GxP news - QFINITY
QFINITY · News · Insights & Events

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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Events, case studies and insights.

Titelbild zum Beitrag: QFINITY auf der 17. GAMP 5 Konferenz in Mannheim

In December 2024, QFINITY presented at the 17th GAMP 5 conference in Mannheim – with a booth, a talk by Oliver Herrmann and Stefan Münch on knowledge-based quality assurance, and a panel on synergies between PQS and ITSM.

Successful Presence of QFINITY at the 17th GAMP 5 Conference in Mannheim

In December 2024, QFINITY participated in the renowned 17th GAMP 5 Conference in Mannheim, one of the most significant platforms for exchanging ideas on Good Automated Manufacturing Practice (GAMP). Organized by APV Mainz, the event provided an ideal setting to showcase our expertise in digitalization and compliance while fostering valuable connections.

More knowledge, less risk: data becomes the basis for strategic decisions – the foundation of effective risk management.

Highlights of Our Engagement

Successful Presence at the Trade Exhibition

At the QFINITY booth, we presented innovative approaches to the validation of computerized systems and data integrity, particularly around digital transformation. Numerous conversations with industry professionals showed strong interest in our services and confirmed the value of our expertise in addressing current industry challenges.

QFINITY-Messestand mit orangem Banner und Glücksrad auf der GAMP 5 Konferenz in Mannheim

Strategic Expert Lecture: ‘Managing and Securing Quality – More Knowledge, Less Risk’

Oliver Herrmann (QFINITY) and Stefan Münch (Körber Pharma Consulting) shared groundbreaking approaches to quality assurance and risk-based decision-making.

Key Takeaways from the Lecture:

  • Transforming data into strategic decision-making tools
  • Holistic approaches as the key to sustainable success
  • Knowledge as the foundation for effective risk management
  • Practical application of ICH guidelines

The audience’s keen interest and active participation underscored the relevance and strategic value of the content for the industry.

Zwei Referenten vor der Begrüßungsfolie der 4. GAMP Konferenz 'GxP in der Cloud' in Mannheim

Interactive Discussion Round: PQS and ITSM – Creating Synergies

Oliver Herrmann and Dr. Bernhard Appel (Roche Diagnostics GmbH) moderated a discussion on central topics around integrating Pharmaceutical Quality Systems (PQS) and IT Service Management (ITSM). Key discussion points included:

  • Efficient alignment of PQS and ITSM processes
  • Optimal interfaces and handover points
  • Quality assurance in the ITSM context

The session provided practical solutions for process optimization and harmonization in regulated environments.

Blick vom Podium in den voll besetzten Konferenzsaal der GAMP 5 Konferenz in Mannheim

GAMP 5 Conference in Mannheim

Conclusion: Success Across the Board

The GAMP 5 Conference offered an excellent platform for sharing expertise, discovering innovative perspectives, and building sustainable partnerships.

We thank all participants for the inspiring exchange. We look forward to shaping the future of pharmaceutical manufacturing together with the industry!

Titelbild zum Beitrag: Artikel in Pharmaceutical Engineering

QFINITY is proud to announce that our team’s work has been featured on the cover of the prestigious journal Pharmaceutical Engineering. The article, titled “Updated GAMP® GPG Incorporates AI and Open Source Software,” highlights forward-looking developments in clinical research and development, including the role of artificial intelligence (AI) and open source software.

The article presents the new guidance and updates in the GAMP Good Practice Guide (GPG) for Clinical Systems and Data and shows how to ensure the quality, efficiency, and reliability of computerized systems in clinical research and development. Key topics include

  • Implementing and validating systems efficiently and in compliance with regulatory requirements
  • Challenges in quality management across organizational boundaries
  • Maintaining data integrity in clinical systems
  • The quality of AI systems, for example in data analysis in clinical research and development
  • The use of open source solutions in regulated environments.

This success demonstrates our employees’ strong technical expertise and capacity for innovation. It also shows QFINITY’s commitment to helping advance the pharmaceutical industry. The article reflects our company’s values: innovation, quality, and championing breakthrough technologies.

We are thrilled to see our employees’ work recognized so prominently. And we look forward to continuing to develop innovative approaches with creative, dedicated professionals.

Read the full article in Pharmaceutical Engineering: Updated GAMP® GPG Incorporates AI and Open Source Software
Read the article at Pharmaceutical Engineering (ispe.org)

Projekt-News bei QFINITY - QFINITY

We are excited to introduce a new feature on our website! From now on, you can explore our Project News section, where we share insights into our ongoing and completed projects. We created this section to give our clients, partners, and anyone interested a better understanding of QFINITY’s diverse activities and innovative solutions.

Our goal with this new section is to offer you a comprehensive look at QFINITY’s work. The Project News section serves as a central hub for current and past projects. Whether you’re interested in validating computerized systems (CSV), implementing and optimizing GxP processes, qualifying suppliers, or building advanced AI and analytics platforms – our Project News delivers valuable information and success stories.

What can you expect in our new section?

  • Detailed project reports: Learn more about the objectives, challenges, and tailored solutions we have developed together with our clients.
  • Success stories and best practices: Be inspired by the impressive results our expertise and innovative approaches have delivered.
  • Technology updates: Stay up to date on the modern technologies, methods, and trends we apply in our projects to deliver optimal outcomes.
  • Tips and inspiration: Gain insights for your own initiatives and discover how QFINITY can support you in tackling your unique challenges.

Click here to visit our Project News section and stay informed about the exciting developments at QFINITY. We look forward to supporting you on your path to successful projects!