欧盟：计算机化系统的验证-核心文件(中英文)
Annex 15Qualification and Validation(附件15确认与验证)正式版中英文对照
上海万逸医药科技有限公司刘伟强译Ref. Ares(2015)1380025 - 30/03/2015EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETYMedicinal Products – Quality, Safety and EfficacyBrussels, 30 March 2015EudraLexVolume 4EU Guidelines forGood Manufacturing Practice forMedicinal Products for Human and Veterinary Use欧盟人用及兽用药品GMP指导原则Annex 15: Qualification and Validation附件15：确认与验证Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/ECon the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products.This document provides guidance for the interpretation of the principles and guidelinesof good manufacturing practice (GMP) for medicinal products as laid down in Directive2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.Status of the document: Revision文件状态：修订Reasons for changes: Since Annex 15 was published in 2001 the manufacturing and regulatory environment has changed significantly and an update is required to this Annexto reflect this changed environment. This revision to Annex 15 takes into account changesto other sections of the EudraLex, Volume 4, Part I, relationship to Part II, Annex11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology.变更原因：附录15至2001年颁布以来，制造业和法规环境发生了显著变化，因此需要更新附录以反应这些环境的变化，附录15的修订还考虑到了欧盟药品监管法规（Eudralex）第四卷第一部分、第二部分有关内容、附录11、ICH Q8、Q9、Q19和Q11、欧盟药品质量工作组（QWP）工艺验证指南的变更以及制造技术变化等因素。
欧盟OMCL计算机化系统的验证附件1：自主开发软件验证
200907 PA/PH/OMCL(08)87 2R 欧盟OMCL计算机化系统的验证附件1：自主开发软件验证（中英文）OMCL Network of the Council of EuropeQUALITY ASSURANCE DOCUMENTPA/PH/OMCL (08) 87 2RVALIDATION OF COMPUTERISED SYSTEMS计算机化系统的验证ANNEX 1: VALIDATION OF COMPUTERISED CALCULATION SYSTEMS: EXAMPLE OFVALIDATION OF IN-HOUSE SOFTWARE附件1：计算机化计算系统的验证：自主开发软件的验证举例This document should be considered as a guide to OMCLs for planning, performing and documenting the validation of their computerised systems. It should not be taken as a list of compulsory requirements. It is left to the professional judgement and background experience of each OMCL to decide on the most relevant procedures to be undertaken in order to give evidence that their computerised systems are working properly and are appropriate for their intended use.本文件应作为OMCL在计划、实施和记录其计算机化系统时的指南。
它不应被当成一个强制的要求。
欧盟GMP附录15确认和验证中英文新版
欧盟GMP附录15确认和验证欧盟GMP附录15确认和验证ANNEX 15 附件15Qualification and Validation确认和验证Table of Contents 目录1. Qualification and Validation 确认和验证2. Planning for Validation 验证计划3. Documentation 文件4. Qualification 确认5. Process Validation 工艺验证6. Cleaning Validation 清洁验证7. Change Control 变更控制8. Revalidation 再验证9. Glossary 术语表Qualification and Validation 确认和验证Principle 原理1.This Annex describes the principles of qualification and validation which are applicable to the manufacture of medicinal products. It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.1.本附件描述了确认和验证的原理，适用于医药产品的生产者。
欧盟OMCL计算机化系统验证附件3-检测设备所用计算机的验证（中英文）
欧盟OMCL计算机化系统验证附件3-检测设备所用计算机的验证（中英文）OMCL Network of the Council of EuropeQUALITY ASSURANCE DOCUMENT质量保证文件PA/PH/OMCL (08) 89 RVALIDATION OF COMPUTERISED SYSTEMS计算机化系统验证ANNEX 3: VALIDATION OF COMPUTERS AS PART OF TEST EQUIPMENT附件3：检测设备所用计算机的验证ANNEX 3 OF THE OMCL NETWORK GUIDELINE“VALIDATION OF COMPUTERISED SYSTEMS”附件3 计算机系统的验证VALIDATION OF COMPUTERS AS PART OF TEST EQUIPMENT 检验设备所用计算机的验证INTRODUCTION 概述The present document is the 3rd Annex of the core document “Validation of Computerised Systems”, and it should be used in combination with it when planning, performing and documenting the validation steps of computerised systems. 本文件是主文件“计算机系统验证”的附录3，在计划、实施和记录计算机系统验证时应将本文与该主文件联合应用。
The core document contains the Introduction, Scope and general requirementsfor the validation of different types of computerised systems. 主文件包括了不同各类计算机系统验证的概述、范围和通用要求。
计算机系统验证方案-中英
Computerised System Validation计算机系统验证Dept. 部门：Effective Date生效日期：Confidential Level 机密等级：□ Top-secret 绝密 □ Confidential 机密 □ Cryptical 秘密 Distribution List : 分发清单：QA 部、QC 部、OSP 固体制剂部、Lo.物控部、EN 工程部、TD 技术部、EQ 设备部1Objective 目的Year/年Month/月QA 质量保证部Date/日Test and assessment should be taken for URS, design, purchase, installation,function, as well as process adaptability of computerized and PLC control systemrelated to GMP in compliance with this SOP so as to ensure that computerized andPLC are fit for design requirement and stated technical criteria and are able to workstably for a long time.根据本SOP，对URS、设计、采购、安装、功能以及GMP相关的计算机控制和PLC控制系统进行测试评估，以确保计算机和PLC符合设计要求和工艺要求并且能够长时间稳定工作。
2 Scope范围This SOP is fit for the validation management of computerized and PLC controlsystem related to GMP, which apply to material control and management, laboratory equipment control and communication management, manufacturing process control, and utilities control.本SOP适用于GMP相关计算机,PLC控制系统的验证管理，物料控制和管理,实验设备控制和通信管理、生产过程控制、公用设施的控制的验证。
欧盟GMP附录11-计算机系统（中英文对照）
欧盟GMP附录11-计算机系统（中英文对照）EUROPEAN COMMISSION欧盟委员会HEALTH AND CONSUMERS DIRECTORATE-GENERAL卫生与消费者协会Public Health and Risk Assessment公共卫生与风险评估Pharmaceuticals药品Brussels,SANCO/C8/AM/sl/ares(2010)1064599EudraLexThe Rules Governing Medicinal Products in the European Union欧盟药品生产规Volume 4卷4Good Manufacturing PracticeMedicinal Products for Human and Veterinary Use人用与兽用药品良好生产管理规Annex 11: Computerised Systems附件11：计算机系统Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laiddown in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.依法发布的具体指导针：2001/83/EC第47条人用药品规和2001/82/EC第51条兽用药品规。
EU 2002-95-EC中英文
DIRECTIVE 2002/95/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 27 January 2003欧盟议会和欧盟理事会2003 年 1 月27 日第2002/95/EC 号on the restriction of the use of certain hazardous substances in electrical and electronic equipment关于在电气电子设备中限制使用某些有害物质指令THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THEEUROPEAN UNION,欧洲议会和欧盟理事会，Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,注意到成立欧洲共同体的条约，特别是其中第95 条，Having regard to the proposal from the Commission (1),注意到欧盟委员会的建议，Having regard to the opinion of the Economic and Social Committee (2),注意到欧盟经济与社会委员会的意见，Having regard to the opinion of the Committee of Regions (3),注意到欧盟地区委员会的意见，Acting in accordance with the procedure laid down in Article 251 of the Treaty in the light of the joint text approved by the Conciliation Committee on 8 November 2002 (4),按照欧洲共同体条约第251 条所规制的程序行事并根据协调委员会于2002 年11 月8日通过的联合文本，Whereas:鉴于：(1) The disparities between the laws or administrative measures adopted by the Member States as regards the restriction of the use of hazardous substances in electrical and electronic equipment could create barriers to trade and distort competition in the Community and may thereby have a direct impact on the establishment and functioning of theinternal market. It therefore appears necessary to approximate the laws of the Member States in this field and to contribute to the protection of human health and the environmentally sound recovery and disposal of waste electricaland electronic equipment.（1）各成员国为限制在电子电气设备中使用有害物质而制订的法规或行政措施之间存在的差异能产生贸易壁垒和扭曲共同体内的竞争，甚至对单一市场的建立及其功能产生直接影响。
GEON质量管理文件-计算机化系统验证-附录1_EXCEL电子表格的验证
Excel 电子表格的验证1注：本指南及其附录中使用“必须”一词表示强制性要求；使用“应”表示建议性要求，即其它经过恰当论证的方法也是可接受的；使用“可”表示一种可能性或一个例子，不具有约束力。
一、 介绍本文件是核心文件“计算机化系统验证”的附录1。
当在计划、实施和记录用于处理实验室数据的Excel 电子表格的验证时，应与核心文件结合使用。
本附录给出了Excel 电子表格验证的一个实例，应与核心文件中给出的通用要求和建议结合使用。
二、 安装和安全为了保证只有最终经验证的电子表格版本可以被使用，以及维护电子表格的已验证状态，所有已验证的Excel 电子表格应以只读形式（针对终端用户而言）保存，如保存在受保护的网络共享文件夹中。
只有相关负责人拥有访问网络共享文件的权限。
终端用户不应具备修改一个已验证的电子表格、在共享文件夹中增加一个未验证的电子表格、以及在共享文件夹中保存数据的权限。
终端用户只能填写（允许的）单元格，以及打印数据或在必要时保存副本至数据储存库。
电子表格的安装必须被记录，如记录在验证文档、系统日志本、或一份QA 表中。
记录的内容必须包括：电子表格的名称、唯一识别号、位置，和负责人。
记录还必须包括确认，定期确认和其它问题如升级或遇到的任何问题。
其中，确认在安装之后进行并被记录。
三、 良好实践当设置一个新的电子表格2时，遵循以下良好的操作实践，可以减少意外的修改模板和错误的数据输入的风险：‐ 所有计算单元格必须被锁定（单元格格式—保护—锁定），以保护含有计算的单元格，不被无意地修改，除了那些用于数据输入的单元格。
1译者：本附录为EDQM 发布的指南：计算机化系统验证核心文件的附录。
本附录及其核心文件的适用范围均为欧洲OMCL 组织（Official Medicine Control Laboratories 官方药品控制实验室）。
2译者：本译文中使用的电子表格为“MS Office 家庭和学生版2016”，所有截图尽量与指南中的一致。
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OMCL Network of the Council of EuropeQUALITY ASSURANCE DOCUMENTPA/PH/OMCL (08) 69 3R VALIDATION OF COMPUTERISED SYSTEMS计算机化系统的验证CORE DOCUMENT核心文件VALIDATION OF COMPUTERISED SYSTEMS计算机化系统验证CORE DOCUMENT核心文件SCOPE 范围This guideline defines basic principles for the validation of computerised systems used within Official Medicines Control Laboratories (OMCLs) with impact on quality of results. The purpose of this validation is to guarantee the confidence in scientific results obtained with each computerised system. A validated system ensures accurate results and reduces the risk of failure of the system.本指南给出了在OMCL化验室使用的计算机化系统验证的基本原则。
本验证的目的是保证由每个计算机化系统所得到的科学结果的可信性。
一个验证体系会保证准确的结果，降低系统失败的风险。
This document covers in-house and commercial software for calculation, database computerised systems, Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELN) and computers as part of test equipment.本文件包括了内控和商业计算软件，数据库计算机化系统，化验室信息管理系统（LIMS），化验室电子笔记本（ELN）和计算机作为检测仪器的一部分。
INTRODUCTION 介绍This guideline outlines general validation principles for computerised systems of OMCLs in accordance with ISO/IEC 17025. It gives general requirements and it also lists the minimum elements required for the validation of different types of software. Actually, due to the great variety of software, it is not possible to state in one single document all the specific validation elements that are applicable.本指南给出了根据ISO/IEC 17025 制订的OMCL计算机化系统通用验证原则的纲要。
它给出了通用要求，同时列出了对不同软件类型的验证所需的最低元素清单。
实际上，由于软件之间差异巨大，不可能在一个文件中给出所有实用的特定的验证元素。
This guideline is intended for use by OMCLs working under Quality Management Systems based on the ISO/IEC 17025 standard, which use computerised systems for a part or the totality of the processes related to the quality control of medicines, and it is not addressed to manufacturers working under GMP requirements.本指南是提供采用计算机系统作为一部分或全部药品质量控制有关的过程的OMCL，在基于ISO/IEC 17025标准的质量管理系统的工作使用，不是针对在GMP 要求下工作的供应商。
In order to simplify the management of the guideline, the present document contains only a general introduction and general requirements for different types of computerised systems. The core document is supplemented with system-related annexes, containing additional requirements and/or practical examples of validation documentation, which are to be used in combination with the general recommendations given in the core document.为了简化指南的管理，本文件仅包括通用介绍和不同计算机化系统类型的通用要求。
本核心文件增补有系统相关附件，包括额外要求和/或部分验证文件举例，这些可以与核心文件中给出的通用推荐结合使用。
The list of annexes, included in this document, will be updated as soon as new annexes are issued.一旦新的附件签署，包括在本文件的附件清单将会被更新。
This document should be considered as a guide to OMCLs for planning, performing and documenting the validation of their computerised systems. It should not be taken as a list of compulsory requirements. It is left to the professional judgement and background experience of each OMCL to decide on the most relevant procedures to be undertaken in order to give evidence that their computerised systems are working properly and are appropriate for their intended use.应将本文作为OMCL计划、实施和记录计算机化系统验证时的指南，而不是作为一个强制的清单。
应该由专家判断和每个OMCL背景经验来决定，为了给出证据说明各实验室的计算机化系统正常工作并适合其用途，哪些最相关的程序是需要执行的。
DEFINITIONS 定义Computer system: Computer hardware components assembled to perform in conjunction with a set of software programmes, which are collectively designed to perform a specific function or group of functions.计算机系统：组装起来的计算机硬件组件，与一系列软件程序相关联，组合设计可以实施一个特定功能或一些功能。
Computerised system: a computer system plus the controlled function that it operates. Includes hardware, software, peripheral devices, personnel, and documentation; e.g., manuals and Standard Operating Procedures (SOPs).计算机化系统：一个计算机系统和其操作的控制功能。
包括硬件、软件、外围设备、人员和文件，例如手册和标准操作程序（SOPs）。
Commercial (off-the-shelf, configurable) software: Configurable programmes that can be configured to specific user applications by “filling in the blanks”, without altering the basic programme.商业（集成、已设定参数）软件：可以由指定用户通过“填写空白”设定参数的程序，不改变基本程序In-house developed software: system developed by the user (or by a contracted company), with the purpose of specifically meeting a defined set of user requirements.自主开发的软件：由用户自己（或由合同公司）开发的系统，可以满足用户设定的专用目的Electronic laboratory notebook (ELN): software programme designed to replace paper laboratory notebooks.化验室电子笔记本（ELN）：设计用于代替纸质化验室笔记本的软件程序Laboratory Information Management System (LIMS): Automated laboratory systems that collect and manage data.化验室信息管理系统（LIMS）：可以收集和管理数据的自动化实验室系统1. HARDWARE 硬件The hardware used shall fulfil the technical requirements so that the work to be completed can be carried out. Such requirements include e.g. minimum system requirements indicated by the manufacturer of the equipment. These requirements should be predefined in accordance with the intended use.使用的硬件应满足技术规格要求，使得需要完成的工作可以实施。