ENT‑001 / INDUSTRIAL ARCHITECTURE
Vikas Phatak
RUNNINGChief Industrial Architect · Senior MES Engineer
I design the systems that turn regulated manufacturing into software you can trust — electronic batch records, GxP-compliant integration, and audit trails that hold up under inspection.
- EXP
- 15 yr+
- DOM
- Pharma / GxP
- STD
- ISA-88/95
- STK
- .NET · Python · React · AI Agents
Experience
Domain
Standards
Core stack
What I build
Four units on the line. Each one designed to pass audit, not just pass tests.
U-101
MES & Electronic Batch Records
Paper-on-glass eBR and digital SOP execution built on ASP.NET Core, SQLite/SQL Server, and Windows Authentication. Review-by-exception, e-signatures, and a hash-chained audit trail at the core.
U-102
GxP Compliance by Design
Systems that meet 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 from the substrate up — not bolted on afterwards. URS, traceability, and validation baked into the build.
U-103
IT / OT Integration & AI Agents
Clean data flow between the plant floor and enterprise: MES to SAP, SCADA, and historians over OPC-UA and MQTT. Autonomous AI agent workflows for engineering and documentation.
U-104
Digital Twins & Equipment Models
ISA-88/95 equipment hierarchies expressed as DTDL v3 models. Reverse-engineered proprietary formats where the vendor left no door open.
Writing & work
One engine, several exhausts. The thinking, the book, and the code.
- PUB-01 Agent-Driven Blog Engineering Dispatches Technical deep-dives and field notes on autonomous AI agent orchestration, MES architecture, and industrial systems. Published autonomously by the agent workflow engine. Read dispatches
- PUB-02 Publication Validated State Field notes on MES architecture and regulated manufacturing — the design decisions behind systems that pass audit. Read the publication
- REPO-01 GitHub Open source & Agent Workflows Equipment libraries, DTDL model generators, and the autonomous Python orchestration engine behind this blog. Built in the open. Browse the repos
Two lines running
Manufacturing systems by day. History research the rest of the time.