Workflow

SmPC DOCX or PDF → validated FHIR ePI Bundle

POST /api/process_stateless · sub-30s end-to-end · 21-field response · every fix logged with rule ID + before/after.

SmPC DOCX or PDF
EU QRD template
Phase 1 — FHIR Conformance
01

Parse

DOCX / PDF input. SmPC strategy. HTML sanitised.

02

FHIR map

Composition + Bundle (collection). SPOR-coded.

03

Validate

validator_cli.jar against hl7.eu.fhir.epil. AutoFixer rules.

Phase 2 — Fidelity
04

Score

Recall 0–100. Target: 99.0. FidelityFixer applied.

05

Iterate

Up to 5×. Each fix logged. Fully idempotent.

FHIR Bundle
+ fidelity score · + immutable fix log

Three competitive moats

01
Moat 01

Fidelity Score

0–100, published, suppressed on errors.

Nobody else publishes this. QA sees how much source content survived the conversion. Versus black-box managed services: “trust us, it converted.”

02
Moat 02

Immutable Fix Log

Rule ID, location, before, after.

Hash-chained, append-only. Every AutoFixer + FidelityFixer rule is idempotent and traceable. Auditor gets a ledger, not a black box.

03
Moat 03

Validator Evidence

HL7 validator_cli.jar, no shortcuts.

Run against hl7.eu.fhir.epil IG. HTTP-fallback runs are flagged in the response and audit log. “Passes EMA validation” means zero errors.

Deep dives

Explore each ePI capability