The sheer volume and growing complexity of the global regulatory environment is no surprise to anyone within Life Sciences. With every new reporting requirement set out by international authorities, there is a call to transform regulatory information management (RIM), while companies themselves are also now understanding more fully the strategically important role that product data in all its forms could play in future, driving productivity, efficiency and competitive differentiation.
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As a direct reaction to these forces, organizations are now increasingly looking for more from the software that helps them log and keep track of everything.
This is a trend that was reflected at AMPLEXOR’s Be the Expert international user conference earlier in 2018. Independent industry expert Andrew Marr, who has recently retired after 30+ years in the business, stressed the rising importance of making product and regulatory information more shareable between and beyond specific functions in the business.
Data - quality, consistent, transparent and shareable
Looking around at the global regulatory landscape, Andrew noted the growing synchronization of efforts to drive up data quality and consistency, the emphasis on transparency and data sharing, and the promotion of online portals for submitting and interacting with data. He urged the industry not to be guided exclusively by the demands of regulators when planning evolving RIM strategies, believing there is vast potential to do something more with the data sets that companies are building about their products, such as structured content authoring.
The ability to tag contents, save files as ‘docx’ and link these to databases, all contribute to the growing range of possibilities for firms to be smarter about how they track and manage knowledge -so that they’re no longer losing time to finding the latest version of something, or recreating documents from scratch when already-approved building blocks already exist somewhere on the company network.
Greater consistency and depth to the way information is recorded across the organisation will enable new process efficiency, and newer technologies such as artificial intelligence will help organizations to improve the way teams find information, even previously unfound insights from right back through a company’s historical product archives.
A high-quality data flow
This all begins with the ability for complete, consistent, high-quality data to flow between departmental and even organisational boundaries, and for this to transcend traditional regulatory data wherever a broader perspective could add greater value for the business. Regulated product data has proven the ideal place to start with data hygiene, standardization and management ambitions, because the authorities have demanded it. But from an internal benefits perspective, there is every reason to expand the same capabilities to a much broader pool of knowledge and content.
But there are no shortcuts to this more dynamic, data-driven world that utilizes RIM in a much more rounded way. and it requires an organization-wide effort and commitment. But once definitive, accurate records, documents and database entries can be readily accessed, processed and searched across an organization, and can be relied upon as an accurate narrative and status marker for what is going on in the business, the benefits will flow.
The next evolution of RIM will provide scope for making better business (not just product)decisions, and the ability to drive greater efficiencies through targeted automation, will be unlimited. RIM is already important, but it is set to become even more so over the coming years.
Romuald has devoted his 25-year career to-date to various roles related to compliance, document management, and content management in the Life Sciences industry. He has held leadership roles both on the client side and in consulting, including delivery, sales, and project and line manager. His experiences bridge on-premise and cloud environments in Europe and the US. Romuald holds a Master’s Degree in Drug Regulatory Affairs from the University of Bonn, Germany, and a diploma in data technology from the Technical University Darmstadt, Germany.