Proprietary Methodology
The VigilaMed Audit Defense Framework
A structured methodology for surviving high-stakes regulatory inspections.
Overview
Most manufacturers fail audits not because of product quality, but because of narrative control. This framework outlines our 5-stage protocol for front-room/back-room management during FDA and Notified Body inspections.
Key Insights
Pre-Audit War Room Setup
The 'Do Not Volunteer' Protocol
Rapid Retrieval Logistics
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