GxP Inspection Readiness Checklist
Most organizations don't fail inspections — whether FDA, EMA, MHRA, or any other regulatory body — because they lack a quality system. They fail because the quality system says one thing and the evidence on the floor says another.
Five of the Areas Regulators Actually Probe
A preview — our free assessment scores your organization across all 8 domains, not just these 5.
Documentation & Records Governance
Could you locate any controlled document's full version history and prove its periodic review is current — in minutes, not hours?
Quality System Governance
Is ownership and escalation for every quality process clearly defined, or does it depend on who happens to be in the room?
Training, Competency & Knowledge
Is training current before staff perform the task it covers, and does the curriculum update automatically when the underlying SOP changes?
Validation & Data Integrity
Are audit trails reviewed as part of routine QA, or only after something has already gone wrong?
Inspection Preparedness & Self-Assessment
Could your team walk a regulator through your quality story today, or would it take a scramble to assemble the evidence?
Why This Is Hard With Spreadsheets and Shared Drives
Answering any of the questions above requires cross-referencing information that usually lives in different places — SOPs in one folder, training records in a spreadsheet, CAPA status in someone's inbox. A regulator asking "show me that this deviation's corrective action was actually effective" is asking you to connect three or four systems in real time. QMSdesk's Risk Intelligence Engine exists specifically to surface these cross-module gaps before a regulator finds them.
Get Your Full, Personalized Readiness Score
These 5 questions are a preview. The free Inspection Readiness Assessment scores your organization across all 8 domains — complexity-adjusted for your industry and stage — in 5 minutes, with a prioritized action plan. No registration required to see your instant result.