07paphomcl08693r欧盟omcl计算机化系统的验证核心文件中英文.docx

1、07paphomcl08693r欧盟omcl计算机化系统的验证核心文件中英文200907 PAPHOMCL(08)69 3R 欧盟 OMCL 计算机化系统的 验证：核心文件(中英文 .OMCL Network of the Council of EuropeQUALITY ASSURANCE DOCUMENTPA/PH/OMCL (08) 69 3RVALIDATION OF COMPUTERISED SYSTEMS 计算机化系统的验证CORE DOCUMENT核心文件Full document title and reference 文件全名和索引号Validation of Compute

2、rised Systems -Core DocumentPA/PH/OMCL(08)69 3RDocument type 文件类型GuidelineLegislative basis 立法基础Date of first adoption首次发行日期May 2009Date of original entry into force首次执行日期July 2009Date of entry into force of revised document 修订后执行日 期Previous titles/other references 原文件名 /其它索引号Custodian Organisation保

3、管机构The present document was elaborated by the OMCLNetwork/ EDQM of the Council of EuropeConcerned Network 相关网络GEONVALIDATION 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 MedicinesContr

4、ol 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

5、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

6、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 valid

7、ation 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

8、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 manufacturer

9、s 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 computeris

10、ed 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。

11、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 t

12、heir 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 pro

13、perly 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,

14、 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 documentat

15、ion; 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, withouspecific user applications by “ filling in the blanksaltering the

16、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 noteboo

17、k （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 t

18、he 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。这些规格要求包

19、括，例如由仪器供应商指出的最低系 统要求。这些要求应根据用途预先设定。The hardware components shall be installed by skilled personnel (e.g. staff from the Information Technology (IT) Unit, the technician from the manufacturer of the equipment, or other trained personnel), and shall be checked for their functionality and compared with

20、 the requirements.硬件组件应由熟练的人员安装 (例如 IT 部门的员工， 设备供 应商的技术人员，或其它经过培训的人员) ，应检查组件的 功能并与规格要求相比较。Computerised systems that are part of test equipment must be labelled unambiguously. 作为检测仪器的一部分的计算机化系统必须清楚地进行标 识。For computerised systems which are components of test equipment, records must be kept on hardware

21、 configuration, installation and changes. These records can be entered in the logbook of the test equipment. 对于检测仪器的组件的计算机化系统，必须保存硬件参数、 安装和变更的记录。这些记录可以输入检测仪器的日志中。2. GENERAL REQUIREMENTS FOR SOFTWARE 软件通 用要求Inventory 系统清单An inventory or listing of all computerised systems shouldbe available.一个计算机化系统的

22、清单应保存The following minimum information should be included inthe computerised systems inventory: 以下最少的信息应包括在计算机化软件的系统清单中 unique identification 唯一识别 Purpose 目的 validation status 验证状态 physical or storage (drive and files path) locationof the software and related documentation软件和相关文件的物理或贮存（驱动器和文件路径）位置 r

23、esponsible or contact person 负责人或联系人In the case of local installation (workstation), each copy of the software needs its own unique identification. 如果在本地进行安装(工作站) ，每个软件的复制件均需要 其唯一的识别号。In the case of software related to scientific equipment (e.g. HPLC) its identification (such as license number or se

24、rial number, and version number) should be independent from the equipment identification, whenever possible. 如果软件与科学仪器相关 (例如 HPLC )，只要是在可能的情 况下，其识别号(例如许可号或序列号，和版本号)应独立 于仪器识别号。Validation of the software 软件验证Prior to routine use, the software should be validated. 在日常使用前，软件需要进行验证。Validation consists in

25、 confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.验证包含在相关的检查确认和客观证据内容中，包括软件规格是否符合用户需求和所设定的使用目的，以及软件应用的 特殊规格要求可以持续地得到满足。

26、Change control 变更控制In case of changes in the software, the validation status needs to be re-established. If a revalidation analysis is needed, it should be conducted not just for validation of the individual change, but also to determine the extent and impact of that change on the entire computerise

27、d system. 如果变更是针对软件的，验证状态需要更新。如果需要一个 再验证分析，则应进行再验证分析，这个分析不仅是针对单 个的变更的验证，同时应确认其验证深度和变更对整个计算 机化系统的影响。In the same way, changes in the computer environment could have an impact on the software running. In this case, a revalidation could be required.同样，对于计算机环境的变更可能会影响到软件运行。在此 情况下，可能需要进行再验证。In both cases,

28、 the extent of the revalidation will depend on the nature of the change. The nature of the changes should be documented.两种情况下，再验证的深度均取决于变更的性质。变更的性质应有记录。Automatic updates should ideally be controlled by IT or a system administrator and installed at pre-defined dates to minimize both disruption and un

29、expected behaviour of the system. Following installation of updates, verification should be carried out, the extent of which will depend on the extent of the update(s). Each update should be documented.自动升级的理想情况是由 IT 来控制，或者由系统管理员控制， 并在预订的日期进行安装，以最大程度减小对系统的干扰和 意外行为。在升级安装完成后，应进行验证，验证的深度取 决于升级的深度。每一次升级

30、均应该记录。Note: this does not necessarily apply to service patches for commercial office software.注：对于商业办公软件的服务补丁，可能不需要这些工作。 Verification of the software 软件确认Commercial software should be checked at installation. 商业软件在安装时应进行检查。Concerning in-house software, it should be verified not only at installation

31、but also on a regular basis to avoid any error and guarantee good results. The regularity of the verification depends on software safety, usage frequency and the possible impact, if there is a failure. 对于自主开发的软件，应不仅对安装进行确认，还要进行常 规确认，以避免任何错误及保证良好结果。确认的常规性取 决于软件的安全性，使用频次和可能的影响，如果有失败的 话。In both cases,

32、the OMCL?s policy should be described in a procedure.OMCL 的政策应在某个程序中描述以上两种情况。Protection of the software 软件保护Software must be protected against any intrusion that could generate wrong scientific results. One way could be to secure software or computers/systems access by a password. It must also be protected against any external interference that could change the data and affect the final results. 软件应受到保护，使其不会受到干扰而产生错误的科学结果。 保护软件或计算机 /系统的一个方法是使用密码登录。 同时还 必须保护使其不受到任何外来干扰而改变数据及影响最终