AI/GxP

Latest pharmacovigilance updates in AI/GxP.

publicEma · Updated May 22, 2026

MHRA reiterates GxP data integrity spans GVP as Annex 11 evolves

Ema update requires triage for Local Affiliate Compliance, Vendor Oversight, Inspection Readiness; confirm local obligations and document follow-up actions.

Local Affiliate ComplianceVendor OversightQPPV

SOP Impact7 SOPs

ConfidenceMedium

Relevant for: QPPV, Local Safety Officer, Signal Management Lead

verifiedRegulatory action: AI/GxP

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