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.
New at QFINITY: Project News – Stay updated on our latest projects!
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?
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!
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)↗