📋 Case Study
Pharmaceutical Manufacturing Plant Batch SCADA Integration
Audit trail integrity across systems, electronic signature enforcement, and 21 CFR Part 11 compliance
🏗️ Project Overview
Integration of legacy DeltaV DCS, Siemens S7 PLCs, and MES into unified GMP-compliant SCADA platform
🎯 Challenge
Audit trail integrity across systems, electronic signature enforcement, and 21 CFR Part 11 compliance
🔧 Design Approach
Centralized identity provider (IdP) with SAML 2.0, blockchain-anchored audit logs, and deterministic timestamping via GPS-synchronized PTP grandmaster
📐 Design Diagram
AI-generated project design illustration
📐 Key Calculations
Audit Log Volume
Events/sec × 3600 × 24 × retention_days
Result: 1.4 TB/year
Drove choice of immutable ledger-backed storage architecture
Signature Verification Latency
RSA-3072 signing + SHA-384 hash
Result: ≤ 8ms avg
Within FDA-accepted real-time batch record validation window
📊 Results
FDA pre-approval inspection passed with zero observations, full electronic batch record (EBR) automation achieved💡 Lessons Learned
- •Timestamp provenance must be cryptographically verifiable—not just synchronized
- •All system integrations require validated electronic signatures at every data boundary
✅ Key Takeaways
- 1Timestamp provenance must be cryptographically verifiable—not just synchronized
- 2All system integrations require validated electronic signatures at every data boundary
📐 Prerequisites
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➡️ Next Step
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🔗 Engineering Applications
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