The CEO of QFINITY, Oliver Herrmann, will take part in Achema 2024 – World Forum and 34th Leading International Trade Fair for the Process Industries.

The event for chemical and pharmaceutical technology, biological technology and industrial environmental technologies will take place from June 10 – 14 in Frankfurt am Main. This year the event will focus on the six innovation themes: Digital, Green, Lab, Pharma, Process and Hydrogen.Achema 2024

Mr. Herrmann will give a presentation and participate in the panel discussion.

QFINITY is honored to participate in Achema 2024 and is looking forward to the event.

Further information about this event can be found here. Further events with QFINITY can be found here.

QFINITY is proud and honored to extend its voluntary contributions to the organization of ISPE Conferences. QFINITY’s CEO, Oliver Herrmann and the Sr. Executive Consultant and current ISPE GAMP Global Steering Committee co-chair Frank Henrichmann are part of the planning committee for the ISPE EU annual Meeting 2024 in Lisbon. ISPE EU Annual Meeting


While Oliver Herrmann is involved in the organization of the track for Digital Transformation, Frank Henrichmann supports the GAMP 5 Track for this exciting conference in April next year. The program will be packed with workshops and presentations from leading industry experts and regulators. Join us at this exciting event in 2024!

More information about the ISPE EU annual Meeting 2024 is available at:

Marcus Schwabedissen, COO, and Frank Henrichmann, Senior Executive Consultant, from QFINITY will be at the ACDM Annual Meeting in Copenhagen. This Meeting will take place from 3rd– to 5th March.ACDM Annual Meeting

We are very pleased that Frank Henrichmann will present on that conference on the topic of “How to comply with EU Guideline on computerised systems and electronic data in clinical trials”. This regulatory guideline was released by the EMA in 2023. It is the most extensive and detailed guidance ever published specifically for GCP systems. The EMA guideline covers key definitions and principles like Source Data, Responsibilities, and Data Integrity, expectations on Computerized systems, and their validation, including vendor management. Electronic data, from capturing data to Audit trail review and migration, are covered along with security expectations.

His presentation will focus on the key topics addressed in that guideline and challenges in the adoption of it.

What were the reasons and intentions of the regulators when creating this guidance?

What are the most critical changes, and how can we address them?

The key focus of the presentation will be the validation of computerised systems used within clinical trials at clinical sites. He will also talk about the expectations on vendor oversight and collaboration especially in the usage of Software-as-a-Service (SaaS) and the detailed expectations on data archiving and retention.

We are looking forward to meeting you there and to discuss technology quality management topics with you.

For more information about the ACDM Annual Meeting click here.

Like the years before, we are pleased to announce that QFINITY will be attending the GAMP conference in Mannheim. The 16th GAMP conference will take place from 5 to 7 December and promises to be another outstanding platform for knowledge exchange and discussion of current topics. Frank Henrichmann will provide an in-depth insight into the topic “Practical aspects of post-disaster recovery” in a presentation on Thursday, 7 December.16th GAMP Conference

QFINITY is honoured and highly motivated to participate in the 16th GAMP conference. We look forward to engaging in a lively exchange with colleagues, experts and interested parties and to discussing issues together.

You can find more information about the 16th GAMP conference at the following link: We cordially invite you to inform yourself about the programme and the conditions of participation.

We would be delighted to meet you in person at the conference.

You can find out more about upcoming events organised or supported by QFINITY on our website.

If you have any questions or concerns, please do not hesitate to reach out to us at any time via our contact form. We are always ready to help you and respond to your enquiries.

We look forward to the GAMP conference and the discussions with you.

On 2/3 November, Frank Henrichmann, together with Global GAMP Steering Committee members Heather Watson (TenTenTen) and Thanabalan Subramanian (Integrity), will present GAMP 5 Second Edition at the ISPE India Manufacturing , Quality & Compliance Conference 2023 in Hyderabad. The programme will cover a wide range of sessions topics e.g. Annex 1, Quality & Compliance, Computerized Systems, Innovations in Technology and much more. We are looking forward to the event and the exchange with our colleagues in India.ISPE India Manufacturing Conference

For more information on the ISPE India Manufacturing, Quality & Compliance Conference, click here.

Further events with and from QFINITY can be found here.

We are looking forward to meeting you on site.

This year’s ISPE GAMP CoP UK Forum will take place on 19 September at Imperial College in London.

Marcus Schwabedissen from QFINITY will moderate a discussion panel there.

Participants will be able to discuss questions on the following topics:ISPE GAMP CoP UK Forum

  • Current regulatory guidelines for GCP systems
  • Compliance of systems at clinical sites
  • Realworld data / realworld evidence
  • Inspection readiness in a highly outsourced environment
  • Data integrity in decentralised studies
  • Audit trail review in GCP systems

The full agenda of the ISPE GAMP CoP UK Forum can be found here.

We look forward to meeting you at the event. For more information on other events by and with QFINITY, please click here.

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



Oliver Herrmann and Frank Henrichmann from QFINITY will be present at this year’s ISPE Europe Annual Conference.

Frank Henrichmann organizes and moderates the GAMP 5 track at the ISPE EU Annual Meeting.

Oliver Herrmann will lead a workshop there together with Elena Vulpe on the topic of GAMP 5 Second Edition – Data Integrity/Computer Software Assurance (CSA). In this interactive workshop, practice examples will be discussed and analyzed together with the developers of the CSA guidelines and practitioners from the EU and the US. Oliver and Elena will be supported by Ken Shitamoto, Ray Murphy and Khaled Moussally from the FISCA team.


More information and details about the process can be found on the ISPE website.


Frank Henrichmann and Oliver Herrmann from Q-FINITY will be present at the European QA Conference in Mainz.

The program includes a wide range of sessions with outstanding and professional speakers. Between the exciting presentations, there will be the opportunity to get in touch with both familiar faces and newcomers during the breaks and at the conference reception on Wednesday.

Our CEO Oliver Herrmann and Sr. Executive Consultant Frank Henrichmann will give an introduction to the new ISPE GAMP® 5 (Second Edition).

The lecture will give an overview of:
– Changes and Updates in GAMP® 5 (Second Edition)
– the role of critical thinking in the validation
– Risk Assessment and Computer Software Assurance

Oliver Herrmann (CEO and founder of QFINITY) and Frank Henrichmann (Senior Executive Consultant at QFINITY) will give two presentations at the Lounges in Karlsruhe.

Oliver Herrmann will give a presentation on the topic GAMP®5 – 2nd Edition – Applying the Key Principles to enable Innovation

The presentation will provide an introduction to the key principles of GAMP 5 Second Edition and how they apply in an ever-changing world In addition, the new GAMP Guides will be briefly introduced. Key challenges arise in the areas of Critical Thinking/CSA/RBA, AI, Agile and IS (Cloud) Management. In addition, the presentation will give an overview and first practical experiences in the application of these special topics as well as their integrated implementation in projects.

Frank Henrichmann will give a presentation about the topic GAMP 5 Second EditionSpecifying Requirements

The presentation will provide an introduction to GAMP 5 Second Edition in general and then explore Requirements Management. After all, GAMP is embracing agile methodologies and the traditional separation into User Requirements, Functional requirements and other requirements is no longer present in the guide. However, some things did not change. Bad Requirements are still bad, whether expressed as user stories in a system or in a specification document. And bad requirements are inevitably lead to systems that are not fit for purpoase and not meeting regulatory expectations.


Marcus Schwabedissen, an active member of ACDM, and Frank Henrichmann, Senior Executive Consultant at QFINITY and member of the GAMP Global Steering Committee, will be attending this year’s ACDM conference in Barcelona.
Frank Henrichmann presents a talk giving a pragmatic and forward-looking overview of how to identify and avoid bias in machine learning solutions. Numerous ML systems have failed to produce acceptable results because the model or training data were biased. Frank’s presentation will explore past mistakes and their consequences, as well as possible strategies for identifying and avoiding bias. Examples from healthcare and other industries are analyzed and the cause of the bias in the system is identified. Based on these insights, the audience will be made aware of possible ways to introduce bias into their systems. Practical guidance is provided on identifying sources of bias and avoiding bias in ML systems.