Compliance & Security by Design

Validation with respect to Regulatory Standards & Guidelines

SafetyEasy® Suite is developed in full alignment with GAMP®5 and FDA 21 CFR Part 11. Every module—whether in IntakEasy, SafetyEasy® Vigilance, or SafetyEasy® BI—operates within a tightly controlled, pre-validated framework ensuring:

• End-to-end traceability
• Audit readiness
• Consistent quality across the platform

AB Cube provides full validation dossier as part of the release package, ensuring proper deployment of each new version.

All validation documentation is centrally stored in the SafetyEasy® Document Management System (DMS).

GDPR & Global Data Protection

AB Cube’s infrastructure is built with data protection by design, meeting and exceeding global privacy regulations:

• No customer data stored or retained by AI models
• Fully encrypted and continuously monitored data flows
• Multi-tenant architecture with strict client-level isolation

High-assurance data integrity and confidentiality.

EU AI Act Alignment

All AI-powered modules in the SafetyEasy® Suite are classified as “minimal or no risk” under the EU AI Act, placing them outside the scope of mandatory obligations. Clients benefit from intelligent automation without added regulatory burden, while maintaining:

• System transparency
• Full control over AI functionalities
• Compliance peace of mind

Regulatory Standards

SafetyEasy® keeps your vigilance processes aligned with global regulatory expectations.

For example:

Pharmacovigilance (Drugs)

• EudraVigilance (EU)
• FDA FAERS (US)
• ICH E2B(R3)

Medical Device Vigilance

• EU MDR 2017/745
• FDA Medical Device Reporting