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What is driving the regulated quality of tomorrow.
Articles and analysis from our own work across GxP, pharma, quality management, GAMP and AI. They cover what is changing in the regulated environment, what it means in practice, and what is happening inside our company.
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QFINITY as training lead by the KKS Network
We were pleased to take on the training lead and moderation of an internal workshop organized by the KKS Network Fulda on “Auditing IT Vendors.”
Audits are a key component of quality assurance in clinical trials – especially when external service providers (vendors) are involved. IT vendor audits are becoming increasingly important for minimizing risks to sponsors and investigational sites while ensuring compliance with legal and regulatory requirements.
Together with auditors and experts from IT, project management, and quality management, we delivered practical, hands-on training. Topics included regulatory fundamentals, compliance with GCP guidelines, and the preparation, execution, and structured follow-up of audits involving IT service providers.
Through interactive group work – for example, on an EDC (Electronic Data Capture) system provider – participants were able to actively explore and reflect on the interplay between theory and practice.
Our conclusion:
The interdisciplinary exchange showed how crucial a shared understanding between IT, quality assurance, and operational units is for designing audit processes that are both effective and sustainable.
We thank the KKS Network for their trust and the successful collaboration. We look forward to continuing to help strengthen quality and compliance in clinical research.
For more information about the training and QFINITY’s role as training lead, please visit the KKS Network on LinkedIn.
Pharma 4.0 Conference with QFINITY | December 9-10, 2025
Oliver Herrmann leads the Smart Validation Track at the Pharma 4.0 Conference 2025.
Our managing director Oliver Herrmann will be leading the track “Smart Validation (CSV) & QA for Smart Technologies: AI and Beyond” at this year’s ISPE Pharma 4.0 Conference.
The event will take place on December 9-10 in Barcelona.
Cloud platforms, AI, and automation have long been a reality. They are changing how systems are developed, validated, and operated – and presenting companies with new regulatory questions. This is exactly where the track comes in: compliance should no longer be seen as a brake but as a driver of digital transformation.
The Pharma 4.0 Conference will focus on:
A highlight: authors and core team members of the official ISPE and GAMP guides will be there in person to share where the field is heading.
The bottom line: digital compliance is more than just a set of rules. It is what makes innovation and sustainable transformation possible in the first place.
👉 Register now for the Pharma 4.0 Conference and secure your spot.
GAMP Events with QFINITY | December 1 & 4, 2025
QFINITY will be at two key GAMP events in Mannheim this year.
The aim is to help shape current developments in regulated environments and to foster professional exchange.
First up, on December 1, 2025, is the official Pre-Conference GAMP 5 Introductory Training, held as part of the ISPE GAMP D-A-CH Conference. This compact training is designed for anyone looking to become familiar with the fundamentals of Computerized System Validation (CSV) according to GAMP 5 – whether in quality management, IT, or operational GxP areas. Oliver Herrmann from QFINITY will co-lead the training with Jens Lambertz (Bayer AG).
You can find further information about this training on the GAMP D-A-CH website.
Just a few days later, on December 4, 2025, the 5th GAMP Conference “GxP in the Cloud” will take place. This event explores how cloud technologies are being used in today’s regulated environments. The focus will be on compliance, data integrity, and modern IT architectures. Topics will include Annex 11, responsibilities between providers and users, validation strategies, and real-world case studies. QFINITY will again contribute actively, with Oliver Herrmann taking part in the program.
Both events offer a valuable opportunity to discuss current challenges related to digitalization, IT systems, and regulatory requirements in a collaborative setting.
For more information, see the “GxP in the Cloud” conference page.