Platform Overview

Comprehensive FDA compliance management powered by AI and formal verification

Data Flow Visualization

Platform data processing workflow from input sources to deliverables

Core Features

Warning Letter Analysis

AI-powered analysis of FDA warning letters to identify patterns and risks

  • Pattern detection across similar violations
  • Statistical analysis of violation types
  • Industry-wide trend identification
  • Risk prediction based on historical data

Prolog Validation

Formal verification system for comprehensive compliance validation

  • Automated validation against CFR requirements
  • Logical flowchart generation
  • Structured validation reporting
  • Complete coverage verification

Platform Capabilities

Data Sources

  • • FDA Warning Letter Database
  • • Title 21 CFR Documentation
  • • FDA Guidance Documents
  • • Historical Compliance Data

Processing

  • • AI-Powered Analysis
  • • Prolog Logic Engine
  • • Pattern Recognition
  • • Risk Assessment

Outputs

  • • Compliance Reports
  • • Validation Results
  • • Risk Predictions
  • • Actionable Insights

Getting Started

  1. 1Access the analytics page and select "New Analysis"
  2. 2Choose between Warning Letter Analysis or Compliance Validation
  3. 3Upload relevant documentation or select CFR codes for validation
  4. 4Review generated insights and validation results