Compliance and Security by Design
SafetyEasy® combines validation support, secure operations, AI governance, and regulatory standards coverage, so life sciences teams can adopt automation without losing control.
Compliance Built into SafetyEasy® Operations
Regulated Platform Foundation
Validation support, audit trails, role-based workflows, and controlled release documentation.
Data Protection
GDPR-aware design, encryption, client-level isolation, controlled access, and monitoring for secure operations.
Governed AI Framework
The AI Gateway controls, customer policies, data minimization, pseudonymization, and human review.
Regulatory Standards
Vigilance processes aligned with global regulatory expectations across product domains.
Regulated Platform Foundation
SafetyEasy® is developed for controlled, traceable, audit-ready safety operations.
GAMP® 5 Alignment and 21 CFR Part 11 Support
SafetyEasy® is developed in alignment with GAMP® 5 and FDA 21 CFR Part 11, supporting a controlled software lifecycle, electronic records, traceability, and auditability.
Validation Documentation with Every Release
Each release ships with a validation dossier: IQ, OQ, PQ, functional specifications, validation plans and reports, test evidence, monitoring guidance, and change-impact documentation, stored centrally in the SafetyEasy® Document Management System.
Audit Trails and Role-Based Workflows
Traceability holds across case handling, review steps, operational decisions, user actions, and escalations.
Configurable Business Rules
Workflows, reportability logic, templates, fields, lists, and rules adapt to your operating model.
Data Protection
SafetyEasy® is designed with data protection and secure operating principles for global safety teams.
GDPR and Privacy by Design
Data protection by design supports organizations operating across regulated markets.
Encrypted Data Flows
Safety data flows are encrypted and continuously monitored.
Client-Level Isolation
Multi-tenant architecture enforces strict client-level isolation and confidentiality.
Controlled Access
Role-based controls govern who can access, review, approve, and act on safety information.
Data Integrity
High-assurance data handling supports safety operations, reporting, and oversight.
Operational Monitoring
Secure, monitored infrastructure supports trusted cloud safety operations.
Governed AI Framework
SafetyEasy® modules never connect directly to AI providers. Every AI request routes through the AB Cube AI Gateway, a governance layer built for regulated pharma, biotech, CRO, and medical device operations.
Policy-Controlled AI Access
Customer-specific rules govern what data is sent, which AI capabilities are available, and how AI is used in safety workflows.
Data Minimization and Pseudonymization
AI requests are controlled to reduce exposure of sensitive safety and patient information. No customer data is stored or retained by AI models.
EU / ZDR Routing and Model Control
Routing and model selection are governed to meet customer requirements around geography, privacy, and zero data retention.
Auditability
AI interactions are logged to support traceability, review, and quality oversight.
Human Review
Users remain in control of validation, acceptance, escalation, and final decisions.
Built for Regulatory Expectations
The governance framework is designed for regulated safety operations: patient data protection, GDPR expectations, EU AI Act readiness, and GAMP® 5 validation needs.
AI Validation Evidence
AI used in pharmacovigilance must be measurable, repeatable, and explainable. EvalAI assesses each AI module against your own representative data, turning performance testing into a defensible validation record.
Human Alignment
Compares AI output with human-reviewed results, highlighting matches, improvements, and discrepancies.
Reproducibility
Scores repeated AI passes to demonstrate predictable, consistent behavior.
AI Accuracy
Measures completeness, fidelity, consistency, and interpretation against source data at case section level.
Confidence Score
Flags low-confidence outputs so reviewers focus attention where it is most needed.
Regulatory Standards Coverage
SafetyEasy® supports vigilance processes aligned with global regulatory expectations across product domains.
Pharmacovigilance
EudraVigilance, FDA FAERS, and ICH E2B(R3) workflows.
Medical Device Vigilance
EU MDR 2017/745 and FDA Medical Device Reporting expectations.
Multivigilance Operations
Configurable workflows for pharmacovigilance, device vigilance, cosmetovigilance, nutrivigilance, and other regulated safety domains.