SmPC & PIL → FHIR bundles, scored and validated.
A repeatable conversion pipeline that takes your approved SmPC (Annex I), labelling (Annex IIIA) and PIL (Annex IIIB) — in DOCX or PDF — and produces a conformant HL7 FHIR ePI Bundle ready for the PLM Portal.
What we deliver
Structural parsing
QRD-aware extractor maps headings to Composition.section codes from the EU IG value sets.
SPOR/IDMP resolution
Substances, products, organisations and dose-forms resolved to SPOR identifiers.
Language packs
All 24 EU languages emitted as parallel sections under one Bundle.
Fidelity scoring (0–100)
Automated similarity score between source and rendered ePI — every divergence logged.
Validator_cli evidence
HL7 validator_cli.jar run captured and attached as the conformance receipt.
Immutable fix log
Every editorial fix recorded with author, timestamp and rationale.
What makes our conversion different
Most platforms output something that looks like ePI. Our pipeline ships with two artefacts no regulator can argue with: a HL7 validator pass and a per-section fidelity score against the approved source. That is what makes a parallel-run defensible during the EMA voluntary phase.
Artefacts you receive
- FHIR Bundle (JSON + XML)
- Fidelity scorecard per section
- validator_cli log
- Immutable fix log
- Rendered HTML preview for QA
Sourced from regulators and industry leaders
- HL7 FHIR validator — HL7
- EU ePI IG — value sets — HL7 Europe
- EMA SPOR — European Medicines Agency
Ready to scope this work?
Talk to an Alnexia specialist about timelines, deliverables and pricing — no obligation.
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