Life Sciences organisations today know storing their information as static documents is no longer sufficient, and the focus is increasingly placed on data. In the regulatory landscape, where efficient management of information is critical, embracing a data-centric approach has become imperative. Regulatory Information Management (RIM) systems serve as the backbone for organising and maintaining regulatory data, enabling streamlined processes and informed decision-making.
From document-centric to data-centric
The shift from a document-centric to a data-centric approach in RIM signifies a fundamental change in how organisations manage regulatory processes and information. In the past, the primary focus was on generating and managing various documents that contained regulatory information. While documents still hold importance, a document-centric approach often led to challenges like data fragmentation, lack of data standardisation, and very limited data reusability.
As the volume and complexity of regulatory data continues to grow, organisations have recognised the need to instead prioritise the underlying data that drives those documents.
This is where Data-centricity comes in.
Data-centricity in RIM
In contrast to a document-centric approach, data-centricity recognises that the real value lies in the underlying data contained within the documents.
In a data-centric approach, the emphasis is placed on capturing, organising, and leveraging regulatory data in a structured and standardised manner. This means treating data as a valuable asset throughout its lifecycle, from collection and entry to analysis and utilisation. Data-centricity in RIM involves implementing robust data governance practices, ensuring data quality and integrity by design, and leveraging technologies to optimise data management processes.
By adopting a data-centric approach, Life Sciences organisations can see benefits in the way of improved decision-making based on reliable data insights, streamlined regulatory interactions, enhanced compliance, and increased operational efficiency.
A holistic approach to data-centric RIM upgrades
Upgrading RIM systems to embrace a data-centric approach can present several challenges for Life Sciences organisations; like upgrading from legacy RIM systems without disruption to ongoing operations, coordinating complex integrations, data migration, and user adoption to name a few.
To overcome these challenges, organisations need to address system, process, and data governance challenges holistically. Here are some key considerations:
System challenges
Upgrading a RIM system requires selecting the right platform that can handle current and future regulatory data needs. The system should be scalable, flexible, and able to integrate with other systems seamlessly. Ensuring system compatibility, security and compliance, and performance are also critical aspects to address.
Business process challenges
Upgrading a RIM system offers an opportunity to optimise and streamline regulatory processes. Organisations should critically evaluate their existing processes, identify inefficiencies, and redesign workflows to align with the data-centric approach. Collaboration between Regulatory, Quality, and other functional domains is crucial to ensure harmonisation between processes, so adopting a platform that can house all functions in one unified space is incredibly valuable.
Data governance challenges
Data governance plays a vital role in data-centric RIM. Organisations should establish a robust data governance framework, including defining roles and responsibilities, data ownership, data standards, and data quality management practices. This involves implementing data validation rules, conducting data quality audits, and establishing protocols for data entry, maintenance, and archival.
RIM on the CARA Life Sciences Platform provides a powerful foundation for regulatory information, managing data to make it easy to identify and reuse efficiently across the organisation thanks to our enterprise-wide information lake. RIM on the CARA Life Sciences Platform manages information aligned with data standards as well as your organisation's global product information. The data powers the end-to-end RIM processes, from planning and triggering new submissions to capturing authorisations and corresponding with health authorities. The data also provides context to regulatory authoring, driving the collaborative creation of submission content plans globally.
Don’t stop at Regulatory, CARA Life Sciences is a comprehensive platform that allows you to connect processes across all Life Sciences applications, including Regulatory, Quality, Safety, and Clinical, all under one license.
Get in touch today to find out more or schedule a demo at info@generiscorp.com