By Juan Miguel Cubillas , Project Manager | Project Management Excellence
Introduction
A global top-five animal health pharmaceutical company initiated a strategic program to enhance and optimize its manufacturing operations through the digitalization of electronic Master Batch Record (eMBR) processes across two international production sites.
This pilot phase was designed as a proof of concept with a dual objective: validating Tulip as a suitable platform for the digitalization of manufacturing documentation and core operational processes, while simultaneously establishing a scalable foundation for long-term digital transformation. Beyond application development, FrontWell focused on capability enablement by training internal teams to actively participate in future development and continuous improvement initiatives.
Following a comprehensive partner evaluation, the client selected FrontWell Solutions to lead this strategic initiative. As the first Tulip-certified partner in life sciences, FrontWell brought a structured methodology, deep domain expertise in regulated manufacturing environments, and a long-term transformation perspective rather than a single-project mindset.
Business Challenges
The engagement involved several critical challenges that required a disciplined yet flexible delivery approach.
- Aggressive timeline and strict budget constraints:
The solution had to be designed, developed, and deployed within a firm three-month timeline and a tightly controlled budget. This required a highly efficient delivery model, prioritization of high-impact processes, and continuous stakeholder alignment to ensure value-driven execution. - Localization requirements:
All operator-facing process applications at one site needed to be translated into the local language within the same timeline and budget. This introduced additional complexity in terms of usability, validation, and documentation consistency while maintaining process clarity for shopfloor users. - Complex and highly regulated manufacturing processes:
The digitalization scope covered end-to-end manufacturing processes, requiring a deep understanding of GMP-relevant workflows, process dependencies, and compliance expectations.
FrontWell’s Approach
FrontWell approached the project not as a standalone implementation, but as the first phase of a long-term digital manufacturing roadmap. The focus was on building a sustainable, scalable process architecture while delivering immediate operational value.
🔷 Onsite Workshops and Structured Process Analysis
- FrontWell facilitated in-depth onsite workshops with cross-functional stakeholders to map core manufacturing workflows, identify process gaps, and define future-state digital processes. Rather than focusing on individual applications, the team structured the solution around key process areas such as batch execution, material management, quality checks, and production oversight.
- Through guided sessions, FrontWell developed a detailed understanding of current-state operations, bottlenecks, and compliance requirements. This process-centric analysis enabled the definition of a phased implementation plan aligned with operational priorities and long-term scalability.
🔷 Rapid Knowledge Immersion and Industry-Driven Methodology
- Leveraging extensive life sciences experience, FrontWell quickly built a deep operational understanding of the client’s manufacturing environment. This was achieved through stakeholder interviews, process walkthroughs, and iterative validation cycles with shopfloor and quality teams.
- This structured immersion allowed FrontWell to translate complex manufacturing requirements into intuitive digital process flows, significantly accelerating alignment and reducing rework during development.
🔷 Agile and Collaborative Delivery Model:
FrontWell implemented a highly agile delivery framework with frequent checkpoints, iterative demonstrations, and continuous feedback loops. This enabled fast decision-making, early process stabilization, and strong stakeholder engagement throughout the project lifecycle.
The team maintained high flexibility, actively supporting ad-hoc discussions, evolving requirements, and cross-site coordination while ensuring project continuity and timeline adherence.
🔷 Strategic Consulting and Long-Term Advisory Perspective
- A key differentiator of FrontWell’s delivery was its advisory-driven approach. FrontWell does not view digitalization projects as single-serving activities but as part of a broader transformation journey aligned with the client’s long-term operational goals.
- Throughout the project, FrontWell provided strategic guidance on future phases, scalability considerations, expected organizational impacts, and preparation required beyond the pilot scope. This included roadmap definition, resource planning, and recommendations for sustainable internal capability building.
Results & Achievements
Despite the compressed timeline and complexity, the project delivered measurable and sustainable outcomes:
- End-to-end digitalization of critical manufacturing process areas:
A total of 33 process-oriented applications were successfully designed, developed, and deployed within three months. These applications supported key operational processes including sterilization workflows, material handling and reconciliation, batch creation and review, line clearance, filtration, mixing, in-process controls, and production monitoring dashboards. - Balanced co-development and knowledge transfer:
Out of the 33 applications, 22 were fully designed and delivered by FrontWell, while 11 were developed by the client’s team under FrontWell’s guidance, training, and technical supervision. This approach ensured immediate delivery while simultaneously building internal competencies for long-term autonomy. - High adoption through user-centric design:
By structuring applications around real manufacturing processes and operator needs, FrontWell ensured high usability, faster adoption, and smoother integration into daily shopfloor operations. - Accelerated process stabilization through iterative deployment:
The agile delivery model enabled rapid iterations, early issue identification, and continuous process refinement, leading to a stable and compliant digital solution within the project timeframe.
Conclusion
The success and tangible impact of the pilot phase led the client to expand the scope of collaboration into further phases of their global digital manufacturing program, with FrontWell continuously involved as a strategic implementation and advisory partner.
By combining deep process analysis, agile execution, and a long-term transformation mindset, FrontWell enabled the client to transition from paper-based records to a scalable digital eBR ecosystem. The engagement demonstrated how a structured, process-oriented and advisory-driven approach can unlock efficiency, compliance, and sustainable digital maturity in regulated pharmaceutical manufacturing environments.
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Our Company
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.
Moreover, we have partnered with prominent digital solutions platforms in the market, showcasing our proficiency in leveraging cutting-edge technology.
We can support you with our well-trained LabVantage experts (Business Analysts and Solution Engineers) as well as our Validation Excellence Team with long-term experience in the field.
Get in Touch with Our Experts
Thinking about taking your next steps towards the digitalization journey?
We are ready to support you! Contact us under ReachUs@frontwell-solutions.com
or via +49 (6101) 595 89 85.
Case Study: Digital Excellence in Animal Health Manufacturing: A Process-Driven Dual-Site EBR Transformation