QFINITY at the 17th GAMP 5 Conference in Mannheim

Successful Presence of QFINITY at the 17th GAMP 5 Conference in Mannheim

In December 2024, QFINITY participated in the renowned 17th GAMP 5 Conference in Mannheim, one of the most significant platforms for exchanging ideas on Good Automated Manufacturing Practice (GAMP®). Organized by APV Mainz, the event provided an ideal setting to showcase our expertise in digitalization and compliance while fostering valuable connections.

Highlights of Our Engagement

Successful Presence at the Trade Exhibition

At the QFINITY booth, we presented innovative approaches to the validation of computerized systems and data integrity, particularly in the context of digital transformation. Numerous discussions with industry professionals highlighted the strong interest in our services and confirmed the importance of our expertise in addressing current industry challenges.

Strategic Expert Lecture: ‘Managing and Securing Quality – More Knowledge, Less Risk’

Oliver Herrmann (QFINITY) and Stefan Münch (Körber Pharma Consulting) shared groundbreaking approaches to quality assurance and risk-based decision-making.

Key Takeaways from the Lecture:

  • Transforming data into strategic decision-making tools
  • Holistic approaches as the key to sustainable success
  • Knowledge as the foundation for effective risk management
  • Practical application of ICH guidelines

The significant interest and active participation of the audience underscored the relevance and strategic value of the presented content for the industry.

Interactive Discussion Round: PQS and ITSM – Creating Synergies

Together with Dr. Bernhard Appel (Roche Diagnostics GmbH), Oliver Herrmann moderated a discussion on central topics related to the integration of Pharmaceutical Quality Systems (PQS) and IT Service Management (ITSM). Key discussion points included:

  • Efficient alignment of PQS and ITSM processes
  • Optimal interfaces and handover points
  • Quality assurance in the ITSM context

The session provided practical solutions for process optimization and harmonization in regulated environments.

GAMP 5 Conference in Mannheim

Conclusion: Success Across the Board

The GAMP 5 Conference offered an excellent platform for sharing expertise, discovering innovative perspectives, and building sustainable partnerships.

We thank all participants for the inspiring exchange. We look forward to shaping the future of pharmaceutical manufacturing together with the industry!

Article in Pharmaceutical Engineering

QFINITY is proud to announce that the work of our staff has been featured on the cover of the prestigious journal Pharmaceutical Engineering. The article, titled “Updated GAMP® GPG Incorporates AI and Open Source Software,” highlights forward-looking developments in the field of clinical research and development, including the role of artificial intelligence (AI) and open source software.

The article presents the new guidelines and updates to the GAMP® Good Practice Guide (GPG) for Clinical Systems and Data and shows how the quality, efficiency and reliability of computer systems can be ensured in clinical research and development. Special focuses of the article include

  • Efficient implementation and validation of systems in compliance with regulatory requirements
  • Challenges in quality management across organizational boundaries
  • Maintaining data integrity in clinical systems
  • The quality of AI systems e.g.: in data analysis in clinical research and development
  • The use of open source solutions in regulated environments.

This success demonstrates the high level of technical expertise and innovative strength of our employees. It also shows QFINITY’s commitment to making a positive contribution to the further development of the pharmaceutical industry. The article reflects the values of our company: innovation, quality and the promotion of breakthrough technologies.

We are thrilled that the work of our employees has been recognized in such a prominent way. Of course, we look forward to continuing to find innovative approaches with creative and dedicated professionals.

Read the full article in the Journal Pharmaceutical Engineering here: Updated GAMP® GPG Incorporates AI and Open Source Software

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. This area has been created to provide our clients, partners, and interested parties with a better understanding of QFINITY’s diverse activities and innovative solutions.

Our goal with this new section is to offer you a comprehensive look into QFINITY’s work. The Project News section serves as a central platform to stay informed about current and past projects. Whether you’re interested in the validation of computer-based systems (CSV), the implementation and optimization of GxP processes, supplier qualification, or the development of cutting-edge AI and analytics platforms – our Project News delivers valuable information and success stories.

What can you expect in our new section?

  • Detailed project reports: Learn more about the objectives, challenges, and tailored solutions we have developed together with our clients.
  • Success stories and best practices: Be inspired by the impressive results achieved through our expertise and innovative approaches.
  • Technology updates: Stay up to date on the modern technologies, methods, and trends we apply in our projects to deliver optimal outcomes.
  • Tips and inspiration: Gain insights for your own initiatives and discover how QFINITY can support you in tackling your unique challenges.

Visit here our Project News section and stay informed about the exciting developments at QFINITY. We look forward to accompanying you on your journey to successful projects!

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 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.

Publication of GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data

Good practice guideThe 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 as significant advances have been made in the conduct of clinical trials in recent years. Some of these changes, such as decentralized clinical trials, have been accelerated by the COVID-19 pandemic. The changes in the industry 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”, which have been taken into account when updating the guide. The content was also significantly expanded to include information 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 had to be adapted to the 2nd edition of GAMP 5.

More information about the GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data can be found here.

The CEO of QFINITY was at the Student Days

Student days

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.

QFINITY’s CEO gave a presentation at ACHEMA 2024

ACHEMA is a world forum for the process industry. Manufacturers and service providers from over 50 countries present products for the chemical, pharmaceutical, biotechnology, energy and environmental sectors. Presentations are also given on various topics.Presentation ACHEMA

Once again this year, a large number of experts gave presentations on a wide variety of topics. The topics ranged from the latest trends in pharmaceutical technology to innovative solutions for industry.

Our CEO Oliver Herrmann gave a presentation on the ZETA Pharma Innovation Stage together with Martin Heitmann. The presentation entitled: “From regulatory perspective to operational AI: Unlocking new digital horizons by applying GAMP” was a success and was discussed in greater depth in a panel discussion.

Further information on ACHEMA 2024 can be found here.

QFINITY’s CEO at the 30th anniversary of ISPE D/A/CH

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

30th anniversary of ISPE D/A/CHA 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.

If you would like to read more news from QFINITY click here.

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

 

article in the ISPE magazine

QFINITY’s CEO Oliver Herrmann, COO Marcus Schwabedissen and Sr. Exc. Consultant Frank Henrichmann have published an article in the official ISPE magazine.Artikel im ISPE Magazin

Due to the increasing digitalization of the industry, we are highly dependent on IT systems and data. Attacks on cyber security have been on the rise for many years. Ransomware and phishing are the biggest threats to our industry. Unfortunately, people tend to think that disasters “only happen to other people”. As a result, they don’t pay enough attention to disaster recovery and business continuity planning. When an organization is hit by a ransomware attack, the value of pre-planning and preparation becomes clear and allows for efficient recovery.

The article examines a hypothetical case of a successful ransomware attack. It outlines what recovery activities are required. The article also highlights the problems that arise from inadequate disaster recovery planning. It also examines the potential challenges for the quality organization, such as root cause analysis and documentation of recovery activities, risk management and assessment of data integrity during recovery activities or the evaluation of short-term workarounds.

We are pleased to have published another article in the official ISPE magazine in the form of this article.

You can find the article at ISPE.

Further news from QFINITY can be found under News.

 

Report 16th GAMP D-A-CH Conference

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

Report 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.

Report 16th GAMP D-A-CH ConferenceAspects 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.

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