eQMS, CSV & Digitalization
Digital Quality Systems That Work – In Compliance and in Practice.
Senior support for eQMS, computerized system validation and digital Quality processes in regulated pharmaceutical, biotech and life-science environments.
From individual CSV activities to eQMS implementation and process digitalization – bringing together Quality, compliance and practical implementation.
Digitalization in GxP Is More Than Implementing Software.
Introducing a digital Quality System can improve efficiency, transparency and data availability – but in a regulated environment, technology alone is not enough.
Systems need to meet regulatory requirements. Processes need to be clearly defined. Validation needs to demonstrate that the system is fit for its intended use. Data integrity needs to be maintained throughout the system lifecycle.
And most importantly:
The digital solution needs to work for the people who actually use it.
With extensive hands-on experience in Quality Systems, CSV and digitalization, I support organizations in bridging the gap between Quality, IT, regulatory requirements and operational reality.
How I Can Support Your Digital Quality Systems
eQMS Implementation & Optimization
Support with the implementation, configuration and improvement of electronic Quality Management Systems.
Requirements · Processes · Configuration · Implementation · Continuous Improvement
Computerized System Validation (CSV)
Practical validation support throughout the lifecycle of computerized systems used in GxP-regulated environments.
Validation Strategy · Risk Assessment · Requirements · Testing · Documentation
Data Integrity
Support in developing and maintaining compliant approaches to electronic data and digital Quality processes.
Data Integrity · ALCOA+ Principles · Data Governance · Electronic Records
Digital Quality Workflows
Analysis and optimization of Quality processes before and during digitalization.
SOPs · CAPA · Deviations · Change Control · Training · Document Management
Electronic Signatures & Digital Documentation
Support with the implementation and practical use of electronic documentation and signature processes in regulated environments.
System & Process Optimization
Existing digital systems don't always work as efficiently as they should.
I can support your organization in reviewing existing workflows, identifying inefficiencies and improving processes, configurations and system use.
Don't Digitalize a Bad Process.
Digitalization doesn't fix inefficient processes. It can make them faster.
Before transferring an existing Quality process into a digital system, it is worth asking:
Does this process actually make sense?
I combine Quality Systems experience with digitalization expertise to help organizations review and optimize processes before – or while – implementing them digitally.
Simplify first. Digitalize second.
From Quality Process to Digital Solution
01 — UNDERSTAND
Understand the existing process, regulatory requirements and business needs.
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02 — OPTIMIZE
Identify unnecessary complexity, gaps and opportunities for improvement.
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03 — DEFINE
Translate the optimized process into clear system and user requirements.
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04 — IMPLEMENT & VALIDATE
Support implementation, testing, validation and compliant documentation.
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05 — IMPROVE
Monitor system performance and continuously improve workflows and usability.
eQMS Experience From the System Owner Perspective
I've Been Responsible for the System – Not Just the Project.
As Head of Quality Systems, I have been responsible for Quality Systems in an international pharmaceutical environment, including acting as System Owner for a global electronic Quality Management System (eQMS).
My experience includes system implementation, operation and continuous improvement as well as the Quality processes that these systems need to support.
GLOBAL eQMS
System Owner
5 COUNTRIES
Austria · France · UK · USA · Canada
GxP + IT
Quality & Digitalization
25+ YEARS
Pharma & Biotech
CSV & GxP Technology Experience
Computer Validation Officer
Concept Heidelberg
IT for Non-IT Professionals
GxP-focused IT systems and computerized-system lifecycle
Cloud Computing in the GxP Environment
Compliance · IT Security · Data Protection · Inspections · Cloud Infrastructure
Technology Should Support Quality – Not Create More Work.
A successful digital Quality System should make compliant work easier – not make compliance more complicated.
Flexible Digital Quality Support
You don't necessarily need a large implementation partner or additional permanent headcount.
Sometimes you need an experienced Quality professional to:
review a validation document, support a CSV activity, optimize a digital workflow, help define requirements, provide an independent Quality perspective during an implementation or temporarily support your existing project team.
That's exactly where flexible senior support can help.