Inspection Readiness Visits

Visits taken to ensure an organization is always prepared for regulatory inspections, with compliant systems, records, and trained staff.
For Cause Audits: These are targeted audit conducted in response to a specific problem, risk, or regulatory concern. The scope is typically different than as part of the routine audit schedule. The triggers are: Regulatory Inspection Findings, Serious deviations / OOS / OOT, Product quality complaints or recalls, Data integrity concerns, Whistleblower complaint