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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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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.
The CEO of QFINITY was at the Student Days
In June 2024, the ISPE Student Days took place in Munich. The main topic was “Shape your future in the pharmaceutical industry”.
There, our CEO Oliver Herrmann and Jens Lambertz gave a presentation entitled “Enabling innovation and digital transformation in GxP-relevant system landscapes”.
The ISPE Student Days provided an excellent platform for students, experts, and industry representatives to exchange knowledge and experience. Numerous workshops, presentations, and networking opportunities gave participants deeper insights, especially into current trends and developments in the pharmaceutical industry.
In their presentation, Oliver Herrmann and Jens Lambertz emphasized the importance of innovation and digital transformation in GxP-relevant system landscapes. They highlighted how essential these processes are for ensuring efficiency and compliance in the pharmaceutical industry. They presented practical examples and implementation strategies, giving the audience valuable ideas for their future careers.
You can find further information on the Student Days, including detailed reports on the various events and presentations, here.