by Steffen Frederiksen | Aug 8, 2017 | Blog
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. How can life sciences organizations keep up and comply with the numerous regulations that are constantly updated or reevaluated, all while keeping consumer health and safety at the forefront? The answer lies in how information is created and used. Traditional methods of creating and storing entire documents for submission won’t help when a regulation is changed or when the same information has to be part of multiple submissions using different formats. Organizations can only stay nimble if their information has been created in an agile and highly organized environment. Structured content helps organize information in an efficient, streamlined manner, making it simpler and more efficient to maintain compliance with changing standards. Let’s take a look at how it can be used to help companies meet regulatory requirements in a specific space – labeling. The value of structure in organizing labeling content Information required to label a certain product will come from many different sources, which can...