Each resource below identifies the specific authorization gap investigators target in a given scenario — what they ask for, why the standard quality record doesn't answer the question, and what a defensible authorization record must contain.
"Who authorized this decision — not who signed the record, not who conducted the investigation — who made the call, on what evidence, at that moment?"
FDA investigator question pattern across deviation, CAPA, batch release, change control, OOS, validation, and supplier qualification inspections.
FDA 483 — Deviation Continuation Authorization
"Who authorized the decision to keep the line running while this investigation was still open?"
Read the reference →FDA 483 — CAPA Closure Authorization
"Who determined this CAPA was effective — not who closed the record, who made that determination?"
FDA 483 — Batch Release Authorization
"Who authorized release of this batch — not who signed, who reviewed the evidence and made the call?"
FDA 483 — Change Control Authorization
"What specific regulatory criteria were used to classify this change — and who made that determination?"
FDA 483 — OOS Disposition Authorization
"Who authorized the invalidation determination — not who conducted the investigation, who made the call?"
FDA 483 — Validation Conclusion Authorization
"Who authorized the conclusion that this process is validated — and what data did they review at that moment?"
Quality management systems are designed to produce the first. They track workflow completion, generate timestamps and signatures, and close records when actions are done.
They are not designed to produce the second. The authorization record — the document that captures who made the call, on what evidence, under which regulatory standard — requires a deliberate act by the accountable decision-maker at the time of the decision.
Most quality files contain one. FDA investigators increasingly require both. The gap between them is where 483 observations are written on files that are otherwise complete.
Each ComplianceWorxs case file produces the specific record FDA investigators require for that scenario — structured to answer the question directly, delivered immediately.