The challenges with digital transformation in pharma manufacturing and how to overcome them

As pharmaceutical companies strive to digitise and automate manufacturing processes, the digital transformation managers leading this activity face huge challenges. The industry is under pressure to reduce time-to-market, increase efficiency and cut carbon emissions. However, digitalisation is not as simple as flipping a switch; it requires meticulous planning, integration with legacy systems, and a phased approach to mitigate risks. It sounds easy, but is detailed and hard, and only worth it some of the time. 

In partnership with industry leaders including AstraZeneca, Atos, Amazon Web Services (AWS), Capgemini, GSK and Siemens, at CPI, we’ve spent the last 3 years leading a large-scale collaboration to develop a game-changing ​‘Digital Architecture’ — a strategic roadmap and coded blueprint to facilitate digital adoption in pharmaceutical manufacturing. Seeing is believing, so to ​‘make it real’ we also checked (by building a suite of systems that show the concepts) and de-risked the Digital Architecture at CPI’s Medicines Manufacturing Innovation Centre, a cutting-edge facility that replicates a factory-like setting. Here’s what we’ve learnt… 

How to navigate a complex digital landscape

Despite the increasing momentum behind digital transformation in pharma, the landscape remains fragmented. Multiple solutions, differing guidance, and inconsistent application of best practices make it difficult for companies to determine the best path forward. 

To overcome this, we recommend that companies align on common data models, enterprise architectures, and best-practice implementation guidelines. Our Digital Architecture provides this much-needed structure, ensuring that pharmaceutical manufacturers can successfully integrate digital technologies in a way that is scalable and effective. 

The framework is built using The Open Group Architecture Framework (TOGAF), a globally recognised standard for data architectures that ensures digital strategies are aligned with business needs. This structured approach allows organisations to define specific outcomes from the outset, ensuring that data structures are designed with the future users and business functions in mind. For example, you could start with senior stakeholders and then move down systemically through the organisation to align with business needs and then move to the data that serves this need. Giving a structured approach to implementing systems that drive both short- and long-term value. 

Scaling your approach to digitalisation is key to success

One of the key concerns for pharmaceutical manufacturers is how to integrate digital solutions without disrupting existing processes. Many companies operate with legacy systems that create data silos, making it difficult to gain a unified, real-time view of manufacturing operations. A complete digital overhaul poses significant risks, particularly in an industry with strict regulatory requirements. 

Using a step-by-step incremental, domain-based approach, companies can prioritise and implement digitalisation in stages, ensuring a smooth transition without unnecessary operational disruptions. This allows businesses to focus on high-impact areas first, while ensuring that all digital projects contribute to a long-term autonomous manufacturing strategy. 

Bridging the gap between legacy systems and digital operations

Legacy infrastructure presents a significant challenge in digital transformation. Many pharmaceutical manufacturers still rely on outdated IT and OT systems that don’t communicate effectively, preventing seamless data integration and analysis. Even when they do, the cultural question of who owns the cost of these systems is an ever-present concern. 

The architectural framework (based on domain-driven data ownership) that the Digital Membership have developed puts organisations in the best position to connect existing (legacy) equipment. This is done by collecting data efficiently, enabling manufacturers to monitor production in real time, detect issues early, and ensure accurate tracking. By adopting this structured approach, companies will then be better placed to bridge the gap between legacy and modern technology without requiring a full infrastructure overhaul. 

Get external validation to avoiding costly mistakes

Large pharma companies often appropriately embark on digitalisation projects using internal teams but having an external reference point on which to ​‘check your homework’, can be invaluable. Independent validation of digital strategies helps teams refine and gain confidence in their approach, ensuring they focus on the most impactful areas, know they’re starting in the right place, all while avoiding costly missteps. Feedback from experts who have been through this process of design and implementation in aligned sectors can highlight potential risks, optimise limited resources and provide comfort that digital investments will deliver the correct measurable benefits. 

Ensure flexibility to future-proof operations

One of the major concerns for companies investing in digital solutions is vendor lock-in. Many available technologies are tied to specific providers, limiting flexibility and potentially increasing long-term costs. A technology-agnostic solution provides flexibility and allows companies to adopt solutions tailored to their needs, future-proofing operations while maintaining adaptability in this evolving digital landscape. 

Understanding and adopting digital solutions can be complex. Without clear visibility into the potential benefits and implementation process, decision-makers often hesitate to invest in digital transformation. 

To address this, we have made a demonstration of the highest level of the Digital Architecture available online, allowing companies to explore its capabilities and scope. The full Digital Architecture gives companies all the tools to practically implement digital manufacturing within their operations. 

The need for speed: real-time release

Reducing the time taken for product release is a major goal in the pharmaceutical industry. Traditional Quality Control and Release processes can take days or even weeks, holding back manufacturing efficiency, often resulting in over-production or delaying patient access to vital medicines. Real-Time Release allows manufacturers to significantly accelerate the product approval process reducing it from weeks or days to just hours. With seamless integration into existing manufacturing setups, this approach ensures faster, more efficient workflows while maintaining regulatory compliance, making it a priority area for many pharmaceutical manufacturers . 

CPI’s digital architecture has been designed to enable the first critical step of transitioning to Reak-Time Release: connecting and moving the right data in a way that allows meaningful automated decision-making. We’ve confirmed that the Digital Architecture technology is suitable for use with small molecule drugs products and substances as well as downstream processing for biologics. As the industry moves toward greater automation, real-time release will play a crucial role in streamlining production. 

Prepare for the future of pharmaceutical manufacturing

The pharmaceutical industry is at a pivotal moment where digitalisation is no longer a choice but a necessity for staying competitive. Successfully integrating digital technologies requires overcoming complex challenges, mitigating risks, and leveraging expert guidance. 

Companies that participate in these efforts are not just investing in their own efficiency but are also contributing to a more sustainable, collaborative future for manufacturing. Digitalisation should not be seen solely as a competitive advantage but as a shared responsibility to improve industry-wide practices. By working together to align on best practices, common data models and enterprise architectures, organisations can drive meaningful progress that benefits both business operations and broader sustainability goals.

To learn more about CPI’s Digital Architecture and access the demonstration site, visit: CPI — The Future of Pharma Manufacturing.