Regulatory Information Management Systems, RIMS, enable life sciences companies to manage, control and drive the process of bringing new products to market, keep existing products on market and manage interactions with authorities. With increased complexity and demand for transparency, the future points to new ways of managing registrations and sharing regulatory data.
With the increasing complexity and use of regulatory data, a more holistic approach to the use of RIMS is needed. Regulatory Affairs needs to make more data-driven decisions, respond faster to authorities’ enquiries and deliver more data to other business units within the company. This requires both an improvement in data quality and an easier access to the data. For Regulatory Affairs, this is not an easy task, with many affiliates spread across the world with varying amounts of data and different regulations to comply with.
The RIMS systems of today should play a much more pivotal role in RA, as the anchor point for the product data and dossiers submitted to the regulators. With RIMS as a central data repository and direct links to the submitted documents, processes in RA can be transformed by eliminating double-entries and time-consuming searches for data and documents in RA.
It is digital transformation in Regulatory Affairs.
Regulatory Affairs needs to become more agile
In the past two decades, life sciences companies have been introduced to more and more regulations and requirements in areas such as clinical trials, submissions and pharmacovigilance. This has led to costly and complex IT solutions aimed at solving the challenges within each business area. As these systems typically do not connect, each system has become a “silo” of data, with no strategy of re-use of data across the company.
With new data requirements from regulators such as EMA’s SPOR program and FDA’s updates to SPL, the demand for a unified and agile access to data is critical, and a modern RIM system with flexible reporting capabilities and data submission plays a crucial role in accomplishing this goal.
By bringing planning, tracking and reporting into a unified platform, a modern RIM system serves to break down existing data “silos” and take advantage of synergies in process alignment and standardization.
All your submission processes and data in one place
By moving all your IT-supported RA tasks to a unified platform rather than keeping them in closed-off systems, you will get simpler and more cost-efficient IT set-up with converged and connected processes.
A unified platform embraces the entire portfolio of RIMS, eCTD, labeling and EDMS as well as connections to Clinical and PV. This means that processes can be aligned – and that RA can begin to use information strategically. This will allow RA to optimize and make the most of the existing resources.
With more than 20 years of experience as an integration partner within Regulatory Affairs, NNIT understands the regulatory processes and how to bring digital transformation to RA. NNIT will advise you on RA systems, data and organization and assist you in implementing a unified platform with RIMS at the core in RA.
