Case Study: PharmaTrack — Automating FDA Compliance With AI Agents
Overview
PharmaTrack, a multinational pharmaceutical manufacturer, faced heavy delays caused by manual FDA documentation, SOP creation, validation checks, and compliance reporting.
Logicwerk built a GenAI compliance automation platform with agent-controlled workflows — reducing documentation time by 70% while improving accuracy and audit readiness.
Challenges
- Thousands of pages of FDA compliance documentation
- Manual SOP updates causing repeat delays
- Expensive validation and verification cycles
- Audit readiness issues
- Fragmented document sources across teams
PharmaTrack needed a system that was fast, accurate, and compliant.
Solution: AI Compliance Automation Platform
1. Unified Knowledge Repository
We built a secure index of:
- FDA 21 CFR Part 11
- GMP/GLP documentation
- Validation test protocols
- Existing SOPs
- Change records
Supported multi-lingual retrieval + audit evidence linking.
2. SOP + Documentation Agent
This agent could:
- Auto-generate SOP drafts
- Map regulatory requirements
- Recommend changes
- Generate validation documentation
- Produce FDA-ready submissions
Every output was traceable, versioned, and cite-backed.
3. Validation & Verification Agent
- Generated test protocols
- Suggested validation steps
- Produced evidence summaries
- Reduced manual workloads by 60%
4. Compliance Audit Dashboard
Enabled:
- Auto-mapped citations to source evidence
- Review workflows
- Full audit log export
All aligned with GxP, HIPAA, and ISO-42001.
Results
📉 70% reduction in compliance documentation time
AI completed tasks that humans did in weeks.
🧪 Fewer validation errors
Agent-driven consistency improved accuracy.
⏱️ Regulatory delays decreased by 40%
Faster documentation = faster approvals.
🔐 100% auditable and regulator-ready
Every AI action logged.
Final Outcome
PharmaTrack now operates with AI-augmented FDA compliance workflows, enabling faster approvals, reduced errors, and massive productivity gains.
Work With Logicwerk
We help life sciences teams deploy:
- GxP-compliant AI agents
- Validation automation workflows
- FDA-ready GenAI systems