Clireo GxPD is a core module based on Microsoft SharePoint. The software suite offers an entire ecosystem for planning, controlling and tracking all notifiable processes in the highly regulated Life Science industry. All areas of information and document management, including extension and change notifications are comprehensively covered, including Global Regulatory Submission Management, in harmony with the requirements of the European Medicines Agency (EMA).
XEVMPD and IDMP
Clireo GxPD as a XEVMPD solution in its core function meets all the requirements for recording, managing and transmitting XEVMPD data and IDMP data planned for the future. The notification obligation for any relevant product information is binding for all market authorization holders in the regulated industry according to the Extended EudraVigilance Medical Product Dictionary (abbreviated to XEVMPD) as per EMA of July 2, 2012. Equipped for the future, Clireo GxPD will also support the ISO standard for international identification of medicinal products (IDMP).
Clireo GxPD – Who are our customers
Pharmaceutical Companies with several hundred to thousands of products who need more flexibility than EVWEB offers (e.g. capturing additional data) and need to interconnect existing internal systems like document management systems.
Clireo GxPD – Reference
Medium Sized Company, ~5000 products
In 2014 arivis was selected as the vendor of choice to provide the XEVMPD solution (replacement for an in-house tool) and associated data cleansing and data maintenance services in order to comply with the December 2014 submission deadline.
Clireo GxPD was provided as a hosted solution in order to minimize initial effort on IT. The arivis team enabled the customer to submit all data in time and compliant to the EMA requirements.
During the course of 2015 the hosted system was transitioned to the customers data center. With the extensive help of the arivis professional services team the customer is now running a fully validated Clireo GxPD environment with some 50 trained employees performing the day to day data maintenance on the product data following defined business processes.
arivis Subject Matter Experts and professional services team support the customer with consulting, training and outsourced data maintenance on an ongoing basis effectively enabling the customer to continuously maintain high data quality and compliance requirements with the least effort possible.