计算机系统验证主计划(中英文对照).pdf

《计算机系统验证主计划(中英文对照).pdf》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

1、MasterPlan计算机系统验证主计划ComputerSystemValidationJune20122012年6月ThisisanexampleofaMasterPlan.Itisaproposalandstartingpointonly.Thetypeandextentofdocumentationdependsontheprocessenvironment.Theproposeddocumentationshouldbeadaptedaccordinglyandshouldbebasedonindividualriskasses

2、sments.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。Publicationfromwww.labcompliance.comGlobalon-lineresourceforvalidationandcompliancewww.labcomplicance.com出版，全球在线验证及合规

3、性资源。CopyrightbyLabcompliance.Thisdocumentmayonlybesavedandviewedorprintedforpersonaluse.Usersmaynottransmitorduplicatethisdocumentinwholeorinpart,inanymedium.Additionalcopiesandlicensesfordepartment,siteorcorporateusecanbeorderedfromwww.labcompliance.com/solutions.版权属于La

4、bcompliance。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www.labcompliance.com/solutions预定。Whileeveryefforthasbeenmadetoensuretheaccuracyofinformationcontainedinthisdocument,Labcomplianceacceptsnoresponsibilityforerrorsoromissions.Noliabilityca

5、nbeacceptedinanyway.MasterPlanPage2of89DocumentNumber:M-173ComputerSystemValidation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,train

6、ingandpresentationmaterial,userclubmembershipwithmorethan500downloadsandaudio/webseminars.Formoreinformationandordering,visitwww.labcompliance.com/solutions.Labcompliance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www.labcompliance.com/solut

7、ions以获得更多的信息。www.labcompliance.com(Replacewithyourcompany’sname)FORINTERNALUSEMasterPlanPage3of89DocumentNumber:M-173ComputerSystemValidationCompanyName公司名称:Controls受控信息:SupersededDocumentN/A,new新文件取代的文件ReasonforRevision修订原因N/AEffectiveDate生效日期June1,2012Signatures签名:Auth

8、orIindicatethatIhaveauthoredorupdatedthisMasterPlan起草人accordingtoapplicablebusinessrequirementsandourco