Decision Tools
Purpose-built tools to examine the evidence, test the reasoning, and identify what needs attention—in CAPA, batch release, deviations, OOS, change control, supplier qualification, and decision reconstruction.
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Choose your situation. The matching tool is marked below.
One tool for one decision. Each asks the questions an investigator asks of that decision. $29 to $59.
Purchases are final unless a file cannot be delivered or opened, in which case we replace it or refund the price. See Terms, Section 3B.
Question Pack
What will the investigator ask about this decision?
A set of the challenge questions an investigator asks about a consequential decision, to answer against your own record.
You finish with The Inspection Question Brief, a readiness count and a prioritized repair plan.
$29 · Fillable PDF
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Kit
Could we reconstruct who authorized this, and why, if an inspector asked today?
Work back through a decision already made and find what the record would not show.
You finish with A readiness count, an exposure list and next actions.
$49 · Fillable PDF
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Decision Check
Is the closure reasoning on this CAPA sufficient to stand on its own?
Test whether the evidence and reasoning behind a CAPA closure support the decision to close it.
You finish with A brief, an exposure list and next actions.
$39 · Fillable PDF
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Decision Check
What was reviewed, and what supported releasing this batch?
Check a release decision for the evidence, risk weighing and authorization an inspector will look for.
You finish with A brief, a readiness count and next actions.
$59 · Fillable PDF
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Decision Check
Why was this deviation considered adequately resolved?
Check the reasoning behind a deviation disposition before it is questioned.
You finish with A brief, a readiness count and next actions.
$39 · Fillable PDF
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Decision Check
Why was this change authorized, and on what assessment of risk?
Check the reasoning behind a change control approval.
You finish with A brief, a readiness count and next actions.
$39 · Fillable PDF
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Decision Check
The first result failed. What justifies the disposition that followed?
Check the reasoning behind an out-of-specification disposition.
You finish with A brief, a readiness count and next actions.
$49 · Fillable PDF
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Decision Check
What supported qualifying this supplier, and who authorized it?
Check the reasoning behind a supplier qualification decision.
You finish with A brief, a readiness count and next actions.
$39 · Fillable PDF
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Most buyers stop at the tool. These are the three places a check can lead.