Free guides, built from real enforcement files.
Practical PDF guides and templates drawn from public FDA records and our Recall Forensics analyses — the same structures we use in our validation work. Enter your work email once per download; we’ll send the file plus one follow-up.
Four downloads. More on the way.
Every guide maps to the regulations behind it — 21 CFR Part 111, 117, 507, and Part 11 where they apply.
GMP Readiness Checklist
28-point self-assessment across the six areas investigators probe first. About 20 minutes with your QA lead.
28 checks · PDF
FDA 483 Response Template
Answer every observation in 15 business days: the 7-element structure, evidence checklist, and five escalation mistakes.
Template · PDF
Supplier Qualification Checklist
25 checks for an FDA-ready supplier program — approval, verification, receiving controls, ongoing oversight.
25 checks · PDF
Validation Master Plan Outline
The 8-section skeleton of an audit-ready VMP: scope, IQ/OQ/PQ strategy, CSV, change control, traceability.
Outline · PDF
GDP Cold Chain Checklist
25 checks for an inspection-ready cold chain — thermal mapping, shipping lane qualification, packaging performance, excursion investigations.
25 checks · PDF
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