Inspection Defense Templates

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Free templates and frameworks for compliance professionals preparing for FDA inspections. Each resource is designed around a specific authorization gap — what the investigator asks, what your file should contain, and what produces a defensible record. Delivered by email.

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Authorization Framework
The 5-Element Authorization Structure Investigators Expect to See
The five elements every authorization record must contain to answer the investigator's question completely: who authorized, what was reviewed, what standard governed, what alternatives were considered, and the frozen timestamp of the decision.
PDF · Free with email
PDF
Batch Release
Inspection Prep Checklist — Batch Release Authorization
A pre-inspection review checklist for batch release files. Identifies the three questions an FDA investigator will ask about any batch containing an exception, and maps each question to the specific documentation that must exist in the file.
PDF · Free with email
PDF
CAPA
Inspection Prep Checklist — CAPA Effectiveness Authorization
A pre-inspection review checklist for CAPA records. Covers the effectiveness determination authorization gap — the most common CAPA-related 483 observation pattern — and the specific documentation that must exist at closure.
PDF · Free with email
PDF
OOS Investigation
Inspection Prep Checklist — OOS Investigation Authorization
A pre-inspection review checklist for OOS investigation records. Covers the invalidity authorization gap, the Phase I/II decision record requirement, and the disposition authorization documentation that must accompany every OOS investigation closure.
PDF · Free with email
PDF
Deviation
Inspection Prep Checklist — Deviation Authorization
Coming April 14 with the Deviation article.
PDF · Coming April 14
PDF
Authorization Template
Batch Release Authorization Record Template
A structured template for producing a batch release authorization record at the time of the release decision. Pre-populated with the five required elements and the CFR citations that govern the release determination.
PDF · Coming April 20
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