Innovative and well-implemented solutions are critical for regulatory functions to evolve and allow structural and operational challenges to be addressed. A well-considered approach to Regulatory Information Management (RIM) is of particular business benefit, especially one that encompasses efficient storage, retrieval and communication of regulatory information.
Solutions can be broadly classified as either ‘best-of-breed’ or ‘end-to-end’ with respect to their underlying deployment approach. ‘Best-of-breed’ solutions comprise discrete applications (including document management, publishing and submissions tracking) that specialise in either one or a collection of specific functions which can be deployed on an as needs basis. This approach can provide deep functional capability with respect to their workflows, however, the potential challenge of connecting capabilities into a coherent whole could lead to integration issues.
The ‘end-to-end’ deployment approach supports workflows across the entire regulatory spectrum from planning to publishing to tracking and archiving. A unified end user experience provides easier access to system functionality, while encouraging unified and standardised data across the regulatory enterprise. This strategy is not without concerns: significant financial investment is likely required with implementation taking longer, and therefore investment break-even occurring later. Moreover, though they may be more user friendly, depth of functionality may not be possible.
In both deployment approaches, companies will also need to consider data migration, validation, training, and change management activities; in the case of an end-to-end approach, this is likely to be significantly greater.
Though technology is beneficial for enhanced control of information and supports global operational efficiency for organisations, on its own it is not the panacea for all the ills of regulatory operations. In lacking robust processes and high-quality data, the potential benefits f technology investment will never materialise. An integrated approach encompassing processes, systems, data and RIM strategy is critical.
For an impactful RIM strategy, companies must consider the following:
Organisations recognise the need to be agile in order to adapt to frequent changes across global markets. This is important not only for reasons of compliance, but to demonstrate to patients the industry’s commitment to product safety throughout the entire product lifecycle. Ultimately, technology combined with a RIM strategy can support an organisation’s readiness and preparedness for future regulatory changes. More crucially, a RIM strategy can help to simplify current operations around compliance procedures, as organisations continue to adapt to an increasingly complex and rigorous regulatory landscape.