Ken Molloy, Technical Success Manager at SolutionsPT, looks at the relationships between digital transformation and the complex — and highly regulated — pharmaceutical sector
The pharmaceutical sector and, in particular, its manufacturing capacity have been right at the centre of the news in recent years following the rapid response to COVID-19 and the global rollout of vaccines. The general public now has a clearer understanding of some of the realities that pharmaceutical companies face when bringing a product to market.
After witnessing the unprecedented speed at which the vaccine and testing kits were produced, many believe that commercial drug production is at the pinnacle of digital transformation (DX) technology … but this isn’t strictly true.
In fact, for the pharmaceutical industry, this rapid response and deployment of brand-new facilities is a massive departure from the norm. But, it also proves the value of digital transformation in the sector — despite the strict regulations that are often perceived as a hurdle to rapid progress.
Where pharmaceutical manufacturing differs from other sectors is the rigorous validation that is tied to every part of the process. The whole process, from the initial mixing of raw ingredients to the final product, must be accurately recorded and validated to meet regulatory requirements.
The pace of digital transformation can be slow because of the high levels of regulatory compliance and validation that are required to make any changes.
Other sectors can test new technologies, adapt processes and experiment with efficiency improving activities as they advance on their own digital transformation. Pharmaceutical manufacturing simply doesn’t have that luxury.
To frame this properly, we are in no way advocating for the relaxing of these regulations. The rigorous proof points help to protect the patient and are a critical tool against fake medicines. Despite the many hurdles to overcome, there are clear opportunities for pharmaceutical manufacturers to make meaningful advancements in DX, futureproofing operations and delivering value throughout the enterprise.
The COVID-derived acceleration of digital transformation in pharmaceutical manufacturing showed companies that DX projects that were expected to span years could be deployed within months, and sometimes even weeks.1
This acts as a shining beacon to those businesses (including those not involved with vaccine production) that were looking to advance but already had validated processes in place. Put simply, there are always DX improvements that can be made that won’t put a dead stop to production.
Recent studies show that biopharma executives are changing their attitudes and now looking to take risks, invest and innovate to gain a strong foothold ahead of the competition.2 The question is: how do they achieve this while still meeting all-important regulations? It’s all about taking small strategic steps; digital transformation is a long journey and pharmaceutical manufacturers don’t need to skip to the end to benefit.
DX capabilities such as preventive maintenance can be achieved through the deployment of AI-driven asset performance software. This is a clear step that companies can take that won’t disrupt the already validated process of a production line. As stated previously, pharmaceutical manufacturers are often at the pinnacle of automation technology, which produces an ever-growing amount of data.
Turning that data into actionable intelligence can mean the difference between replacing a bearing and continuing production and a full downtime event.
By putting the data to work, pharmaceutical manufacturers can achieve an unrivalled insight into machine health that can be viewed remotely and securely with the right software choice. An AI-infused preventive maintenance approach is one of the fastest returns on investment during a DX journey.
Highly skilled operators are no longer spending time manually investigating asset health; instead, they have more time for value-adding activities and, in the event of an issue, are alerted in plenty of time to implement a solution.
Optimisation of the workforce is another example of a DX benefit that can easily be achieved in pharmaceutical manufacturing. One sector-specific challenge is the abundance of documents — everything from clinical trial documents and medical records all the way down to recording raw ingredients.
Digitalising this process, again, frees up the time of the highly educated pharmaceutical manufacturing operator.
This digital thread that runs throughout the enterprise also works to alleviate another challenge associated with pharmaceutical production: traceability. More than any other market, pharmaceutical companies must be able to track and trace batches throughout the manufacturing and supply chain process from the staging of raw materials to product shipment.
This complicated process involves a mountain of forms, label inspection, serialisation and scanning, all of which can be digitalised to create a single version of truth.
Navigating the complex regulations of the pharmaceutical sector can seem like a daunting challenge and those that have already beaten that challenge can be reluctant to change, even if they want to advance in digital transformation and reap the benefits.
What organisations can do is take meaningful steps as part of an ongoing journey; this can lead to benefits that result in improved efficiency and workforce optimisation, all without disrupting those validated processes.
Pharmaceutical manufacturing can see the same digital transformation results as other sectors, even with the added challenges of regulation. The first step of this journey should always be working with a partner that not only understands the nuanced challenges of the sector … but how to best deploy new technologies without disrupting validated processes.