翻译后计算机化系统验证模板.doc

Author's 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 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 Reviewer's Signature: 审查员签名：审查员签名： Your signature indicates that, you have reviewed 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 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 Approver's Signature: 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 Manufacturing 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ＧＭＰ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 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.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 5.Validation Deliverables.10 5.1 Traceability and Linkages 描述和链接 11 5.2Master List of all Validation Products and Supporting Documentation 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 Verification 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.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 SOP15 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 Timeline验证执行时间表17 Appendix A 附录 A参与组织参与组织18 Appendix B 附录 B缩写词，定义缩写词，定义.19 Appendix C 附录 C责任/时间22 Appendix D 附录 D 可交付的验证.23 Appendix E 附录 E 参考24 (Reminder of Page Intentionally Left Blank) 1. Introduction 绪论 1.1 Purpose 目的 This document, also referred to as the Plan, outlines the planned tasks and expectations for validation of the . 这份文件，也称计划，略述计划的任务和〈设备名称〉的预期验证。

WHO will be responsible for completion, review, and approval of these tasks. 世界卫生组织将负责任务的完成、审阅和批准世界卫生组织将负责任务的完成、审阅和批准 WHAT documentation/deliverables will be generated and/or retained as part of the Validation Package(s). 什么文件/可交付使用的将会作为验证包的一部分被产生和/或保留 HOW this documentation will be produced/created (at a macro level). 这份文件将被如何制作这份文件将被如何制作/产生（在宏观上）产生（在宏观上） 1.2 Policy Compliance 遵守政策 This Plan is being written to comply with corporate policy requirements for validation as stated in the , and the appropriate Appendix of the current revision of GAMP. 这份计划将会遵守在〈涉及特殊验证总计划，公司政策，公司标准和公司指导方针〉和适当性（现 行 GAMＰ附录）中关于验证的统一要求。

The validation of the system is a cGMP requirement. 《设备名称》的验证系统是现行ＧＭＰ的一个要求 1.3 Scope of Validation 验证范围 This Validation Plan for the is limited to the unique components and control system that define t。