Brodish D L
Research Triangle Institute, Research Triangle Park, NC 27709, USA.
Qual Assur. 1998 Oct-Dec;6(4):185-99. doi: 10.1080/105294199277752.
The application of computer validation principles to Good Laboratory Practice is a fairly recent phenomenon. As automated data collection systems have become more common in toxicology facilities, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency have begun to focus inspections in this area. This historical review documents the development of regulatory guidance on computer validation in toxicology over the past several decades. An overview of the components of a computer life cycle is presented, including the development of systems descriptions, validation plans, validation testing, system maintenance, SOPs, change control, security considerations, and system retirement. Examples are provided for implementation of computer validation principles on laboratory computer systems in a toxicology facility.
将计算机验证原则应用于良好实验室规范是一个相当新的现象。随着自动化数据收集系统在毒理学设施中变得越来越普遍，美国食品药品监督管理局和美国环境保护局已开始将检查重点放在这一领域。这篇历史回顾记录了过去几十年中毒理学领域计算机验证监管指南的发展情况。文中概述了计算机生命周期的各个组成部分，包括系统描述的制定、验证计划、验证测试、系统维护、标准操作规程、变更控制、安全考量以及系统停用。文中还给出了在毒理学设施的实验室计算机系统上实施计算机验证原则的示例。
