This paper describes the application of document comparison software to the quality assurance (QA) audit of reports from preclinical safety tests. A secure audit system has been constructed in which the results of document comparison between the study report and a master template direct the conduct of the audit. The qualitative and quantitative benefits arising from this approach are both significant and immediate. The quality of the audit process is improved and the auditor time required is reduced. Document comparison software is a logical progression from the computerization of the data collection phases and offers the QA professional a greater degree of confidence in the report and its audit.
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