Case Study: Organically Bridging the IT/OT Gap for a Pharmaceutical Industry Customer

Bridging the IT (information technology) and OT (operational technology) gap is essential when modernising pharmaceutical manufacturing and laboratory operations. It is also crucially important for the success of your digital transformation strategy.

(To find out more about the IT/OT gap in your pharmaceutical facility and why it exists, read more on our blog – There’s an IT/OT Gap in Your Pharmaceutical Laboratory. Here’s How to Bridge It.)

One of the most difficult things to work out is the next steps you need to take – what should you do next that will bridge the IT/OT gap?

This case study demonstrates that bridging the IT/OT gap doesn’t have to be a big-bang event with a definitive start date and a big price tag. Instead, it can be a day-to-day organic process that is often more about the expertise and support that is available than it is about the projects you implement.

The Problem

Our customer operates in the pharmaceutical industry and has multiple major pharmaceutical companies in its order book. It is a US company with facilities in the US and an EU operation based in Ireland.

The company has a strong IT support team based in the US but didn’t have dedicated technical resources on the ground in its facility in Ireland. Therefore, it needed a solution that would provide the highly specific technical support it needed as the Irish facility moved from a greenfield site to full-scale operations.

The support we provided also needed to adapt and evolve according to the needs of the business, and it needed to cross seamlessly between IT and OT. A good example of this need for seamless delivery of both IT and OT support was the immediate requirements of the company. Those immediate requirements included tasks such as setting up workstations for office-based users as well as resolving issues with the laboratory’s Empower system (Empower is a leading chromatography data system).

What We Did

We adopted a flexible approach in the delivery of services for this customer, starting with assigning an engineer to the facility with a strong IT background as well as good OT knowledge and capabilities. This engineer provides technical support across all parts of the facility, including the laboratory, factory floor, and offices, and works closely with both Ireland-based staff and the US-based IT team.

The requirements of our customer have since evolved. The IT support element remains, but additional requirements arose driven by technical necessity, especially in relation to Empower, and by the demands of its clients.

For the Empower requirement, we provided dedicated lab specialists who could support both Empower and other lab platforms and systems. This laboratory support extended beyond the Irish facility to also support our customer’s labs in the US.

The client demands of our customer related to validating IT systems. As our customer’s customers are major pharmaceutical brands, the requirement to validate computer systems according to FDA guidance has become a higher priority. We now have validation engineers working on-site who are implementing a roadmap to compliance.

The range of projects and support that we have been involved with (and continue to be involved with) are organically bridging the IT/OT gap for our customer. Examples of those projects include:

• Implementing a backup broadband connection.
• Implementing a backup Wi-Fi controller.
• Helping to roll out the wireless network to the lab and the factory.
• Resolving issues with Empower.
• Implementing a new time and attendance system.
• Implementing a new temperature monitoring device in the lab.
• Validation projects across a range of IT systems.

The Results

The work we do for this customer is ongoing. While there are specific projects, tasks, and objectives, the overall impact is a bridging of the IT/OT gap and the facilitation of the company’s digital transformation and modernisation agenda. Westbourne IT is a trusted partner for this customer, seamlessly taking care of both IT and OT technical and support requirements at its Irish facility.

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