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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.

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Challenges & Solutions

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.

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