Inspection Intelligence
"If the decision cannot be defended,
the outcome does not matter."
DDR produces the authorization record investigators require.
Definition
DDR is the process that makes a regulatory decision defensible under inspection.
Why it exists
✓ Work is performed
✓ Results are documented
✗ Decision authorization is not recorded
No record = no defensibility.
Investigators do not validate work.
They validate the decision that authorized it.
DDR enforces four elements
No abstraction. Every element is deterministic.
01
Decision ownership
Named individual accountable at the moment of authorization
02
Evidence review
Exact data reviewed before the decision was made
03
Standard applied
Regulatory expectation used to justify the decision
04
Justification recorded
Documented rationale that survives investigator scrutiny
Input → Output
Stage
Description
Scenario
Decision context — e.g., batch release, CAPA closure, change control
Evidence
Supporting data reviewed at the moment of decision
Decision Evaluation
Evidence evaluated, ownership assigned, justification recorded
Output
Authorization Record — inspection-ready artifact
The Authorization Record
This is what is handed to an investigator.
— Documented decision
— Evidence reviewed at time of decision
— Explicit standard applied
— Named accountable owner
DDR turns a decision that happened into a decision that can be defended.
Without a Decision Defense Record
✗ Decision exists as judgment
✗ Evidence is reconstructed after the fact
✗ Ownership is unclear
✗ Justification is inferred
This is indistinguishable from an undocumented decision during inspection.
How it fits the system
Case Files
Expose the gap
→
DDR
Resolve the decision
→
Authorization Record
Prove it under inspection
Aligned to FDA, EU Annex 11, and GAMP 5 expectations for decision documentation.
Produce the Authorization Record
Upload your evidence. The system drafts a structured authorization record for your review. Generation is free. You authorize when ready.
Produce the Authorization Record →