GxP news - QFINITY
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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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Event banner: QFINITY as exhibitor at the 17 GAMP 5 conference

exhibitorQFINITY will once again be among the exhibitors at this year’s 17th Official GAMP 5 Conference. The event, considered one of the most important for Good Automated Manufacturing Practice (GAMP), will take place on 3 and 4 December in Mannheim.

Our team will be there to talk to you about the latest trends and challenges in quality management, validation, and compliance. Stop by our booth and see how we help companies meet growing regulatory requirements.

The GAMP 5 conference is the perfect place to exchange ideas, pick up fresh perspectives, and benefit from exciting presentations and workshops. Don’t miss this opportunity to connect with industry experts and like-minded people – and, of course, to get to know us!

We look forward to meeting you at the conference and chatting about smart solutions for the life science industry. Drop by – we look forward to seeing you!

Do you have questions? Just drop us a line through our contact form. You can find more about the event and QFINITY as an exhibitor here.

Meistgelesener Beitrag GAMP Guide klinische Daten - QFINITY

We are pleased to announce that Frank Henrichmann’s article was the third most-read article on the Clinical Supplier Leader platform in October. The topic of the article was ‘Massive Data, More Decentralisation Drive Updates To ISPE GAMP Guide’. This underscores the article’s relevance to the clinical research and development community.

The article highlights the need for a new version of the ISPE GAMP Guide. Mr. Henrichmann addresses the far-reaching changes in the clinical data landscape. He focuses on risk-based system validations under Good Clinical Practice. He offers insights and recommendations to help clinical trial stakeholders overcome new challenges and make the most of modern data architectures.

At QFINITY, we see the strong response to Mr. Henrichmann’s article as confirmation of how much pharmaceutical and clinical research depend on current, practical information. It also shows how much the dialogue about innovative, decentralized data systems and adapting to new regulatory requirements matters.

Congratulations to Frank Henrichmann on this recognition of his work, which gives the industry valuable food for thought!

You can find the full interview here. More information on the Clinical Supply Leader placement is available here.

Check our News page for more about QFINITY’s work.
Read the article at Clinical Leader (clinicalleader.com)

Event banner: ISPE GAMP Southasia Webinar with Senior Executive Consultant from QFINITY | November 28, 2024

South Asia WebinarWe are pleased to announce the next GAMP webinar for South Asia, focusing on Good Clinical Practice (GCP) and presented by Frank Henrichmann.

Frank Henrichmann is Senior Executive Consultant at QFINITY, co-leader of the second edition of the ISPE GAMP Good Practice Guide on Validation and Compliance of Computerized GCP Systems and Data and co-chair of the GAMP Global Steering Committee.

The webinar will be held on November 28th at 9am PKT and will run for 60 minutes.

His presentation will cover:

  • GCP: What makes it different from other GxP areas?
  • Overview and challenges of validating computerized systems in a GCP environment
  • Introduction to ISPE GAMP GPG: Validation and compliance of computerized GCP systems and data – Good eClinical practice (2nd edition)
  • Q&A Session

The South Asia webinar is free of charge, but you need to register in advance at https://tinyurl.com/GAMPGCP.

We look forward to seeing you there.