Although these trends won’t necessarily be the exclusive preserve of regulated industries, I can safely predict that a next wave of digital transformation, and existential debate about the role of documents in a data-driven world, will both dominate the tech headlines in 2022.
Well, let’s start with digital transformation 16.0 or whatever the next moniker will be. The pandemic was a powerful catalyst for driving standardisation across companies, focused particularly on how teams communicated and shared information. With teams dispersed and working remotely, it became critical that people could contact each other and share files in standardised ways, using the same platforms and tools.
Switching between Microsoft and Google, Teams and Zoom, or Box, Dropbox and SharePoint depending on who you were dealing with, became inefficient and frustrating. Roche, for instance, defaulted to Google Workspace. Most companies were heading in this direction anyway, but the disruption of the last 18 months made this activity a priority for maintaining productivity.
One platform, multiple process transformations
My prediction now is that the momentum will continue, giving rise to a new wave of deeper digital transformation which extends beyond the low-hanging fruit and looks to standardise and digitalise more involved business processes – including more streamlined and connected workflow and data/content use across adjacent teams, such as Quality, Safety and Regulatory functions. One very powerful way to make complex processes more efficient is to bring them onto a common platform, point them at the same common content and data pools, and hone their design on screen – until repetition of activity, or data re-input/content recreation, has been reduced to a minimum.
Efforts to consolidate diverse data sources, and improve the overall quality of data, are already underway, setting companies in good stead to perform more ambitious analytics, and re-use core data in new ways. This has become a real focus now and, with much of the preparatory work almost complete, we should see companies designing new master data management and product information management applications that can harness that data in new ways. The goal is to get these core underlying systems to a point that they are usable as a means of driving all business applications and compliance activities.
Meaningful, actionable insights on a global scale
So what’s the impact of all of this? At the top of the stream, companies will gain new insight into what’s going on across the global business, with the ability to understand and compare data on a like-with-like basis.
There will be a new opportunity for discovery, too, as teams are exposed to certain information for the first time – such as product information, or adverse event data across different regions, allowing trends to be identified and earlier action to be taken. Perhaps patterns in AE data will point to a manufacturing issue at a particular plant.
The point is that, once data-based insights are no longer siloed, the scope increases considerably to perform deeper and more useful analysis and problem-solving. We’re already seeing this trend ripple through our client base – customers that first adopted our CARA platform in one function, such as Regulatory Affairs, and are now expanding its reach to encompass other teams and applications such as Quality and/or Safety management. Each additional use case increases their return on investment; reduces complexity, data re-entry and scope for human error; and saves a lot of time while providing unprecedented end-to-end visibility across global operations.
Ultimately, the more organisations consolidate and harmonise their activities, the more efficient their processes and the lower their total IT overhead will be.
Documents aren’t dead yet
So what about documents? People have been sounding the death knell for static documents for a good while now: it’s something we’ve debated in virtual roundtables with some of the industry’s most respected experts. Certainly, the promise of structured document authoring does offer an interesting way forward – a means of increasing the fluidity between documents and the data or master content fragments used to build them. But even those companies leading the way here, such as AbbVie, remain some way off achieving that nirvana: it all takes time.
In the meantime, I would argue that the humble PDF or Word document still has an important role to play, as a locked-in snapshot or summary of a situation at a given point in time. While data-based summaries might fulfil the same role, and add new value because of the scope for interaction and manipulation of the summary data, there is arguably a place for maintaining fixed status logs which can be referred back to over time. If these can be accessed alongside original and evolving data, via the same platform, at the point of need within a given process so much the better.
In the meantime, if I’m right in my prediction that 2022 will see digital process transformation move on to the next level, the ideal is that any reinvention of the role of data and documents will happen within that context – ensuring maximum value from endeavours to improve operational efficiency globally.