Evidence
Does the record include the key data, test results, and documents relied on?
INSPECTION RESPONSE RECORD
When the inspector asks who authorized a decision—and why—the answer should already be in the record.
The Inspection Response Record captures the evidence, rationale, risk assessment, and accountable authorization behind a critical GMP decision—when it is made, not reconstructed for inspection.
Recorded at the point of decision. Review-ready when needed.
WHAT THE IRR DOES
It preserves the reasoning behind one critical GMP decision as a permanent record.
Your quality systems preserve what happened: the signature, the disposition, the outcome. They do not preserve why the decision was authorized. When an inspector asks, that reasoning gets reconstructed from memory and email threads.
The IRR captures that reasoning as one structured record: who authorized the decision, on what evidence, how risk was weighed, and why it was justified. The Decision Documentation Assessment shows where a record is incomplete. The IRR is the record itself.
WHAT THE IRR RECORDS
Four questions. One clear answer.
Decision rationale
Is the rationale recorded, including alternatives considered?
Risk
Are the key risks, assumptions, and residual risk addressed?
Authorization
Is accountable ownership and sign-off documented?
WHAT HAPPENS WHEN YOU START
What happens when you start.
The IRR process is designed to be straightforward, transparent, and efficient.
Provide details
Complete a short intake — about 10–15 minutes to begin.
Secure checkout
Your details are saved before Stripe opens for payment.
We prepare your IRR
Once payment is confirmed, preparation starts automatically.
Review your IRR
You receive your record for review.
GET STARTED
Inspection Response Record (IRR)
$497
One decision. One record.
Start Your IRR → About 10–15 minutes to begin.▣
Your details are saved before payment.
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Preparation starts automatically once payment is confirmed.
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If preparation fails, it can be retried without a second charge.
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Refunds are governed by our Terms of Service.
Start with one decision
Inspection Response Record · $497
Begin with the decision you need recorded.
Start with the essentials. You can add evidence and context in the next step.
1 Decision — 2 Basis — 3 Review
FREQUENTLY ASKED QUESTIONS
Frequently asked questions
What is the IRR?
A structured record of the authorization reasoning behind one completed consequential GMP decision: who authorized it, on what evidence, how risk was weighed, and why it was justified. Anything the record cannot support is shown as a finding.
What do I need to get started?
One completed decision and the context you have available. No document upload is required to begin.
How long does it take?
About 10–15 minutes to begin the intake.
Will you rebuild or create missing records for us?
No. Missing support remains visible as a finding rather than being invented or backfilled.
What happens after I receive my IRR?
You review the findings and decide whether the existing record is sufficient or whether remediation is warranted.
Is the Decision Record included?
No. The $1,500 Decision Record is optional and is offered only when a completed IRR identifies material gaps.
Can I purchase multiple IRRs?
Each IRR covers one completed consequential GMP decision.
What if preparation fails?
The same paid record can be retried without a second charge.
What is your refund policy?
Refund terms are governed by the Terms of Service.