Covid-19 has accelerated a phenomenon that life sciences companies around the world were already grappling with: how to achieve and maintain regulatory compliance in a sustainable way that resonates with the people required to deliver it.
It has been apparent for some time now that the ways of the past, of endless training and achieving one quality certificate on top of another, drain energy and resources without necessarily delivering any benefits for the business or better outcomes for patients. When new hires join the organization, they are quickly overwhelmed by all of the standard operating procedures (SOPs) they must absorb, and the piles of paper documents associated with them, which soon saps them of any motivation.
Surely there has to be a better way.
Thankfully, technology-enabled transformation/digitalization of compliance processes, supported by a more rounded approach to the discipline – which focuses as much on the ‘why’ as on the ‘how’ – paves the way for new possibilities. It’s an approach that depends on high-quality data that people can rely on to give them an end-to-end view of systems, processes and output, to ensure they are consistently achieving the high standards that are required to ensure patient safety. In the modern, digital age, this is achievable with the right application of focus and resource.
In my session, taking place on the fourth day of this year’s virtual Amplexor BE THE EXPERT event, I’ll be talking about the need for transformation of compliance in the context of VUCA.
The term, an acronym coined by the US Military, stands for ‘Volatile’, ‘Uncertain’, ‘Complex’, and ‘Ambiguous’, framed the response of the US Army War College to the collapse of the USSR in the early 1990s, when a new strategy, and new ways of seeing and reacting, were required in the face of a more diverse enemy.
In the context of Covid-19, the need to be ready for anything is magnified many times over. Indeed, VUCA evangelists are positioning Covid-19 as a game-changer, shifting the emphasis to “Making health, not war” (in other words, demanding that public spending moves away from amassing arms, toward much-needed new investment in health systems).
Success will involve people from different disciplines coming together, believing in the same cause, and collaborating in the most efficient ways to achieve something for the greater good - in this case: upholding patient safety through consistent process rigor at all times and in all areas.
I will be emphasizing the importance of building the right culture, and having end-to-end visibility of the impact of continuous improvements – underpinned by high-quality data and cloud-based coordination of this beyond single departments. Together, these pillars will enable a continuous, collective aspiration towards the highest standards.
Most importantly, I’ll be advocating the pursuit of quality and excellence as a good code of practice – one that leads to better outcomes for all - rather than something that has to be ‘policed’.
Alexander Tryba’s session at Amplexor’s virtual BE THE EXPERT forum, being hosted online between Tuesday 26 May and Friday 29 May, opens proceedings on the last day. It is entitled "The Compliance – Quality – Benefit – Culture Paradigm."
MAIN5 Management Consulting in Germany specializes in advising on and helping to deliver organizational change in life sciences. As Managing Partner, Alexander Tryba is responsible for the commercial expansion and development of the business, while serving as a consultant on matters of digitization, quality, and compliance.