Everything You Need for Compliance with the EU AI Act
VivaComply combines traditional QMS capabilities with cutting-edge AI automation to make compliance efficient, intelligent, and human-centric. Built specifically for startups and SMEs entering the world of AI regulation.
Core Platform Capabilities
Four integrated modules that work together to deliver comprehensive AI Act compliance
Core Quality Management System
Foundation for all your quality processes
Document Templates
Pre-configured templates with AI Act-specific requirments.
Multi-Format Document Repository
Import and manage SOPs, quality manuals, regulatory submissions, competitor analyses, and technical documentation.
Document Control System
Complete version control with automated change documentation and immutable audit trails.
Project and Team Management
Organize quality initiatives and manage team access across regulatory projects with role-based permissions.
AI-Powered Risk Management
Smart automation for complex compliance tasks
EU AI Act Risk Classification
Automated assessment and categorization of AI system risk levels with reasoning.
Process and Product Risk Analysis
Use expert an AI auditor to analyze your processes and products.
Smart Risk Management
AI-assisted risk management for mitigations and controls.
Select Risk Analysis Method (optional)
Choose from FMEA,FTA, orFTA, or use AI to analyze your processes and products.
Compliance and Reporting
Export-ready documentation with EU sovereignty
EU Data Sovereignty
GDPR-compliant data residency with on-premise options for regulated industries.
End-to-End Encryption
Secure data transmission meeting pharmaceutical and medical device security requirements.
Multi-Format Export
Generate regulatory submissions in required formats (eCTD*, PDF, Word, JSON) with one click.
Blockchain Audit Trail (optional)
Immutable version control for GxP and FDA 21 CFR Part 11 compliance requirements.
Operational Excellence
Streamlined workflows and intelligent monitoring
Comprehensive AI Auditing
Review and cross-check documents and regulations with AI.
Smart Suggestions
AI-driven suggestions for document reviews and closing compliance gaps.
Translate to Legal Language
Rephrase your words to legal language with AI.
Intelligent versioning and audit trails
Track document versions and changes with AI-powered audit trails.
Strategically Focused Approach
Get compliant fast with essential AI governance features
🎯 Essential Features First
We prioritize core AI Act compliance requirements to get you regulated and operational quickly.
🚀 Speed to Compliance
Purpose-built for teams that need AI governance now, without the complexity of enterprise-grade systems.
Advanced Features for Later:
- ⏳ Continuous Compliance Monitoring - Essential for mature operations, but not needed for initial compliance
- ⏳ Automated Evidence Collection - Powerful feature for established teams, comes after core compliance
- ⏳ CAPA Management - Full corrective action workflows for advanced QMS maturity
- ⏳ Calibration Management - Enterprise-grade equipment tracking and validation
- ⏳ Training Management - Comprehensive learning management and certification tracking
Our Philosophy: Master the fundamentals of AI compliance first. Advanced automation and monitoring capabilities become valuable investments once your core processes are established and you're ready to scale.
Experience AI-First Compliance
See how our AI assistant transforms complex regulatory tasks into simple, guided workflows
Intelligent Risk Detection
AI continuously monitors your documentation for potential compliance risks and suggests mitigations.
Smart Document Generation
Generate compliant documentation from simple descriptions with AI-powered templates and suggestions.
Automated Gap Analysis
AI reviews your current state against AI Act requirements and provides actionable improvement plans.
Real-time Compliance Scoring
Get instant feedback on your compliance readiness with AI-powered scoring and recommendations.
Ready to Transform Your AI Compliance?
Join forward-thinking companies who are making compliance a competitive advantage with VivaComply's AI-first approach.
