200907paphomcl(08)693r欧盟omcl计算机化系统的验证：核心文件(中英文.pdfVIP

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 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 Full document title and reference 文件全名和索引号 Validation of COmputerised Systems – Core Document PA/PH/OMCL(08)69 3R Document type 文件类型 Guideline Legislative basis 立法基础 - Date of first adoption 首次发行日期 May 2009 Date of original entry into force 首次执行日期 July 2009 Date 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 保管机构 The present document was elaborated by the OMCL Network/ EDQM of the Council of Europe Concerned Network 相关网络 GEON 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 requirem