Procedures规程..................................................................................................133.3Checklists,Forms,Templates,Examples检查表、表格、模版和样例...............153.4ValidationProjectPlans验证项目计划................................................................164.Responsibilities职责..............................................................................................164.1ValidationSteeringCommittee验证指导委员会........................................