翻译后计算机化系统验证

1、Company LogoDOCUMENT NUMBER:PAGE:# - #1 of 34LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >File Name: 717430126.docLast Save Date: 18-Feb-2019Print Date: 2/18/19<设备名称 >验证的必要。Company LogoDOCUMENT NUMBER:PAGE:# - #2 of 34LOCATION:Revi

2、sion:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >Author's Signature:授权者签名Your signature indicates that this document has been prepared in accordance with existing project standards andadequately reflects the tasks and deliverables necessary for valid

3、ation of the <equipmentname >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<设备名称 >验证的必要。Authored By:经授权：Typed/Printed Name, TitleSignatureDateUnit姓名，职称签名日期单位Reviewer's Signature:审查员签名：Your signature indicates that, you have reviewed this document and that it accurately and completely reflect

4、s the tasksand deliverables necessary for validation of the <equipment name>.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Reviewed By:经审阅：Typed/Printed Name, TitleSignatureDateUnit姓名，职称签名日期单位Typed/Printed Name, TitleSignatureDateUnit姓名，职称签名日期单位Typed/Printed Name, TitleSignatureDateUnit姓名，职称签名日期单位Quali

5、ty Control/Compliance Approver's Signature:质检 /承认签名Your signature indicates that this document complies with < reference Validation Master Plan, company standards or guidelines > and that the documentation and information contained herein complies with applicable regulatory, corporate, div

6、isional/departmental requirements, and current Good Manufacturing Practices.File Name: 717430126.docLast Save Date: 18-Feb-2019Print Date: 2/18/19Company LogoDOCUMENT NUMBER:PAGE:# - #3 of 34LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >您

7、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：Typed/Printed Name, TitleSignatureDateUnit姓名，职称签名日期单位Typed/Printed Na me, TitleSignatureDateUnit姓名，职称签名日期单位File Name: 717430126.docLast Save Date: 18-Feb-2019Print Date: 2/18/19Company LogoDOCUMENT NUMBER:PAGE:#

8、 - #4 of 34LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >Revision History修订历史纪录RevisionRevision DateReason for Revision/Change RequestRevised By修订本修订日期修订 /更改要求的原因修订人004-DEC-2002Original ReleaseMichael T. Filary2002/12/4原始版本迈克尔116-JAN-2003

9、Updated the JETT logo on the cover page.Michael T. Filary2003/1/16更新封页面的 JETT 的标识迈克尔Table of Contents目录1.Introduction 绪论 .181.1Purpose目的 .181.2Policy Compliance 适用的政策 .181.3Scope of Validation 验证范围 .181.4Objectives 目标 .181.5Periodic Review 定期审查 .182.Organizational Structure 组织结构 .183.GxP Criticality

10、 AssessmentGxP 关键性评估 .183.1GxP Criticality Assessment - RequirementsGxP 关键性评估要求 .183.2GxP Criticality Assessment - Procedures GxP 关键性评估程序183.3GxP Criticality Assessment Current StatusGxP 关键性评估现行标准 .184.Validation Strategy 验证策略 .184.1Life Cycle 生命周期 .184.2Risk Assessment风险评估 .184.3Hardware Categories

11、 硬件分类 .184.4Software Categories 软件分类 .184.5Project Inputs/Outputs for Stages 项目各阶段的输入 /输出 .184.6Acceptance Criteria for Stages 各阶段的接受标185. Validation Deliverables .185.1 Traceability and Linkages 描述和链接18File Name: 717430126.docLast Save Date: 18-Feb-2019Print Date: 2/18/19Company LogoDOCUMENT NUMBER

12、:PAGE:# - #5 of 34LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >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185.3User Requirements Specification (URS) 使用说明书 .185.4Functional Requirement Specificati

13、on (FRS) 功能说明书 .185.5Configuration Management and Change Control Documentation18配置管理和变速控制文件5.6Vendor Qualification documentation 卖主资格认证185.7Design Specifications 设计说明 .185.8 Testing and Verification Requirements Documentation 试验和确认所需文件185.9System Security 系统安全性 .195.10Operational Support 运行支持 .205.1

14、1Business Continuity Plan 业务持续计划 .205.12Disaster Recovery, Backup and Restoration 灾难性恢复，备份及修复 .215.13System Acceptance Final Report 系统接受终报告 .215.14<List any additional validation products required> 列出任何其他需要验证的产品 .216.Acceptance Criteria 可接受标准 .217.Change Control 变更控制 .227.1Pre-Implementation C

15、hanges 预执行变更 .227.2Post-Implementation Changes 执行后变更 .228.Standard Operating ProceduresSOP .228.1SOP Responsibilities SOP 职责 .228.2Listing of SOPs SOP 列表 .239.Training 培训 .2310.Documentation Management 资料管理 .2310.1Document Production 文件产生 .2310.2Document Review 文件回顾 .2310.3Document Approval 文件批准 .23

16、10.4Document Issue 文件发布 .2410.5Document Changes文件变更 .2410.6Document Withdraw 文件撤销 .2410.7Document Storage 文件保存 .2411.Maintaining the Validated State 验证状态的维护 .2411.1System Retirement 系统引退 .2412.Validation Activities Timeline 验证执行时间表 .25Appendix A 附录 A 参与组织 .26Appendix B 附录 B 缩写词，定义 .27Appendix C 附录 C

17、 责任 /时间 .30Appendix D 附录 D 可交付的验证 .32Appendix E 附录 E 参考 .34(Reminder of Page Intentionally Left Blank)File Name: 717430126.docLast Save Date: 18-Feb-2019Print Date: 2/18/19Company LogoDOCUMENT NUMBER:PAGE:# - #6 of 34LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipm

18、ent Name , ID# 12345 >1.Introduction绪论1.1Purpose目的This document, also referred to as the Plan, outlines the planned tasks and expectations for validation of the<equipment name >.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

19、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/产生（在宏观上）。1.2Policy Compliance遵守政策This Plan is being written to comply with

20、corporate policy requirements for validation as stated in the <refer to specific Validation Master Plan(s), company policies, company standards, and/or company guidelines >, 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

21、求。The validation of the < equipment name> system is a cGMP requirement.设备名称的验证系统是现行的一个要求。1.3Scope of Validation验证范围This Validation Plan for the < equipment name> is limited to the unique components and control system that define the equipment. This validation effort will be conducted as

22、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 whi

23、ch 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。1.3.1In-Scope验证范围File Name: 717430126.docLast Save Date: 18-Feb-2019Print Date: 2/18/19Company LogoDOCUMENT NUMBER:PAGE:# - #7 of 34LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equi

24、pment Name , ID# 12345 >The scope of validation for the < equipment name> includes all the following that are necessary for the system to operate. <clearly define all boundaries>（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

25、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. <list all that are appropriate>其他需要的名单1.3.2Out-of-Scope验证范围例外The scope of validation for the <equipment name> 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

26、Historian is validated separately.数据历史单独验证3. <list all that are appropriate>其他名单1.3.3Related Validation相关验证<Insert a description of any existing or planned validation that is relevant to the validation of this system. The use of prior data may be considered either as reference for test meth

27、ods or directly replacing tests, if the systems configuration can be shown to be the same now as at the time the data was collected>File Name: 717430126.docLast Save Date: 18-Feb-2019Print Date: 2/18/19Company LogoDOCUMENT NUMBER:PAGE:# - #8 of 34LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:V

28、ALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >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 < necessary for the system to be placed into operation. <equipment name> includes all the following that are

29、clearly define all boundaries>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. <list all that are appropriate>其他名单1.4O

30、bjectives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 < equipment name> are appropriate for cGMP-regulated processes. The qualifications outlined are to be

31、based on < company name> 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。1.5Periodic Review定期回顾File Name: 717430126.docLast Save

32、Date: 18-Feb-2019Print Date: 2/18/19Company LogoDOCUMENT NUMBER:PAGE:# - #9 of 34LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >This Plan should be reviewed periodically to ensure compliance and or to determine if a change is required.Some

33、 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 t

34、he 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. Inequipment namegeneral, the

35、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：<The defined role and responsibilities should include at a minimum the individuals listed below - Describe each role and responsibility in a gene

36、ral way as they apply >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/projectobjectives are correctly addressed/resolved, rep

37、orting to senior management, interface to QA to ensurecompliance, 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 appropriateregulatory/business/technical/user community requirements, provi

38、ding support for the criterion/independentreview/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 usercommunity, approving comple

39、tion 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。<These role and responsibilities may be defined as appropriate - Describe each role and responsibility in a general way as they apply>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。File Name: 717430126.docLast Save Date: 18-Feb-2019Print Date:

40、 2/18/19Company LogoDOCUMENT NUMBER:PAGE:# - #10 of 34LOCATION:Revision:EFFECTIVE:Rev #yyyy.mm.ddTITLE:VALIDATION PLAN FOR THE <Equipment Name , ID# 12345 >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 - Respo