XML Validator

E2B(R2) E2B(R3) FAERS FDA CVM eMDR
What is supported?

Auto-detects and validates four dialects:

  • E2B(R2) — ICH ICSR DTD v2.1 + Attribute List v4.5 (generic ICH rules); when receiver is FDA (CDER / CBER / CVM / ZZFDA / ZZFDATST) also runs FDA FAERS regional rules (messageformatversion 2.1/2.2/3.0, FDA-hosted DTD URL, country=US, safetyreportid format, encoding checks per FDA E2B(R2) FAERS IG Draft V1.9).
  • E2B(R3) — ICH E2B(R3) IG v1.11.1 (HL7 v3 MCCI_IN200100UV01 / PORR_IN049016UV, generic ICH rules); when profile / receiver is FDA also runs FDA FAERS R3 regional rules (FDA.C.*, FDA.G.k.10a, FDA.G.k.12.r device fields, FDA.D.11.r Race / D.12 Ethnicity, safety-report-id shape).
  • FDA CVM — VICH GL42 (PORR_IN049006UV) Veterinary AER, profile-aware (AE / PP / AEPP) per FDA CVM Validation Procedure v1.0.9 Table 1-3.
  • FDA eMDR — HL7 v3 PORR_IN040001UV01 Medical Device Reports (Manufacturer / User Facility / Importer variants), scenario-aware.

Runs structural, per-field, and cross-field business rules — including scenario-aware checks (Initial / Follow-up / Nullification / Amendment, Literature / Non-Literature, Spontaneous / Clinical Trial, Expedited / Periodic).

Validates ICSR XML against dialect-appropriate schemas (DTD, XSD, or HL7 v3 message package) plus per-field data rules and cross-field business rules.