ACDM26 Conference Berlin - Talk

QFINITY will participate in the ACDM26 Conference in Berlin. The international conference is one of the leading events for professionals in Clinical Data Management and clinical research. It also draws experts in regulatory affairs and digital innovation across the life sciences industry.

As part of the conference program, Frank Henrichmann, Senior Executive Consultant at QFINITY, will deliver a presentation titled “Rewriting the Rulebook: How AI Will Transform Computer System Validation.”

The presentation will explore how Artificial Intelligence (AI) could fundamentally transform Computerized System Validation (CSV) in GxP-regulated environments. Traditional validation approaches are often time-consuming, highly manual, and resource-intensive.

The session will demonstrate how modern AI technologies may one day analyze and structure requirements, generate and execute test cases, and automatically document validation evidence. This has the potential to make the validation of clinical systems more efficient. It could also enable continuous compliance monitoring and improve audit readiness.

At the same time, the presentation highlights that the success of this transformation depends heavily on high-quality, well-structured requirements. It will also address key challenges such as the regulatory acceptance of AI-generated evidence, the validation of the AI tools themselves, and the role of human oversight in AI-supported validation processes.

Key Learning Objectives of the Presentation

Participants will gain insights into three central aspects of AI-supported validation:

1. Application of AI in system validation
Understanding how AI technologies can be applied to the validation of GCP and other clinical systems. In particular, it shows how they can improve efficiency, test coverage, and compliance.

2. Importance of high-quality requirements
Recognizing the critical role that precise, structured, and complete requirements play in enabling successful AI-supported validation.

3. Transition to AI-supported validation processes
Identifying key challenges and practical steps involved in moving from traditional CSV approaches to AI-supported validation workflows in regulated environments.

Exchange at ACDM26

The ACDM26 conference provides a platform for international exchange on current developments in Clinical Data Management. It also covers emerging technological and regulatory challenges in clinical research.

QFINITY looks forward to contributing to the discussion. The focus will be on how AI, regulatory requirements, and technological innovation will shape the future of Computer System Validation.

You can find further information about the ACDM26 Conference here.