Good Laboratory Practice (GLP)– guidelines for the validation of computerised systems

Quality Assurance Journal Pub Date : 2007-09-01 DOI:10.1002/QAJ.426

Peter M. Esch, G. Donzé, Bruno Eschbach, S. Hassler, Leo Hutter, H. Saxer, U. Timm, R. Zühlke

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引用次数: 3

Abstract

The aim of this document is to provide guidance on the validation of computerised systems, compliant with Good Laboratory Practice (GLP). It specifies more precisely the procedures to follow in carrying out validations of computerised systems. It intends to help test facilities promote a common standard. However, the test facility management may use different approaches, as long as they are in compliance with the Organisation for Economic Co-operation and Development (OECD) Principles of GLP [1]. The extent of a validation may vary depending on the complexity of the computerised system. In any case the validation should demonstrate that the computerised system is suitable for its intended purpose. The Arbeitsgruppe Informations-Technologie (AGIT) is a working group consisting of representatives from Swiss industry and Swiss GLP monitoring authorities with the aim of proposing procedures that are practical for use in test facilities fulfilling GLP regulatory requirements. These guidelines have been adapted to current practices and replace those issued in June 2000. Copyright © 2008 John Wiley & Sons, Ltd.

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良好实验室规范(GLP) -计算机化系统验证指南

本文件的目的是为符合良好实验室规范(GLP)的计算机化系统的验证提供指导。它更精确地规定了在进行计算机化系统验证时应遵循的程序。它旨在帮助测试机构推广通用标准。然而，测试设施管理可以使用不同的方法，只要它们符合经济合作与发展组织(OECD)的GLP原则[1]。验证的程度取决于计算机化系统的复杂程度。在任何情况下，验证都应证明计算机化系统适合其预期用途。Arbeitsgruppe informations - technology (AGIT)是一个工作组，由来自瑞士工业界和瑞士GLP监管机构的代表组成，旨在提出可用于满足GLP监管要求的测试设施的实用程序。这些准则已根据目前的做法进行了修改，并取代了2000年6月发布的准则。版权所有©2008 John Wiley & Sons, Ltd

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Quality Assurance Journal

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