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.
Article by QFINITY’s Senior Executive Consultant ranks 3rd most read article in Clinical Supplier Leader
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)↗
Publication of GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data
ISPE has just published the second edition of the GAMP Good Practice Guide (GPG): Validation and Compliance of Computerized GCP Systems and Data. QFINITY employees were part of the team that worked on this edition. The content has been significantly expanded, making this the most comprehensive guide to computerized clinical systems and data currently available.
The first edition was published in 2017. This update was necessary because the conduct of clinical trials has seen significant advances in recent years. The COVID-19 pandemic accelerated some of these changes, such as decentralized clinical trials. Industry changes have also prompted regulators to issue guidance such as the EMA’s “Guideline on computerized systems and electronic data in clinical trials” and the “Notice to sponsors on the validation and qualification of computerized systems for clinical trials”, both of which the update takes into account. The new edition also adds content on real world data / real world evidence, data protection in clinical trials, artificial intelligence and data science, and decentralized clinical trials. Last but not least, the guide has been aligned with GAMP 5 Second Edition.
You can find more information about the GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data here.
View the Good Practice Guide at ISPE (ispe.org)↗
New QFINITY e-learning academy goes online
Starting this summer, the new QFINITY e-learning academy is going online! It offers e-learning courses on a range of topics related to GxP and the validation of computerized systems.
From free short courses that introduce the format to modular e-learning courses with a certificate – there is something for everyone, and we add new content continuously!
Current German-language courses:
Current English-language courses:
Why not take a look? Here is the link to the e-learning academy.
If you have further questions, feel free to contact us via our contact form.