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1、EXECUTION APPROVAL SIGNATURES批准执行签名The signatures below indicate approval of this protocol and its attachments and indicate that it is ready for execution. Any changes or modifications to the intent or the acceptance criteria of this protocol, following approval, requires the generation of an amendm
2、ent which must be approved prior to execution. 下面的签名表示批准本文件及其附件，且表明已经为执行作好了准备。在批准后，对本文件的目的或验收标准进行的任何改变或修正都必须起改善的作用，在执行以前就必须取得批准。*Company LTD:Date*:Date*:Date1.0SCOPE: 范围42.0PURPOSE: 范围43.0BACKGROUND: 背景44.0INTRODUCTION: 介绍45.0REFERENCES: 参考书目56.0RESPONSIBLE PARTIES AND RESPONSIBILITIES: 责任方及其责任77.0S
3、YSTEM DESCRIPTION: 系统说明98.0TESTING PROCEDURES: 测试程序109.0ACCEPTANCE CRITERIA: 验收标准:11Attachment 1 - Validation Test Equipment and Materials附件1确认测试设备和材料13Attachment 2 - Specification and Purchase Order Verification附件2规范和采购单确认14Attachment 3 - Engineering Drawing List附件3工程图纸清单15Attachment 4 - Standard O
4、perating Procedures List附件4标准操作程序清单16Attachment 5 - Preventive Maintenance附件5预防性维护17Attachment 6 - Operation and Maintenance Manual List附件6操作和维护手册清单18Attachment 7 - Major Component Labeling List附件7主要部件标签清单19Attachment 8 - Critical Instrument List附件8关键仪器清单20Attachment 9 - Non-Critical Instrument List
5、附件9非关键仪器清单21Attachment 10 - Spare Parts List附件10备件清单22Attachment 11 - Utility Data Sheet: Electrical附件11公用工程数据表：电23Attachment 12 - Utility Data Sheet: Compressed Air附件12公用工程数据表：压缩空气20Attachment 13 - Operational Testing, TOC Analyzer附件13操作测试，TOC分析器241Attachment 14 - ROM and Configuration Test附件14ROM和
6、构造测试262Attachment 15 - Mechanical Check Test附件15机械检查测试29Attachment 16 - Flow Test附件16流量测试31Attachment 17 - Linearity/ Sample Measurement Test附件17线性/样品测量测试33Attachment 18 - Operational Testing, TOC AutoSampler附件18操作测试，TOC自动取样30Attachment 19 - Mechanical Test附件19机械测试41Attachment 20 - Sample Test附件20样品
7、测试43Attachment 21 - Sparge Test附件21喷射测试44Attachment 22 - Magnetic Stirrer Test附件22磁力搅拌器测试45Attachment 23 - Signature Verification List附件23签名确认清单36Attachment 24 - Protocol Deviation Log附件24文件偏差日志37Attachment 25 - Protocol Deviation Record附件25文件偏差记录38Attachment 26 - Protocol Execution Approval Signatu
8、re Data Sheet附件26文件执行批准签名数据表391.0SCOPE:范围This Installation/Operational Qualification (IOQ) study will be performed on the Total Organic Carbon Analyzer (TOC) located in *.本安装/操作确认（IOQ）文件应用于位于*的总有机碳分析器(TOC)。This protocol describes the equipment, test procedures, specifications, documents, and referen
9、ces used to establish that the TOC has been installed and operates in accordance with the manufacturers design specifications, and those of * Company, LTD. The facility will be referred to as * through out the remainder of this document. The unit will be referred to as the “TOC” throughout this docu
10、ment.本文件内容涉及设备、测试步骤、规格、文档和参考书目，这些是用来确保TOC已经按生产商设计规范和*公司要求安装和操作。本文件下文中工厂指的是*，单元指的是“TOC”。All firmware that is qualified, as part of this protocol, shall be identified as to version or other unique characteristic during Installation Qualification and a Firmware Letter of Assurance included in the docum
11、entation. Hardware or firmware associated with the instrument or system shall be under configuration control with change control procedures in place.作为本文件的一部分，在安装确认和文件中的固件质保书中，固件的版本和其他唯一的标识号都必须识别。与仪器或系统有关的硬件或固件都有结构控制，且有在线变化控制。Functional testing of the integrated system will be performed to ensure sy
12、stem integrity where necessary.如果需要，可对整个系统进行功能性测试，确认系统的完整性。2.0PURPOSE:目的The execution of this protocol will demonstrate and document that the TOC has been installed and operates according to the manufacturers specifications and * requirements.本文件的执行将记录和证明TOC已经按生产商规范和*要求安装和操作。3.0 BACKGROUND:背景The TOC
13、 is a new piece of equipment purchased specifically for use at *. TOC是为*使用而特别采购的一套新设备。4.0INTRODUCTION:介绍Installation checks will be performed to verify and document that the equipment is installed with the proper supporting utilities, services, and components. All instrument calibration, standardiza
14、tion, or adjustment will be performed and documented for the measuring equipment used during the execution of this protocol. Standards used will be traceable to the National Institute of Standards and Technology (NIST). Other accepted standards will be used where applicable if NIST standards do not
15、exist.进行安装检查，以确认和记录设备已经与相关的公用工程、服务和部件连接。在文件执行过程中，作为测量工具，所有的仪器校验、标准化或调整都将进行，且记录下来。所使用的标准都可追溯到美国国家标准和技术研究院(NIST)。如果NIST不涉及的地方也可使用其他的验收标准。Documentation associated with the TOC, such as operators or owners manuals, system drawings, purchase specifications, cut sheets, component specification sheets, material listings, installation diagrams, component plans, and other data, etc., may be reviewed in this report. Copies of
