Development of a framework for the validation of computer-aided systems with AI components and introduction and validation of a high-performance AI and analytics platform

The project This project involved the introduction and validation of a high-performance AI and analytics platform and the development of a framework for the validation of computerized systems with AI components. The first step was a review of the CSV…
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Development of a validation framework for computerized systems incl. introduction and validation of a study management system

The project This project, at a university hospital, involved the introduction and validation of a study management system, including the development of a framework for the validation of computerized systems and the training of staff. A central component was the…
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Creation of a global quality management system

The project This project involved the creation of a global quality management system. QFINITY supported a global service provider, which had grown significantly through acquisitions, in the harmonization and global implementation of a uniform quality management system for all areas…
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INTRODUCTION OF A PARTICLE MONITORING SYSTEM IN A PHARMACEUTICAL PRODUCTION FACILITY

The project QFINITY supported a manufacturer of pharmaceutical products in the implementation and validation of a computerized particle monitoring system. This project included processes and services in the area of validation planning and execution. It also included the coordination and…
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INTRODUCTION OF A DOCUMENT MANAGEMENT SYSTEM (DMS)

The project This project is about the introduction of a document management system (DMS). QFINITY assumes the combined role of project manager and validation manager. With the support of QFINITY, a system selection was carried out that ensured the requirements…
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QFINITY as exhibitor at the 17 GAMP 5 conference

QFINITY will once again be one of the exhibitors at the 17th Official GAMP 5 Conference this year. The event, which is considered one of the most important in the field of Good Automated Manufacturing Practice (GAMP), will take place…
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Article by QFINITY’s Sr. Exc. 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 emphasizes…
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ISPE GAMP Southasia Webinar with Sr. Exc. Consultant from QFINITY | 28. November 2024

We are pleased to announce the next GAMP webinar for South Asia, focusing on Good Clinical Practice (GCP) and expertly presented by Frank Henrichmann. Frank Henrichmann is Senior Executive Consultant at Q-FINITY, co-leader of the second edition of the ISPE…
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QFINITY`s Sr. Exc. Consultant at the ISPE Annual Meeting | 13.-16. October 2024

QFINITY’s Senior Executive Consultant Frank Henrichmann will be attending the ISPE Annual Meeting 2024. Together with Martin Heitmann, he will give a presentation on the topic “GAMP 5 Second Edition as a starting point: AI governance in the regulated areas…
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ISPE Annual Meeting with QFINITY´s CEO | 13.-16. October 2024

The CEO of QFINITY, Oliver Herrmann, will be attending the ISPE Annual Meeting again this year. The event will occur from October 13-16 in Orlando, Florida. Participation is possible both virtually and in person. Further registration information can be found…
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