GOOD LABORATORY PRACTICE AND INFORMATION TECHNOLOGY IN THE 90S

Since the 1983 publication by the US Food and Drug Administration (FDA ) of its 'Bluebook', the role of computer systems in compliance to goo d laboratory practice (GLP) has had an increasing level of visibility for both regulatory authorities and laboratory managers around the wor ld. Recent publication by the US Environmental Protection Agency (EPA) in 1991 of the good automated laboratory practices (GALP) guideline h as enabled a closer examination of the critical issues surrounding val idation of laboratory data from automated instruments and laboratory i nformation management systems (LIMS). This paper discusses factors imp ortant to laboratory managers who are looking to be compliant with GLP regulations for computer systems that gather, store, transform, and r eport data for safety, quality, and efficacy submissions to regulatory authorities. It discusses the type of vendor support one should expec t for GLP compliance and the concerns of regulatory inspectors looking at computer systems in laboratories operating under GLP regulations.