Driving value from regulatory information management (RIM) is an important objective for virtually every organization in pharma, Life Sciences and medical devices. Yet for too long, a case-by-case approach to information and content management has been holding back such organizations’ ambitions for innovation and process automation.
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In Life Sciences, as in most other industries, it is now a commonly-stated strategic aim for organisations to become more ‘data-driven’: able to react at speed and to predict, plan and pre-empt future scenarios using sophisticated intelligence gleaned from everyday data.
The pursuit of this data-driven approach is driving Life Sciences and pharma firms to rethink the way they organize and manage routine information, but ‘integral RIM’, not ‘integrated RIM’ should be their principal aim.
Don’t limit data value
Achieving this should start with fresh thinking about the way information is captured and stored. If information is locked inside static documents, or proprietary, single-use database entries specific to a particular function, its value will be limited.
Yet this is a common restriction. Re-using information in other parts of the organisation may involve manual data re-entry into other systems, or complex and expensive systems integration. Unless data-sharing capabilities were envisioned from the outset, organisations risk complexity, cost and data integrity as they try to fashion something empowering and inclusive from systems which, by and large, were designed to stand alone.
Attempts to achieve more holistic regulatory information management (RIM) have highlighted the constraints and challenges caused by the traditional piecemeal approach to managing data.
A ‘big data’ approach can pay dividends
To really unlock the value of RIM, a ‘big data’ approach can be hugely beneficial. The big data analytics world sees information combined to create meaningful insights at speed, however large and diverse the original sources, a sharp contrast how Life Sciences firms have historically worked, with the different elements of product information and regulatory intelligence existing in pockets across the business.
It’s here that the key to more dynamic RIM lies: the ability to slice and dice contributing data and content sources quickly, easily and reliably to arrive at something insightful, meaningful and of new value. The relevance of big data thinking comes from the concept of a ‘data lake’ – which promotes a definitive central store for all related data in all its forms - ranging from raw source data to information and content which has been collated and prepared for a range of different tasks.
As opposed to having different document stores and databases in each business function or department, which must all be updated individually, the starting point should be a single master resource from which everything else flows. Each onward manifestation of that information will be correct because every document, every use case will be drawing its content from the same, correct original.
Master data and reusable content blocks
All approved data and combinations of data should be regarded as a series of ‘objects’, held in a graph database where they can be utilized as required. Organizations that do so are less at risk of using the wrong information, filing unsatisfactory submissions, and creating excess work and cost each time they access and do something with product or regulatory information.
Turning definitive master data into reusable content building blocks could contribute to scenario where companies are able to take advantage of increased automation opportunities – such as structured authoring. The picture we are moving towards is one not of ‘integrated’ RIM, but of ‘integral RIM’, where systems have been architected from the outset to support the confident re-use of master data for multiple different purposes.
The technology is already here to support the drive towards ‘integral RIM’. The remaining challenge is for people to embrace change and distance themselves from the inefficient and unsafe workarounds that have become entrenched over preceding decades of duplicated data entry, and manual reporting, document creation and form filling.
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.