Recap: DHC Life Sciences Days 2026
SAP AI in the GxP Environment – From Use Case to Validated Reality
On 16 and 17 September 2026, DHC Dr. Herterich & Consultants GmbH once again opened its doors in Saarbrücken for the DHC Life Sciences Days.
This year, the event focused on current developments in Artificial Intelligence, SAP Business AI and the specific requirements of regulated companies under the motto “SAP AI in GxP – From Use Case to Validated Reality.”
Karsten Schulz, Director Sales, Marketing & BDM
Following the successful launch last year, the event was held for the first time as a two-day format consisting of two half-day sessions. This proved to be an ideal framework for combining a comprehensive programme of expert presentations with sufficient time for personal conversations and networking. One central question ran like a common thread through both days:
How can SAP AI innovations be operated, qualified and validated in a compliant manner in the GxP environment?
Video-Recap: DHC Life Sciences Days 2026
Day 1: AI & Cloud – From Vision to Application
The first day of the event was opened by Dr. Rudi Herterich, Managing Director of DHC, and Karsten Schulz, Director Sales, Marketing & Business Development. In their welcome address, they placed the rapid development of SAP AI in the context of regulated companies: As Artificial Intelligence becomes increasingly integrated into standard processes, questions relating to data quality, governance, auditability and validation must be considered from the outset.
A key part of the opening presentation was the DHC Compliance Factory. It combines consulting, validation and digital tools to make GxP compliance efficient, traceable and audit-ready throughout the entire system lifecycle – particularly in the context of cloud systems and frequent release cycles.
SAP’s Vision of the Autonomous Enterprise
In their keynote and subsequent presentation on Agentic AI, Timo Vogelgesang, Head of Product Management – SAP BRH for Life Sciences, Sascha Schlick, E2E Product Manager – SCM for Life Sciences, and Dr. Christian Lander, Product Manager at SAP, demonstrated how SAP Business AI, Joule and agentic AI could be integrated into business processes in the life sciences industry in the future. The focus was on autonomous process chains and the question of how much autonomy is appropriate in a regulated process. One point became clear: reliable data, in-depth process knowledge, governance and a human-in-the-loop approach remain essential.SAP Cloud ALM and Autonomous Application Lifecycle Management
Lisa Sanders, Product Expert Application Lifecycle Management Cloud at SAP, presented SAP Cloud ALM as a cloud-based foundation for implementation and application lifecycle management. In the future, the platform is expected to support increasingly automated and agent-assisted processes while connecting documentation, testing and change management in a traceable way.AI in Quality Management
Timo Guhl, Product Manager, ERP PCE PM Prog. Delivery at SAP, presented concrete AI use cases in quality management – ranging from intelligent navigation and search to the processing of quality certificates and the AI-supported recording of quality notifications. The role of people remained central throughout: AI provides support, while the responsible employees review the results and make the decisions.From Vision to Reality
At the end of the first day, Karsten Schulz turned his attention to the prerequisites for successful AI adoption: data quality, standardised processes, AI governance, regulatory requirements and the involvement of employees. His message was clear: AI is ready – the decisive question is whether the organisation is ready, too.A Shared Evening at Weinbistro HAUCK
Following an intensive half-day of expert presentations, the evening continued at Weinbistro HAUCK. The relaxed and open atmosphere provided plenty of opportunity to meet new people, deepen existing relationships and continue conversations in an informal setting.Day 2: AI & GxP Compliance – Rethinking Established Principles
The second day began with the question of how the new possibilities of AI can be integrated into the established GxP framework.
Keynote: SAP AI (GxP) Compliance – Does the Wheel Need to Be Reinvented?
Robert Geiger-Lebailly, Product Owner GxP Compliance at SAP, demonstrated that the fundamental principles of GxP compliance remain valid in the age of Artificial Intelligence. Risk-based approaches, data integrity, traceability and documented evidence of fitness for intended use continue to form the foundation. At the same time, probabilistic outputs, changing models and shorter release cycles present new challenges for traditional validation approaches.AI & GxP Compliance – Current Regulations and Challenges
Stefan Krieg, Practice Manager IT Compliance at DHC AG, subsequently explored the regulatory and practical perspective in greater depth. He provided an overview of current developments, including the EU AI Act, ISO/IEC 42001, Draft Annex 22 and the ISPE GAMP AI Guide, and placed them in the context of validation practice. A particularly important aspect was the distinction between the GxP criticality of a system and its criticality under the AI Act. The intended use is decisive, as are the potential effects on patient safety, product quality, data integrity, health, safety and fundamental rights. These factors determine the necessary compliance activities and the depth of risk analysis, specification, testing and ongoing monitoring. The traditional risk-based CSV approach is therefore not being replaced, but expanded to include AI-specific risks. These include model drift, data and cybersecurity risks, as well as operational and user-related risks. This combination of established validation principles and new AI requirements was one of the key messages of the second day.Qualification, Toolchains and Digital Validation
Florian Kattner, Product Manager Cloud Service Qualification at p36, used SAP BTP as an example to show why qualification in dynamic cloud environments cannot be regarded as a one-time status. Instead, continuous assurance is required: detecting changes, assessing their impact, verifying them in a targeted manner and securing the relevant evidence. Florian Rauch, Senior Consultant at SIRIUS Consulting & Training GmbH, focused on the transition from SAP Solution Manager to a cloud-based toolchain. SAP Cloud ALM is not simply a one-to-one successor, but a newly developed platform with regular enhancements and interfaces for integrated toolchains. The technical programme concluded with Dominik Hubertus, Director Innovation & Technology at DHC, and use cases for the DHC Smart Validation Accelerator. The central message was: Validation must not lag behind change – it must accompany change. By integrating validation into SAP Cloud ALM, validation objects, risks, tests, approvals and evidence can be digitally linked with one another.Feedback and a Successful Conclusion
After two intensive half-days, the DHC Life Sciences Days concluded with a networking lunch.
Feedback from the participants was once again very positive. They particularly highlighted the pleasant atmosphere, the moderation, the current and relevant topics, the organisation and the opportunities to exchange ideas with SAP, partners, DHC and the other guests. Among the key takeaways, participants mentioned topics such as human in the loop, GxP readiness, SAP Cloud ALM, the DHC Smart Validation Accelerator and concrete AI use cases in quality management.Outlook
The DHC Life Sciences Days 2026 demonstrated that the path to AI in the GxP environment requires both technology and compliance. The key is to combine the two perspectives. SAP is creating new opportunities for autonomous and intelligent processes. At the same time, companies must establish the necessary foundations to bring these innovations into practice in a safe, traceable and validated manner.
DHC would like to thank all speakers, partners and participants for two inspiring, intensive and highly personal days in Saarbrücken.
DHC Life Sciences Days 2026
How companies can safely put SAP AI into practice in GxP environments with Compliance Factory, SAP Cloud ALM and digital validation.
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