VigiHelp is built for pharmacovigilance teams that need strong data protection, traceable workflows, and alignment with global safety reporting expectations.
The platform combines privacy-by-design principles with controlled tenant separation, encrypted data storage, and governance practices for AI-assisted safety workflows.
GDPR and global data protection, EU AI Act readiness, pharmacovigilance regulatory standards, and ESG submission support
VigiHelp supports privacy-conscious operations with multi-tenant separation, database encryption, controlled access, and no customer data used to train the VigiHelp AI engine.
AI-assisted workflows are designed with transparency, human review, traceability, and risk-aware governance in mind for organizations preparing for EU AI Act expectations.
VigiHelp supports structured pharmacovigilance workflows aligned with EudraVigilance, FDA FAERS, and ICH E2B(R3) regulatory reporting expectations, including Electronic Submissions Gateway delivery workflows.
Controls focused on tenant separation, encrypted storage, and customer data protection
Customer environments are separated so each organization can manage its own data and workflows.
Data stored in the database is protected with encryption controls for sensitive safety information.
Customer data is not used to train the VigiHelp AI engine, helping preserve confidentiality and data ownership.
AI-assisted outputs remain reviewable by pharmacovigilance experts and can be prepared for authority submission through the Electronic Submissions Gateway.