Resources
Inspection readiness, in plain language.
Short guides on problems reviewers see under deadline, plus animated training, prep worksheets and reference.
Training
Guides
Circular root causes
Why “operator error → retrain” fails as a root cause, how to smell it on a second read, and what a usable cause looks like.
Read →Mechanical findings vs judgment
What a second read can catch on the page — and what still needs a human. Why triage is not clearance.
Read →ALCOA for quality records
Attributable, legible, contemporaneous, original, accurate — in plain language, tied to the overlay criteria.
Read →What 21 CFR 211.192 requires
Four obligations in one paragraph of regulation: thorough, extended to other batches, written, concluded. Where records come up short, in the order a reviewer finds it.
Read →Documenting a Form 483 response
What each observation needs, why fifteen business days matters, and the four things that weaken a response before the technical content is read.
Read →CAPA effectiveness checks
Completion is not effectiveness. What a defensible check states up front, and why training records are not evidence that anything worked.
Read →Reference
Prep & worksheets
Mock-inspection binder checklist
What to pull and order before a room walk.
Open →Root-cause language worksheet
Rewrite drills for circular causes.
Open →Doc-type → criteria chooser
Which pack applies to this pile.
Open →Consultancy engagement one-pager
How to describe a dry-run pass in a client SOW.
Open →Export / QMS handoff map
How findings land in Excel or a QMS import.
Open →Criteria feedback for experts
Pressure-test the rules with QC reviewers.
Open →Look up