QFINITY · Updates
The latest from QFINITY and the field.
An overview of updates beyond events and projects: articles and publications, work in industry bodies and committees, awards, and our perspective on new regulations.
At a glance
An overview of updates beyond events and projects: articles and publications, work in industry bodies and committees, awards, and our perspective on new regulations.
QFINITY at the SAP & Partners Expert Series
On May 27, Oliver Herrmann, Managing Director of QFINITY, spoke at the third session of the SAP & Partners Expert Series for Life Sciences. The event focused on one of the key challenges in regulated GxP environments: how to drive innovation without losing sight of compliance.
His presentation centered on one theme: Innovation through modern quality assurance.
In his talk, Mr. Herrmann shared practical approaches that help life sciences companies leverage innovative technologies while still meeting strict regulatory requirements.
Key topics included:
The role of Computer Software Assurance (CSA) in fostering critical thinking and modern quality approaches
Iterative and incremental methods for meeting compliance requirements
Hands-on insights into dealing with CSV requirements and cloud-based solutions
This session was part of a ten-part series specifically designed for companies in life sciences, pharmaceuticals, and medical technology.
You can watch the session recording here:
https://lnkd.in/evupNNxG
Explore the full Expert Series and register here:
https://lnkd.in/evupNNxG
We’re proud to have been part of the SAP & Partners Expert Series.
QFINITY at the 17th GAMP 5 Conference 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.
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.
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:
The audience’s keen interest and active participation underscored the relevance and strategic value of the content for the industry.
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:
The session provided practical solutions for process optimization and harmonization in regulated environments.
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!
Article 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
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)↗