TOC验证.docVIP

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 amendment 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 ***: Date 1.0 SCOPE: 范围 4 2.0 PURPOSE: 范围 4 3.0 BACKGROUND: 背景 4 4.0 INTRODUCTION: 介绍 4 5.0 REFERENCES: 参考书目 5 6.0 RESPONSIBLE PARTIES AND RESPONSIBILITIES: 责任方及其责任 7 7.0 SYSTEM DESCRIPTION: 系统说明 9 8.0 TESTING PROCEDURES: 测试程序 10 9.0 ACCEPTANCE CRITERIA: 验收标准: 11 Attachment 1 - Validation Test Equipment and Materials附件1—确认测试设备和材料 13 Attachment 2 - Specification and Purchase Order Verification附件2—规范和采购单确认 14 Attachment 3 - Engineering Drawing List附件3—工程图纸清单 15 Attachment 4 - Standard Operating Procedures List附件4—标准操作程序清单 16 Attachment 5 - Preventive Maintenance附件5—预防性维护 17 Attachment 6 - Operation and Maintenance Manual List附件6—操作和维护手册清单 18 Attachment 7 - Major Component Labeling List附件7—主要部件标签清单 19 Attachment 8 - Critical Instrument List附件8—关键仪器清单 20 Attachment 9 - Non-Critical Instrument List附件9—非关键仪器清单 21 Attachment 10 - Spare Parts List附件10—备件清单 22 Attachment 11 - Utility Data Sheet: Electrical附件11—公用工程数据表：电 23 Attachment 12 - Utility Data Sheet: Compressed Air附件12—公用工程数据表：压缩空气 20 Attachment 13 - Operational Testing, TOC Analyzer附件13—操作测试，TOC分析器 241 Attachment 14 - ROM and Configuration Test附件14—ROM和构造测试 262 Attachment 15 - Mechanical Check Test附件15—机械检查测试 29 Attachment 16 - Flow Test附件16—流量测试 31 Attachment 17 - Linearity/ Sample Measurement Test附件17—线性/样品测量测试 33 Attachment 18 - Operational Testing, TOC AutoSampler附件18—操作测试，TOC自动取样 30 Attachment 19 - Mechanical Test附件19—机械测试 41 Attachment 20 - Sample Test附件20—样品