Definitions


392. quality assurance All those planned and systematic actions that are stablished to ensure that the trial is performed and the data are generated, documented (recorded) and reported in compliance with the applicable regulatory requirement(s). May also refer to the independent quality unit required within good laboratory practices (GLPs) for quality oversight.


393. quality control Activities undertaken within the quality-management system to verify that operational activities and derived data have been verified.


394. quality control sample (QC) A sample spiked with a known quantity of analyte, typically in the same matrix as the unknown samples that are used to monitor the performance of a bioanalytical method and to assess the integrity and validity of the results of the unknown samples analyzed in an individual run.


395. quantification range The range of concentrations, including ULOQ and LLOQ, which can be reliably and reproducibly quantified with accuracy and precision through the use of a concentration–response relationship.


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