Best Practices for Unified Namespace (UNS) Pilot Projects

The Unified Namespace (UNS) is an architectural framework for data integration and communication that is growing in popularity in the life sciences sector, including in pharmaceutical and medical device manufacturing organizations.

It has significant scope and potential use applications, but the starting point for most companies will be a pilot project.  

Best practices for ensuring UNS pilot project success include developing a comprehensive business case, aligning the priorities of IT and OT functionalities, and selecting vendors with scalability in mind. It is also important to identify the benefits of the UNS pilot for all stakeholders. 

Develop a Business Case  

A business case is a formal document that provides justification for undertaking the UNS pilot project. Its main purpose is to evaluate and present the benefits, costs, and risks of the different options. The aim is to enable decision-makers to determine whether a proposed investment is worthwhile and aligns with the organization’s strategic goals.  

A business case for a UNS pilot project should include:  

Executive summary  

• Define the purpose, expected benefits, and strategic alignment of the UNS pilot with your organization’s digital transformation and compliance goals.  

Problem statement and objectives  

• Define current challenges such as data silos, inconsistent data standards, and integration issues across OT (Operational Technology) and IT systems. 

• Articulate the objectives. For example, improving data accessibility for regulatory compliance, enabling real-time process monitoring, or automating/semi-automating workflows. 

Scope and Remit for the Pilot 

• Identify a focused pilot use case, such as batch-to-batch quality comparisons, real-time process monitoring, or data integration for regulatory reporting. 

• Justify the selection based on business priorities and potential impact. 

Solution Overview and Implementation Plan 

• Describe the UNS concept and proposed architecture. 

• Outline the phases, including requirements gathering, architecture design, integration, internal training, and pilot execution. 

• Identify the interdisciplinary team (DataOps, IT, Quality, Operations, Enterprise Architecture) that will be responsible for delivery. 

• Outline the plan for user training, documentation, and ongoing support to ensure effective adoption and use of the UNS. 

Benefits and Value Proposition 

• Quantify expected improvements (enhanced data integrity, improved operational efficiency, etc) 

• Detail how the UNS solution will support regulatory requirements, data integrity, and audit readiness. 

Risks and Mitigation 

• Address potential risks and propose mitigation strategies. 

KPIs and Success Criteria 

• Define KPIs 

• It can be beneficial to distinguish between improvement KPIs, such as productivity, and stabilization KPIs, such as data integrity. 

Financial Analysis 

• Estimate costs and ROI. 

Aligning IT and OT Priorities, Influencing Decision-Making 

UNS is a connectivity and integration solution that could, in theory, be implemented across an organization's full technology stack. This includes the most niche manufacturing systems through to enterprise-wide business systems such as ERP (enterprise resource planning) platforms. 

In practice, an OT engineer proposing a UNS pilot may have to justify their proposal to an Enterprise Architecture (EA) group through an Architectural Review Board (ARB) process. An enterprise-wide EA group will certainly be part of the IT organization so it is wise to prepare for an ARB with answers to likely IT-centric questions. Seeking out these business partners early and being proactive with engagement is more advisable than waiting for an ARB to be triggered through an IT project intake process. 

Therefore, it is essential to establish a basis where OT and IT data integration and connectivity solutions can not only exist within the same organization but can co-exist. This involves aligning OT priorities with the priorities of IT leaders and stakeholders, as well as influencing decision-making. The latter is likely to include highlighting how IT-focused data integration and connectivity solutions are not suitable for OT environments. 

Selecting Vendors with Scalability in Mind 

There are multiple factors to be taken into account when choosing the technologies to build your UNS architecture. These factors include MQTT brokers, IIoT platforms, data historians, and edge protocol conversion solutions. 

Factors such as cost, complexity, flexibility, compatibility, configurability, and extensibility are all essential considerations when selecting vendors for components in your UNS architecture. When doing so, scalability should also always remain front of mind. 

One of the objectives of a pilot project is to prove the concept and its benefits, enabling a more widespread implementation. When you get to this stage, you don't want to go back to a vendor research and selection phase because the original choice doesn't scale sufficiently or effectively. 

Identify Benefits for Key Stakeholders 

Key stakeholders, such as software and platform owners, can have a positive, negative, or neutral influence on UNS pilot projects. The obvious objective is to create an environment that is as positive as possible. 

A crucial first step in achieving this objective is identifying the benefits of UNS for those key stakeholders. How will their processes, workflows, and pain points be improved by the introduction of a UNS architecture? 

It is also important to communicate with key stakeholders throughout the process, from planning the pilot project through to its development and implementation. 

The Steps to UNS Pilot Project Success 

Data integration and communication are significant challenges in the life sciences sector because of the operational, technology, and equipment complexities that exist in manufacturing environments. Implementing a UNS architecture is a viable solution that can be proven and then extended with a well-structured and managed pilot project.  

Developing a strong business case, involving key stakeholders, thinking about the bigger picture, and focusing on the operational, quality, and compliance benefits are the keys to success. 

For more information, download our whitepaper: Unified Namespace – Optimized System Connectivity and Data Exchange in Your Smart Factory.