编号No：IQP-XXXX安装确认InstallationQualification起草于2015年04月PreparedApril2015名称Title超净工作台-安装确认Laminarflowcabinet-InstallationQualification房间号RoomNo1410验证的仪器、设备或程序Instrument/Equipment/ProceduretobeValidated设备供应商Suppliedby:上海汇析精密仪器有限公司ShanghaiHuixiPrecisionInstrumentCo.,Ltd.设备序列号EquipmentRegister:2013-82096设备编号EquipmentNumberMEC-06-02验证方案的批准ApprovaloftheValidationProtocol审核和批准了相关SOP、标准和日程表之后在下表签字SignhereafterreviewingandapprovingtheSOPs,standardsandschedules头衔Title姓名Name签名Signature日期Date起草人WrittenBy:验证负责人VD王雨蒙YumengWang批准人ApprovedBy:QA负责人QAManager刘振超ZhenchaoLiu机构负责人Testfacilitymanager夏玉叶YuyeXia目录TableofContents页码page1of9编号No：IQP-XXXX1通用说明和先决条件GENERALINSTRUCTIONSANDPREREQUISITE..................31.1目的和范围OBJECTIVEANDSCOPE.............................................................................31.2设备或仪器描述EQUIPMENT/INSTRUMENTDESCRIPTION...........................................31.3主要组件列表MAJORCOMPONENTSLIST...................................................................31.4术语和定义TERMSANDDEFINITIONS..........................................................................42责任RESPONSIBILITIES..................................................................................................43文件DOCUMENTATION..................................................................................................53.1完成本文件COMPLETIONOFTHISDOCUMENT............................................................53.2文件列表QUALIFICATIONDOCUMENTSLIST...............................................................54公用设施要求UTILITIESREQUIREMENTS..................................................................64.1公用设施列表UTILITIESLIST......................................................................................65列举需要检定的项目CALIBRATIONITEMS.................................................................66安装、接线、安全和外观检查INSTALLATION,HOOKUP,SAFETYANDPHYSICALINSPECTION.............................................................................................................................77预防性维护和安全评估PREVENTIVEMAINTENANCEANDSAFETYASSESSMENTS77.1预防性维护PREVENTATIVEMAINTENANCE.................................................................77.2安全评估SAFETYASSESSMENT....................................................................................78缺陷报告附件列表DEFICIENCYREPORTATTACHMENTSLIST.............................79批准APPROVALS..........................................................................................................89.1临时批准INTERIMAPPROVAL...................................................................................89.2最终批准FinalApproval...........................................................................................8页码page2of9编号No：IQP-XXXX1通用说明和先决条件GeneralInstructionsandPrerequisite1.1目的和范围ObjectiveandScope通常一份方案包含以下方面Thedifferentaspectsthatanormalprotocolwouldaddressare:I.主要组件列表MajorComponentListII.所需文件RequiredDocumentsIII.公用系统需求UtilityRequirementsIV.检定CalibrationV.安装、接线、安全和外观检查Installation,Hookup,SafetyandPhysicalInspectionVI.预防性维护需要PreventiveMaintenanceRequirements...
