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 the relevance of the article for 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 in the context of Good Clinical Practice. He provides insights and recommendations to support various clinical trial stakeholders in overcoming new challenges and utilizing modern data architectures.

We at QFINITY see the high response to Mr. Henrichmann’s article as confirmation of the importance of up-to-date and practical information for pharmaceutical and clinical research. It shows how important the dialogue about innovative, decentralized data systems and the adaptation to new regulatory requirements is.

Congratulations to Frank Henrichmann on this recognition of his work, which provides valuable impetus for the industry!

You can find the full interview here. Further information on the Clinical Supply Leader placement can be found here.

Check our News Site for more information about QFINITY´s work.

In June 2024, the ISPE Student Days took place in Munich. The main topic was “Shape your future in the pharmaceutical industry”.

Our CEO Oliver Herrmann gave a presentation there together with Jens Lambertz entitled “Enabling innovation and digital transformation in GxP-relevant system landscapes”.

The ISPE Student Days provided an excellent platform for the exchange of knowledge and experience between students, experts and industry representatives. Numerous workshops, presentations and networking opportunities enabled participants to gain 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 emphasized how essential these processes are to ensure efficiency and compliance in the pharmaceutical industry. Practical examples and strategies for implementation were presented, giving the audience valuable ideas for their future careers.

Further information on the Student Days, including detailed reports on the various events and presentations, can be found here.

Our CEO Oliver Herrmann was at the 30th anniversary of ISPE D/A/CH.

A total of 165 registered members celebrated the 30th anniversary of ISPE D/A/CH last week at the Annual General Meeting in Leverkusen. The motto of the event was “Shape the pharma world of tomorrow” and participants were treated to a two-day program full of expert presentations on current trend topics.

Oliver Herrmann also gave a presentation at the event.

We are delighted that Oliver Herrmann was able to take part in this event.

You can find more impressions of the event here.

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If you have any questions, please contact us via our contact form.

QFINITY´s CEO Oliver Herrmann, COO Marcus Schwabedissen and Sr. Executive Consultant Frank Henrichmann were at the 16th GAMP D-A-CH Conference.

Innovation, Digital Transformation and GxP

Our CEO Oliver Herrmann and Bernhard Appel were leading a discussion round on the topic “Innovation, Digital Transformation and GxP – now more than ever!”. In their discussion their mentioned that in today’s world, companies are faced with the challenge of driving innovation and digitalization. At the same time their having to adhere to strict regulations and compliance requirements. The discussion centres on the possibility of combining innovation and compliance. It is emphasised that it is entirely possible to achieve both without jeopardising patient safety and product quality. Quality Management & Compliance plays a crucial role in this, as it ensures that processes run at the highest level without compromising on safety.

Aspects of recovering from a disaster

Frank Henrichmann presented on Dec. 7th, 2023, as part of the 3. GAMP® Konferenz GxP in der Cloud in Mannheim, on practical aspects of recovering from a disaster. This is a hot topic as current data clearly demonstrate that it is only a question of time till a company is hit by a cyberattack. He used a Ransomware Attack on a Cloud service provider as a hypothetical case study to highlight the potential challenges in the recovery process. It was shown that good planning before the attack happens is key to a successful und timely recovery. But even the best plans need to be adapted and adjusted to the actual scenario when the disaster happens. He focused on the challenges and questions that quality functions need to address and support to ensure the validation state of the applications and the integrity of the recovered data in the pharmaceutical industry.

Sustainability and GxP

The panel discussion on “Sustainability and GxP” was moderated by Marcus Schwabedissen (QFINITY) and Steffen Ruttscheidt (d-fine GmbH). It provided an insight into the growing importance of sustainability in the context of the life science industry (GxP). It also showed its impact on the industry. In their presentation they showed that the Corporate Sustainability Reporting Directive (CSRD) plays a crucial role in this context. CSRD will oblige companies to produce more detailed sustainability reports. This will promote better transparency and accountability in terms of environmental impact and social responsibility. This will also affect companies in GxP-regulated industries, as they will also have to implement sustainable practices.

QFINITY is proud to have participated in this year’s GAMP Conference. Further information about the conference can be found at ISPE. For more information on events with QFINITY, please visit our website.

Marcus Schwabedissen (COO at QFINITY) has been an active member of ACDM for many years and is particularly involved in the field of artificial intelligence. At the recent ACDM: Association for Clinical Data Management Annual Symposium on Artificial Intelligence in Clinical Trials, the speakers and participants, including Marcus Schwabedissen, were asked for their personal opinion on the topic of AI.

In this video, you can hear Marcus Schwabedissen’s opinion on how artificial intelligence can help in all areas of the value chain.

Watch the video here.Following the success of the AI Symposium, the ACDM community will meet again in London on 24 November. The discussion on risk-based quality management will continue on site. QFNITY is looking forward to being a part of it.

If you have any questions on the Topic AI, you can reach us at any time via our contact form.