Biotechnology Company Digitalizes Manufacturing Facility to meet increased Production Demand

Customer Background 

The customer, a leading biotechnology company, planned to scale up production at its manufacturing facility located in the United States. To achieve this goal, digitalization of the facility’s manufacturing processes was required to enable efficiency, quality and compliance at scale.  

Scope 

FrontWell was brought in to achieve the following goals:  

1. Define a system architecture for aphased digitalization approach. The approach would follow key milestones in the ramp-up of production capacity over the next two years.  
2. Development of adigitalization roadmap and governance model to ensure streamlinedimplementation & ongoing maintenance. 

A digitization roadmap and architecture refer to a strategic plan and framework designed to guide an organization through the process of digital transformation.  

1. Digitization Roadmap: 
   A digitization roadmap outlines the steps and milestones that an organization needs to follow to achieve its digital transformation goals. It typically includes an assessment of current capabilities, identification of target areas for digitization, prioritization of initiatives, timeline for implementation, allocation of resources, and metrics for measuring progress and success. The roadmap provides a structured approach for organizations to navigate the complexities of digital transformation and ensure alignment with business objectives. 
2. Digitization Architecture: 
   Digitization architecture refers to the underlying framework and design principles that govern how digital technologies are integrated into the organization's infrastructure, systems, processes, and applications. It encompasses the technical components, standards, protocols, data models, interfaces, and security mechanisms necessary to support digitization initiatives effectively. Digitization architecture provides a blueprint for building scalable, interoperable, and secure digital solutions that enable seamless integration, data exchange, and collaboration across the organization. It ensures that digital investments are aligned with the organization's overall IT strategy and architecture principles. 

In summary, a digitization roadmap provides a strategic plan for digital transformation, while digitization architecture defines the technical framework for implementing digital solutions effectively. Both are essential components of an organization's efforts to leverage digital technologies for innovation, efficiency, and competitive advantage. 

IT program governance refers to the set of processes, policies, and procedures established within an organization to ensure that IT programs and projects align with the organization's strategic objectives, are effectively managed, and deliver value. It encompasses decision-making structures, accountability frameworks, and oversight mechanisms to ensure that IT initiatives are planned, executed, and monitored in a controlled and transparent manner. Effective IT program governance helps organizations optimize their IT investments, manage risks, and achieve their business goals. 

McKinsey has highlighted the importance of governance as one of the key levers to effectively and efficiently support operations and describes three steps central to ensuring successful program governance. The first step is to identify and prioritize the most important activities to support the program’s mission. The second step is to define the functional roles within the program to facilitate smooth interactions between business divisions. The third step is to allocate decision-making authority between business functions. A successful governance model should give all stakeholders a voice to influence the scope, quality, and cost of the program while maintaining the organizations' ability to manage constraints and achieve cost and compliance goals. 

 

Project success was defined as delivery of the proposed system architecture, digitalization roadmap, and program governance model and endorsement of these items by site stakeholders. 

System Architecture	Digitalization Roadmap	Program Governance
Wave 1 (MVP)  Wave 2  Wave 3 (Long-term, fully realized architecture)	System dependencies tied to key production capacity milestone dates  Intersystem dependencies	Governance structure including team structure    Communication plan and decision-making approach    Program tracking    Risk management    Change management

Challenge 

The information needed to define architecture & roadmap was scattered across many different teams and mostly living in silos. Resources were constrained on the customer side and many meetings were required to gather information and understand dependencies. Information quickly became outdated if it was not manually updated by the various stakeholders. Consequently, to ensure long term success and enable effective decision-making, it was paramount to put in place processes that would allow for an automated way of maintaining information to ensure it remained accurate and future challenges and changes surfaced quickly and with minimal manual uncovering. 

Project Approach & Outcomes 

FrontWell started with a thorough analysis of local and global stakeholders impacted by the site’s digitization. Having understood the business goals and timelines of each stakeholder, the next step was to recommend the use of an already existing but underutilized tool as a single source of truth for creation and maintenance of architecture and roadmap data. FrontWell then defined the digitalization roadmap and system architectures within the tool and developed a process that allowed for changes and updates to automatically reach relevant stakeholders without the manual lift of reaching out to individuals who housed this knowledge. With this new process developed, the customer is now enabled to identify changes in project timelines and scope quicker and with less effort. The developed governance model facilitates evaluation of an identified change’s impact and provides the escalation pathway to reach decisions at the appropriate level.  

FrontWell was selected to help with this project based on their deep experience and proven track record with manufacturing digitization. While the on-time definition and delivery of the system architectures, digitalization roadmap, and program governance was a huge benefit to the customer, an ever more important and long-term benefit the customer received through delivery of this project was the definition of processes that will allow for simplified internal maintenance of the now defined and endorsed concepts. 

After successful completion of this project, FWS is now partnering with the same customer and leading their MES implementation project, one of the systems defined as crucial to the MVP architecture. 

FrontWell Solutions is a consulting firm specializing in implementation and advisory services around manufacturing digitalization in regulated industries. Reach out to us for help with software selection and vendor evaluation, roadmap definition and planning/governance structures, program/project setup (budgeting, staffing, ROI), and beyond. 

  Author: Nick Tremols