“Who authorized this batch release, and what evidence did they review before making that decision?”
At risk: the batch can be released while the basis for the release judgment remains hard to retrieve.
21 CFR 211.188 · 21 CFR 211.192
View scenario →FDA Inspection Scenarios
Know which decision you may have to defend.
FDA inspections often come down to one question: who authorized this decision, and what evidence supported it?
Choose the decision you need to defend and see the inspection question, evidence gap, and record required.
Find the decision you need to defend →Start with the decision in front of you
Which decision do you need to defend?
Pick the situation that is closest to the decision under scrutiny.
Batch release or disposition
Release becomes difficult to defend when the record shows results, but not the judgment behind the final disposition.
View decision scenarios →Deviation continuation or closure
A deviation decision becomes exposed when the evidence reviewed, risk accepted, and accountable owner are not preserved together.
View decision scenarios →CAPA closure or effectiveness
Closure becomes vulnerable when completed actions are visible but the effectiveness judgment and residual uncertainty are not.
View decision scenarios →OOS investigation conclusion
An OOS conclusion is hard to defend when the basis for the final determination cannot be reconstructed from the record.
View decision scenarios →Change control approval
A change becomes difficult to explain when the regulatory impact assessment, alternatives, and approval basis are scattered.
View decision scenarios →Not sure which one applies? Identify your exposure →
Common inspection questions
Questions Quality leaders should be able to answer from the record.
Six common decision moments. No price tags, no detours—just the question, the exposure, and the underlying scenario.
“Who made the disposition decision for this deviation, and what evidence did they review?”
At risk: the disposition can be documented without preserving why the evidence supported that decision.
21 CFR 211.192
View scenario →“Who made the determination that this CAPA was effective, and what evidence supported that conclusion?”
At risk: a closed CAPA can show completed work without showing why Quality accepted effectiveness.
21 CFR 820.100
View scenario →“Who made the final determination that this OOS result was assignable, and what was the basis?”
At risk: the investigation can close without a durable record of why the final conclusion was accepted.
21 CFR 211.192 · FDA OOS Guidance 2006
View scenario →“Who made the regulatory impact determination for this change, and what was the basis for that assessment?”
At risk: the change can be approved while the regulatory-impact judgment remains distributed across records.
21 CFR 820.70 · EU Annex 11
View scenario →“Who made the determination that this process was validated, and what evidence supported that conclusion?”
At risk: validation can be accepted without a clear record connecting the evidence to the authorization.
21 CFR 211.68 · FDA Process Validation Guidance 2011
View scenario →When the decision is active
Need to defend a decision now?
See the completed record before you close, release, or respond.