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1、Company Logo DOCUMENT NUMBER: # - # PAGE: 1 of 55 LOCATION: Revision: Rev # EFFECTIVE: yyyy.mm.dd TITLE: VALIDATION PLAN FOR THE File Name: 114966c0f7a1b649020587553974b5b8.pdfCLast Save Date: 21-1 月-2016 Print Date: 2/23/1916-1 月-2003 Company Logo DOCUMENT NUMBER: # - # PAGE: 2 of 55 LOCATION: Revi
2、sion: Rev # EFFECTIVE: yyyy.mm.dd TITLE: VALIDATION PLAN FOR THE File Name: 114966c0f7a1b649020587553974b5b8.pdfCLast Save Date: 21-1 月-2016 Print Date: 2/23/1916-1 月-2003 Authors Signature: 授权者签名授权者签名 Your signature indicates that this document has been prepared in accordance with existing project
3、standards and adequately reflects the tasks and deliverables necessary for validation of the 您的签名表明这份文件的准备符合现行项目标准并且充分反映人物 u 和可交付使用对验证的必 要。 Authored By: 经授权：经授权： Typed/Printed Name, Title 姓名，职称 Signature 签名 Date 日期 Unit 单位 Reviewers Signature: 审查员签名：审查员签名： Your signature indicates that, you have rev
4、iewed this document and that it accurately and completely reflects the tasks and deliverables necessary for validation of the . 您的签名表明您已经审阅了这份文件，确认它精确并完全的反映任务和可交付使用对验证的必 要。 Reviewed By: 经审阅：经审阅： Typed/Printed Name, Title 姓名，职称 Signature 签名 Date 日期 Unit 单位 Typed/Printed Name, Title 姓名，职称 Signature 签名
5、 Date 日期 Unit 单位 Typed/Printed Name, Title 姓名，职称 Signature 签名 Date 日期 Unit 单位 Quality Control/Compliance Approvers Signature: Company Logo DOCUMENT NUMBER: # - # PAGE: 3 of 55 LOCATION: Revision: Rev # EFFECTIVE: yyyy.mm.dd TITLE: VALIDATION PLAN FOR THE File Name: 114966c0f7a1b649020587553974b5b8.p
6、dfCLast Save Date: 21-1 月-2016 Print Date: 2/23/1916-1 月-2003 质检质检/承认签名承认签名 Your signature indicates that this document complies with ; and that the documentation and information contained herein complies with applicable regulatory, corporate, divisional/departmental requirements, and current Good M
7、anufacturing Practices. 您的签名表明这份文件符合证明人验证总计划，企业标准或政策，并且在此包含的文件和信息符合可 应用的可调整的，共同的以及部门所有的部门的要求和现行的标准。 Approved By: 经核准：经核准： Typed/Printed Name, Title 姓名，职称 Signature 签名 Date 日期 Unit 单位 Typed/Printed Na me, Title 姓名，职称 Signature 签名 Date 日期 Unit 单位 Company Logo DOCUMENT NUMBER: # - # PAGE: 4 of 55 LOCAT
8、ION: Revision: Rev # EFFECTIVE: yyyy.mm.dd TITLE: VALIDATION PLAN FOR THE File Name: 114966c0f7a1b649020587553974b5b8.pdfCLast Save Date: 21-1 月-2016 Print Date: 2/23/1916-1 月-2003 Revision History 修订历史纪录修订历史纪录 Revision 修订本修订本 Revision Date 修订日期修订日期 Reason for Revision/Change Request 修订修订/更改要求的原因更改要
9、求的原因 Revised By 修订人修订人 004-DEC-2002 2002/12/4 Original Release 原始版本 Michael T. Filary 迈克尔 116-JAN-2003 2003/1/16 Updated the JETT logo on the cover page. 更新封页面的 JETT 的标识 Michael T. Filary 迈克尔 Table of Contents 目录 1.Introduction 绪论5 1.1Purpose 目的5 1.2Policy Compliance 适用的政策5 1.3Scope of Validation 验证
10、范围 .5 1.4Objectives 目标 .6 1.5Periodic Review 定期审查6 2.Organizational Structure 组织结构 7 3.GxP Criticality AssessmentGxP 关键性评估.7 3.1GxP Criticality Assessment - RequirementsGxP 关键性评估要求7 3.2GxP Criticality Assessment - Procedures GxP 关键性评估程序 8 3.3GxP Criticality Assessment Current StatusGxP 关键性评估现行标准8 4.
11、Validation Strategy 验证策略.9 4.1Life Cycle 生命周期9 4.2Risk Assessment 风险评估 .9 4.3Hardware Categories 硬件分类.9 4.4Software Categories 软件分类9 4.5Project Inputs/Outputs for Stages 项目各阶段的输入/输出10 4.6Acceptance Criteria for Stages 各阶段的接受标 10 Company Logo DOCUMENT NUMBER: # - # PAGE: 5 of 55 LOCATION: Revision: R
12、ev # EFFECTIVE: yyyy.mm.dd TITLE: VALIDATION PLAN FOR THE File Name: 114966c0f7a1b649020587553974b5b8.pdfCLast Save Date: 21-1 月-2016 Print Date: 2/23/1916-1 月-2003 5.Validation Deliverables.10 5.1 Traceability and Linkages 描述和链接 11 5.2Master List of all Validation Products and Supporting Documentat
13、ion 所有批准产品和证明文件的总清单 11 5.3User Requirements Specification (URS) 使用说明书11 5.4Functional Requirement Specification (FRS) 功能说明书.11 5.5Configuration Management and Change Control Documentation 配置管理和变速控制文件 11 5.6Vendor Qualification documentation 卖主资格认证 11 5.7Design Specifications 设计说明12 5.8 Testing and V
14、erification Requirements Documentation试验和确认所需文件 12 5.9System Security系统安全性13 5.10Operational Support运行支持.14 5.11Business Continuity Plan业务持续计划14 5.12Disaster Recovery, Backup and Restoration灾难性恢复，备份及修复.14 5.13System Acceptance Final Report系统接受终报告14 5.14列出任何其他需要验证的产品15 6.Acceptance Criteria可接受标准15 7.
15、Change Control变更控制15 7.1Pre-Implementation Changes预执行变更15 7.2Post-Implementation Changes执行后变更15 8.Standard Operating Procedures SOP.15 8.1SOP Responsibilities SOP 职责15 8.2Listing of SOPs SOP 列表16 9.Training培训.16 10.Documentation Management资料管理.16 10.1Document Production文件产生.16 10.2Document Review文件回顾16 10.3Document Approval文件批准.16 10.4Document Issue文件发布16 10.5Document Changes文件变更.17 10.6Document Withdraw文件撤销17 10.7Document Storage文件保存17 11.Maintaining the Validated State验证状态的维护17 11.1System Retirement系统引退17 12.Validation Activities Timelin
