Martyn Williams, managing director of COPA-DATA UK discusses digitalisation of pharma and what's holding firms back.
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Digitalisation concept.
If you're working in the office today, look around. Peer over your laptop. How many of your colleagues are still clinging to paper-based processes? Clutching SOPs, annotating batch records, copying notes by hand?
It’s not a dig. It’s a reflection of where the pharmaceutical industry still finds itself in 2025.
According to a 2025 survey by the Pistoia Alliance, more than half of life sciences professionals say internal resistance to change is the number one barrier to transformation.
I’ve seen it too - in conversations with manufacturers across the UK. People know digitalisation is critical. But knowing and doing are two different things.
Pharma 4.0 is no longer a future ambition. It’s the baseline. The ability to operate with real-time data, integrated systems and validated automation is now essential to staying compliant, scaling production and remaining competitive in an increasingly volatile market.
Yet far too many UK pharmaceutical firms are still on the sidelines. Still stuck in proof-of-concepts. Still treating digital transformation like an IT initiative instead of what it truly is: a commercial, regulatory and operational imperative.
These delays aren’t not happening because the technology isn’t ready. The tools exist. The case studies are there. What’s missing is alignment at the top, and a willingness to confront the four core issues that continue to slow the sector down.
You don’t need more money. You need a better plan.
The most common excuse for stalled digital initiatives is budget. But it rarely stands up to scrutiny.
What we’re really seeing is not a lack of funds, but a lack of strategic ownership. Digital transformation projects often get caught in the crossfire between operations, IT and finance.
Each has a stake, but no one has complete control. That results in disjointed planning, inconsistent funding and initiatives that fail before they begin.
This fragmented approach is particularly dangerous in regulated industries where change needs to be planned, documented and validated at every stage. When digitalisation is treated as a bolt-on, it never gains the traction it needs to deliver meaningful return on investment.
So what needs to change? Funding for digital transformation must be embedded into the strategic planning process, not treated as a separate line item to be justified each quarter. It should sit within a multi-year roadmap, with clear accountability and business-critical KPIs attached.
Scalable platforms such as zenon are built for this kind of approach. Rather than demanding a full system overhaul, they allow companies to begin with targeted use cases, deliver value quickly, and scale based on success. That kind of phased, incremental model is far easier to budget for (and far less likely to be cut when times get tough).
Digital transformation is 80% people, 20% tools
The next major blocker isn’t technical. It’s human.
Change in pharmaceutical environments is difficult for a reason. These are highly regulated, quality-driven operations where risk aversion is hardwired into every process, and for good reason. But that same caution often leads to inertia, especially when it comes to digital tools and automation.
The Pistoia Alliance’s recent findings highlight what I’ve seen first-hand: resistance to change is the biggest obstacle to progress. And that resistance only hardens when digital transformation is rolled out from the top down without engaging the people who actually use the systems.
In those situations, it’s not just resistance that emerges, it’s workarounds. Teams revert to old habits because they don’t understand or trust the new tools.
Leadership teams must treat digital adoption as a strategic culture shift, not a software deployment. That means engaging staff early, giving them the chance to feed into planning, and making the case for change in operational language, not just technical terms.
Tools that are intuitive and non-disruptive, make a measurable difference here. When automation platforms integrate seamlessly into existing environments, rather than replacing them overnight, teams are more likely to adopt them and build confidence over time. That’s where real change takes hold.
No skills, no scale
Digital transformation without the right skills is like putting a Formula One engine in a car with no driver. It looks good on paper, but it’s not going anywhere.
The ABPI’s 2022 report, Bridging the Skills Gap in the Biopharmaceutical Industry, made the challenge clear, and, frankly, little has changed since. The sector still faces a critical shortage of digital, data and automation expertise. While STEM efforts are improving, key gaps remain in computational, informatics and statistical skills. These skills underpin modern manufacturing and R&D.
It’s something I hear again and again, from senior leaders to line managers: “We want to move faster, but we don’t have the right people.” And they’re not wrong.
Initiatives like the Resilience programme are a step in the right direction. Bringing digital lab training into schools and colleges will help build the long-term pipeline. But the impact of that work is still years away. In the meantime, businesses are already struggling to recruit, retain and develop talent capable of supporting transformation.
This is not a training day problem. It is a strategic workforce issue. Companies need to embed digital upskilling into their operations now across roles, departments and seniority levels. That means moving beyond ad-hoc training and creating structured, ongoing development that builds digital confidence into the core of the business.
Firms should also stop waiting for national policy to solve the problem. Instead, they need to take an active role in shaping the talent landscape themselves. Partnering with local universities, technical colleges and training providers is the fastest way to align skills development with real industry needs.
Your old systems are holding you hostage
One of the most underestimated barriers to digitalisation is outdated infrastructure. Many facilities still operate with legacy equipment, siloed databases and disconnected OT and IT systems. These environments were not built to be flexible. They were built to maintain the status quo.
As a result, even small changes can feel high risk. Teams worry about downtime. Validation processes become longer. Integrating new tools often means building complicated workarounds just to make the data flow.
This challenge is not unique to pharma, but the consequences in this sector are more serious. When data cannot be accessed in real time, quality suffers. When systems don’t talk to each other, compliance risk increases. When teams are forced to duplicate tasks manually, you lose both time and traceability.
Modernisation shouldn’t be all-or-nothing. It should be pragmatic, built around phased rollouts that deliver value fast without disrupting core operations.
The first step is understanding where the real friction exists. From there, businesses can prioritise the areas with the greatest impact and focus on deploying systems that work with existing infrastructure rather than replacing it outright. Integration, not disruption, is the way forward.
Interoperability should be the starting point. That’s why platforms like zenon are built to connect with existing systems, standardise data, and provide centralised oversight across operations. It’s about building a bridge between where you are now and where you need to be.
Transformation is now a matter of survival
The consequences of inaction are no longer theoretical. They’re commercial.
Pharmaceutical businesses that modernise are gaining competitive edge through faster time-to-market, tighter quality control, and more agile responses to both regulation and market demand.
The ones that don’t? They’re being left behind.
Regulators are not going to slow down. Nor are competitors. Digital maturity is no longer optional - it is now one of the strongest predictors of operational resilience and long-term value.
At COPA-DATA, we’ve supported pharmaceutical manufacturers for more than three decades, helping teams transition from manual processes to validated, digital-ready operations without compromising compliance.
I’ve been part of this industry long enough to know change doesn’t come easy, especially when quality and safety are at stake. But I’ve also seen what happens when the right tools, people and mindset come together. The shift is real. And it works.
The tools are ready. The strategy is clear. The risks of delay are rising. Whether you move now or not, the direction of travel for the industry is already set.
Digital transformation in pharma is not a matter of “if.” It’s a matter of “when”, and “how well.”