Life Sciences Industry Forum: Digital Transformation for an Evolving Industry 

During this year’s Automation Fair, Kalypso principial Sachin Misra was joined by other industry experts to discuss digital transformation within the life sciences industry.

It’s a risk-adverse industry, but there are things to be learned from others. Life sciences organizations should consider how digital transformation has been delivered in other industries and why they don’t have to reinvent the wheel.  

Here are three important topics the panel discussed:

• Digitization and Digitalization 
• The Importance of Culture 
• The Future of the Cloud in Life Sciences 

What’s the Difference between Digitization and Digitalization? 

When talking about digital transformation, it’s important to note there’s a difference between digitalization and digitization. Digitizing is only the transition from analog to digital. Digitalizing is what we do and want to be associated with - using digital technology to transform business operations. Take for example, tech transfer. It’s been done on paper for many years and some organizations have transitioned to PDF. While that’s a step in the right direction, electronic is not necessarily digital. Information needs to be useable and leverageable. 

How Big of a Component is Culture in Digital Transformation? 

Culture was a topic that came up continuously during our Automation Fair forum. While many industries are on their digital transformation journey, the life sciences industry has the added component of regulations and compliance concerns. That has led to a lot of fear, as Misra pointed out.  

Fear drives hesitations - fear of being non-compliant, failing audits or not having right documentation. One piece of Misra’s advice is to work with the FDA. They have helped organizations in the past design their information models and advise them on what they need to do with that model to remain compliant. Organizations need to overcome that fear and take the first step to the overall digital transformation.    

When thinking about the evolution of digital transformation to closed-loop optimization, the process may not become fully autonomous as it will in other industries. Pharma organizations will most likely continue to involve human decision intelligence in their processes.

What Should Organizations Consider with the Cloud? 

There is a rapid uptake of cloud solutions. For the foreseeable future, Misra says hybrid looks like the path many organizations are taking, especially from the OT side. There is always going to be an edge component in the pharmaceutical industry, but there are things organizations can shift to the cloud, while keeping in mind the impact to validation that this move has on the organization.  

If your organization is thinking of making the move to cloud, make sure quality and validation can keep up with the cloud updates. There are benefits, such as speed and cost. The computing power available with the cloud would be very expensive to run on edge. Leveraging cloud can help your organization avoid those higher total cost of ownership on the edge.  

Misra explained an easy way to look at it. Is process control critical and latency intolerant for your organization? It will need to run on the edge. If real-time data isn’t critical, it can probably move to the cloud.  

Getting Started  

Want to learn more about Kalypso’s work in the medical device or pharmaceutical and biotechnology industry? Reach out to our team today.