Prevent FDA warning letters with multi-agent AI that identifies compliance risks 70% faster than manual review

See Pharma Demo View Compliance Metrics

FDA Compliance Solution

Reduce warning letter remediation costs by $2.3M per incident

Document Analysis

Automated review of SOPs, batch records, and submissions against 21 CFR regulations

Accuracy: 92% vs manual review

3-Agent Debate

Regulatory, Scientific, and Quality AI agents identify conflicting interpretations

Risk Reduction: 83% in pilot

Audit Trail

Blockchain-verified decision logs for FDA inspections

Compliance: 21 CFR Part 11

Pharma Compliance Demo

Live FDA Document Analysis

Multi-Agent FDA Document Review

Select a Pharma Scenario

Compliance Metrics

92%

CFR Citation Accuracy

89%

Warning Letter Prediction

76%

Bias Detection

94%

Audit Trail Completeness

Pilot Results

  • 65% faster submission reviews
  • 83% reduction in 483 observations
  • $1.2M saved per warning letter prevented

Model Performance Matrix

Specialized AI agents for pharmaceutical compliance

Evaluation Metric Regulatory Agent Scientific Agent Quality Agent Consensus Score
21 CFR Accuracy 95% 82% 91% 92%
Warning Letter Prediction 93% 78% 88% 89%
Bias Detection 72% 85% 74% 76%
Audit Compliance 96% 90% 98% 94%

Technical Implementation

  • Model Architecture: 3 specialized LLMs fine-tuned on FDA docs
  • Training Data: 1,200+ warning letters with CFR mappings
  • Debate Framework: Patent-pending consensus algorithm
  • Compliance: 21 CFR Part 11 validated
  • Security: HIPAA/GMP compliant
  • Integration: Works with Veeva, SAP, and Documentum