21 CFR Part 58 - Good Laboratory Practice (GLP)
Organization and Personnel (Subpart B)

21 CFR Part 58 - Good Laboratory Practice (GLP) 58.35: Quality Assurance Unit

A QAU must be entirely separate from study personnel. The QAU maintains a master schedule, audits each study at intervals, and reports findings in writing to management and the Study Director.

Other controls in Organization and Personnel (Subpart B)

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.