Qualified before, monitored through
This audit sets the baseline; vendor and CRO oversight audits confirm that baseline is held once the vendor is live on the study.
What's included
What the qualification audit covers
- Vendor SOPs, quality system, and staff qualifications reviewed against GCP and the scope of work
- Prior regulatory inspection history and audit findings requested and evaluated for unresolved risk
- System and data-handling capabilities checked against what the study quality plan requires of that vendor
- Qualification findings documented and, where gaps exist, resolved before the vendor is engaged
- Qualification outcome feeding directly into the vendor's risk tier in the risk-based audit plan
One process audit lens, start to close-out
The same process-audit discipline continues through conduct with TMF, safety, and data system audits, so process integrity is checked at every phase.
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