System Integration & Interface Development

Healthcare & BioPharma – From Information Silos to Connected Plant

25+ years of experience in connected information systems across various projects and industries.

My USP: I combine Requirements Engineering , Project Management , and Technical Development in one person – from stakeholder workshops through interface specifications to production integration.

In regulated environments (GxP, CSV), this combination is particularly valuable: requirements are not just understood, but directly translated into implementable, validatable solutions.

Why Integrations Are Strategically Critical

Digital Plant Maturity Model (Biophorum)

The Digital Plant Maturity describes the maturity level of digitalization in BioPharma production environments.

The decisive step: From information silos to Connected Plant – through networking of subsystems (LIMS, MES, ERP, analytical instruments, process control systems).

Only connected data enables:

  • Real-time transparency across production processes
  • Data-driven decisions (Process Analytics, PAT)
  • Automated compliance documentation
  • Digital workflows without media breaks
Why Requirements Engineering Is Critical for Integrations

Integrations often fail not due to technology, but because of:

  • Unclear requirements: Which data, when, in what format?
  • Missing stakeholder alignment: IT, business units, QA, vendors – all have different perspectives
  • Underestimated governance effort: CSV, traceability, change control in regulated environments
  • Lack of traceability: Which business requirement leads to which technical interface?

My approach: Structured requirements workshops, interface specifications with use cases, traceability matrix between business and system requirements, vendor coordination with clear acceptance criteria.

My Approach to 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, 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, instrument vendors
  • Risk Management: Identification & 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 facilities
  • 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)
  • Bi-directional communication: Requests from HIS → PACS, reports/images back
  • DICOM workflow integration
Archiving (d.velop D.3)
  • Generic archiving interface for various 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 (not implemented)
  • Kuhlmann MBS Easy : Middleware for dictation systems
Order Entry Module for Lab/Radiology
  • Requirements engineering with stakeholders: physicians, nurses, lab, IT, management
  • Bi-directional communication: Request → 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
  • Bi-directional communication: LIMS sends worklists → instrument executes → results back to LIMS
QIAGEN: Azure IoT Hub, Event Hub, Shop Floor Data Acquisition
  • IPC (In-Process Control) : Real-time data acquisition from production facilities
  • 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 regulated production environment
PAuLa: ERP Integration (Navision Financials)
  • Bi-directional data synchronization: Production orders, batches, material
  • Custom LIMS (Delphi) ↔ Navision ERP
  • Elimination of information silos 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 25+ years, I have designed, specified, and implemented integrations for a wide variety of systems:

Laboratory Instruments
  • Hamilton Pipetting Robots : Automated liquid handling
  • Tecan Fluent Pipetting Robots : 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 : Archive 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 integrations 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 fully automated production line (QIAStatDx Large Scale Line)

Responsibilities:
  • Interface definition & coordination for Large Scale Line
  • IPC concept & 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 Feature:

Combination of 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

Responsibilities:
  • Requirements workshops with lab scientists, QA, IT
  • Interface specification: Worklists, result import, error handling
  • Custom integration framework (C#, LIMS Basic, Oracle PL/SQL)
  • Bi-directional communication: LIMS ↔ AMBR, TECAN, Siemens BGA
  • CSV-compliant documentation (IQ/OQ, traceability matrix)
Special Feature:

Development of a reusable integration framework that can be configured for different instruments – significantly reduces 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)

Responsibilities:
  • Generic interface development for PACS (Visus), archiving (d.velop D.3)
  • Integration of 5 different dictation systems (Philips, 4voice, Dictanet, etc.)
  • Requirements engineering: Physicians, nurses, lab, IT, management
  • Development of an order entry module (lab/radiology)
  • FAP/RIS (Functional Workplace / Radiological Information System)
Special Feature:

Stakeholder management in highly complex environment: Clinicians expect intuitive UIs, IT expects maintainability, management expects ROI – requirements engineering as a bridge between all worlds.

PAuLa: ERP Integration (Navision Financials)

Period: 2002–2015 | Role: LIMS Designer & Developer

Context: Peptide Automation Lane – Custom LIMS for peptide production

Responsibilities:
  • Requirements engineering: Audit of existing workflows, stakeholder interviews
  • Concept & design: From information silos to connected system
  • ERP integration (Navision): Production orders, batches, material
  • Database design (MSSQL), software design & implementation (Delphi)
  • Integration of synthesizers, HPLC, barcode scanners
Special Feature:

Complete LIMS developed from scratch – from requirements through data model to implementation. Elimination of media breaks between production, QC, and financial accounting.

Governance & Compliance for Integrations

In regulated environments (GxP, FDA 21 CFR Part 11, EU GMP Annex 11), integrations are particularly critical – they transfer data between validated systems and must themselves be validated.

GxP-Compliant Interface Documentation
  • Interface Specification Document (ISD): Detailed description of the interface (data model, mapping, protocol)
  • Data Flow Diagrams: Visualization of data flow between systems
  • Error Handling & Logging: What happens with errors? How is it audited?
  • Security Considerations: Encryption, authentication, authorization
CSV for Integrated Systems
  • IQ (Installation Qualification): Is the integration correctly installed?
  • OQ (Operational Qualification): Does the interface work as specified?
  • PQ (Performance Qualification): Does the integration meet business requirements?
  • Test Scripts: Automated & manual tests for regression testing
Traceability Between Systems
  • Requirements Traceability Matrix (RTM): From business requirement to test case
  • Data Lineage: Where does a data point come from? What transformations were performed?
  • Audit Trail: Who transferred/changed which data when?
Data Integrity (ALCOA+)
  • Attributable: Who created/transferred the data?
  • Legible: Is the data readable and understandable?
  • Contemporaneous: Is data transferred in a timely manner?
  • Original: Is the source of the data traceable?
  • Accurate: Was data transferred correctly (checksums, validation)?
Change Control
  • Impact Assessment: Which systems are affected by a change?
  • Re-Validation: Must tests be repeated?
  • Version Control: Interface versions must be traceable
Why I'm Particularly Good at This:

As a requirements engineer, project manager AND developer, I understand all three perspectives: I know which governance requirements are needed, 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 & 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

Coordination with LIMS, PACS, ERP, instrument vendors, interface agreements, SLA definition

Technical Writer

Interface specification documents, user manuals, SOPs, change control documentation

One Contact for All Phases

The advantage: I can fill all these roles – depending on project phase and needs. This reduces communication overhead and ensures that requirements, project management, and technical implementation seamlessly integrate.

Ready for Your Integration Project?

Are you planning a system integration in Healthcare IT or BioPharma?
Do you need a contact person who combines requirements engineering, project management AND technical implementation?

Let's talk – whether LIMS, PACS, ERP, OPC/UA, or Azure IoT Hub:
I bring 25+ years of experience in connected information systems.

Related Topics
Requirements Engineering
LIMS Consulting
Software Development
Integrations Overview

Integrations with Laboratory Context

In the laboratory environment, the networking of production and quality data creates a laboratory information system.

By combining the various technical aspects of a product or analyte, we achieve a comprehensive and meaningful overall perspective.


I have already integrated or developed integration concepts for the following systems:

Healthcare IT & Clinical Systems

During my time in healthcare IT, I contributed to the development and integration of clinical information systems. My work focused on ensuring seamless communication between medical software components and improving clinical workflows.

  • Generic integration of archiving systems — specifically for a project involving the D.3 system by d.velop within MCC.NET.
  • Design and implementation of integrations for various dictation and speech recognition systems into MCC, enabling clinicians to document efficiently:
  • Integration of Visus PACS (Picture Archiving and Communication System) into a RIS (Radiology Information System) to centralize medical imaging and related patient data.

Integrations in Laboratory Environments

In laboratory environments, networking production and quality data creates a laboratory information system.

By bringing together the various technical aspects of a product or analyte, a holistic and meaningful overall perspective emerges.


I have already implemented or developed integrations and integration concepts for the following systems:

Healthcare IT & Clinical Systems

During my time in healthcare IT, I contributed to the development and integration of clinical information systems. My focus was on ensuring seamless communication between medical software components and improving clinical workflows.

  • Generic integration of archiving systems — specifically in a project with the D.3 system from d.velop within MCC.NET .
  • Concept and implementation of integrations for various dictation and speech recognition systems in MCC, enabling efficient documentation for clinicians:
  • Integration of Visus PACS (Picture Archiving and Communication System) into an RIS (Radiology Information System), centralizing medical imaging data and associated patient information.

These projects required both an understanding of the technical constraints of the systems and clinical workflows. The goal was to implement integrations that efficiently support healthcare professionals while ensuring compliance and data integrity.

This work required understanding both the technical constraints of the systems and the clinical workflows, ensuring that the integrations supported healthcare professionals efficiently while maintaining compliance and data integrity.