In today’s global regulatory environment, Life Sciences companies are challenged with having to manage terabytes of data for products and registrations worldwide as well as extracting the required business intelligence for improving processes and overall decision-making. Managers and executives are demanding real-time information on the status of registrations, upcoming renewals and agency interactions in various countries and across products. The lack of timely retrieval and analysis of data to address the above questions could significantly hamper the effectiveness of a regulatory team.
How it works
Clireo GxTRACK is a regulatory tasks tracking solution with integrated business intelligence (BI) functionalities. Supports known world-wide registration procedures, including Europe (e.g. centralized, decentralized (MRP and DCP) and national procedures), United States, Canada and so on. With the usage of SQL Server Reporting Services (SSRS) it provides powerful reporting capabilities. It empowers regulatory teams with the information they need when they need it. The workflow functionality allows the creation of regulatory tasks. This includes creation of regulatory tasks at management or headquarter and assignment of these tasks to employees in different departments or several affiliates. The notification functionality can be used to inform the assigned users about new tasks or send reminders before due date of a renewal or other activities.
Additionally, Clireo GxTRACK supports batch functionalities for complex environments. One example is the batch creation of variation tasks for all MRP countries or batch-update functionality to ensure that the manufacturer of an active ingredient can be changed for several products in an easy way. Integrated charts supports management overview of critical renewal dates, current ongoing activities as well as finalized tasks in the last few months.
Clireo GxTRACK is implemented as an off-the-shelf product to fit all business needs and supports extensive and individual configuration possibilities such as additional fields, complex workflows to reach a higher level of automation, integrate additional reports and subscription of reports via email, notifications and alerts for all data fields, limited field access for specific users, etc.