Abstract:BackgroundA validation is crucial to ensure the quality of an analytical method and its results. However, the validation is only a first step, further quality assessment has to be utilised to ensure high quality research. Specifications for the validation process, but also for the assessment of data, acquired in a study setting, are given by the EMA and FDA to ensure highest quality of the data.1 2
MethodsA multi-level analytical quality system was established. Data of the calibration standards (CSs), quality … Show more
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