Inspection Readiness System
Find out if your decisions would survive an inspection.
Eight questions. Six domains. The same logic an FDA inspector uses — in order. You get a scored readiness profile and the exact record you need to close the most critical gap.
Takes 4 minutes. No login required.
How the Inspection Readiness check works
What you get
1
A scored readiness profile across 6 domains
Audit readiness, evidence confidence, decision ownership, risk exposure, enforcement signals, and regulatory change — scored in real time as you answer.
2
Ranked findings by inspection exposure
Each gap is classified as Critical, High, or Medium based on how frequently FDA inspectors cite that domain in 483 observations and Warning Letters.
3
The exact record that resolves your first gap
Your results route you directly to the inspection-defensible authorization record for your most critical failure. One decision. One record. Delivered in minutes.
✓ No data collected during the simulation. Your answers are processed in your browser. Nothing is sent anywhere until you choose to act on your results.
Example results
Score
45
Status
At Risk
Findings
4
A score below 50 means your decision trail would not survive a direct inspector challenge.
System State
Audit Readiness
ExposedEvidence Confidence
ExposedOwnership Clarity
At RiskRisk Exposure
At RiskEnforcement Pressure
Defensible CRITICAL Evidence packages cannot be produced on-demand
You cannot produce this record under inspection conditions.
Generate the record that defends this decision → Question 1 of 8 Audit Readiness
⚠ Inspection Pressure Event
▶ Click an answer to select it
Your Live Readiness Score
—
Updates as you answer
Result is 0 days old. Revalidate before your next inspection.
System State