Who authorized this?
Accountable authorizer, authority basis, timing, approval evidence.
Decision Records
The record behind a consequential decision.
Preserve what can be supported about a Quality or Regulatory decision — the evidence, judgment, risk, authorization, and unresolved limitations — before the organization has to reconstruct it under scrutiny.
Inspection Response Decision Record
| Evidence | Inspection observations, lab data, prior assessments, relevant SOPs and guidance. |
| Judgment | Based on available evidence, the proposed response is reasonable and proportionate. |
| Risk | Moderate risk of regulatory concern if not addressed; limited product impact. |
| Authorization | Unresolved — no contemporaneous approval record identified. |
Provenance summary
3 contemporaneous sources · 1 subsequently corroborated source · 2 retrospective statements · 1 unresolved historical limitation
A decision can be reasonable and still be difficult to defend
A response position may have been discussed, evidence may have been reviewed, and responsibilities may have been assigned.
But if a later reviewer cannot establish who authorized the decision, what they relied on, why the position was selected, and what risk remained, the organization must reconstruct the record after the fact.
What evidence supported it?
Identifiable records and a traceable connection to the decision.
Why was this position selected?
Criteria, judgment, alternatives, and rationale.
What risk was accepted?
Uncertainty, controls, residual-risk basis, and accountable owner.
Four Lenses for the Decision Record
Find the part of the decision you need to understand.
Evidence
What was known and which records informed the decision.
Judgment
How the available information was evaluated.
Risk
What uncertainty and residual exposure were weighed.
Authorization
Who accepted the decision and why.
From exposure to a reviewable record
How ComplianceWorxs works.
Identify the weakness
The Inspection Response Record documents who authorized one critical decision, on what evidence, and why, and shows what the existing record is missing.
Establish what can be supported
The Decision Record starts from the IRR findings and organizes evidence, judgment, risk, and authorization around the actual decision.
Preserve the record
A qualified reviewer can see the decision boundary, supporting material, provenance, retrospective statements, and unresolved gaps — without relying on the original team's memory.
The record does not rewrite history
A Decision Record distinguishes between four kinds of support.
Contemporaneous
Created at or near the original decision.
Subsequently corroborated
Existing material identified later that supports the record.
Retrospective
Created during review or remediation, and clearly labeled as such.
Unresolved
Information the available evidence cannot establish.
A completed Decision Record is not a document with every box filled. It is an accurate, bounded, traceable account of what can — and cannot — be supported.
First implementation
Inspection Response Decision Record
For FDA 483 response decisions that need to be understood, reviewed, and supported under inspection scrutiny.
The process begins with an Inspection Response Record, which documents who authorized the decision and on what evidence, and shows where the existing documentation cannot stand independently. Where it cannot, the Decision Record preserves the available basis, provenance, and remaining limitations for one response decision.