翻译后的计算机化系统验证模板

1、Company LogoDOCUMENT NUMBER: # - #PAGE:1 of 56LOCATION: Revision: Rev #EFFECTIVE: yyyy.mm.ddTITLE: VALIDATION PLAN FOR THE File Name: 8f1d8fc5f95f49a41c4a23b49c793731.pdfCLast Save Date: 02-9 月-2011Print Date: 11/29/2116-1 月-2003Company LogoDOCUMENT NUMBER: # - #PAGE:2 of 56LOCATION: Revision: Rev #

2、EFFECTIVE: yyyy.mm.ddTITLE: VALIDATION PLAN FOR THE File Name: 8f1d8fc5f95f49a41c4a23b49c793731.pdfCLast Save Date: 02-9 月-2011Print Date: 11/29/2116-1 月-2003Authors 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 a

3、dequately 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 reviewed this document and that

4、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Sig

5、nature签名Date日期Unit单位Quality Control/Compliance Approvers Signature:Company LogoDOCUMENT NUMBER: # - #PAGE:3 of 56LOCATION: Revision: Rev #EFFECTIVE: yyyy.mm.ddTITLE: VALIDATION PLAN FOR THE File Name: 8f1d8fc5f95f49a41c4a23b49c793731.pdfCLast Save Date: 02-9 月-2011Print Date: 11/29/2116-1 月-2003质检质检

6、/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

7、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 LogoDOCUMENT NUMBER: # - #PAGE:4 of 56LOCATION: Revision: Rev #EFFECTIVE: yyyy.mm.ddTITLE: VALIDATION PLAN FOR THE File Name: 8f1d8fc5f

8、95f49a41c4a23b49c793731.pdfCLast Save Date: 02-9 月-2011Print Date: 11/29/2116-1 月-2003Revision 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-20022002/12/4Original Release原始版本Michael T. Filary迈克尔116-JAN-20032003/1/16

9、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.51.1Purpose 目的.51.2Policy Compliance 适用的政策.51.3Scope of Validation 验证范围 .51.4Objectives 目标 .61.5Periodic Review 定期审查.62.Organizational Structure 组织结构 .73.GxP Criticality AssessmentGxP 关键性评

10、估.73.1GxP Criticality Assessment - RequirementsGxP 关键性评估要求.73.2GxP Criticality Assessment - Procedures GxP 关键性评估程序 83.3GxP Criticality Assessment Current StatusGxP 关键性评估现行标准.84.Validation Strategy 验证策略.94.1Life Cycle 生命周期.94.2Risk Assessment 风险评估 .94.3Hardware Categories 硬件分类.94.4Software Categories

11、 软件分类.94.5Project Inputs/Outputs for Stages 项目各阶段的输入/输出.10Company LogoDOCUMENT NUMBER: # - #PAGE:5 of 56LOCATION: Revision: Rev #EFFECTIVE: yyyy.mm.ddTITLE: VALIDATION PLAN FOR THE File Name: 8f1d8fc5f95f49a41c4a23b49c793731.pdfCLast Save Date: 02-9 月-2011Print Date: 11/29/2116-1 月-20034.6Acceptance

12、 Criteria for Stages 各阶段的接受标 105.Validation Deliverables.105.1 Traceability and Linkages 描述和链接 115.2Master List of all Validation Products and Supporting Documentation所有批准产品和证明文件的总清单 115.3User Requirements Specification (URS) 使用说明书.115.4Functional Requirement Specification (FRS) 功能说明书.115.5Configura

13、tion Management and Change Control Documentation 配置管理和变速控制文件 115.6Vendor Qualification documentation 卖主资格认证 115.7Design Specifications 设计说明.125.8 Testing and Verification Requirements Documentation试验和确认所需文件125.9System Security系统安全性.135.10Operational Support运行支持.145.11Business Continuity Plan业务持续计划.1

14、45.12Disaster Recovery, Backup and Restoration灾难性恢复，备份及修复.145.13System Acceptance Final Report系统接受终报告.145.14列出任何其他需要验证的产品.156.Acceptance Criteria可接受标准.157.Change Control变更控制.157.1Pre-Implementation Changes预执行变更.157.2Post-Implementation Changes执行后变更.158.Standard Operating Procedures SOP.158.1SOP Resp

15、onsibilities SOP 职责.158.2Listing of SOPs SOP 列表.169.Training培训.1610.Documentation Management资料管理.1610.1Document Production文件产生.1610.2Document Review文件回顾.1610.3Document Approval文件批准.1610.4Document Issue文件发布.1610.5Document Changes文件变更.1710.6Document Withdraw文件撤销.1710.7Document Storage文件保存.1711.Maintai

16、ning the Validated State验证状态的维护.1711.1System Retirement系统引退.1712.Validation Activities Timeline验证执行时间表.17Appendix A 附录 A参与组织参与组织.18Appendix B 附录 B缩写词，定义缩写词，定义.19Appendix C 附录 C责任/时间.22Company LogoDOCUMENT NUMBER: # - #PAGE:6 of 56LOCATION: Revision: Rev #EFFECTIVE: yyyy.mm.ddTITLE: VALIDATION PLAN F

17、OR THE File Name: 8f1d8fc5f95f49a41c4a23b49c793731.pdfCLast Save Date: 02-9 月-2011Print Date: 11/29/2116-1 月-2003Appendix D 附录 D 可交付的验证.23Appendix E 附录 E 参考 .24(Reminder of Page Intentionally Left Blank)Company LogoDOCUMENT NUMBER: # - #PAGE:7 of 56LOCATION: Revision: Rev #EFFECTIVE: yyyy.mm.ddTITLE

18、: VALIDATION PLAN FOR THE File Name: 8f1d8fc5f95f49a41c4a23b49c793731.pdfCLast Save Date: 02-9 月-2011Print Date: 11/29/2116-1 月-20031. 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

19、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/creat

20、ed (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

21、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

22、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

23、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 LogoDOCUMENT NUMBER: # - #PAGE:8 of 56LOCATION: Revision: Rev #EFFECTIVE: yyyy.mm.ddTITLE: VALIDATION PLAN FOR THE File Name: 8f1d8fc5f95f49a41c4a23b49c793731.pdfCLast Save Date: 02-9 月-2011Print Date: 11/29/2116-1 月-20031.3.1 In-Scope验证范围Th

24、e 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.

25、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 LogoDOCUMENT NUMBER: # - #PAGE:9 of 56LOCATION: Revision: Rev #EFFECTIVE: yyyy.mm.ddTITLE: VALIDATION

26、PLAN FOR THE File Name: 8f1d8fc5f95f49a41c4a23b49c793731.pdfCLast Save Date: 02-9 月-2011Print Date: 11/29/2116-1 月-20031.3.3 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 th

27、at 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 o

28、bjective 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 LogoDOCUMENT NUMBER: # - #PAGE:10 of 56LOCATION: Revision: Rev #EFFECTIVE: yyyy.mm.ddTITLE: VALI

29、DATION PLAN FOR THE File Name: 8f1d8fc5f95f49a41c4a23b49c793731.pdfCLast Save Date: 02-9 月-2011Print Date: 11/29/2116-1 月-2003cGMP-regulated processes. The qualifications outlined are to be based on policies and procedures and applicable regulations, guidelines, and accepted industry practices for v

30、alidation.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

31、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 r

32、efer 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

33、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, initiati

34、ng 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 assur

35、ing compliance with appropriate Company LogoDOCUMENT NUMBER: # - #PAGE:11 of 56LOCATION: Revision: Rev #EFFECTIVE: yyyy.mm.ddTITLE: VALIDATION PLAN FOR THE File Name: 8f1d8fc5f95f49a41c4a23b49c793731.pdfCLast Save Date: 02-9 月-2011Print Date: 11/29/2116-1 月-2003regulatory/business/technical/user com

36、munity 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

37、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.Valid

38、ation 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 AssessmentGxP 关键性估计Detail the GxP criticality assessment information related to the . This section may reference another

39、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 LogoDOCUMENT NUMBER: # - #PAGE:12 of 56LOCATION: Revision: Rev #EFFECTIVE: yyyy.mm.ddTITLE: VALIDATION PLAN FOR THE File Name: 8f1d8fc5f95f49a41c4a23b49c793731.pdfCLast

40、Save Date: 02-9 月-2011Print Date: 11/29/2116-1 月-20033.1GxP Criticality Assessment RequirementsGxP 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, Indi

41、rect 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 Syst

42、em 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

43、 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

44、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 ProceduresGxP 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 determi

45、ne 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

46、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 StatusGxP 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 LogoDOCUMENT NUMBER: # - #PAGE:13

47、of 56LOCATION: Revision: Rev #EFFECTIVE: yyyy.mm.ddTITLE: VALIDATION PLAN FOR THE File Name: 8f1d8fc5f95f49a41c4a23b49c793731.pdfCLast Save Date: 02-9 月-2011Print Date: 11/29/2116-1 月-2003The 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.Cont

48、rols 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 - Th

49、is 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 fol

50、lowing. （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

51、 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 toCompany LogoDOCUMENT NUMBER: # - #PAGE:14 of 56LOCATION: Revision: Rev #EFFECTIVE: yyyy.mm.ddTITLE: VALIDATION PLAN FOR THE File Name: 8f1d8fc5f95f49a41c4a23b49c793731.pdfCLast Save Date: 02-9

52、月-2011Print Date: 11/29/2116-1 月-2003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

53、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

54、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 LogoDOCUMENT NUMBER: # - #PAGE:15 of 56LOCATION: Revision: Rev #EFFECTIVE: yyyy.m

55、m.ddTITLE: VALIDATION PLAN FOR THE File Name: 8f1d8fc5f95f49a41c4a23b49c793731.pdfCLast Save Date: 02-9 月-2011Print Date: 11/29/2116-1 月-2003Define the internal requirements for development, testing, delivery, and support that define the period of time that begins when a system is conceived and ends

56、 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。

57、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

58、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

59、 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Define the categories of the software associated with the . Company LogoDOCUMENT NUMBER: # - #PAGE:16 of 56LOCATION: Revision: Rev #EFFECTIVE: yyyy.mm.ddTITLE: VALIDATION PLAN FOR THE

60、File Name: 8f1d8fc5f95f49a41c4a23b49c793731.pdfCLast Save Date: 02-9 月-2011Print Date: 11/29/2116-1 月-2003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 System