Writing URS Together

In many regulated industries, the User Requirements Specification (URS) is considered the formal starting point of a project.

In theory, the process is simple:

the user defines the requirements, writes the URS, and the equipment manufacturer designs the system accordingly.

But anyone who has worked on real automation projects knows that reality is often more nuanced.

Many companies know exactly what they want to achieve, but translating those needs into a structured engineering document is not always straightforward. This is particularly true when the project involves custom equipment, new workflows, or innovative laboratory processes.

Our goal is always the same: to ensure that the customer receives a machine that truly meets the required performance, reliability, and regulatory expectations. Achieving this often means working together with the customer to clarify requirements, evaluate technical options, and transform operational needs into realistic engineering solutions.

This effort is not only about delivering a machine.

It is about building trust, and respecting the professional responsibility that comes with designing systems that people will rely on in their daily work.

For this reason, some of the most successful automation projects do not begin with a finished URS.

They begin with a conversation.

The URS is meant to capture the voice of the user.

It defines what the system should do, how it should perform, and under which conditions it must operate. It becomes the reference for the design, development, and validation of the machine.

However, writing a URS requires more than describing an operational need.

Questions such as:

•required throughput

•environmental constraints

•product-contact materials

•traceability and data integrity

•interaction with operators

•integration with other equipment

These are engineering decisions, not just operational preferences.

That is why, in many cases, the most effective URS is developed together with the equipment manufacturer.

When equipment suppliers are involved early in the discussion, they can help transform a general need into a structured and realistic system specification.

For example, a laboratory may initially describe a need such as:

"We need to fill tubes faster and reduce manual work."

This statement is clear in terms of intention, but it does not yet define the parameters required to design a machine.

Through technical discussion, this idea gradually becomes a set of concrete requirements:

•target production capacity

•acceptable dosing accuracy

•container formats

•cleaning requirements

•operator interaction

•integration with labeling or traceability systems

At that point, the URS begins to take shape as a shared technical document.

Another important aspect is that the structure and level of detail of a URS can vary significantly depending on the industry.

In pharmaceutical manufacturing environments, URS documents are usually highly structured and strongly connected to GMP validation processes.

They often define requirements related to:

•material traceability

•software audit trails

•validation protocols

•documentation structure

•strict process control

In this context, the URS is often prepared internally by quality, validation, or engineering departments.

In diagnostic laboratories and IVD environments, projects have traditionally been considered more dynamic and application-driven.

Typical priorities often include:

•flexibility of container formats

•integration with laboratory workflows

•compact equipment footprint

•ease of operation

•reliable sample and data traceability

For many years this environment required equipment that was able to adapt quickly to different laboratory needs. As a result, URS documents in this sector were often less rigid at the beginning of a project and tended to evolve as the system architecture became clearer.

However, the IVD industry is currently evolving very rapidly, and this traditional picture is no longer entirely accurate.

Today the sector includes large industrial players with global production networks. These companies must guarantee extremely high levels of consistency, quality control, and regulatory compliance. As a consequence, their approach is increasingly similar to the pharmaceutical manufacturing mindset, with stronger emphasis on:

•standardized processes

•validated production systems

•strict traceability

•controlled automation environments

•reduced process variability

In these contexts, the URS tends to become more structured and formal, reflecting the need for repeatable and highly controlled production processes.

At the same time, another important part of the diagnostic ecosystem continues to exist.

Many laboratories and specialized companies act as true innovation drivers, developing customized formulations, niche diagnostic solutions, or highly specialized products for specific clinical or research applications.

These organizations often operate with small or medium production volumes and must maintain a certain degree of flexibility and adaptability in their workflows.

This is where modern automation technologies can play a crucial role.

With the increasing availability of compact, flexible automation systems, it is now possible to introduce higher levels of process control, reduce manual handling, and improve repeatability without sacrificing the flexibility required for specialized applications.

The diversity of this market makes it particularly interesting.

Different production philosophies coexist, ranging from highly standardized industrial environments to agile laboratories developing innovative solutions.

Working closely with these different realities is an important learning process for equipment manufacturers. Through our work on platforms such as the E-Lab Filler for flexible laboratory automation and more industrial systems such as the Smart Filler line, we continue to gain deeper insight into the evolving needs of this sector.

At the same time, the industry is progressively moving toward even more advanced concepts, including fully autonomous robotic cells capable of handling complex workflows with minimal human intervention.

The challenge for system designers is therefore not simply to build machines, but to develop solutions that can support this wide spectrum of operational models.

For medical device production, especially in controlled or sterile environments, URS documents usually combine elements from both worlds.

They must address quality and regulatory requirements, while also allowing the machine to adapt to specific product formats and production processes.

This often requires close cooperation between the user and the equipment designer from the earliest design stages.

One of the most valuable roles of the URS is that it forces stakeholders to make key project decisions early.

Defining the requirements means answering questions such as:

• What level of automation is really necessary?

• Which level of precision is required?

• How should the operator interact with the system?

• What documentation and traceability will be needed?

These decisions directly influence the architecture, complexity, and cost of the machine.

Clarifying them early helps avoid costly design changes later in the project.

For complex automation systems, the most effective URS is rarely written in isolation.

Instead, it emerges from a structured dialogue between users and engineers.

The user brings the operational knowledge.

The equipment manufacturer contributes engineering experience and an understanding of what is technically achievable.

The result is a URS that is not only theoretically correct, but also practical, realistic, and optimized for the intended application.

The URS should never be seen as a purely administrative step.

When developed collaboratively, it becomes one of the most powerful tools in the design of a successful automation system.

Because the best machines rarely start from a document.

They start from a conversation that gradually turns into a clear and shared technical vision.