Health Products Regulatory Authority
Solution : ECM
Formally known as Irish Medicines Board, Health Products Regulatory Authority (HPRA) is a regulator for all products and medicines in the health system, including medical devices, cosmetics, controlled drugs, and human and veterinary medicines. The HPRA implemented SoftCo ECM to transform its complex application process.
The HPRA processes over 10,000 applications associated with human medicines every year. The process involved assessing each application based on product quality, safety, and efficacy. The HPRA needed a solution to manage and gain visibility over the volume of incoming applications and improve the application processes.
To transform HPRA’s existing application process, SoftCo developed a workflow management system called NIMBUS, which streamlined the existing process and automated application processing. SoftCo NIMBUS improved communications to external organizations providing tracking visibility over each stage in the process.
Since the deployment of the workflow system, HPRA was able to improve the underlying business process and the organizational structure. Access to all information allows the HPRA to react to changing business demands. The HPRA has seen a significant increase in productivity, and has gained visibility and control over the application process and related decision making.
“The tools and data available have improved our ability to react quickly to rapidly changing business and regulatory requirements, with the overall effect of a significant increase in productivity.”
Caitriona Diviney, HPRA
The HPRA automated the application process in human medicines, gaining control and visibility at each stage in the process.
“SoftCo has successfully translated a relatively complex business environment into a system that has quickly become part of everyday life at the HPRA.”
Kevin Horan, HPRA