翻译后的计算机化系统验证模板.doc

. .

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<设备名称>验证的必要。

Authored By:
经授权：

Typed/Printed Name, Title
XX，职称
Signature
签名
Date
日期
Unit
单位

Reviewer's 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 <equipment name>.
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<设备名称>验证的必要。

Reviewed By:
经审阅：

Typed/Printed Name, Title
XX，职称
Signature
签名
Date
日期
Unit
单位

Typed/Printed Name, Title
XX，职称
Signature
签名
Date
日期
Unit
单位

Typed/Printed Name, Title
XX，职称
Signature
签名
Date
日期
Unit
单位

Quality Control/pliance Approver's Signature:
质检/成认签名
Your signature indicates that this document plies with <reference Validation Master Plan, pany standards or guidelines>; 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ＧＭＰ标准。

Approved By:
经核准：

Typed/Printed Name, Title
XX，职称
Signature
签名
Date
日期
Unit
单位

Typed/Printed Na me, Title
XX，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
0
04-DEC-2002
2002/12/4
Original Release
原始版本
Michael T. Filary
迈克尔
1
16-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
1.1 Purpose目的5
1.2 Policy pliance适用的政策5
1.3 Scope of Validation验证围 5
1.4 Objectives目标6
1.5 Periodic Review定期审查6
2.Organizational Structure组织构造7
3.GxP Criticality AssessmentGxP关键性评估7
3.1 GxP Criticality Assessment - RequirementsGxP关键性评估——要求7
3.2 GxP Criticality Assessment - Procedures GxP关键性评估——程序 8
3.3 GxP Criticality Assessment – Current StatusGxP关键性评估——现行标准8
4.Validation Strategy 验证策略9
4.1 Life Cycle生命期9
4.2 Risk Assessment风险评估9
4.3 Hardware Categories硬件分类9
4.4 Software Categories软件分类9
4.5 Project Inputs/Outputs for Stages工程各阶段的输入/输出10
4.6 Acceptance Criteria for Stages各阶段的承受标 10
5.Validation Deliverables10
5.1 Traceability and Linkages描述和 11
5.2 Master List of all Validation Products and Supporting Documentation
所有批准产品和证明文件的总清单 11
5.3 User Requirements Specification (URS) 使用说明书11
5.4 Functional Requirement Specification (FRS) 功能说明书11
5.5 Configuration Management and Change Control Documentation
配置管理和变速控制文件11
5.6 Vendor Qualification documentation卖主资格认证 11
5.7 Design Specifications设计说明12
5.8 Testing and Verification Requirements Documentation试验和确认所需文件
12
5.9 System Security系统平安性13
5.10 Operational Support运行支持14
5.11 Business Continuity Plan业务持续方案14
5.12 Disaster Recovery, Backup and Restoration灾难性恢复，备份及修复14
5.13 System Acceptance – Final Report系统承受――终报告14
5.14<List any additional validation products required>列出任其他需要验证的产品15
6.Acceptance Criteria可承受标准15
7.Change Control变更控制15
7.1 Pre-Implementation Changes预执行变更15
7.2 Post-Implementation Changes执行后变更15
8.Standard Operating Procedures SOP15
8.1 SOP Responsibilities SOP职责15
8.2 Listing of SOPs SOP列表16
9.Training培训16
10.Documentation Management资料管理16
10.1 Document Production文件产生16
10.2 Document Review文件回忆16
10.3 Document Approval文件批准16
10.4 Document Issue文件发布16
10.5 Document Changes文件变更17
10.6 Document Withdraw文件撤销17
10.7 Document Storage文件保存17
11.Maintaining the Validated State验证状态的维护17
11.1 System 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18
Appendix B附录B缩写词，定义19
Appendix C附录C责任/时间22
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)

Introduction
绪论
Purpose
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 <refer to specific Validation Master Plan(s), pany policies, pany standards, and/or pany guidelines >, 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GAMＰ附录〕中关于验证的统一要求。
The validation of the <equipment name> system is a cGMP requirement.
?设备名称?的验证系统是现行ＧＭＰ的一个要求。
Scope of Validation
验证围
This Validation Plan for the <equipment name> 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 <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
<list all that are appropriate>
其他需要的
Out-of-Scope
　　　　　验证围例外
The scope of validation for the <equipment name> does not include:
〔设备名称〕验证的围不包括：
The XYZ system is validated separately.
ＸＹＺ系统单独验证
The Data Historian is validated separately.
数据历史单独验证
<list all that are appropriate>
其他
Related 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 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 <equipment name> includes all the following that are necessary for the system to be placed into operation. <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
<list all that are appropriate>
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 <equipment name> are appropriate for cGMP-regulated processes. The qualifications outlined are to be based on < pany name> 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ＧＭＰ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ＩＱ和ＯＱ之前
pletion of IQ and OQ　ＩＱ和ＯＱ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 <equipment name> 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Ａ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：
<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
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。
<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。
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…
<List all that are appropriate>
其他
3.GxP Criticality Assessment
GxP关键性估计
Detail the GxP criticality assessment information related to the <equipment 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 – Requirements
GxP 关键性评估——要求
Define the requirements used in the determination of the levels for GxP criticality 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 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 – 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 <equipment name>. Develop a documented path that will be followed to determine the levels for GxP criticality for each item associated with the <equipment name>. 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 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 <equipment name>.
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 <equipment name> include all the following. <Clearly develop supporting rationale>
〔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…
<List all that are appropriate>
其他

The Indirect Impact Systems associated with the <equipment name> include all the following. <Clearly develop supporting rationale>
〔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…
<List all that are appropriate>
其他

The No Impact Systems associated with the <equipment name> include all the following. <Clearly develop supporting rationale>
〔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