IT Governance

Privacy and Operational Assurance

AI and DP Assessment

AI and data protection assessment for high-risk AI systems under the EU AI Act

Overview

AIIA is a professional-grade software platform specifically designed to support organisations in achieving and demonstrating compliance with the EU Artificial Intelligence Act (Regulation (EU) 2024/1689) for high-risk AI systems. It provides a structured, auditable, and collaborative framework that integrates regulatory obligations from the AI Act, GDPR, and harmonised standards, including EN 18286 (Quality Management Systems for AI). The solution guides users through a systematic assessment process structured around three core pillars:

  • Proportionality, Necessity, and Foundational Controls - Ensuring minimal, purpose-bound processing and robust baseline safeguards.
  • Operational Rights Delivery, Transparency, and Oversight - Guaranteeing effective exercise of data subject rights, clear information provision, and meaningful human oversight.
  • Broad Compliance Assessment, Governance, Risk, Security, and Sustainability - Embedding enterprise-wide governance, lifecycle risk management, cybersecurity, and environmental responsibility.

Multi-role collaboration (preparer, reviewer, approver) enables cross-functional teams and external parties (e.g., providers, suppliers) to contribute to system description, technical documentation, risk assessment, control implementation, and final acceptance.

AIIA focuses on pre-market readiness, generating the documentation and evidence required for conformity assessment, technical documentation (Annex IV), EU declaration of conformity, and regulatory audits.

Key Features

Comprehensive Regulatory Roadmap
Step-by-step guidance covering all high-risk AI obligations, from classification and technical documentation to post-market monitoring and serious incident reporting.

Precise Regulatory Referencing
Every question links directly to specific AI Act articles, GDPR provisions, and harmonised standards (e.g., EN 18286, prEN 18284, prEN 18283), with required mandatory documents and objective evidence clearly identified.

Automated Traceability and Gap Analysis
Real-time visibility of compliance coverage; automated traceability matrices linking answers to regulatory requirements; instant identification of gaps.

One-Click Documentation Generation
From user responses, AIIA automatically generates audit-ready outputs including:

  • Technical Documentation (Annex IV compliant)
  • EU Declaration of Conformity (Annex V)
  • Fundamental Rights Impact Assessment (FRIA - Art. 27)
  • Post-Market Monitoring Plan (Art. 72)
  • Residual Risk Acceptance Statement

Integrated FRIA and Lifecycle Risk Management
Dedicated modules for Fundamental Rights Impact Assessment, continuous risk management (Art. 9), and post-market monitoring with closed-loop feedback to design and mitigation controls.

Sustainability and Resource Tracking
Built-in monitoring of energy consumption, carbon footprint, and environmental impact, supporting responsible AI deployment.

Secure Multi-User Collaboration
Role-based access, version control and secure exchange of documentation with external parties.

Extensive Knowledge Base
Curated regulatory guidance, recommended controls, templates, and best practices continuously updated by compliance experts.

Benefits

  • Regulatory Confidence - Structured, evidence-based approach minimises compliance risk and prepares for notified body or authority scrutiny.
  • Efficiency - Reduces manual documentation effort by up to 80% through automation and reusable templates.
  • Collaboration - Enables seamless teamwork across technical, legal, compliance, and executive functions.
  • Scalability - Suitable for single systems or enterprise-wide AI portfolios.
  • Future-Proof - Regularly updated for new standards, codes of practice, and regulatory developments.

Who It Is For

  • AI System Providers and Manufacturers
  • Deployers of High-Risk AI Systems
  • Quality and Compliance Managers
  • Risk and Data Protection Officers
  • Legal and Regulatory Affairs Teams
  • Internal Auditors and Conformity Coordinators
  • Notified Bodies and Consultants

Availability

AIIA is delivered as a secure, cloud-based SaaS platform with enterprise-grade security, regular updates, and dedicated support.