About
Nine years in FDA-regulated IT.
The architecture that closes the compliance gap.
Nine years in FDA-regulated IT. A decade observing the exact compliance gap this architecture closes. The math to prove it works.
Ahmed M. Mansour
Founder & Principal Architect · Steward and Sync LLC
GxP systems validation: Takeda, Astellas, Sun Pharma, Fate Therapeutics, Mirati, Intercept Pharmaceuticals
Nine years validating computerized systems in FDA-regulated pharma — 21 CFR Part 11, GAMP 5, IQ/OQ/PQ, ALCOA+, GxP CSV. That work produced a specific observation: separation of duties, electronic signatures, tamper-evident audit trails, and reviewer independence already describe exactly what AI governance should look like. Nobody had encoded them as architecture. Every existing system layered policy on top. Policy is bypassable.
The insight was to move enforcement below ordinary application policy — and to replace probabilistic approval with deterministic authorization. The result is a system where non-compliant writes are structurally impossible for any actor: human, AI, script, or pipeline.
The companion mathematics was developed to prove the authorization structure is correct. Not heuristically correct. Exhaustively verified across 13.8 billion cases with zero exceptions.
The system is operational on sovereign on-premise infrastructure with no cloud dependency. More than 8.3 million authorized decisions minted. The enforcement gate is active.
By the Numbers
Program
NSF I-Corps Northeast Hub
Lehigh University · Propelus Track · June 2026
Customer discovery: defense, pharma/GxP, and critical infrastructure operators deploying agentic AI in regulated environments.
Intellectual Property
Five U.S. Provisional Patents Pending
STS-001 family · Non-provisional target April 2027
Why Now
Agentic AI is entering regulated industries. Nothing governs it at the write layer.
Regulatory Pressure
EU AI Act Article 12 requires automatic logging of events over the lifetime of high-risk AI systems, retained and accessible for audit. FDA guidance on AI/ML in regulated workflows is moving toward pre-execution traceability requirements. SOX, HIPAA, and NERC CIP require audit artifacts that prove authorization preceded action — not just logs of what happened.
The Gap
Every AI governance product on the market operates at the application layer — guardrails, content filters, behavioral monitors. None enforce authorization at the persistence layer. None produce a cryptographic pre-execution receipt. The audit trail they generate records what happened. It does not prove what was authorized before it happened.
The Moment
AI agents are being deployed as first-class actors in LIMS, MES, EHR, and trading systems. The question is no longer whether AI will write to systems of record — it is whether those writes will be authorized before they happen. STS-001 enforces this structurally — at the persistence layer, for any actor.
Applicable Frameworks — Encoded by Construction
Working with a limited set of design partners.
Regulated industries: pharma, finance, critical infrastructure, defense.