System Integration & Interface Development – From Information Islands to the Connected Plant
This part of software development has always fascinated me in particular. A substantial part of a system’s value comes from how well it can communicate with other systems: distributed data becomes centrally available information.
As digitalization has advanced, it has become essential to connect, extract, transfer, and transform information from different subsystems into a usable form. That is the path from “information islands” to a “connected plant”.
I have experience connecting information systems across a wide range of projects and industries.
My USP: I combine requirements engineering, project management, and technical development in one role — from stakeholder workshops and interface specifications to productive integration.
In regulated environments (GxP, CSV), this combination is especially valuable: requirements are not only understood, but translated directly into implementable, validatable solutions.
Why Integrations Are Strategically Critical
Digital Plant Maturity Model (Biophorum)
Digital Plant Maturity describes the maturity level of digitalization in BioPharma production environments.
The decisive step: from information islands to the connected plant — through the integration of subsystems such as LIMS, MES, ERP, analytical instruments, and process control systems.
Only connected data enables:
- Real-time transparency across production processes
- Data-based decisions (process analytics, PAT)
- Automated compliance documentation
- Digital workflows without media breaks
Why Requirements Engineering Is Critical in Integrations
Integrations often fail not because of technology, but because of:
- Unclear requirements: which data, when, in what format?
- Lack of stakeholder alignment: IT, business units, QA, and vendors all have different perspectives
- Underestimated governance effort: CSV, traceability, change control in regulated environments
- Insufficient traceability: which business requirement leads to which technical interface?
My approach: structured requirements workshops, interface specifications with use cases, a traceability matrix between business and system requirements, and vendor coordination with clear acceptance criteria.
My Approach in Integration Projects
Successful integrations require more than technical know-how. I cover the entire project cycle:
Requirements & Concept
- Stakeholder Workshops: IT, business units, QA, management, vendors
- Interface Specifications: data models, mapping tables, protocols
- Use Cases & User Stories: who needs which data, when, and why?
- Traceability: from business requirement to technical interface
- Acceptance Criteria: measurable success criteria for go-live
Project Management
- Vendor Coordination: alignment with LIMS, PACS, ERP, and instrument vendors
- Risk Management: identification and mitigation of integration risks
- Testing Strategy: IQ/OQ/PQ in regulated environments
- Stakeholder Communication: status reports, escalation, change requests
- Milestones & Deliverables: structured project phases with clear deliverables
Technical Implementation
- REST APIs: design, implementation, documentation (Swagger/OpenAPI)
- OPC/UA: Industry 4.0 standard for production equipment
- Custom Integrations: C#/.NET, file-based (CSV, XML, JSON), database triggers
- Cloud Integration: Azure IoT Hub, Event Hub, Blob Storage, Functions
- Instrument Integration: Hamilton, Tecan, AMBR, Siemens BGA, SIMCA
Industry Expertise: Healthcare IT & BioPharma
Healthcare IT (MCC.NET 2006-2011)
PACS Integration (Picture Archiving and Communication System)
- Visus PACS : integration into RIS (Radiology Information System)
- Bidirectional communication: requests from HIS → PACS, findings/images back
- DICOM workflow integration
Archiving (d.velop D.3)
- Generic archiving interface for different document types
- Metadata mapping between HIS and archive system
- Audit-proof long-term archiving
Dictation & Speech Recognition
- Philips SpeechMagic : speech recognition for clinical documentation
- 4voice : dictation workflow management
- Dictanet : network-based dictation solution
- Grundig DIGTA : concept phase only (not implemented)
- Kuhlmann MBS Easy : middleware for dictation systems
Order Module for Laboratory/Radiology
- Requirements engineering with stakeholders: physicians, nursing staff, laboratory, IT, management
- Bidirectional communication: order → FAP → report → HIS
- Appointment management
BioPharma & Life Science
LabWare LIMS: Instrument Integration
- AMBR (Automated Mini Bioreactor): fermentation, Process Science
- TECAN Fluent : pipetting robot, high-throughput screening
- Hamilton : pipetting robot, sample preparation
- Siemens BGA/Rapidlab : blood gas analyzer, interface service
- Sartorius SIMCA : multivariate data analysis
- Bidirectional communication: LIMS sends worklists → instrument executes → results return to LIMS
QIAGEN: Azure IoT Hub, Event Hub, Shop Floor Data Acquisition
- IPC (In-Process Control) : real-time data capture from production equipment
- Azure IoT Hub : device-to-cloud messaging
- Azure Event Hub : high-throughput event streaming
- Mettler-Toledo LabX : balance integration
- B&P LP4/LP5 : label printing integration
- Vendor coordination in a regulated production environment
PAuLa: ERP Integration (Navision Financials)
- Bidirectional data synchronization: production orders, batches, material
- Custom LIMS (Delphi) ↔ Navision ERP
- Elimination of information islands in peptide production
Additional Integrations
- OPC/UA : standardized communication with PLCs (SIMATIC)
- Computer Vision : Infaimon/Stemmer Imaging
- Leak Tester : Tecnics
- MOXA : industrial networking
Integrated Systems & Devices
Over more than 25 years, I have designed, specified, and implemented integrations for a wide range of systems:
Laboratory Instruments
- Hamilton Pipetting Robot : automated liquid handling
- Tecan Fluent Pipetting Robot : high-throughput screening
- AMBR (Automated Mini Bioreactor) : fermentation, Process Science
- Siemens BGA/Rapidlab : blood gas analyzer, interface service
- Sartorius SIMCA : multivariate data analysis
- Mettler-Toledo LabX : balance integration
- Oligonucleotide Synthesizers (various types)
- Peptide Synthesizers (various types)
Healthcare IT Systems
- Visus PACS : picture archiving and communication system
- d.velop D.3 : archiving system
- Philips SpeechMagic : speech recognition
- 4voice : dictation workflow management
- Dictanet : network-based dictation
- Kuhlmann MBS Easy : dictation middleware
- Grundig DIGTA : dictation concept
- MCC.NET HIS/KIS : hospital information system
Manufacturing & IPC
- OPC/UA : Industry 4.0 standard
- SIMATIC (Siemens) : PLC integration
- MIKRON : manufacturing equipment
- Tecnics Leak Tester : quality control
- Infaimon/Stemmer Computer Vision : optical inspection
- MOXA : industrial networking
- B&P LP4/LP5 : label printing
- Azure IoT Hub / Event Hub : cloud data acquisition
ERP & Business Systems
- Navision Financials : ERP integration (PAuLa LIMS)
- LabWare LIMS : v6, v7 – custom integration framework
- Custom LIMS (PAuLa): Delphi-based, MSSQL
Integration Technologies
- REST APIs : design, implementation, documentation
- File-based : CSV, XML, JSON
- Database : triggers, stored procedures, views
- Message Queuing : Azure Service Bus, Event Hub
- Custom Protocols : serial, TCP/IP, OPC/UA
Project Highlights: References
QIAGEN: Azure IoT/Event Hub, Shop Floor Data Acquisition
Period: 2020–2023 | Role: IT Project Engineer
Context: Transition from isolated workstations to a fully automated production line (QIAStatDx Large Scale Line)
Tasks:
- Interface definition and coordination for the large-scale line
- IPC concept and implementation for shop floor data acquisition
- Azure data transfer (IoT Hub, Event Hub, Blob Storage, MSSQL)
- Vendor coordination (Mettler-Toledo LabX, B&P label printing)
- Cross-functional collaboration: hardware, data science, QA
Special Aspect:
Combining requirements engineering (stakeholder workshops), project management (vendor coordination), and technical implementation (Azure IoT) in a regulated production environment.
LabWare LIMS: Instrument Integration (AMBR, TECAN, BGA)
Period: 2015–present | Role: LIMS Consultant & Requirements Engineer
Context: BioPharma Process Science – fermentation, upstream/downstream analytics
Tasks:
- Requirements workshops with lab scientists, QA, IT
- Interface specification: worklists, result import, error handling
- Custom integration framework (C#, LIMS Basic, Oracle PL/SQL)
- Bidirectional communication: LIMS ↔ AMBR, TECAN, Siemens BGA
- CSV-compliant documentation (IQ/OQ, traceability matrix)
Special Aspect:
Development of a reusable integration framework that can be configured for different instruments — significantly reducing time-to-market for new integrations.
MCC.NET: PACS/RIS, Archiving, Dictation Systems
Period: 2006–2011 | Role: Developer & Requirements Engineer
Context: Healthcare IT – hospital information system (HIS/KIS)
Tasks:
- Generic interface development for PACS (Visus), archiving (d.velop D.3)
- Integration of 5 different dictation systems (Philips, 4voice, Dictanet, etc.)
- Requirements engineering: physicians, nursing staff, laboratory, IT, management
- Development of an order module (laboratory/radiology)
- FAP/RIS (Functional Workplace / Radiological Information System)
Special Aspect:
Stakeholder management in a highly complex environment: clinicians expect intuitive UIs, IT expects maintainability, management expects ROI — requirements engineering as the bridge between all worlds.
Peptide LIMS: ERP Integration (Navision Financials)
Period: 2002–2015 | Role: LIMS Designer & Developer
Context: Peptide Automation Lane – custom LIMS for peptide production
Tasks:
- Requirements engineering: audit of existing workflows, stakeholder interviews
- Concept and design: from information islands to a connected system
- ERP integration (Navision): production orders, batches, material
- Database design (MSSQL), software design and implementation (Delphi)
- Integration of synthesizers, analytical and preparative HPLCs, barcode scanners, mass spectrometers
Special Aspect:
Complete LIMS developed from scratch — from requirements through data model to implementation. Elimination of media breaks between production, QC, and accounting.
Governance & Compliance in Integrations
In regulated environments (GxP, FDA 21 CFR Part 11, EU GMP Annex 11), integrations are especially critical — they transfer data between validated systems and must themselves be validated.
GxP-Compliant Documentation & CSV
Interface Documentation
- Interface Specification Document (ISD): detailed description of the interface (data model, mapping, protocol)
- Data Flow Diagrams: visualization of the data flow between systems
- Error Handling & Logging: what happens in case of errors? How is it audited?
- Security Considerations: encryption, authentication, authorization
CSV for Integrated Systems
- IQ (Installation Qualification): is the integration installed correctly?
- OQ (Operational Qualification): does the interface work as specified?
- PQ (Performance Qualification): does the integration fulfill the business requirements?
- Test Scripts: automated and manual tests for regression testing
Traceability & Data Integrity
Traceability Across Systems
- Requirements Traceability Matrix (RTM): from business requirement to test case
- Data Lineage: where does a data point come from? Which transformations were applied?
- Audit Trail: who transferred/changed which data and when?
Data Integrity (ALCOA+)
- Attributable: who created/transferred the data?
- Legible: is the data readable and understandable?
- Contemporaneous: is the data transferred in a timely manner?
- Original: is the source of the data traceable?
- Accurate: was the data transferred correctly (checksums, validation)?
Change Control
- Impact Assessment: which systems are affected by a change?
- Re-Validation: do tests need to be repeated?
- Version Control: interface versions must be traceable
Why I Am Especially Strong in This Area
As a requirements engineer, project manager, and developer, I understand all three perspectives: I know which governance requirements apply, how to integrate them into project plans, and how to implement them technically — without one slowing down the other .
Typical Project Roles in Integration Projects
Requirements Engineer
Stakeholder workshops, interface specifications, use cases, traceability matrix, acceptance criteria
Integration Project Manager
Vendor coordination, risk management, testing strategy, stakeholder communication, milestones
Integration Developer
REST API design and implementation, OPC/UA, custom integrations (C#/.NET), cloud integration (Azure)
Validation Lead
CSV documentation (IQ/OQ/PQ), test scripts, traceability matrix, data integrity (ALCOA+)
Vendor Coordinator
Alignment with LIMS, PACS, ERP, and instrument vendors, interface agreements, SLA definition
Technical Writer
Interface specification documents, user manuals, SOPs, change control documentation
One Point of Contact for All Phases
The advantage: I can cover all of these roles — depending on project phase and need. This reduces communication overhead and ensures that requirements, project management, and technical implementation fit together seamlessly.