Identification of Medical Products(IDMP) compliance made simple
Overview
EU legislation requires pharmaceutical companies to submit their product information in conformance with a set of ISO standards – IDMP. Regulatory organizations are enabling this for effective pharmacovigilance and patient safety.
Preconfigured data model and business rules relevant to IDMP can be deployed out of the box minimizing implementation time and cost.
Compliance requires a corporate wide, cross functional effort alignment on the standards, identification of source systems and data, master data management and data governance, and associated interfaces with electronic gate.
Infosys 4 fold solution Processes, Systems, Reporting and Data – Upgradation of processes, enhancement of existing systems, tools to assemble data in required formats, data quality checks.