A Unified Framework for Operationalizing EU AI Act Compliance Integrating Risk Management, Technical Documentation, and Human Oversight for High-Risk Systems

Title: A Unified Framework for Operationalizing EU AI Act Compliance: Integrating Risk Management, Technical Documentation, and Human Oversight for High-Risk Systems Author: Hernan HuwylerAffiliation: Law School Executive Education, IE University, Madrid, SpainORCID: 0009-0002-1249-7387DOI: 10.5281/zenodo.17703640Publication Date: 24/11/2025JEL Codes: K24, L15, M15, O33, L86 Description: From Voluntary Ethics to Mandatory Law: Operationalizing the EU AI Act The Era of "Move Fast and Break Things" is Over.With the enactment of the European Union's Artificial Intelligence Act (EU AI Act), organizations face a stark new reality: compliance is no longer a theoretical exercise in ethics, but an existential business imperative carrying penalties of up to 7% of global annual turnover. This research paper bridges the critical "Implementation Gap" between high-level legal mandates and the day-to-day technical realities of MLOps and Governance. 📄 Research OverviewAddressed to the IE Compliance and AI Research Call 2025, this paper presents a Unified Technical Framework designed to translate the EU AI Act’s stringent Article requirements into a coherent, 6-stage operational lifecycle: Planning: Role identification (Provider vs. Deployer) and Risk Classification. Requirements: Gap analysis against ISO/IEC 42001 and NIST AI RMF. Design: Engineering "Documentation as Code" and continuous Risk Management Systems. Testing: Adversarial "Red Teaming" and Fundamental Rights Impact Assessments (FRIA). Deployment: Designing effective Human-in-the-Loop (HITL) oversight interfaces. Maintenance: Continuous post-market monitoring for model drift and bias. Key Contributions for Practitioners Role Clarity: A definitive guide to navigating the fluid boundary between "Deployer" and "Provider" and how fine-tuning models can inadvertently trigger massive liability. Technical Documentation: Moving beyond static reports to living compliance artifacts that satisfy Conformity Assessments. Integrated Governance: How to fuse GDPR data protection impact assessments (DPIAs) with AI Act fundamental rights impact assessments (FRIAs) for efficiency. AbstractThe enactment of the European Union's Artificial Intelligence Act (EU AI Act) creates a pressing need for applied governance, risk, compliance, and audit (GRCA) frameworks that translate legal text into actionable corporate protocols. This research provides a comprehensive technical framework for organizations to achieve and maintain compliance, with a specific focus on the stringent obligations for high-risk AI systems and general-purpose AI models. Derived from an analysis of practitioner-oriented source material, the proposed framework structures compliance across six critical stages: Planning, Requirements, Design, Testing, Deployment, and Maintenance. The analysis shows that successful operationalization hinges on the integration of three core pillars: a continuous risk management system, meticulous technical documentation, and effective human oversight mechanisms. The paper bridges the gap between regulatory theory and practice by offering concrete steps for role identification, risk classification, and control implementation, providing immediate, actionable guidance for AI providers, deployers, and importers navigating the new regulatory landscape.