S/4HANA, cloud transformation and process validation from a single source - How Wörwag Pharma charted the course for the future of IT
One year. Three major IT initiatives combined in one project. A highly regulated market. Wörwag Pharma faced a challenge that would give many companies pause: the simultaneous migration to SAP S/4HANA, the move to the Microsoft Azure Cloud and GxP-compliant validation. Find out how Wörwag Pharma, together with the Life Sciences Alliance, mastered the transformation project in just 11 months and what best practices can be derived from it.
Wörwag Pharma is a family-run pharmaceutical company based in Böblingen with 1,400 employees at 25 production sites. The company develops, produces and distributes drugs for the prevention and treatment of civilization diseases such as diabetes. Since its foundation 50 years ago as a pharmacy, Wörwag has grown rapidly on an international level.
The rapid growth of recent years has led to more complex business processes, pushing the existing SAP infrastructure to its limits. In addition, the end of support for SAP ECC was approaching, which increased the need for action. In order to ensure lean, flexible processes, enable further growth and accelerate digitalization, Wörwag decided to migrate to SAP S/4HANA. This process had to be flawless not only in terms of technology, but also from a regulatory perspective, as the company is subject to strict requirements as a pharmaceutical manufacturer with its own production facilities.
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S/4HANA migration & validation hand in hand
The transformation project was accompanied by the Life Sciences Alliance under the leadership of All for One. The Life Sciences Alliance - a strategic partnership between All for One, DHC Dr. Herterich & Consultants and KEK Anwendungssysteme - supports pharmaceutical companies in the validated implementation of SAP S/4HANA. While All for One was responsible for the S/4HANA implementation and the managed cloud, DHC ensured compliance with GxP requirements. Thanks to the combined technological and regulatory expertise, all GxP-relevant processes within the SAP environment were validated simultaneously with the system transformation to ensure product and patient safety.
This integrated, harmonized approach prevented redundancies, inconsistencies and errors, and thus accelerated the overall process. "As a customer, at some point we no longer even realized: Are we talking to All for One or DHC? Because it all came from a single source," says Clare Hirschle, Teamlead SAP Consulting & Projects, describing the collaboration.
The preliminary project: the foundation for a successful migration
A preliminary project determined the objectives for the future S/4HANA environment and established a clear roadmap for the transformation process. The project team analyzed the existing process landscape and documented all relevant processes, interfaces and systems. This digital process map covers all business and detailed processes without redundancies and breaks down the complex ERP system into manageable units. On this basis, the implementation team defined which processes and data were to be adopted, optimized and newly introduced, while the validation team identified the processes that required validation and therefore documentation.
A key part of the preliminary project was choosing the ideal transformation path. Wörwag opted for the Bluefield™ approach: they started with a new system, while only relevant data and processes were migrated - legacy data was left behind. "As a customer, I am able to decide with full flexibility: Which data do I take with me into my SAP S/4HANA landscape?" emphasizes Patrick Martin, Head of IT Applications at Wörwag. "Above all, the Bluefield approach has enabled us to save an enormous amount of time," he adds.
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Technical basis: cloud infrastructure and S/4HANA installation
As a first step, the implementation team set up the cloud infrastructure in Microsoft Azure. Wörwag opted for private cloud operation in order to retain full control over future S/4HANA releases. Operations were outsourced to All for One's Managed Services team. The cloud environment was set up in accordance with documented standards so that all regulatory requirements - including security, compliance and traceability - were fully met.
On this basis, the S/4HANA system was installed as an empty shell - an empty system without migrated data. The project team then adapted the system to the company's specific requirements and gradually transferred business processes and master data to the new system - in accordance with a conversion plan - until it reached the desired business-ready status.
While the S/4HANA consulting team implemented the processes in the system, the validation team worked on the detailed description and documentation of user requirements. Every step of the system configuration and process definition was fully documented to ensure complete traceability and compliance.
Preparation for the test phase: risk-based validation strategy
A risk-based approach was adopted during computer system validation to ensure that all validation measures focused specifically on critical functions. All relevant system components - including data, interfaces and processes - were subjected to a comprehensive risk assessment. The GxP relevance of individual components was determined through a GxP assessment, while a detailed risk analysis evaluated the potential impact on patient safety, product quality and data integrity.
The validation strategy was closely supported by the validation team, which worked together with the specialist departments to identify risks, define the testing scope and develop risk-based test cases. This involved analyzing where exactly negative tests or extreme tests were required, for example to check for potential rounding errors.
Testing phase: ensuring system stability and Validation
An informal functional testing phase was followed by integration and system tests, which included checking interfaces to third-party systems and business-critical processes.
Only after sufficient system stability had been achieved did the formal, validation-compliant testing phase begin, in which all test cases had to be released and documented. The tests were repeated iteratively until the system could be qualified officially.
Go-live and hypercare: ensuring stable operation
The system validation and go-live marked the transition into the operational phase. Final approval was given by the quality and validation team, who verified full regulatory compliance. After the go-live came the hypercare phase, in which errors were identified and rectified during operation.
Integrative approach and early planning as strategic factors of success
The key factor in the success of the project was the integrative approach: implementation and validation were viewed as equally important components of the transformation from the outset. Regulatory requirements were consistently taken into account as early as the pre-project phase, so that validation aspects were incorporated into all decision-making processes. The interdisciplinary composition of the project team, which combined technological, process-related and regulatory expertise, proved particularly successful.
The extensive pre-project phase with the creation of the process map also paid off. Processes that deviated from the standard were examined critically, as they increased the effort and risk involved. All deviations were therefore analyzed at an early stage and evaluated for their necessity in order to avoid unnecessary complexity. This made it possible to manage the risk in a targeted manner and reduce subsequent adjustment costs.
More transparency, more security, more possibilities
By migrating to SAP S/4HANA in the Azure Cloud, Wörwag Pharma has created a scalable and sustainable platform. It serves as a basis for further growth and the continuous advancement of the IT landscape - from IoT scenarios and new services to gradual fiorization. The validated IT landscape also ensures stable compliance and long-term legal security. The focus is always on patient safety, product quality and data integrity. The project thus marks a decisive milestone in the digital transformation of Wörwag Pharma.
About the Authors
Thomas Hein is Industry Manager Life Sciences at All for One Group SE.
Nicole Steffensky is Practice Manager SAP Validation at DHC Dr. Herterich & Consultants GmbH.
