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Jonathan Boel

Division Head Software Solutions & Services | Industrial Engineer

Jonathan Boel is a trusted leader in software validation and regulatory compliance for life sciences, with over 10 years of experience in the pharmaceutical and biotech sectors. At QbD Group, he heads the Software Solutions & Services division, guiding clients through GxP compliance and digital transformation.

Biography

Jonathan Boel is a seasoned expert in software compliance and quality assurance, with a strong foundation in GMP, GCP, and GLP environments. Over the past decade, he has built a reputation for excellence in implementing software validation strategies that help organizations meet complex regulatory demands while optimizing their digital workflows.

He has led numerous successful projects within pharma and biotech, supporting companies in navigating shifting regulations and increasing digital maturity. Jonathan’s collaborative mindset and problem-solving abilities allow him to drive continuous improvement while maintaining the highest standards of quality and safety.

As Division Head of Software Solutions & Services, Jonathan actively supports his team and clients in adopting fit-for-purpose, risk-based validation strategies. His experience spans both pharma and medical device software, and he remains closely engaged with developments in AI/ML and digital health.

Jonathan is an active member of the ISPE SIG on AI/ML, and regularly shares his insights at international and Belgian industry events, including recent presentations on Agile Validation and the EU AI Act for medical device software.

Whitepaper - Digital Health - Exploring the landscape and future opportunities - QbD Group

Jonathan's key areas of expertise

GxP Software Validation

Deep expertise in risk-based validation of GxP-relevant software in pharma and medical devices.


 

Digital Transformation in Life Sciences

Supporting organizations in streamlining validation strategies through automation, innovation, and regulatory insight.

Agile & Modern Validation Approaches

Advocating for pragmatic validation methods aligned with modern development lifecycles.

AI & ML in Regulated Environments

Engaged in the evolving regulatory landscape around Artificial Intelligence in pharma and medical device software.

Explore our expert content

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AI Literacy Under the AI Act: Turning Compliance Into Opportunity

As of February 2, 2025, Article 4 of the EU AI Act is in force. This means...
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How to Perform Periodic Reviews of Computerised Systems

In regulated environments such as pharmaceutical manufacturing, laboratory...
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Pharma 4.0: The Next Leap in Pharmaceutical Innovation

The pharmaceutical industry has seen its fair share of revolutions. From...
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MDR & Cybersecurity: What Your Technical File Needs to Prove

Cybersecurity has become a fundamental requirement under the Medical Device...
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MDSW for Start-ups: A Practical Guide to Compliant Medical Software Development

Medical Device Software (MDSW) development can feel like a regulatory...
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Webinar - ATMP Supply Chain Navigating the Challenges and Exploring the Vein-to-Vein Strategy - QbD Group (2)

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