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Shaping the regulated quality of tomorrow.
Articles and analysis from our own work across GxP, pharma, quality management, GAMP and AI - what is changing in the regulated environment, what it means in practice, and what is happening inside our company.
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5th Annual ACDM Symposium on AI in Clinical Trials | June 23-24, 2026
QFINITY will be attending the 5th ACDM Symposium on Artificial Intelligence in Clinical Trials (June 23-24, 2026, London) – represented by COO Marcus Schwabedissen, who will co-moderate the panel discussion “Turning AI into Impact: Real-World Applications in Clinical Data Management.”
QFINITY will be attending the 5th Annual ACDM Symposium on Artificial Intelligence in Clinical Trials, taking place on June 23-24, 2026, in London. The symposium brings together experts from pharmaceutical companies, CROs, and technology providers to discuss the current and future role of AI in clinical trials. The focus is on practical insights, real-world case studies, expert discussions, and opportunities for exchange on topics such as agentic AI, AI strategies, practical implementation experience, and the next phase of AI in clinical trials.
QFINITY will be represented by Marcus Schwabedissen, COO and Consultant at QFINITY. With his extensive experience in GxP-regulated life sciences and IT environments, computerized system validation, IT quality management, risk management, and regulatory compliance, he brings a practice-oriented perspective on the responsible and compliant use of AI-supported systems in regulated environments.
Together with Jennifer Duff and Tim Armitage, Marcus Schwabedissen will co-moderate the panel discussion “Turning AI into Impact: Real-World Applications in Clinical Data Management.” The focus is on where AI already creates real value in clinical data management today, where implementation remains challenging, and which organizational, technical, and regulatory prerequisites are needed to translate the potential of AI into measurable impact.
For QFINITY, the symposium is an important opportunity to exchange with international experts and discuss practical approaches to AI governance, validation, data integrity, and lifecycle management – and how AI can be used in regulated environments in a controlled, risk-based, and auditable way.
Live online training “GxP Systems & Digital Compliance Fundamentals” with QFINITY | May 8, 2026
The live online training “GxP Systems & Digital Compliance Fundamentals” takes place on 8 May 2026. QFINITY CEO Oliver Herrmann will deliver the training together with Martin Heitmann. The focus is on AI compliance, GMP requirements, Annex 11, and the Annex 22 Draft. The session will also present practical approaches for using AI safely in regulated GxP environments.
Artificial intelligence is making its way into more and more GMP-relevant processes and systems. This creates new opportunities – and new requirements for validation, data integrity, governance, and inspection readiness. The training addresses exactly this interface. It covers fundamentals and current developments in computerized systems and digital compliance, along with the regulatory-compliant use of AI in the GMP environment.
Participants will get a structured overview of the current Annex 11 requirements. The session will also discuss the possible impact of the revised Annex 11 drafts and the new regulatory perspectives arising from the Annex 22 Draft, and will include the ISPE GAMP perspective on good practices for the quality of computerized systems. A particular focus is the effective, safe, and compliance-oriented use of AI in GxP environments.
Oliver Herrmann, CEO and Founder of QFINITY, and Martin Heitmann will deliver the training. Oliver Herrmann is an internationally recognized expert in validation, technology quality, data integrity, and system implementation. Martin Heitmann brings extensive expertise in GAMP AI and GxP compliance. Among other roles, he is Co-Lead of the ISPE GAMP Guide: Artificial Intelligence.
You can find further information about the training here. For more QFINITY events, see Meet QFINITY.
Enabling GxP-Compliant Cloud Services through Global QMS Enhancement
A CDMO wanted to use cloud services – including hosting GxP-relevant systems. QFINITY evolved the global quality management system so that Infrastructure as a Service, Infrastructure as Code, and cloud operation and monitoring are covered in a fully GxP-compliant way – on time and on budget.
Problem Statement
The customer is an international contract development and manufacturing organization (CDMO) in the pharmaceutical industry. Its services span comprehensive product development, from the early research phase through commercial-scale production. It also manufactures active pharmaceutical ingredients and finished medicinal products.
The company plans to expand its use of cloud services, particularly for infrastructure (IaC), and later use them to host GxP-relevant systems. To achieve this, the customer needed:
Project Execution
In the first phase, QFINITY analyzed the company’s existing quality management system for its suitability for cloud services and evaluated it against regulatory requirements and relevant industry standards. QFINITY then developed concrete change proposals for the affected processes and aligned them with the responsible departments. The customer approved the finalized documents in accordance with its own processes and implemented them within the company.
Results and Benefits
The project was completed successfully, on schedule and within the planned budget. This was possible because the analysis, creation, and approval activities were properly planned and precisely coordinated.
The revised processes of the global quality management system provide a clear, regulatory-compliant framework for the use of cloud services. In particular, they cover Infrastructure as a Service (IaaS), Infrastructure as Code (IaC), and the deployment and operation of computerized systems in cloud environments. They also define consistent requirements for planning, qualification, change and release management, monitoring, and incident and problem management in cloud contexts. These requirements ensure that all activities are documented consistently in a GxP-compliant manner.