AI-Powered ePIL Creation: FHIR R4 Compliant Electronic Package Insert Platform
eLeaflet Building — ePIL Authoring, FHIR R4 & HL7 Platform | ARRIS IT
Summary
This service provides an end-to-end platform for pharmaceutical companies to author, validate, and distribute electronic package inserts (ePIL). By utilizing AI, it automates the conversion of existing paper media or PDFs into structured, FHIR R4 compliant data, significantly reducing manual effort.
Details
This integrated system is designed for pharmaceutical enterprises managing Electronic Package Inserts (ePIL). A key feature is its AI assistance, which automatically extracts and converts unstructured data from sources like SmPC documents or Word files into FHIR R4 compliant XML. The platform incorporates real-time validation against multiple international regulatory requirements, including JFDA, EMA, and FDA standards, ensuring structural compliance during the process. Users can manage content authoring, multi-language support, and role-based review workflows before exporting validated FHIR R4 XML/JSON for distribution to national health registries or pharmacy systems. Furthermore, all edits are logged as an audit trail, guaranteeing complete GxP traceability.
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