Pharma is undergoing tectonic shifts regarding regulations, affecting both costs and processes across the board. Millions are spent every year by organizations seeking to achieve and retain compliance, one of the biggest challenges facing the life sciences industry.
As the sheer number of regulatory requirements grows worldwide, the challenge of not only meeting the requirements, but also maintaining consistency and integrity across all submissions becomes ever greater. As a consequence, as stated in Deloitte’s regulatory outlook for 2017, life sciences organizations are under pressure to add more business value by embedding compliance into business processes. Quality, consistency and compliance issues should no longer be addressed after the fact, but instead in real time before they trickle downstream.