IT/OT Integration
Connecting shopfloor equipment, automation, manufacturing systems and enterprise IT.
RN-SYCON GMBH
Connecting manufacturing, quality, automation and IT.
RN-Sycon supports life-sciences and industrial organizations at the intersection of manufacturing systems, IT/OT integration and regulated operations — from strategy and architecture through implementation, validation and lifecycle support.
Industrial Systems
MES, eBR, SAP integration, manufacturing data and regulated system lifecycle.
IT Solutions
Infrastructure, architecture, cybersecurity and reliable operational technology.
EXPERTISE
Pharma manufacturing systems — from Level 1 to Level 4.
MES
Körber PAS-X · Siemens Opcenter
ERP
SAP S/4HANA / ECC · PP · QM · Manufacturing interfaces
OT
PLC · HMI/SCADA · DCS / PCS 7 · OPC UA · MQTT
Data
OSIsoft / AVEVA PI · SQL / PostgreSQL · APIs · Manufacturing data
Compliance
GAMP 5 · CSV · CQV · Data Integrity · Annex 11 · 21 CFR Part 11
Architecture
ISA-95 / ISA-88 · IT/OT networks · segmentation · system lifecycle
SERVICES
Focused expertise for digital manufacturing.
MES & eBR
Manufacturing execution, MBR/eBR lifecycle, batch execution, exception handling and Review by Exception.
Automation & IT/OT
Manufacturing IT/OT architecture, equipment integration, PLC/SCADA/DCS environments and OT lifecycle coordination.
GxP · CSV · CQV
GAMP 5, CSV, CQV, Data Integrity, EU GMP Annex 11, 21 CFR Part 11, risk-based validation, qualification and change control.
SAP & Integration
SAP manufacturing integration, interfaces between ERP, MES, quality systems, equipment and manufacturing data.
Manufacturing Data
Historian and process-data integration, CPP/CQA context, APIs and interoperable manufacturing architectures.
OT Cybersecurity
Segmentation, secure connectivity, infrastructure lifecycle, backup/restore and disaster-recovery concepts.
PEOPLESOLUTIONSEXPERTISEA CONNECTED MANUFACTURING FUTURE
CONNECTED EXECUTION
From fragmented manufacturing
From fragmented manufacturing
systems to one connected
execution flow.
Production orders originate in ERP. Process values come from equipment. Quality results may live in LIMS, while time-series data resides in the historian. Batch execution and review can span several systems — and sometimes paper.
The RN-Sycon Manufacturing Platform is being designed to connect these elements around the manufacturing batch while preserving existing systems where they add value.
RN-SYCON SOLUTIONS · IN DEVELOPMENT
RN-Sycon Manufacturing Platform
Modular GxP Manufacturing Execution, eBR & Quality Integration for Life Sciences.
Integration-first · Brownfield-friendly · Validation-ready design
SAP / ERP→MBR→Batch Execution→
Equipment→CPP / CQA→IPC / QC→
eBR→Review by Exception→QA Release
LEVEL 4ERP / SAP
LEVEL 3MES · eBR · Quality · LIMS
LEVEL 2SCADA / DCS · Historian
LEVEL 1PLC · Equipment · OPC UA / MQTT
THE CHALLENGE
Manufacturing data is often fragmented across paper, ERP, equipment, quality systems and historians.
→
THE RN-SYCON APPROACH
Connect execution, equipment, quality and batch data around one controlled manufacturing workflow.
PRODUCT HIGHLIGHT
Graphical MBR Designer
Build regulated manufacturing workflows visually instead of hiding process logic in cryptic formulas. Configure process steps, transitions, parameters, CPPs, CQAs and required equipment in one understandable model.
01Material VerificationMaterial · Batch · Quantity
→
02Equipment ReadinessClean · Calibrated · Qualified
→
03Process StepCPP: Temperature · Pressure
→
04IPC / CQASample · Result · Specification
→
05QA RevieweSignature · Release
REFERENCE ARCHITECTURE
Connected Manufacturing from ERP to Equipment
Open integration across business, manufacturing, quality and shopfloor systems — without coupling the MES directly to every control system.
ISA-95 · LEVEL 4
SAP / ERPOrders · Materials · BOM · Routing
Data PlatformAnalytics · Reporting · Cross-system data
Production Orders↓Confirmations / Release
ISA-95 · LEVEL 3
RN-Sycon Manufacturing PlatformMBR · Batch Execution · Equipment Readiness · eBR · RbE
Quality / LIMSIPC · QC Results · Holds · Release
CMMS / CalibrationMaintenance · Calibration · Qualification
INTEGRATION LAYER
REST / APIOPC UAMQTTEvents / Messaging
ISA-95 · LEVEL 2
SCADA / DCSProcess supervision · Equipment status
HistorianTime-series · CPP / CQA · Process context
Commands / Context↓Actual Values / Status
ISA-95 · LEVEL 1
PLCControl
EquipmentState · Parameters
Sensors / IPCMeasurements · Samples
Integration-firstBrownfield-friendlyGxP-orientedSegmented IT/OTVendor-neutral interfaces
Start small. Prove value. Scale deliberately.
Discuss a pilot, design partnership or brownfield integration use case.
Discuss a Pilot / Design Partnership
Concept and development platform. Production use in regulated environments requires project-specific validation, qualification and governance.
INTERIM & PROJECT SUPPORT
Senior Pharma MES / Manufacturing IT & IT/OT Consulting.
RN-Sycon provides independent interim and project support for pharmaceutical manufacturing organizations — bridging Manufacturing, Quality, Automation and IT while permanent capabilities are built or transformation programs are delivered.
Discuss interim supportTypical scope
- Automation & OT strategy and roadmap
- MES / equipment / data integration
- GMP / CSV / CQV lifecycle & change management
- OT infrastructure & security coordination
- Validation and technical documentation
- Vendor and stakeholder management
CONTACT
Let’s connect manufacturing and technology.
For interim support, project consulting or an initial discussion about digital manufacturing and IT/OT integration.
Pharma Manufacturing
MES & eBR
IT/OT Integration
GxP · CSV · CQV
Robert Nemsow
Senior Consultant
RN-Sycon GmbH · Switzerland
E-MAIL
info@rn-sycon.com
PHONE
+41 76 443 82 57
WEBSITE
www.rn-sycon.com
LOCATION
8404 Winterthur, Switzerland
PHARMA DIGITAL MANUFACTURING
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Connecting Pharma Manufacturing from ERP to Shopfloor
RN-Sycon helps regulated manufacturers connect execution, quality, equipment and manufacturing data — from the production order to the electronic batch record and QA release.
Digital Manufacturing
Paperless batch execution, MBR/eBR and controlled manufacturing workflows.
Connected Operations
Integration across ERP, MES, LIMS, historian, SCADA/DCS and equipment.
GxP by Design
CSV, CQV, Data Integrity and controlled system lifecycle for regulated environments.
SOLUTION AREAS
Manufacturing solutions built around the process
Manufacturing Execution & eBR
From production order to guided execution, electronic batch record, Review by Exception and QA release.
Manufacturing IT/OT Integration
Connect SAP, MES, LIMS, historian, SCADA/DCS and equipment through maintainable interfaces.
GxP Digitalization
CSV, CQV, Data Integrity, eSignatures, audit trail and lifecycle-oriented implementation.
Manufacturing Data & Intelligence
Bring equipment, process and quality data into manufacturing context for operations, review and improvement.
BROWNFIELD FIRST
Keep what works. Connect what is missing.
RN-Sycon supports existing manufacturing landscapes by integrating ERP, MES, quality, historian and automation systems rather than requiring a complete system replacement.
WHY RN-SYCON
Manufacturing. Quality. Automation. IT.
Manufacturing. Quality. Automation. IT.
Connected.
RN-Sycon brings pharmaceutical manufacturing-system experience, IT/OT integration and GxP delivery together — from strategy and architecture to implementation and lifecycle support.
Pharma Manufacturing Experience
Experience across sterile manufacturing, API environments and regulated batch processes.
MES & eBR Expertise
PAS-X, Siemens Opcenter, MBR/eBR concepts, batch execution and Review by Exception.
ERP-to-Shopfloor Integration
SAP PP/QM, manufacturing interfaces, equipment integration and contextual manufacturing data.
GxP · CSV · CQV Delivery
GAMP 5, Data Integrity, Annex 11 / Part 11 principles, validation and controlled lifecycle support.
SELECTED EXPERIENCE
Global PharmaSterile ManufacturingAPI ManufacturingMES / PAS-XSAP PP/QMManufacturing IT/OT