Computer validation in toxicology: historical review for FDA and EPA good laboratory practice

摘要

The application of computer validation principles to GoodLaboratory Practice is a fairly recent phenomenon. As automated datacollection systems have become more common in toxicology facilities,the U.S. Food and Drug Adminis- tration and the U.S. EnvironmentalProtection Agency have begun to focus inspections in this area. Thishistorical review documents the development of regulatory guidance oncomputer validation in toxicology over the past several decades. Anoverview 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 providentfor implementation of computer validation principles on laboratorycomputer systems in a toxicology facility.