The QAU is not expected to perform a scientific evaluation of a study or to “second-guess”
the scientific procedures that are used. QAU inspections are made to ensure that the GLPs,
SOPs and protocols are being followed and that the data summarized in the final report
accurately reflect the results of the study. A variety of procedures can be used to do this but
certainly the procedures should include an examination and correlation of the raw data
records.
