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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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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.
ISPE Annual Meeting | October 26-29, 2025
The event will take place from October 26-29, 2025, in Charlotte, NC.
Workshop: Implementing an AI Solution in a Pharma 4.0 Context
📅 Sunday, October 26, 2025 | 1:00 – 4:00 pm
👥 Speakers: Martin Heitmann (The Triality Group, LLC), Frank Henrichmann (QFINITY), Brandi Stockton (The Triality Group, LLC), Paige Kane (CAI)
In this interactive workshop, participants will learn hands-on methods for implementing and validating AI/ML solutions in GxP-regulated environments. Key topics include:
Maturity assessments for evaluating the digital readiness of organizations.
Risk assessment of AI systems for patient safety, data integrity, and product quality.
Beyond the expert input, the workshop makes room for discussion and knowledge-sharing with industry professionals, offering valuable insights into the validation challenges of digital transformation.
Presentation: Future-Proof QA – From Documentation to Control Objective
📅 Tuesday, October 28, 2025 | 10:30 – 11:00 am
👥 Speakers: Oliver Herrmann (QFINITY), Frank Henrichmann (QFINITY)
The role of Quality Assurance in IT validation projects is changing: moving away from paper-heavy documentation toward risk-based, system- and data-focused approaches.
This presentation highlights how to build a future-oriented QMS for CSV that combines flexibility and compliance. Key aspects include:
What skills QA needs to effectively support projects.
Which content QA should review – and which it should not.
How control objectives and critical thinking can add value.
How to use standards and templates effectively without letting them become a burden.
With these two contributions, QFINITY adds its expertise in digital transformation, Pharma 4.0, and modern quality assurance to the international conversation.
👉 We look forward to seeing you in Charlotte! For more information about the ISPE Annual Meeting 2025, please visit ISPE.