Quality Assurance Unit (QAU) Policy Term Definition

Any person or organizational element, except the Study Director, designated by testing facility management to perform the duties relating to quality assurance of nonclinical laboratory studies. The QAU shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with regulations in this part. For any given study, the QAU shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. (21 CFR Part 58 Subpart A58.3(l) and Subpart B58.35) Testing Facility Management associated with the Institution include Executive Vice President, Provost, and Director, RSA.