欧盟：计算机化系统的验证-核心文件(中英文)

OMCL Network of the Council of Europe

QUALITY ASSURANCE DOCUMENT

PA/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