What does the future hold for regulatory information management?

Romuald Braun, VP of Strategy at Amplexor discusses how organizations can gain additional value from their product data

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Romuald Braun

With every new reporting requirement set out by international authorities, the call to transform regulatory information management (RIM) is growing louder. This is not just ISO IDMP but international variations and other transparency initiatives throughout the global life sciences industry.

At the same time, life sciences firms themselves are now realising the strategically important role that product data in all its forms could play in the future; driving new productivity, efficiency and competitive differentiation.

As a result of these two forces, firms are looking to get more from the software they use to log and keep track of their data. 

There is a rising importance to make product and regulatory information more shareable between and beyond specific functions

Speaking at AMPLEXOR’s 2018 Be The Expert international user conference, independent industry expert Andrew Marr, stressed the rising importance of making product and regulatory information more shareable between and beyond specific functions in the business. His perspective – gained from a 30-year career helping life sciences organizations grapple with product lifecycle visibility and the need to keep accurate records for regulatory reporting purposes – was fascinating, especially when factoring in developments that have taken place in parallel with advances in software and data management technology.

Related: Catherine Gambert discusses how to improve the manufacturing-regulatory data flow


Data-orientated RIM

Andrew described at length how we have progress 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. That’s as long as information is complete, captured in a standard form, readily accessible, and reliable as a robust source of product truth.

There is a growing synchronisation of efforts to drive up data quality and consistency, with an 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 the data companies are building about their products across the complete lifecycle.

With the level of data companies can collect across their product lifecycle there is more use than just regulatory compliance

One example is structured content authoring. This is the ability to automate the assembly of routine documents, such as regulatory submissions or labelling, using pre-approved content assets or ‘fragments’. With the right conditions converging to make this a viable and trustworthy option, many are starting to take advantage of this opportunity.

The ability to tag contents, save files as ‘doc.x’ and link these to relevant databases, all contribute to the growing range of possibilities for firms to be smarter about how they track and manage knowledge. This lessens the need to lose time to finding the latest version of a document or recreating pieces from scratch as pre-approved building blocks can now exist on the company network.

This greater level of consistency and depth to the way information is recorded across the organization will enable process efficiency. Newer technology, such as artificial intelligence and machine learning, will also help companies improve the way their teams find what they are looking for.

Find out more: Discover how pharma companies are making use of artificial intelligence and machine learning at our upcoming webinar series Smart Labs Digital. View the full agenda


Consistent and high-quality data flow

However, this process begins with the ability to gather complete, consistent, high quality data flow between departments. This data can then transcend the traditional use of regualtory data, adding greater value to the business. Regulated product data has proven the ideal starting ground for data hygiene, standardisation and management ambitions, in no small part because the authorities have demanded it.

From an internal benefits perspective, there is every reason to expand the same capabilities to a much broader pool of knowledge and content – not just immediate operational insight, but also wider knowledge about markets and the competitive playing field.

There are no shortcuts in the move towards a dynamic, data-driven organization

Unfortunately there are no shortcuts in the move towards a dynamic, data-driven organization. As one client described it, the key to the steep change in data utility that companies crave is being able to bottle good data at the source. Once every part of the business is drinking from the same cup, the benefits can flow – but not before.

Then and only then will the scope for making better decisions, and driving greater efficiencies through targeted automation, be unlimited. The future of RIM lies beyond regulatory compliance towards a value add for the entire organization. 


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