The document everything else points back to
The risk-based audit plan, training tracker, and CAPA process all derive their scope and thresholds from this plan, not from separate ad hoc decisions.
What's included
What goes into the plan
- Critical-to-quality factors identified from the protocol, indication, and prior study experience
- Audit strategy and escalation pathway defined ahead of the risk-based audit plan that will direct scope and frequency
- Roles, responsibilities, and sign-off authority documented for QA decisions across sponsor, CRO, and site
- Training and certification requirements set for study staff, feeding directly into GCP/SOP training tracking
- CAPA process and finding-severity definitions established before the first audit is ever run
- The plan reviewed and version-controlled as a living document through study conduct
Written before, not during
Because the plan is finalized before site activation, audit strategy is never improvised mid-study — deviations are the exception, and they're documented.
← Back to Quality Assurance
More in Audit Planning