What's included

What goes into a vendor oversight audit

  • Audit scope built from the vendor's contracted deliverables and the study's vendor oversight plan, not a generic checklist
  • Performance reviewed against contracted timelines, quality metrics, and service levels, with evidence pulled from vendor-held systems and records
  • GCP and applicable regulatory requirements checked alongside the vendor's own SOPs, to confirm the vendor is doing what it committed to do
  • Recurring audits scheduled across the vendor relationship, frequency set by risk rather than a fixed one-time visit
  • Findings routed directly into CAPA management so gaps are tracked to closure, not just reported

Qualification is the start, not the finish

The vendor qualification audit confirms a vendor is fit to start; oversight audits confirm they stay fit for the duration of the study.

Consistent with site audits

Run on the same risk-based footing as investigator site audits, so oversight across sites and vendors is directed by one audit strategy.