翻译后的计算机化系统验证模板.doc

Company Logo DOCUMENT NUMBER PAGE 1 of 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 Company Logo DOCUMENT NUMBER PAGE 2 of 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 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 Company Logo DOCUMENT NUMBER PAGE 3 of 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 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 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 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 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 Company Logo DOCUMENT NUMBER PAGE 5 of 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 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 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 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 Company Logo DOCUMENT NUMBER PAGE 6 of 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 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 Company Logo DOCUMENT NUMBER PAGE 7 of 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 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 GAM 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 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 the equipment This validation effort will be conducted as a prospective validation 这份为 设备名称 的验证计划仅限于特殊构成和定义设备的控制系统 该项验证成就将会被作为 一项预期的验证执行 Provide a Brief description of equipment and principal function Refer to User Requirement Specifications Provide a description of the research manufacturing processing packaging holding or distribution process for which the equipment is planned 对用户必备使用的说明书中的设备和主要功能的阐述 对实施计划的设备进行研究 生产 加工 包 装 存储 分配过程的说明 Company Logo DOCUMENT NUMBER PAGE 8 of 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 1 3 1 In Scope 验证范围 The scope of validation for the includes all the following that are necessary for the system to operate 设备名称 验证的范围包括以下所有的系统运作所必需的内容 明确界限 1 Controls system hardware and software 控制系统得硬件和软件 2 Mechanical Hardware 机械的硬件 3 Instrumentation 仪器 4 Process piping 输水管道工艺 5 Utility Systems 通用系统 6 Facility 设施 7 其他需要的名单 1 3 2 Out of Scope 验证范围例外 The scope of validation for the does not include 设备名称 验证的范围不包括 1 The XYZ system is validated separately 系统单独验证 2 The Data Historian is validated separately 数据历史单独验证 3 其他名单 Company Logo DOCUMENT NUMBER PAGE 9 of 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 1 3 3 Related Validation 相关验证 插入现有的或计划的与本验证系统有关的验证的描述 如果系统配置和数据采集时是一致的 前期 数据的使用可以作为试验方法的参考或直接替代试验 The related validation that will occur in support of the includes all the following that are necessary for the system to be placed into operation 支持 设备名称 的相关验证在以下情况发生 包括系统运行必需的几点 清晰的定义分界线 1 Process Validation 工艺验证 2 Cleaning Studies 清洁研究 3 Air Classification 风力分级 4 Microbiological Testing 微生物试验 5 Chemical Testing 化学试验 6 Drying Studies 干燥研究 7 Sterilization Studies 无菌研究 8 其他名单 1 4 Objectives 目标 The objective of this validation plan is to outline the requirements that will demonstrate and document that all components control system s and functionality associated with the are appropriate for Company Logo DOCUMENT NUMBER PAGE 10 of 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 cGMP regulated processes The qualifications outlined are to be based on policies and procedures and applicable regulations guidelines and accepted industry practices for validation 该项验证计划的目标是简述一项要求 该要求能够证明所有与设备名称相关的组成 控制系统和功 能都是恰当的符合现行 标准的工艺 资格的综述要基于 公司名称 政策 程序以及可应用 的规则 指导方针和公认的工业验证实践 1 5 Periodic Review 定期回顾 This Plan should be reviewed periodically to ensure compliance and or to determine if a change is required Some appropriate times to review are 这份计划应该被定期回顾来保证符合并确定是否需要更改 一些适当的回顾时间是 1 Change in Validation Master Plan验证主文件的更改发生时 2 Change in scope occurs验证范围的更改发生时 3 Design change occurs设计更改发生时 4 Prior to IQ and OQ 在进行 和 之前 5 Completion of IQ and OQ 和 完成时 See section 5 for a description of Validation Management and the process for review and revisions to this plan or refer to the applicable corporate policy review cycle 见第五部分有关验证管理和针对该项计划见第五部分有关验证管理和针对该项计划 的回顾 修订过程或指适应公司政策的回顾周期 的回顾 修订过程或指适应公司政策的回顾周期 2 Organizational Structure 组织结构 Specific responsibilities related to the validation of the are outlined in Appendix A In general the activities associated with this project are the responsibility of the following individuals and groups 与 设备名称 验证相关的具体职责在附录 中概述 大体上 与验证相关的活动项目由以下个人 和部门负责 确定个人的任务和责任至少应包括以下几点 总体根据岗位不同描述每项任务和责任 1 Management level Responsible for project management and planning control of project activities resources costs monitoring process initiating corrective action ensuring issues project objectives are correctly addressed resolved reporting to senior management interface to QA to ensure compliance reviewing and approving validation documentation for the project 管理层 负责项目管理和计划 方案 活动 资源 成本的控制 监控工艺 2 Quality Assurance Responsible for assuring compliance with appropriate Company Logo DOCUMENT NUMBER PAGE 11 of 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 regulatory business technical user community requirements providing support for the criterion independent review approval of deliverables approving completion of stage validation status 质保 负责保证符合适当的调整 商业 技术 用户群要求 支持维护标准 独立审查 可交 付的批准 审批完成阶段和身份验证等 3 System Owner Responsible for implementation management of the system by the business user community approving completion of stage validation status 系统所有者 负责执行和管理系统的用户群 审批完成阶段和验证身份 这些任务和责任可以适当的定义 按照他们的分工总体上定义每项任务和责任 1 Operations Responsible for providing 操作 负责提供 2 Project Level Responsible for providing 项目水平 负责提供 3 Technical and Engineering support Responsible for providing 技术和工程支持 负责提供 4 Validation Specialist Responsible for providing 验证专家 负责提供 5 System Administrator Responsible for providing 系统管理 负责提供 6 Purchasing Responsible for providing 采供 负责提供 7 其他名单 3 GxP Criticality Assessment GxP 关键性估计 Detail the GxP criticality assessment information related to the This section may reference another source of information covering this topic such as a system inventory 详述和 设备名称 有关的 GxP 关键性估计信息 该部分包括另外一种信息 包括该主题 例如系统详细目录 Company Logo DOCUMENT NUMBER PAGE 12 of 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 3 1GxP Criticality Assessment Requirements GxP 关键性评估 要求 Define the requirements used in the determination of the levels for GxP criticality for the The requirements for determination of the levels for GxP criticality may include Direct Impact Indirect Impact and No Impact systems 定义在决定 设备名称 Gxp水平中使用的关键性要求 包括直接影响 间接影响和无影响系统 Direct Impact System or component within a system where the operation contact data control alarm or failure will have a direct impact on product quality 直接影响 系统或系统中的一个组成 对产品质量有直接影响的操作 接触 控制 预警或失败 Indirect Impact System or component within a system where the operation contact data control alarm or failure will not have a direct impact on product quality Indirect Impact systems typically support Direct Impact systems thus indirect impact system may have an affect on the performance or operation of a direct impact system 间接影响 系统或系统中的一个组成 对产品质量无直接影响的操作 接触 控制 预警或失败 间接影响系统专门支持直接影响系统 因此间接影响系统会对直接影响系统的执行和运作构 成影响 No Impact System or component within a system where the operation contact data control alarm or failure will not have a direct or indirect impact on product quality No Impact systems will not support Direct Impact systems 无影响 系统或系统的一个组成 对产品质量不构成直接或间接影响的操作 接触 控制 预警或 失败 无影响系统不能支持直接影响系统 3 2GxP Criticality Assessment Procedures GxP 关键性评估 程序 Define the procedures used followed in the assessment of the levels for GxP criticality for the Develop a documented path that will be followed to determine the levels for GxP criticality for each item associated with the It may be helpful to develop a decision tree to demonstrate the overview to the process required in determining levels for GxP criticality Internal procedures may be referenced if available 定义使用的程序 设备名称 的 Gxp 关键性水平的评估的标准 开发一种具有证明的文件路径 作 为 设备名称 GxP 关键性水平每一项目的评估标准 创建一个决策树将对在 GxP 关键性评估中论 证工艺的一般观察要求有帮助 如果必要 可以引用国际程序作为参考 3 3GxP Criticality Assessment Current Status GxP 关键性评估 现行标准 State the current status of the assessment for the GxP criticality levels for the 陈述现行 设备名称 的 GxP 关键性水平评估的要求 Company Logo DOCUMENT NUMBER PAGE 13 of 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 The Direct Impact Systems associated with the include all the following 设备名称的 直接影响因素包括以下的所有项 清楚的规定支持理论 1 Controls system hardware and software This has been deemed a direct impact system due to 控制系统硬件和软件 该项是一个直接影响由于 2 Mechanical Hardware This has been deemed a direct impact system due to 机械硬件 该项是一个直接影响由于 3 Instrumentation This has been deemed a direct impact system due to 仪器 该项是一个直接影响由于 4 Process piping This has been deemed a direct impact system due to 工艺流程 该项是一个直接影响由于 5 Utility Systems This has been deemed a direct impact system due to 效用系统 该项是一个直接影响由于 6 Facility This has been deemed a direct impact system due to 设备 该项是一个直接影响由于 7 其他名单 The Indirect Impact Systems associated with the include all the following 设备名称的 间接影响因素包括以下的所有项 清楚的规定支持原理 1 Controls system hardware and software This has been deemed an indirect impact system due to 控制系统硬件和软件 该项是一个间接影响由于 2 Mechanical Hardware This has been deemed an indirect impact system due to 机械硬件 该项是一个间接影响由于 3 Instrumentation This has been deemed an indirect impact system due to 仪器 该项是一个间接影响由于 4 Process piping This has been deemed an indirect impact system due to Company Logo DOCUMENT NUMBER PAGE 14 of 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 工艺流程 该项是一个间接影响由于 5 Utility Systems This has been deemed an indirect impact system due to 效用系统 该项是一个间接影响由于 6 Facility This has been deemed an indirect impact system due to 设备 该项是一个间接影响由于 7 其他名单 The No Impact Systems associated with the include all the following 设备名称的 无影响因素包括以下的所有项 清楚的规定支持原理 1 Controls system hardware and software This has been deemed a no impact system due to 控制系统硬件和软件 该项是一个无影响系统由于 2 Mechanical Hardware This has been deemed a no impact system due to 机械硬件 该项是一个无影响系统由于 3 Instrumentation This has been deemed a no impact system due to 仪器 该项是一个无影响系统由于 4 Utility Systems This has been deemed a no impact system due to 工艺流程 该项是一个无影响系统由于 5 Facility This has been deemed a no impact system due to 设备 该项是一个无影响系统由于 6 其他名单 4 Validation Strategy 验证策略 4 1Life Cycle 生命周期 Company Logo DOCUMENT NUMBER PAGE 15 of 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 Define the internal requirements for development testing delivery and support that define the period of time that begins when a system is conceived and ends when the system is no longer available for use 陈述国内研发 测试 运输和维护的要求 定义验证开始的时间段 系统存在时开始 系统结束 的时间 系统不可用时结束 4 2Risk Assessment 风险评估 State the current status of the assessment for the GxP Risk and Business Risk for the The process needs to address the following questions 陈述现行 设备名称 的 GxP 关键性水平评估的风险和商业风险 该程序必须包括以下问题 Does this automated system require validation 自动化系统需要验证吗 How much validation is required for this system 该系统要求多少验证 What aspects of the system or process are critical to product and patient safety 系统的哪个方面或工艺对产品和患者安全性是关键性因素 What aspects of the system or process are critical to business 系统的哪个方面或工艺过程对商业是关键性因素 4 3Hardware Categories 硬件分类 Define the categories of the hardware associated with the 定义 设备名称 的硬件种类 Hardware components of a system can be analyzed and categorized into one of the following GAMP defined categories 硬件系统组成可以按照以下GAMP详述的分类方法进行分析和归类 Hardware Category 1 Standard Hardware Components 硬件分类1 标准硬件组成 Hardware Category 2 Custom Built Hardware Components 硬件分类2 定制的硬件组成 4 4Software Categories 软件分类 Company Logo DOCUMENT NUMBER PAGE 16 of 56 LOCATION Revision Rev EFFECTIVE yyyy mm dd TITLE VALIDATION PLAN FOR THE File Name 4519aad0f2b1fb0303813aa35da785dc pdfCLast Save Date 01 1 月 0001 Print Date 3 18 2001 1 月 0001 Define the categories of the software associated with the 定义 设备名称 的软件种类 Software components of a system can be analyzed and categorized into one of the following GAMP defined categories 软件系统组成可以按照以下GAMP详述的分类方法进行分析和归类 Software Category 1 Operating Systems 软件分类1 运行系统 Software Category 2