ACDM26 Conference with QFINITY

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. In addition, it attracts those in regulatory affairs and digital innovation in 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 in the future analyse 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. Moreover, it could enable continuous compliance monitoring and improve audit readiness.

At the same time, the presentation highlights that the success of this transformation strongly depends on high-quality and well-structured requirements. It will also address key challenges such as the regulatory acceptance of AI-generated evidence. In addition, it covers 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-enabled 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 these can improve efficiency, test coverage, and compliance.

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

3. Transition to AI-enabled 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. Furthermore, it 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.

Further information about the ACDM26 Conference can be found here.