Gens & Associates recently published their IDMP (Identification of Medicinal Products) software vendor readiness and capability survey, overviewing the planned offerings and timelines of the software solutions needed to meet the European Medicines Agency’s (EMA) upcoming IDMP/SPOR submission requirements. The survey is intended to help life science organizations adjust to the significant changes imposed by this new requirement.
We are thrilled to be one of the 11 vendors to be represented in this survey. We present our IDMP solution, the MPDmanager powered by CARA, and with it our vision for the future: a registration application within the EXTEDOpulse RIM platform that makes registering products effortless and efficient.
The survey covers a wide range of questions pertaining to vendors’ ability to transition to the new IDMP requirements. In total, the analysis includes a detailed overview of 22 core IDMP requirements such as reference data management (RMS and OMS), FHIR message preparation & submission, integration with customer business processes, as well as vendor implementation services and licensing models.
For us, it is interesting and insightful to see the many different approaches other participating vendors have taken in making the move to the new ISO IDMP standard.
We are proud to see that our approach along with the availability of our solution makes us one of the leading companies in the report. Especially MPDmanager’s forthcoming capability to validate FHIR messages against eAF and the side-by-side view of data and documents with the option to comment discrepancies have been pointed out as innovative and highly useful functionalities. These capabilities, like many others, are a direct result of our involvement in task forces and workgroups that develop the standards, as well as collaboration with our industry and agency clients, who have played a critical role in the development of EXTEDOpulse. As always, it is our goal to ensure excellence in our product development by pinpointing our customers’ current and future needs and tailoring our product to these.
MPDmanager powered by CARA is a comprehensive Master Data Management (MDM) solution that enables you to effortlessly manage all your IDMP, xEVMPD and Core Data. It is built based on the lifecycle of a medicinal product from molecule to market, fully supporting your processes and the IDMP requirements. It empowers organizations to generate compliant xEVPRM and future FHIR PMS messages while maintaining the validity of their current authorized products in line with their authorized dossiers. This approach enables users to better manage day to day regulatory changes while preserving data integrity. Additionally, users will be able to validate FHIR messages against eCTD submissions, ensuring future effortless compliance.
MPDmanager is an on-premise and cloud solution that provides you with maximum flexibility in your IT environment setup. All major capabilities for the support of the new IDMP requirements will be available by Q4 2021, making it a comprehensive solution for today and the future.