Audit Program Design & Scheduling: A Risk-Based Blueprint for Inspection-Ready Clinical Quality
Audit Program Design & Scheduling: A Risk-Based Blueprint for Inspection-Ready Clinical Quality Designing and Scheduling a Risk-Smart Clinical Audit Program that Stands Up to Inspectors Set the Strategy: Purpose, Governance, and the “Audit Universe” A well-built clinical audit program is the backbone of inspection readiness. It demonstrates that sponsors and CROs exert effective oversight over…