Quality assurance unit. A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facili- ties, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. The quality as- surance unit shall conduct inspections and maintain records appropriate to the study.
Appears in 9 contracts
Samples: Testing Consent Agreements and Test Rules, Testing Consent Agreements and Test Rules, Testing Consent Agreements and Test Rules
