Modern software companies rarely look past three-to-five-year planning cycles because of the rapid change of technology and, of course, the immediacy of many business requirements. However, when we consider a variety of factors – including the current change in pace of automation, regulatory requirements, and consumer demands – it’s clear that the role of software in manufacturing is exponentially increasing. Exciting times lie ahead! And not just for vendors who stand to profit of course, but also for pharma customers who will benefit from increasing software innovation. Privacy is perhaps one of the biggest issues in the new era of data and software, especially when it comes to pharmacovigilance. The introduction of patient involvement and the accompanying data can open privacy concerns both from a regulatory perspective and a consumer privacy standpoint, which can have dramatic brand protection concerns. That said, changing regulations, even more stringent ones, can have advantages. Regulatory changes force companies to seek out more flexible and comprehensive solutions – in the process abandoning many of the silo or stovepipe solutions previously prevalent. Ultimately, companies have the opportunity to become more efficient and profitable.
The world is growing smaller as we become increasingly connected by growing mountains of data. As pharma companies attempt to balance multiple markets, different geographies and increasing regulatory requirements, advanced software systems can be a huge help. By reducing errors and ensuring that the correct requirements are followed, software can have a far-reaching impact from initial planning and algorithms that support sales efforts across the marketplace, to the most granular operational tasks needed to fulfill production requirements.
I believe software’s ability to increase quality and support “right-the-first-time” production goals will only be surpassed by the power to provide lifecycle management for all products, even immediate consumable medications. Powerful management tools will allow us to fully understand a particular medication. We will know when and where source components were produced for recall purposes; we’ll be able to witness medicines’ journeys across supply chain networks to ensure compliance in handling and storage conditions; and we will be able to challenge and verify those medicines’ authenticity – the crux of regulations currently being rolled out across the globe. The pharma market is under increasing pressures to balance shareholder values and rights with regulatory requirements, global marketplace competitiveness, consumer perception, intellectual property protection, and return on investment. Most research does not yield a marketable, profitable product, but there is an increasing viewpoint – a false one, in my opinion – that big pharma is a purely profit-driven machine. I believe that as more information is made available and as transparency increases – driven by software that can make better use of data – consumers and patients will be better informed about the inner workings of the world of pharma. In time, the public will hopefully begin to see the complexities of producing and delivering the medicines they need, shining a more positive light on the pharma industry.
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