The intent of the Good Laboratory Practice Standards are to ensure that data generated in a scientific study intended for submission to regulatory authorities are produced in a manner such that their consistency, reliability, conformity and robustness can be adequately validated. Scientific data generated in accordance with these operating principles may then be evaluated against these same criteria by all regulatory authorities, enabling the harmonization of testing procedures and the results thereof to be uniformly assessed. The Klimisch Method is one such process that has been proposed as a systematic approach for evaluating the quality of toxicological data; its application was intended to harmonize data evaluation processes worldwide. Systems such as these are valuable tools in the assessment of data quality; however, the critical role of the QAU in ensuring management and regulatory agencies that data is conducted and reported according to the GLPs cannot be overlooked or underestimated, particularly in reliable application of these assessment tools. In this presentation, the QAU impact in the assessment and evaluation of data quality will be discussed.

Klimisch approach to evaluating quality data

254th National Meeting (2017)

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