Case Study: A fast-paced MES implementation with an interface to SAP

By Dr. Paria Pouyan, Managing Consultant and Nikolas Görg, Consultant Tulip Excellence, FrontWell Solutions   

Introduction 

A leading global pharmaceutical company initiated a project to upgrade and optimize its manufacturing processes by adopting a compliant electronic Master Batch Record (eBR) system. The objective was to leverage the Tulip platform and integrate it seamlessly with the company’s Enterprise Resource Planning (ERP) system, SAP. This implementation aimed to create an efficient, transparent, and regulatory-compliant production environment, covering both upstream and downstream manufacturing processes of a newly discovered compound.

After a thorough evaluation of potential partners, the client chose FrontWell Solutions for this critical project. As the first Tulip-certified partner in life sciences, we brought deep expertise in digital manufacturing transformation, agile execution, and system integration to the table.

 

Business Challenge 

The client encountered various challenges requiring a structured and agile implementation: 

• Aggressive timeline: A strict six-month deadline to implement the solution while simultaneously managing multiple parallel projects. 
• Unclear business requirements: The product was still in its clinical trial phase, making it difficult to define the final Master Batch Record (MBR) structure upfront. 
• Complex system architecture: The solution required a refined architecture with well-defined SAP touchpoints to enable seamless system integration. 
• Localization challenges: Applications had to be translated into German within the project timeline to support operational needs. 
• Regulatory compliance and validation: The system needed to meet stringent pharmaceutical industry regulations, requiring meticulous testing and validation procedures. 
• Legacy SAP system: The customer was using an older SAP ECC6 system, which posed integration and compatibility challenges. 

 

Our Approach 

To tackle these challenges, we adopted a dynamic and agile framework that ensured rapid development while maintaining compliance and stakeholder alignment. Our approach included:

1. Onsite Workshop & Business Workflow Structuring:

• Conducted an intensive onsite workshop to identify key business workflows and define process requirements.

• Created a refined architecture diagram that mapped out SAP touchpoints and interactions.

• Developed a phased implementation strategy to manage dependencies effectively.

2. Agile Development & Iterative Execution:

• Structured development into two-week sprint cycles with demo sessions at the end of each sprint. 
• Conducted backlog grooming sessions before each sprint to align priorities with business needs. 
• Conducted daily internal check-ins to monitor progress and promptly address any issues. 
• Facilitated weekly stakeholder meetings to ensure alignment and address emerging concerns. 
• Established a dedicated steering committee to monitor risks, remove blockers, and optimize decision-making. 

3. Technical Implementation & Seamless Integration:

• Developed a custom XML parser to handle inbound messages, enabling automated data transfer between Tulip and SAP. 
• Configured Tulip applications to support both upstream and downstream manufacturing workflows. 
• Delivered a fully documented design framework, which was uploaded to Jira for real-time review and approval. 

4. Validation, Compliance & Localization:

• Wrote user stories and acceptance criteria based on identified requirements and provided detailed test scripts to ensure all requirements were captured. Executed system testing to verify regulatory compliance.

• Organized daily touchpoints with customers during engineering runs to prioritize feedback and make necessary adjustments in real time. 

• Coordinated localization efforts ensured timely translation of applications into German while maintaining accuracy and consistency. Additionally, the applications were designed to automatically adapt to the user’s language settings, providing a seamless experience across different regions. 
  

 

Results & Achievements 

Despite a highly complex implementation with evolving requirements, the project delivered significant results:

• Successful deployment of 53 applications within six months: The project delivered a fully functional system on time, despite tight deadlines and complex requirements. The deployed applications covered all USP and DSP processes, ensuring end-to-end digitalization. Key applications included Line Clearance, Preculture, Fermentation, Harvest Separation, Osmotic Shock, Clarification and Filtration, Cleaning, Capto Adhere, Filling, Freezing, and Diafiltration. Additionally, dedicated applications for Review and Approval were developed to streamline process oversight. The USP applications were seamlessly integrated with DSP, ensuring a smooth data flow and operational continuity across the entire manufacturing pipeline. 
• Seamless integration of Tulip with SAP, supported by a validated in-house designed and developed XML parser. 
• A highly agile and responsive development process that enabled rapid iterations and process stabilization. 
• A scalable eBR framework that allowed for future enhancements and compliance updates. 
• Comprehensive documentation and validation, ensuring long-term sustainability of the solution.
  

Conclusion 

By combining agile methodologies with a structured implementation framework, FrontWell Solutions successfully enabled the client to transition to a fully digital eBR system within a tight deadline. As the first Tulip-certified partner in life sciences, we provided not just technical implementation but also strategic guidance to ensure a smooth, compliant, and future-ready digital transformation. This case study showcases how a well-coordinated and adaptive approach can drive efficiency, compliance, and innovation in biopharmaceutical manufacturing.

Our Expertise Go Far Beyond Tulip 

FrontWell Solutions is an expert in the digital transformation of the pharmaceutical manufacturing process. Our team of experts is engaged in providing digital solutions to 12 of the 20-leading pharmaceutical, biotechnology, chemical, and medical device companies and suppliers spanning Europe, the United States, and Asia.  

Our expertise lies in delivering specialized consulting services, primarily centered around Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), seamlessly integrating these Level 3 systems with Enterprise Resource Planning (ERP) platforms and driving Manufacturing Intelligence initiatives such as Overall Equipment Effectiveness (OEE) reporting. 

 

Meet the Team behind this Success:

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