Where is regulatory information management headed next?
Life sciences firms are under growing pressure to raise the quality and consistency of their regulatory data. Amplexor’s VP of strategy for life sciences Romuald Braun asks how this influencing the way organisations manage it - and what will be their best bet for exploiting the transformation for the benefit of their own businesses?
Across the life sciences industry there is a call to transform regulatory information management (RIM). While international authorities setting new and often onerous reporting requirements, simultaneously the companies themselves are grasping the strategically important role that product data can play could play in future, in terms of driving productivity, efficiency and competitive differentiation.
This means that life sciences firms are looking for more from the software that helps them log and keep track of everything. A key part of this means making product and regulatory information more shareable between and beyond specific functions in the business.
Speaking at Amplexor’s Be the Expert international user conference earlier in 2018, retiring RIM expert Andrew Marr, spoke of the challenges facing life sciences organisations as they grapple with product lifecycle visibility whilst also needing to keep accurate records for regulatory reporting purposes. This is a development that has taken place as software and data management technology has advanced.
Utilising data - structured content authoring
Andrew spoke about how we have moved from paper records to dynamic and intelligent digital versions of submissions which can be searched and interrogated more readily, paving the way for smarter, data-oriented RIM.
There is a growing synchronisation 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. Whilst the demands of regulators are important, there is more that can be done with this data that companies are building about their products across the complete lifecycle.
One such example is structured content authoring – the ability to automate the assembly of routine documents such as regulatory submissions, labelling, or even translations of these assets to some degree, using pre-approved content assets or ‘fragments’ thereof – is among the opportunities now ripe for exploitation because the right conditions have converged to make this viable and trustworthy.
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.
This 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 and machine learning will help companies to improve the way teams find what they are looking for - and more besides.
Cross-departmental and organisational data flow
But any future benefits are based around the idea of consistent and high-quality data to flow between departmental and even organisational boundaries. Regulated product data has proven the ideal place to start with data hygiene, standardisation and management ambitions, because the authorities have demanded it. But from an internal benefits perspective, there are many reasons to expand the same capabilities to a much broader pool of knowledge and content.
Unfortunately, there are no shortcuts to the more dynamic, data-driven world organisations need to be working towards, and it requires a unified approach right across a business.
But once this has happened, and definitive, accurate records, documents and database entries from one end of an organisation to the other can be readily accessed, processed, searched and relied upon, the benefits will also flow. There will be scope for making better decisions and driving greater efficiencies through targeted automation. The future of RIM lies beyond regulatory and will be central in driving business value across an organisation.