Auditing Crossword

Systematic, independent process for obtaining evidence and evaluating it objectively to determine the extent to which the criteria are fulfilled
Regulation which requires a QA statement for the final study report
Third party, accredited by European authorities, to audit medical device companies and products
Set of policies, procedures or requirements used as a reference against which audit evidence is compared
Results of the evaluation of the collected audit evidence against audit criteria
First phase in the audit process
Severity of grading when an observation is considered a GXP Show-stopper
Laboratory study on absorption, distribution, metabolism and excretion of a test item by a human or animal body
Document in which you describe your audit observations
Key characteristic of an auditor required to identify a finding