翻译后的计算机化系统验证模板.doc

. .Authors 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 您的签名说明这份文件的准备符合现行工程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：Typed/Printed Name, TitleXX，职称Signature签名Date日期Unit单位Reviewers Signature:审查员签名：Your signature indicates that, you have reviewed this document and that it accurately and pletely reflects the tasks and deliverables necessary for validation of the .您的签名说明您已经审阅了这份文件，确认它准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：Typed/Printed Name, TitleXX，职称Signature签名Date日期Unit单位Typed/Printed Name, TitleXX，职称Signature签名Date日期Unit单位Typed/Printed Name, TitleXX，职称Signature签名Date日期Unit单位Quality Control/pliance Approvers Signature:质检/成认签名Your signature indicates that this document plies with ; and that the documentation and information contained herein plies with applicable regulatory, corporate, divisional/departmental requirements, and current Good Manufacturing Practices.您的签名说明这份文件符合证明人验证总方案，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, TitleXX，职称Signature签名Date日期Unit单位Typed/Printed Na me, TitleXX，职称Signature签名Date日期Unit单位Revision History修订历史纪录Revision修订本Revision Date修订日期Reason for Revision/Change Request修订/更改要求的原因Revised By修订人004-DEC-20022002/12/4Original Release原始版本Michael T. Filary迈克尔116-JAN-20032003/1/16Updated 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 pliance适用的政策51.3Scope of Validation验证围 51.4Objectives目标61.5Periodic Review定期审查62.Organizational Structure组织构造73.GxP Criticality AssessmentGxP关键性评估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生命期94.2Risk Assessment风险评估94.3Hardware Categories硬件分类94.4Software Categories软件分类94.5Project Inputs/Outputs for Stages工程各阶段的输入/输出104.6Acceptance Criteria for Stages各阶段的承受标 105.Validation Deliverables105.1Traceability and Linkages描述和 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115.5Configuration 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125.8Testing and Verification Requirements Documentation试验和确认所需文件125.9System Security系统平安性135.10Operational Support运行支持145.11Business Continuity Plan业务持续方案145.12Disaster Recovery, Backup and Restoration灾难性恢复，备份及修复145.13System Acceptance Final Report系统承受终报告145.14列出任其他需要验证的产品156.Acceptance Criteria可承受标准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 SOP158.1SOP Responsibilities 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文件回忆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.Maintaining 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18Appendix B附录B缩写词，定义19Appendix C附录C责任/时间22Appendix D附录D可交付的验证23Appendix E附录E参考24(Reminder of Page Intentionally Left Blank)Introduction绪论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，也称方案，略述方案的任务和设备名称的预期验证。WHO will be responsible for pletion, 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。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局部被产生和/或保存。HOW this documentation will be produced/created (at a macro level).这份文件将被如制作/产生在宏观上。Policy pliance遵守政策This Plan is being written to ply with corporate policy requirements for validation as stated in the , and the appropriate Appendix of the current revision of GAMP.这份方案将会遵守在涉及特殊验证总方案，公司政策，公司标准和公司指导针和适当性现行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。Scope of Validation验证围This Validation Plan for the is limited to the unique ponents 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方案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. 对实施方案的设备进展研究、生产、加工、包装、存储、分配过程的说明。In-Scope验证围The scope of validation for the includes all the following that are necessary for the system to operate. 设备名称验证的围包括以下所有的系统运作所必需的容。明确界限Controls system hardware and software控制系统得硬件和软件Mechanical Hardware机械的硬件Instrumentation仪器Process piping输水管道工艺Utility Systems通用系统Facility设施其他需要的Out-of-Scope验证围例外The scope of validation for the does not include:设备名称验证的围不包括：The XYZ system is validated separately.系统单独验证The Data Historian is validated separately.数据历史单独验证其他Related Validation相关验证插入现有的或方案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限：Process Validation工艺验证Cleaning Studies清洁研究Air Classification风力分级Microbiological Testing微生物试验Chemical Testing化学试验Drying Studies枯燥研究Sterilization Studies无菌研究其他Objectives目标The objective of this validation plan is to outline the requirements that will demonstrate and document that all ponents, control system(s) and functionality associated with the are appropriate for cGMP-regulated processes. The qualifications outlined are to be based on policies and procedures and applicable regulations, guidelines, and accepted industry practices for validation.该项验证方案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那么、指导针和公认的工业验证实践。Periodic Review定期回忆This Plan should be reviewed periodically to ensure pliance and or to determine if a change is required. Some appropriate times to review are:这份方案应该被定期回忆来保证符合并确定是否需要更改。一些适当的回忆时间是：Change in Validation Master Plan验证主文件的更改发生时Change in scope occurs验证围的更改发生时Design change occurs设计更改发生时Prior to IQ and OQ在进展和之前pletion 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.见第五局部有关验证管理和针对该项方案 的回忆、修订过程或指适应公司政策的回忆期。2. Organizational Structure组织构造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，与验证相关的活开工程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 pliance, reviewing and approving validation documentation for the project管理层：负责工程管理和方案。案，活动，资源，本钱的控制，监控工艺，Quality Assurance Responsible for assuring pliance with appropriate regulatory/business/technical/user munity requirements, providing support for the criterion/independent review/approval of deliverables, approving pletion of stage/validation status质保：负责保证符适宜当的调整、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。System Owner Responsible for implementation/management of the system by the business user munity, approving pletion 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。Operations Responsible for providing操作：负责提供Project Level Responsible for providing工程水平：负责提供Technical and Engineering support Responsible for providing技术和工程支持：负责提供Validation Specialist Responsible for providing验证专家：负责提供System Administrator Responsible for providing系统管理：负责提供Purchasing - Responsible for providing采供：负责提供其他3.GxP Criticality AssessmentGxP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。该局部包括另外一种信息，包括该主题，例如系统详细目录。 3.1GxP 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, 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 ponent 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 ponent 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 ponent 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 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 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关键性水平每一工程的评估标准。创立一个决策树将对在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 . 述现行设备名称的GxP关键性水平评估的要求。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Instrumentation This has been deemed a direct impact system due to仪器：该项是一个直接影响由于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Facility - This has been deemed a direct impact system due to设备：该项是一个直接影响由于其他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Instrumentation This has been deemed an indirect impact system due to仪器：该项是一个间接影响由于Process piping - This has been deemed an indirect impact system due to工艺流程：该项是一个间接影响由于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Facility - This has been deemed an indirect impact system due to设备：该项是一个间接影响由于其他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 Controls system hardware and software - This has been deemed a no impact sys