58  Inspection Types & Stakeholders

58.1 Common Inspection Types

Type	Conducted By	Purpose
Regulatory Inspection	FDA / EMA / MHRA	Regulatory compliance
Sponsor Audit	Sponsor QA	Oversight of CRO/site
CRO Audit	CRO QA	Internal quality control
IRB Audit	IRB	Human subjects protection

58.2 CRA Role by Stakeholder

Stakeholder	CRA Role
Regulatory Authority	Provide documentation, clarify processes
Sponsor QA	Support evidence collection
CRO QA	Ensure SOP compliance
Site	Guide inspection logistics