Compliance professional reviewing a signed decision document

You're about to approve something you may need to defend later.

If that decision was questioned right now — could you explain why it was safe?

Where authorization fails under inspection

✗ Decision made, but no recorded rationale

✗ Evidence exists, but not tied to the decision

✗ Signature present, but no authorization logic

Start with the decision you need to defend.

Each scenario is a $149 case file that shows exactly what your authorization record is missing.

High Exposure CAPA Closure Effectiveness decisions are frequently challenged Get the Case File — $149 → High Exposure Batch Release Release authorization is a primary inspection target Get the Case File — $149 → High Exposure Deviation Resolution Root cause conclusions are often re-evaluated Get the Case File — $149 → Frequently Challenged Change Control Risk assessments are challenged after downstream issues Get the Case File — $149 → Frequently Challenged OOS Investigation Root cause and closure authority are scrutinized Get the Case File — $149 → Frequently Challenged Data Integrity Data decisions are scrutinized for traceability and control Get the Case File — $149 →

See all 10 case files →

Inspection Scenario

Your CAPA is closed. Your records are complete. An investigator asks one more question.

During a routine FDA inspection, an investigator pulls a CAPA closed fourteen months ago. The effectiveness check is marked complete. All corrective actions are documented.

Then the investigator asks the question your quality system was not designed to answer.

The issue was not the CAPA. It was the absence of a defensible authorization record.

FDA Inspection — CAPA Effectiveness Review

“Who made the determination that this CAPA was effective — and what evidence did they review before authorizing the closure?”

Record That Does Not Exist

✗Who evaluated the effectiveness evidence

✗What standard governed the determination

✗Who formally authorized the closure decision

Decision Authorization Environment

Produce the Authorization Record.

Upload your evidence. The system drafts a structured authorization record for your review. Generation is free. You authorize when ready.

Produce the Authorization Record →

Free to generate · Authorize and Lock — $2,500 · Membership from $299/mo

You're about to approve something you may need to defend later.

Where authorization fails under inspection

Start with the decision you need to defend.

Your CAPA is closed. Your records are complete. An investigator asks one more question.

Produce the Authorization Record.

You've reviewed the problem. Now check if it exists in your system.