A pharma fixed pharmacovigilance gaps after critical EMA findings by moving to a new validated safety database.

After an EMA inspection with critical findings, the company needed a PV system meeting FDA, EMA and national expectations. Qinecsa designed, validated and implemented a new safety database, migrated large volumes of cases and added governance and knowledge retention processes. The page says the next EMA inspection had no critical findings and all milestones were met on time.

Qinecsa is a pharmacovigilance technology and services company, used by pharma to automate adverse event intake and run signal detection and safety operations

This sits in the Ship stage of the AI use-case lifecycle: Named examples from the vendors pharma teams use to get an AI system live inside a real, regulated production workflow — validation, CRM, safety and clinical systems of record.