翻译后的计算机化系统验证模板

1、精品感谢下载载精品Author's Signature: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< equipment name >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 &

2、gt; 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 completelyreflects the tasks and deliverables necessary for validation of the <equipment name>

3、.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< 设备名称 > 验证的必要。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感谢下载载reference Validation Master Plan,日期精品姓名，职称签名单位Quality Control/Compliance

4、 Approver's Signature:质检 / 承认签名Your signature indicates that this document complies with <company standards or guidelines > and that the documentation and information contained herein complies with applicable regulatory, corporate, divisional/departmental requirements, and current Good Man

5、ufacturing 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：Typed/Printed Name, TitleSignatureDateUnit姓名，职称签名日期单位Typed/Printed Na me, TitleSignatureDateUnit姓名，职称签名日期单位感谢下载载精品Revision History修订历史纪录RevisioRevisionReason for Revision/Change RequestRevi

6、sed BynDate修订 / 更改要求的原因修订人修订本修订日期004-DEC-Original ReleaseMichael T. Filary2002原始版本迈克尔2002/12/4116-JAN-Updated the JETT logo on the cover page.Michael T. Filary2003更新封页面的 JETT 的标识迈克尔2003/1/16Table of Contents目录1.Introduction 绪论 .221.1Purpose 目的 .221.2Policy Compliance适用的政策 .221.3Scope of Validation验证

7、范围 .221.4Objectives 目标 .221.5Periodic Review 定期审查 .222.Organizational Structure组织结构 .223.GxP Criticality AssessmentGxP关键性评估 .223.1GxP Criticality Assessment - RequirementsGxP关键性评估要求 .22感谢下载载精品3.2GxP Criticality Assessment - Procedures GxP关键性评估程序223.3GxP Criticality AssessmentCurrent StatusGxP 关键性评估现

8、行标准. 224.Validation Strategy验证策略 .224.1Life Cycle 生命周期.224.2Risk Assessment风险评估 .224.3Hardware Categories硬件分类 .224.4Software Categories软件分类 .224.5Project Inputs/Outputs for Stages项目各阶段的输入 / 输出 .224.6Acceptance Criteria for Stages各阶段的接受标225.Validation Deliverables.225.1 Traceability and Linkages描述和链接

9、225.2Master List of all Validation Products and Supporting Documentation所有批准产品和证明文件的总清单225.3User Requirements Specification (URS)使用说明书 .225.4Functional Requirement Specification (FRS)功能说明书 .225.5Configuration Management and Change Control Documentation配置管理和变速控制文件225.6Vendor Qualification documentati

10、on卖主资格认证225.7Design Specifications设计说明.225.8 Testing and Verification Requirements Documentation试验和确认所需文件225.9System Security系统安全性 .235.10Operational Support运行支持 .245.11Business Continuity Plan业务持续计划 .245.12Disaster Recovery, Backup and Restoration灾难性恢复，备份及修复 .255.13System AcceptanceFinal Report 系统接

11、受 终报告.255.14<List any additional validation products required>列出任何其他需要验证的产品266.Acceptance Criteria可接受标准 .267.Change Control 变更控制.267.1Pre-Implementation Changes预执行变更 .267.2Post-Implementation Changes执行后变更.27感谢下载载精品8.Standard Operating ProceduresSOP .278.1SOP ResponsibilitiesSOP 职责 .278.2Listin

12、g of SOPsSOP 列表 .289.Training培训 .2810.Documentation Management资料管理 .2810.1Document Production文件产生 .2810.2Document Review文件回顾 .2810.3Document Approval文件批准.2910.4Document Issue文件发布 .2910.5Document Changes文件变更.2910.6Document Withdraw文件撤销 .2910.7Document Storage文件保存 .2911.Maintaining the Validated State

13、验证状态的维护 .3011.1System Retirement系统引退 .3012.Validation Activities Timeline验证执行时间表 .30Appendix A附录 A参与组织 .31Appendix B附录 B缩写词，定义 .33Appendix C附录 C责任 / 时间 .37Appendix D附录 D可交付的验证 .39Appendix E附录 E参考 .41(Reminder of Page Intentionally Left Blank)感谢下载载精品1.Introduction绪论1.1Purpose目的This document, also ref

14、erred to as the Plan, outlines the planned tasks and expectations forvalidation of the <equipmentname>.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。?WHOwill 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。?WHATdocumentation/deliverables will be generated and/or retaine

15、d as part of the ValidationPackage(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。?HOWthis 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 corporate policy requirements for validation as stated in the <refe

16、r 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求。The validation of the <equipment name> system is a cGMP requirem

17、ent.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 andcontrol 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

18、。感谢下载载精品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

19、产、加工、包装、存储、分配过程的说明。1.3.1In-Scope验证范围The scope of validation for the <equipment name>includes all the following that arenecessary 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 Ha

20、rdware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.感谢下载载精品系统单独验证

21、2. The Data 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

22、for test methods or directly replacing tests, if the systems configuration can be shown to be the same now as at the time the data was collected>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 <equipment name>includ

23、es all thefollowing that are necessary for the system to be placed into operation. <clearly define allboundaries>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 S

24、tudies感谢下载载精品干燥研究7. Sterilization Studies无菌研究8. <list all that are appropriate>其他名单1.4Objectives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 n

25、ame>are appropriate for cGMP-regulated processes. The qualificationsoutlined are to be 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

26、（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This Plan should be reviewed periodically to ensure compliance and or to determine if achange 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

27、 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.感谢下载载精品见第五部分有关验证管理和针对该项计划的回顾、修订

28、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< equipment name> are outlined inAppendix A. In general, the activities associated with this project, are the responsibility of thefollowing 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

29、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 general 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 levelResponsible for project management and planning,

30、 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 approvingvalidation documentation for the project管

31、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 AssuranceResponsible for assuring compliance with appropriateregulatory/business/technical/user community requirements, providing support for the criterion/independent review/approval of deliverables, approving completion ofstage/validation status质保：负责保证符合

32、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 thebusiness 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。<These role and responsibilities may be defined as appropriate -

33、Describe each role andresponsibility 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。1.OperationsResponsible for providing操作：负责提供 感谢下载载精品2.Project LevelResponsible for providing项目水平：负责提供 3.Technical and Engineering supportResponsible for providing技术和工程支持：负责提供 4.Validation Specia

34、listResponsible for providing验证专家：负责提供 5.System AdministratorResponsible for providing系统管理：负责提供 6.Purchasing - Responsible for providing采供：负责提供 7. <List all that are appropriate>其他名单3.GxP Criticality AssessmentGxP 关键性估计Detail the GxP criticality assessment information related to the< equipm

35、ent name> .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。3.1GxP Criticality AssessmentRequirementsGxP 关键性评估要求Define the requirements used in the determination of the levels for GxP critic

36、ality for the< equipment name>.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, da

37、ta, 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。感谢下载载精品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

38、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

39、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 AssessmentProceduresGxP 关键性评估 - 程序Define the procedures used/followed in the assessment of the levels for GxP criticality for the< equipment name>. Develop a documented path that will be followed to determine the levelsfor GxP criticality for each item associated with t