Guided Notes
Inspection Readiness for Data Management
Preparing for regulatory inspections and audits — the TMF, SOP compliance, typical CDM findings, storyboards, mock inspections and responding to findings with CAPAs.
Inspection basics
Slide 1 / 5Regulators (FDA, EMA member states, MHRA, PMDA…) inspect sponsors, CROs and sites to verify GCP compliance and data reliability — often before approving a marketing application. Inspectors interview staff, review documents and systems, and trace data from source to submission. Being 'inspection-ready' means you could explain and evidence any decision at any time.