LIMS Consulting & Project Management
From strategic consulting to successful go-live
With over 25 years of experience in Laboratory Information Management Systems, I support you in the selection, implementation, migration, and optimization of your LIMS – across industries in BioPharma, Healthcare, and Life Science .
As an IREB/CPRE certified Requirements Engineer and experienced Project Manager , I combine structured methodology with technical hands-on expertise and deep understanding of regulated environments.
My Service Portfolio
End-to-End LIMS Services – from initial concept to productive operation
Strategic Consulting
- LIMS Readiness Assessment
- System Selection & Vendor Evaluation
- Make-or-Buy Analysis
- ROI & Business Case
- Roadmap Development
Requirements Engineering
- Stakeholder Workshops
- AS-IS / TO-BE Analysis
- Requirements Specification (SRS)
- Use Cases & UML
- Traceability Management
Project Management
- End-to-End Project Leadership
- Agile & Waterfall
- Resource & Timeline Planning
- Risk & Change Management
- Stakeholder Communication
Implementation
- System Design & Architecture
- Customization & Configuration
- Workflow Design
- Interface Development
- Reporting Concepts
Migration
- Migration Strategy
- Gap Analysis
- Data Migration
- Labware v6→v7
- Legacy System Replacement
Integration
- Instrument Integration
- ERP Integration
- HIS/KIS Integration
- PACS/RIS Integration
- REST APIs, OPC/UA
Validation Support
- CSV Documentation (SRS, URS)
- Requirements Traceability
- Test Scenarios & Acceptance Criteria
- GxP-compliant Specifications
- Validation-Ready Documentation
Optimization
- Performance Tuning
- Workflow Optimization
- User Adoption
- Training & Education
- Continuous Improvement
Industry Expertise
25+ years of experience in regulated and innovation-driven environments
BioPharma & Life Science
Labware LIMS Expertise (2012–2025)
- Biopharma Process Science: Fermentation, Upstream/Downstream, IPC, QC/QA
- Biotech: Peptide/DNA Synthesis, Biopolymers, Oligonucleotide Production
- PCR Test Kit Production: QA Workflows, Shop Floor Data Acquisition
Projects & Focus Areas
- Labware v6→v7 Migration: Requirements Engineering, Gap Analysis, Custom Frameworks
- LIMS Development (PAuLa): Greenfield LIMS for Peptide Automation (Thermo Fisher, 2002-2015)
- Instrument Integration: AMBR, TECAN, Siemens BGA/Rapidlab, Hamilton, Synthesizers
- Custom Frameworks: AutoCalc, ProdSpec2Result, CSV Import, HTML Reporting
- ERP Integration: Navision Financials
Healthcare IT & Clinical Laboratories
MCC.NET – Hospital Information System (2006–2011)
MEIERHOFER AG, Munich – Software Engineering for Electronic Patient Record (EPR/HIS)
LIMS-Relevant Experience
- Requirements Engineering: Clinical workflows, laboratory requirements, functional area integration
- Requirements Module: Order management for laboratory, radiology, therapy
- FAP/RIS Development: Functional Workplace / Radiology Information System
-
System Integrations:
- PACS: Visus PACS (Picture Archiving and Communication System)
- Archiving: d.velop D.3 (Document Archiving)
- Dictation & Speech Recognition: Grundig DIGTA, Dictanet, Philips SpeechMagic, 4voice
- Data Integration: Patient Data, Lab Results, Medical Imaging
- Compliance: Medical Device Directive, Data Protection, Clinical Workflows
Transferable Skills
- Complex stakeholder landscapes (physicians, nurses, lab, IT, management)
- Regulated environments & compliance
- System integration (Lab ↔ Hospital ↔ Archive ↔ Imaging)
- Workflow design for highly specialized user groups
Why LIMS Projects Succeed with Me
Structured Methodology
IREB/CPRE Certified: Requirements Engineering according to international standards guarantees traceable, testable requirements – essential for CSV/GxP and critical for project success.
PRINCE2 Agile: Flexible adaptation to your project methodology (Agile, Waterfall, Hybrid).
Stakeholder-Centric
People at the Center: Laboratory staff, QA, IT, management – I understand the different perspectives and create alignment.
Empathy + Analytics: Through active listening, targeted questions, and workshops, requirements emerge that reflect real needs.
Regulatory Competence
GxP Experience: 21 CFR Part 11, Data Integrity (ALCOA+), CSV, GAMP 5
Audit-Ready: Traceability Matrix, complete documentation, Validation-Ready
Technical Depth
Hands-on Developer: Not just a "PowerPoint consultant" – I understand and implement technical solutions myself.
Tech Stack:
- Labware LIMS (v6/v7, LIMS Basic, Oracle PL/SQL)
- C# / .NET Core (Custom Tools, Integrations, Services)
- Node.js (Reporting Frameworks, JANUS Code Review Tool)
- Databases: Oracle, MSSQL (Performance Tuning, Stored Procedures)
- Integration: REST APIs, OPC/UA, Azure IoT/Event Hub
End-to-End Perspective
From Strategy to Support: Not just partial aspects, but the complete LIMS lifecycle.
Integration Mindset: LIMS is not a standalone system – I think in networked information systems (ERP, instruments, HIS, PACS).
Innovative Tooling
JANUS: Own tool for code quality assurance in Labware migrations (Package Diff, Code Review)
Custom Frameworks: Reusable solutions that save time and costs
Flexibly Deployable: Possible Project Roles
Depending on project size, phase, and your needs, I can take on or combine various roles:
Requirements Engineer
Requirements analysis, workshops, specification, use cases, traceability
LIMS Consultant
Strategic consulting, system selection, best practices, architecture review
Project Manager
End-to-end project leadership, planning, risk management, stakeholder communication
Business Analyst
Process analysis, optimization, data modeling, KPI definition
System Architect
LIMS architecture, integration design, technology selection
LIMS Developer
LIMS Basic, PL/SQL, custom frameworks, integrations, reporting
Validation Support
CSV documentation, test scenarios, traceability matrices, requirements validation
Integration Specialist
Instrument, ERP, HIS, PACS integration, REST APIs, OPC/UA
Selected References
QIAGEN GmbH (2020–2023)
IT Project Engineer for IPC & Shop Floor Data Acquisition in fully automated PCR test kit production
BioPharma Process Science (2024–2025)
Labware LIMS Consulting: v6→v7 Migration, Requirements Engineering, Custom Frameworks
Thermo Fisher Scientific (2002–2015)
PAuLa – Peptide Automation Lane: Greenfield LIMS development for peptide production & QA
MEIERHOFER AG (2006–2011)
MCC.NET Development: Healthcare IT, EPR/HIS, PACS/RIS integration, archiving
Your LIMS Project Deserves Professional Support
Are you planning a
LIMS implementation, migration, or optimization
?
Do you need an experienced
Requirements Engineer, consultant, or project manager
?
Let's talk – I look forward to your inquiry.
Get in Touch