MES & OEE platforms
ISA-95-aligned MES with production orders, WIP tracking, downtime reasons, OEE/TEEP calculation and ERP/PLM integration.
Industries IEC 62443 AI-native
Manufacturing and Industry 4.0 Software Development Services for US & EU Plants
YuSMP Group builds manufacturing and Industry 4.0 software for US and EU plants: discrete and process manufacturers, automotive tier suppliers, FDA-regulated pharma and medical-device producers, and ESCO-style energy and utilities OEMs. Senior engineers ship MES and OEE platforms, IIoT and SCADA gateways, predictive-maintenance ML, digital-twin simulations, WMS and traceability systems. Work runs under ISO 9001 QMS, IEC 62443 OT cybersecurity, NIS2 governance for EU essential entities, GDPR and 21 CFR Part 11 where the production touches regulated outputs.
Our manufacturing practice serves four buyer profiles: plant operators modernizing MES, OEE and shop-floor connectivity under ISA-95; equipment OEMs adding IIoT, remote service and outcome-based business models; regulated manufacturers (pharma, medical device, food and beverage) needing 21 CFR Part 11, EU Annex 11 and DSCSA serialization; and supply-chain leaders pursuing end-to-end traceability, WMS modernization and supplier visibility. We design OT/IT boundaries to IEC 62443 zones and conduits, treat NIS2 incident-reporting duties as architectural inputs, and ship OPC UA, MQTT Sparkplug B and ISA-95-compliant integrations.
What we build
What we build
Industrial IoT & SCADA gateways
Edge gateways across OPC UA, MQTT Sparkplug B, Modbus, EtherNet/IP and Siemens S7. Unified namespace for cloud and on-prem.
Predictive maintenance ML
Anomaly detection, RUL estimation and condition-based maintenance with model drift monitoring and CMMS write-back.
Digital twin / simulation
Asset and line digital twins for what-if scheduling, layout optimization and operator training, with NVIDIA Omniverse and Unity-based viewers.
Supply chain visibility & WMS
WMS modernization, ASN management, supplier portals and end-to-end visibility with EDI (X12, EDIFACT) and EPCIS event capture.
Quality & traceability systems
Genealogy, batch and serial-number traceability, SPC dashboards and CAPA workflows compliant with ISO 9001 and 21 CFR Part 11.
Compliance
Regulations & standards we work to
ISO 9001 · ISO 27001 ready · SOC 2 Type II in progress · IEC 62443 OT security · NIS2 aware
ISO 9001 ISO 27001 IEC 62443 (OT security) NIS2 (EU) GDPR 21 CFR Part 11 (FDA) EU Annex 11 (GMP) OPC UA MQTT Sparkplug B ISA-95 ISA-88 (batch) DSCSA (US pharma supply chain) EU FMD EPCIS / GS1 CMMC (US defense) NIST SP 800-82 (ICS) CE / UKCA marking awareness
Process
Delivery process
1. Discovery
Plant walk-through, OT/IT inventory, ISA-95 level mapping, ERP and PLM landscape, regulator scope (FDA, EMA, NIS2 competent authority).
2. Architecture
IEC 62443 zone/conduit diagram, ISA-95 data model, edge-vs-cloud split, validation strategy and SL-T targets agreed before sprint one.
3. Build
Two-week sprints with hardware-in-the-loop testing, OPC UA conformance checks, 21 CFR Part 11 audit-trail regression and shop-floor pilots.
4. Launch & operate
Line-by-line rollout, operator training, OT-aware 24/7 on-call, change-control to GAMP 5 and quarterly OT cybersecurity reviews.
Cases
Selected Manufacturing case studies
Industrial · Manufacturing
CheckList
Offline-first ecosystem replacing paper journals for reactor process control — Android, admin, controller dashboard.
Manufacturing · E-commerce
REHAU
B2B e-commerce and product configurator for a global polymer manufacturer with multi-region pricing, stock and dealer workflows.
Why YuSMP
Why manufacturing teams choose YuSMP
OT-aware engineers
Senior engineers who respect plant-floor reality: IEC 62443 zones, change-window discipline, deterministic protocols and validated states.
ISA-95 and OPC UA fluency
ISA-95 information models, OPC UA companion specifications and Sparkplug B unified namespaces — production-grade, not POC.
Validation-friendly SDLC
GAMP 5 categorization, URS/FS/DS/IQ/OQ/PQ artefacts and 21 CFR Part 11 audit trails — without grinding velocity to a halt.
Compliance posture: ISO 9001 · ISO 27001 ready · IEC 62443 aware · NIS2-ready governance · 21 CFR Part 11 / Annex 11 capable · GDPR-aligned · CMMC-aware for US defense supply chains.
FAQ
Manufacturing FAQ
How do you handle OT cybersecurity under IEC 62443 and NIS2?
We design plant-floor systems against IEC 62443-3-3 system requirements (zones, conduits, SL targets) and align governance to NIS2 essential-entity duties — including incident reporting timelines, supply-chain controls and board-level accountability.
Do you build MES and OEE platforms?
Yes. We deliver MES and OEE platforms aligned to ISA-95 levels 2-4: production orders, work-in-progress tracking, downtime classification, OEE/TEEP calculation and ERP integration with SAP S/4HANA, Oracle and Microsoft Dynamics.
Can you integrate via OPC UA, MQTT and Modbus?
Yes. We build edge gateways speaking OPC UA, MQTT Sparkplug B, Modbus TCP/RTU and proprietary PLC protocols (Siemens S7, Rockwell EtherNet/IP, Beckhoff ADS), normalized into a unified namespace for cloud and on-prem consumers.
What about 21 CFR Part 11 for pharma and medical-device manufacturing?
For FDA-regulated production we deliver 21 CFR Part 11 electronic records and signatures, audit trails, role separation and validation packages (URS/FS/DS/IQ/OQ/PQ) and align with EU Annex 11 for European facilities.
Do you build predictive maintenance ML?
Yes. We build sensor pipelines, anomaly detection and remaining-useful-life models with explainability, drift monitoring and a clear feedback loop to maintenance and reliability engineers — not just dashboards.
How do you cover DSCSA for US pharma supply chain?
We deliver DSCSA-compliant serialization, aggregation and EPCIS event capture across packaging lines and warehouses, with trading-partner verification and saleable-returns workflows in line with FDA enforcement timelines.
Ship your next plant-floor system with senior US & EU engineers
Response within 1 business day. NDA on request.