Audit Defense Briefs
Inspection-grade explanations for defensible decisions.
What It Is
An Audit Defense Brief is a regulator-ready explanation generated from an authorized Decision Defense Record (DDR). It documents why a decision was made, what governed it, and what evidence supported it.
When It Is Issued
Issued after a DDR is authorized. Used during:
- FDA inspections
- Internal audits
- Partner or acquirer diligence
What It Contains
- Decision context
- Governing logic
- Evidence references
- Approval authority
- Time and scope boundaries
Note: Issued with Professional and Enterprise Authorization.