Core Assessment Tools
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Program Overview
This playbook provides comprehensive guidance for Enterprise Risk Management professionals conducting technical risk assessments of AI systems to ensure compliance with the EU AI Act, ISO 42001, and NIST AI Risk Management Framework.
Who This Is For:
Enterprise AI Risk Assessors, Compliance Officers, Risk Management Professionals, AI Governance Teams. Note: This guide assumes you are NOT a Tenant Administrator and will need to request infrastructure resources from IT.
Target Industries:
Fintech, Financial Services, Industrial sectors - particularly organizations deploying high-risk AI systems as defined by EU AI Act Annex III.
Two Assessment Tracks
| Aspect |
Azure AI Solutions Full Governance Track |
Copilot Studio Fast-Track Governance |
| Use Cases |
Custom agentic AI, in-house LLMs/SLMs, complex ML models, high-risk classification systems |
Low-code agentic AI, Copilot agents, business automation, conversational AI |
| Infrastructure |
Dedicated Azure subscription, OpenAI Service, ML Workspace, GPU compute, Purview, extensive tooling |
Copilot Studio license, Power Platform environment, minimal additional infrastructure |
| Setup Time |
2-4 weeks (full infrastructure provisioning) |
3-5 days (primarily licensing and access) |
| Monthly Cost |
$3,700 - $8,600 (Azure services + tools) |
$800 - $2,500 (licenses + limited tools) |
| Tool Complexity |
18+ specialized tools (Garak, PyRIT, MLflow, Evidently, etc.) |
6-8 essential tools (simplified testing suite) |
| Security Testing |
Full adversarial testing, custom red teaming, deep penetration testing |
Managed security testing, built-in safeguards validation, configuration review |
| Data Governance |
Azure Purview, custom lineage mapping, extensive PII scanning |
Power Platform DLP, built-in compliance features, connector governance |
| EU Control Coverage |
All 25 controls with deep technical validation |
All 25 controls with configuration-based validation |
| Best For |
Custom AI development, high-risk systems, complex architectures, advanced ML |
Business users building copilots, low-code solutions, rapid deployment, managed services |
Assessment Program Objectives
-
Compliance Verification
Validate adherence to all 25 EU AI Act control requirements (Articles 9-67) with documented evidence for conformity assessment.
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Risk Identification & Mitigation
Identify technical risks across security, privacy, bias, performance, and safety domains. Develop mitigation strategies.
-
Continuous Monitoring
Establish production monitoring for drift detection, performance degradation, security threats, and incident response.
-
Documentation & Reporting
Generate comprehensive assessment reports, model cards, risk registers, and conformity declarations for regulatory submission.
Regulatory Framework Alignment
Getting Started
Choose Your Assessment Track:
Navigate to "Azure AI Assessment" for comprehensive infrastructure-based assessments of custom AI solutions, or "Copilot Studio Assessment" for fast-track governance of low-code agentic AI built in Microsoft Copilot Studio.
Reference Materials:
Visit the "Summary & Reference" section for detailed EU AI Act control catalog, complete technical resource inventory, and risk assessment methodology.
Assessment Scope Definition
-
Identify AI Systems in Scope
Azure OpenAI Deployments: GPT-4, GPT-3.5-turbo, custom fine-tuned models
Azure ML Models: Classification, regression, clustering models
Agentic Systems: LangChain agents, AutoGPT, custom agent frameworks
Custom LLMs/SLMs: Self-hosted or Azure-deployed language models
-
Classify AI Systems by EU Risk Tier
High-Risk (Annex III): Credit scoring, employment decisions, critical infrastructure, law enforcement, biometric identification
Limited-Risk: Chatbots with transparency obligations
Minimal-Risk: Spam filters, inventory management
-
Map Stakeholders
Approvers: Azure Platform Team, IT Infrastructure, Security Team, Compliance Officer, Budget Approvers
Collaborators: Model developers, data scientists, business owners, legal counsel
Governance: AI Ethics Board, Risk Committee, Audit Team
Budget & Resource Planning
| Resource Category |
Monthly Cost Estimate |
Justification |
| Azure OpenAI (Testing) |
$500 - $1,500 |
Security testing requires 1000+ adversarial queries per assessment (EU-07) |
| Azure ML Workspace + Compute |
$1,000 - $2,000 |
Model versioning, experiment tracking, conformity assessment (EU-03, EU-09) |
| GPU VM (Adversarial Testing) |
$300 - $500 |
Adversarial robustness testing required by EU Article 15 |
| Azure Storage (WORM, 10-year) |
$100 - $200 |
Immutable log storage mandated by EU Article 12 |
| Azure Purview |
$500 - $800 |
Data governance and lineage tracking (EU-02, EU-10) |
| Application Insights + Monitor |
$600 - $1,300 |
Comprehensive logging and 10-year retention (EU-04, EU-08) |
| LangSmith (Agentic AI) |
$500 - $2,000 |
Agent tracing required for EU-04, EU-06, EU-17 compliance |
| Total |
$3,500 - $8,300/month |
Regulatory compliance program |
Program Timeline
| Timeframe |
Activities |
Deliverables |
| Week 1 |
Submit IT infrastructure request, secure budget approval, workstation setup |
Approved IT ticket, budget confirmation |
| Weeks 2-3 |
IT provisions Azure resources, install local tools, configure authentication |
Access credentials, tool installations complete |
| Week 4 |
Test connectivity, run first security scans, configure monitoring |
First Garak scan, MLflow operational |
| Month 2+ |
Monthly assessments, quarterly compliance reviews, continuous monitoring |
Assessment reports, EU control evidence |
Priority 1: Critical Resources
Submit these requests immediately - 2-3 week lead time required. See Planning phase for complete details.
Key Infrastructure Requests: Azure testing subscription/RG, Azure OpenAI Service, Azure ML Workspace, Service Principal, Assessment VM, Azure Storage (WORM), Azure Purview, Application Insights, Azure Monitor Logs, Network/VPN access.
Essential Software
Install while waiting for Azure infrastructure provisioning.
- Azure CLI - Authentication and resource management
- Python 3.10+ - Create virtual environment for assessment tools
- Visual Studio Code - Script development and notebooks
- Git - Version control
- Docker Desktop (optional) - Containerized tools
Monthly Assessment Workflow
Week 1: Discovery & Security Testing
- Query Azure ML model registry for systems to assess
- Run Garak security scan on all Azure OpenAI deployments
- Execute PyRIT red team campaign on high-risk models
- Test agentic systems for tool access control violations
Week 2: Performance & Bias Testing
- DeepEval hallucination testing for LLMs
- Agent reasoning validation using LangSmith traces
- Fairness testing on classification models (Fairlearn)
- Performance metrics validation in MLflow
Week 3: Privacy & Explainability
- Presidio PII scanning on training data and outputs
- Azure Purview data lineage audit
- SHAP/LIME explainability analysis
- Evidently drift detection on production data
Week 4: Documentation & Reporting
- Update model cards and technical documentation
- Compile evidence for all 25 EU AI Act controls
- Generate assessment report with risk ratings
- Log findings in Azure DevOps, present to stakeholders
Copilot Studio Assessment Overview
When to Use This Track:
Use the Copilot Studio assessment track when evaluating conversational AI agents built in Microsoft Copilot Studio (formerly Power Virtual Agents), including custom copilots, business automation agents, and customer service bots.
Microsoft Copilot Studio is a low-code platform for building conversational AI agents. Unlike custom Azure AI solutions, Copilot Studio provides managed services with built-in security, compliance features, and governance capabilities that simplify the assessment process.
Key Differences from Azure AI Track
| Assessment Area |
Azure AI (Custom Solutions) |
Copilot Studio (Managed Platform) |
| Infrastructure Setup |
Dedicated subscription, OpenAI service, ML workspace, GPU compute, Purview |
Copilot Studio license, Power Platform environment, minimal add-ons |
| Security Testing |
Custom red teaming with Garak, PyRIT; adversarial attack generation |
Configuration review, built-in content filter validation, connector security |
| Data Governance |
Azure Purview for full lineage mapping, custom PII scanning |
Power Platform DLP policies, built-in data connectors with pre-configured governance |
| Monitoring |
Custom MLflow, Evidently dashboards, Application Insights configuration |
Built-in Copilot Studio analytics, Power Platform Center of Excellence toolkit |
| Explainability |
SHAP, LIME analysis, custom reasoning traces |
Built-in conversation transcripts, topic analysis, automated summaries |
| Logging |
Custom Azure Monitor configuration, 10-year retention setup |
Dataverse for Teams with retention policies, built-in audit logs |
EU AI Act Compliance in Copilot Studio
All 25 EU AI Act controls still apply, but implementation differs:
Assessment Scope: What to Evaluate
-
Copilot Configuration
Authentication settings, generative AI features enabled, topic design, entities and variables, fallback behavior, escalation paths
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Data Connectors & Integrations
Power Automate flows, SharePoint connections, Dynamics 365 integrations, custom connectors, API permissions, OAuth scopes
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Content & Knowledge Sources
SharePoint sites indexed, generative answers configuration, citation requirements, content freshness, data classification
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Security & Access Controls
DLP policies applied, authentication requirements, role-based access, environment security, connector governance
-
User Experience & Transparency
AI disclosure messages, system instructions visible to users, conversation handoff to humans, error handling, user feedback collection
Required Licenses & Access
-
Copilot Studio License
Request from IT: Copilot Studio license ($200/user/month or consumption-based)
Access Level: At minimum "User" role to test copilots; "Admin" role preferred for full configuration review
Environment: Access to Production environment where copilots are deployed
Justification: Required to review copilot configuration, test conversations, access analytics (EU-01, EU-03)
-
Power Platform Admin Center Access
Request from IT: Power Platform Administrator or Environment Admin role
Purpose: Review DLP policies, environment settings, connector governance, audit logs
Justification: Required for EU-02 (Data Governance), EU-15 (Data Confidentiality) validation
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Dataverse for Teams Access
Request from IT: Read access to Dataverse tables storing conversation logs
Purpose: Access conversation history, user interactions, copilot performance metrics
Justification: Required for EU-04 (Record Keeping), EU-08 (Automatic Logging)
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Microsoft Purview (Optional)
Request from IT: Purview Compliance Portal access for DLP policy management
Purpose: Review sensitivity labels, DLP rules, compliance reports
Priority: Optional but recommended for enterprise deployments
Workstation Setup (Simplified)
| Tool |
Purpose |
Installation |
| Web Browser |
Access Copilot Studio portal, Power Platform Admin Center |
Microsoft Edge or Chrome (latest version) |
| Power Platform CLI |
Automate environment queries, export copilot configurations |
Download from: aka.ms/PowerPlatformCLI |
| Excel / Power BI |
Analyze conversation data, create compliance dashboards |
Part of Microsoft 365 |
| Python (Optional) |
Script automated testing, analyze exported data |
python.org - Only if automation needed |
| Presidio (Optional) |
Validate PII detection in conversations |
pip install presidio-analyzer |
| CoE Toolkit (Optional) |
Power Platform Center of Excellence analytics |
Install from PowerApps solution gallery |
No Azure Infrastructure Required: Unlike Azure AI track, Copilot Studio assessments do not require dedicated Azure subscriptions, GPU VMs, or custom ML workspaces. All infrastructure is managed by Microsoft.
Cost Comparison
| Component |
Azure AI Track Cost |
Copilot Studio Track Cost |
| Licenses |
N/A |
$200-600/month (Copilot Studio) |
| Azure Infrastructure |
$3,000-6,500/month |
$0 (managed service) |
| Assessment Tools |
$500-2,000/month (LangSmith, etc.) |
$200-500/month (minimal tooling) |
| Storage & Logging |
$600-1,300/month |
$100-200/month (Dataverse storage) |
| Total |
$4,100-9,800/month |
$500-1,300/month |
85-90% Cost Reduction: Copilot Studio's managed service model significantly reduces infrastructure costs while maintaining EU AI Act compliance through built-in governance features.
Setup Timeline
| Day |
Activities |
Deliverables |
| Day 1 |
Request Copilot Studio license and Power Platform admin access |
IT ticket submitted |
| Day 2-3 |
Receive access, install Power Platform CLI, browser setup |
Access confirmed, basic tools ready |
| Day 4 |
Review copilot inventory, identify assessment targets |
Copilot inventory spreadsheet |
| Day 5 |
Conduct first configuration review, test sample conversations |
Initial assessment findings |
| Week 2+ |
Complete assessments, document EU controls, generate reports |
Compliance documentation |
Phase 1: Configuration Review
-
Access Copilot Studio Portal
Navigate to copilotstudio.microsoft.com → Sign in with corporate credentials → Select environment (Production) → View all copilots
-
Review Authentication Settings EU-06, EU-14
Check: Authentication required? No authentication allows anonymous access
Validate: OAuth configuration for Teams, web channel security
Document: Who can access the copilot, how identity is verified
Evidence: Screenshot of authentication configuration
-
Audit Generative AI Configuration EU-07, EU-20
Settings → AI Capabilities: Is "Generative answers" enabled?
Content Moderation: What content filtering level is set? (Low/Medium/High)
Citation Requirement: Are citations enabled for generated responses?
Model Version: Which GPT model is configured? Document model name
Evidence: Export configuration as JSON
-
Review Knowledge Sources EU-02, EU-10
Check: Which SharePoint sites or URLs are indexed?
Data Classification: Are knowledge sources properly labeled (Public/Internal/Confidential)?
Refresh Schedule: How often is content re-indexed?
Consent: Do you have authorization to use this data for AI?
Evidence: List of knowledge sources with classification labels
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Validate Topics & Conversation Design EU-17
Review: All topics, trigger phrases, conversation flows
Check: Are escalation paths to humans defined?
Validate: Error handling and fallback topics configured
Test: Out-of-scope queries properly handled
Evidence: Topic list export, flow diagrams
Phase 2: Security & Data Governance Testing
-
Power Platform DLP Policy Review EU-15, EU-21
Navigate to: Power Platform Admin Center → Policies → Data policies
Check: Which DLP policies apply to copilot environment?
Connector Classification: Business | Non-business | Blocked
High-Risk Connectors: Ensure SQL, SharePoint, external APIs have proper governance
Evidence: DLP policy export, connector classification list
-
Test Conversation for PII Handling EU-15
Manual Test: Start conversation, provide fake PII (SSN, credit card, phone number)
Observe: Does copilot refuse to process? Store? Display PII?
DLP Validation: Confirm DLP policy blocks PII in Power Automate flows
Optional Tool: Use Presidio to scan conversation logs for PII leakage
Evidence: Test conversation transcripts, DLP block notifications
-
Review Power Automate Flow Security EU-06, EU-18
Identify Flows: List all Power Automate flows triggered by copilot
Connector Permissions: What data sources can flows access?
Approval Gates: Are there human approval steps for high-risk actions?
Error Handling: What happens if flow fails?
Evidence: Flow diagrams, connection references, permission matrix
-
Audit Dataverse Data Access EU-04, EU-21
Check: Which Dataverse tables does copilot read/write?
Role-Based Access: Are security roles properly configured?
Field-Level Security: Is PII protected at field level?
Retention: How long are conversation logs retained?
Evidence: Security role assignments, table permissions, retention policies
Phase 3: Performance & User Experience Testing
-
Conversational Testing EU-07
Test Scenarios: Create 20-30 test conversations covering: in-scope topics, out-of-scope queries, ambiguous requests, multi-turn conversations, error conditions
Accuracy Assessment: Did copilot provide correct answers? Rate each response (Correct/Incorrect/Partially Correct)
Hallucination Check: Did copilot invent information not in knowledge sources?
Evidence: Test conversation logs with accuracy ratings
-
Review Built-in Analytics EU-09
Navigate to: Copilot Studio → Analytics tab
Metrics to Document: Total conversations, resolution rate, escalation rate, CSAT scores, topic performance
Trend Analysis: Compare last 7/30/90 days - is performance degrading?
Evidence: Analytics dashboard screenshots, exported metrics
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Transparency Validation EU-05, EU-13
Check Welcome Message: Does it disclose "You're talking to an AI"?
System Messages: Are limitations clearly communicated?
Citations: For generative answers, are sources cited?
Handoff Message: Is human escalation clearly explained?
Evidence: Screenshots of disclosure messages
Phase 4: Logging & Auditability
-
Access Conversation Logs EU-04, EU-08
Method 1: Copilot Studio → Analytics → Conversations (last 30 days)
Method 2: Dataverse → ConversationTranscript table (long-term storage)
Verify: Full conversation history captured (inputs, outputs, timestamps, user IDs)
Retention: Confirm 10-year retention policy configured in Dataverse
Evidence: Sample conversation transcript with metadata
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Audit Log Review EU-06
Power Platform Admin Center: Analytics → Audit logs
Filter: Copilot-related activities (edits, publishes, permission changes)
Validate: Who modified copilot configuration? When?
Evidence: Audit log export showing configuration changes
-
Export Compliance Data EU-23
Export Copilot: Settings → Export (saves as .zip with all topics and settings)
Export Conversations: Analytics → Export to Excel (last 30 days)
Export DLP Policies: Power Platform Admin Center → Export
Storage: Save to secure location with version control
Evidence: Exported files with timestamp for audit trail
Copilot Studio Testing Checklist
| Test Category |
Tests Performed |
Pass/Fail Criteria |
Evidence |
| Authentication |
Verify auth required, test unauthorized access |
PASS: Auth required and enforced |
Config screenshot, test log |
| Content Filtering |
Test harmful prompts, inappropriate content |
PASS: Content blocked by filters |
Test conversation transcripts |
| PII Handling |
Submit PII, check DLP enforcement |
PASS: PII not stored or exposed |
DLP block notifications |
| Accuracy |
20 test conversations, rate responses |
PASS: >85% accurate responses |
Test results spreadsheet |
| Transparency |
Check AI disclosure, citations |
PASS: All disclosure present |
Screenshots of messages |
| Logging |
Verify conversation capture, retention |
PASS: All logs captured, 10-year retention |
Sample logs, retention policy |
Simplified Compliance: Built-in vs. Custom
Key Advantage: Many EU AI Act requirements are satisfied through Copilot Studio's built-in features rather than custom tooling. This section maps each control to the appropriate validation method.
| EU Control |
Azure AI Approach |
Copilot Studio Approach |
Complexity |
EU-01 Risk Management |
Custom risk register in Azure DevOps, quarterly reviews |
Risk register in SharePoint/Excel, review copilot analytics for incidents |
Same |
EU-02 Data Governance |
Azure Purview for lineage, custom PII scans |
Document SharePoint sources, verify DLP policies, sensitivity labels |
Simpler |
EU-03 Documentation |
Model Cards Toolkit, Azure ML registry |
Export copilot configuration, document topics and flows |
Simpler |
EU-04 Record Keeping |
Azure Monitor, Application Insights, WORM storage |
Dataverse conversation logs with retention policy |
Simpler |
EU-05 Transparency |
Custom disclosure implementation |
Built-in system messages, configure welcome message |
Much Simpler |
EU-06 Human Oversight |
Custom Logic Apps approval workflows, LangSmith tracing |
Escalation topic design, Power Automate approval flows |
Simpler |
EU-07 Accuracy & Security |
Garak, PyRIT, adversarial testing, custom performance tests |
Manual conversation testing, validate content filters, review analytics |
Moderately Simpler |
EU-15 Data Confidentiality |
Presidio scanning, Purview DLP, custom encryption checks |
Power Platform DLP validation, test PII handling |
Much Simpler |
EU-16 Bias Mitigation |
Fairlearn, AIF360, custom fairness audits |
Review conversation analytics by user demographics (if captured) |
Similar |
EU-17 Explainability |
SHAP, LIME, LangSmith reasoning traces |
Conversation transcripts show topic flows, citations enabled |
Simpler |
EU-20 Generative AI Transparency |
Custom watermarking, training data documentation |
Citation feature enabled, document knowledge sources |
Simpler |
Evidence Collection for Copilot Studio
For each EU control, collect the following evidence:
Copilot Studio Assessment Report Template
Report Structure: Create a standardized assessment report for each copilot evaluated.
Report Sections:
- Executive Summary - Copilot name, risk tier, overall compliance rating, key findings
- Copilot Overview - Purpose, users, channels (Teams/Web/etc.), knowledge sources, integrations
- Configuration Review - Authentication, generative AI settings, DLP policies applied
- Security Testing Results - PII handling tests, content filter validation, connector security
- Performance Assessment - Accuracy testing results, analytics review, user satisfaction scores
- EU Control Compliance - Status for all 25 controls with evidence references
- Findings & Recommendations - Issues identified, remediation steps, priority levels
- Evidence Appendix - Links to stored evidence (exports, screenshots, test logs)
How to Use This Catalog
Purpose: This catalog provides detailed information for each of the 25 EU AI Act controls that must be validated during AI system assessments. Use this as your compliance checklist and evidence mapping guide.
Risk Management Process
Purpose / Risk Mitigated: Identify, analyze, and mitigate risks during development and operation of AI systems.
Operational Implementation
Maintain documented risk register; evaluate each use case via AI risk taxonomy; re-assess quarterly. Include likelihood, impact, detectability scores.
Evidence Required
Risk register (Excel/DevOps), impact assessments, mitigation action plans, quarterly review reports
Data Governance & Data Quality Controls
Purpose / Risk Mitigated: Ensure training and input data are relevant, representative, and error-free to prevent discriminatory outcomes.
Operational Implementation
Apply data lineage tracking (Azure Purview); conduct data audits and quality checks; label dataset sources and licenses; document data collection methodology
Evidence Required
Dataset inventory, data quality reports, lineage diagrams, source documentation, consent records
Technical Documentation & Model Card
Purpose / Risk Mitigated: Provide documentation for transparency and auditability of AI system design and capabilities.
Operational Implementation
Maintain system card + model card; include intended purpose, architecture, limitations, performance metrics, training procedure, validation results
Evidence Required
Technical documentation, model cards, architecture diagrams, change logs, version history
Record Keeping & Logging
Purpose / Risk Mitigated: Enable traceability of agent decisions and tool actions for post-incident analysis and regulatory inspection.
Operational Implementation
Log inputs, prompts, tool calls, decisions, outputs, approvals, outcomes in immutable format (Azure Monitor, Dataverse). Minimum 10-year retention for high-risk systems
Evidence Required
Tamper-evident logs (WORM storage), hash verifications, log retention policies, sample log exports
Transparency & Disclosure
Purpose / Risk Mitigated: Inform users that they interact with AI and describe system capabilities to prevent deception.
Operational Implementation
Provide user-facing disclosure banners ("You are interacting with AI"); publish "Agent System Card" with capabilities and limitations
Evidence Required
Transparency statement, system card copy, website/app disclosure screenshots, user notification logs
Human Oversight
Purpose / Risk Mitigated: Guarantee meaningful human control over automated decisions, especially high-risk actions.
Operational Implementation
Define "human-in-loop" and "human-on-loop" approval gates per action type; dual approvals for high-risk decisions; kill-switch capability
Evidence Required
Oversight policy document, approval logs with timestamps, training materials for human reviewers, escalation workflows
Accuracy, Robustness, and Cybersecurity
Purpose / Risk Mitigated: Ensure reliable outputs and protection against manipulation, attacks, and security breaches.
Operational Implementation
Evaluate model accuracy ≥95% on defined test set; run adversarial and jailbreak tests monthly (Garak, PyRIT); secure APIs with mTLS; implement content filtering
Evidence Required
Performance test results (accuracy, precision, recall), red-team logs, adversarial robustness scores, penetration test reports, security scan outputs
Automatic Logging of Decisions & Actions
Purpose / Risk Mitigated: Provide continuous audit trail for post-incident analysis and regulatory inspection.
Operational Implementation
Implement telemetry pipeline capturing every tool-call and user interaction (Application Insights, LangSmith). Automatic, no manual intervention required
Evidence Required
Structured JSON logs, retention policy documentation (≥10 years), sample traces showing complete decision chains
Post-Market Monitoring System
Purpose / Risk Mitigated: Detect risks emerging during deployment through continuous performance monitoring.
Operational Implementation
Establish monitoring pipeline (drift detection, incidents, user complaints); triage via risk dashboard; monthly reviews; alert on performance degradation
Evidence Required
Monitoring plan document, incident register, escalation logs, monthly monitoring reports, drift detection alerts
Corrective Action Procedure
Purpose / Risk Mitigated: Rapidly mitigate non-conformities and safety issues when identified.
Operational Implementation
Maintain "kill-switch" capability; define retraining workflow triggers; report corrective actions to compliance officer within defined SLA
Evidence Required
Corrective action reports with timestamps, root-cause analysis documents, retraining justifications, kill-switch activation logs
Provider Declaration of Conformity
Purpose / Risk Mitigated: Certify compliance of system before market deployment via formal declaration.
Operational Implementation
Draft Declaration referencing control evidence and CE mark process; legal review required; signed by authorized representative
Evidence Required
Signed Declaration of Conformity document, supporting test summary, CE mark documentation (if applicable)
Registration in EU AI Database
Purpose / Risk Mitigated: Register high-risk systems before deployment for regulatory visibility.
Operational Implementation
Submit registration form via Commission database with conformity reference; update annually or upon significant changes
Evidence Required
Database entry receipt, registration confirmation number, annual renewal tracking
Instructions for Use
Purpose / Risk Mitigated: Supply clear operational guidance to deployers and users.
Operational Implementation
Publish usage manual including inputs, risks, monitoring requirements, maintenance intervals, troubleshooting guides
Evidence Required
"Instructions for Use" PDF/document, version control, distribution logs showing who received instructions
Information Provision to Users
Purpose / Risk Mitigated: Provide clear user documentation on limitations and accuracy.
Operational Implementation
Include accuracy scores, performance ranges, known failure modes in user-facing documentation; create FAQ
Evidence Required
User documentation package, FAQ, training content, user acceptance testing records
Data Access & Confidentiality Safeguards
Purpose / Risk Mitigated: Ensure data confidentiality in processing, prevent unauthorized access and PII exposure.
Operational Implementation
Apply encryption (at rest and in transit), DLP policies, sensitivity labeling, access controls (Azure Purview, MIP). Regular PII scanning (Presidio)
Evidence Required
Data protection logs, DLP configurations, encryption certificates, PII scan results, access control matrices
Bias & Discrimination Mitigation
Purpose / Risk Mitigated: Prevent bias in datasets and model behavior that could lead to discriminatory outcomes.
Operational Implementation
Run fairness audits using Fairlearn/AIF360 quarterly; test demographic parity, equalized odds; maintain mitigation records; 80% rule compliance
Evidence Required
Fairness audit reports, demographic parity metrics, bias remediation logs, group-level performance comparisons
Explainability & Justification of Outputs
Purpose / Risk Mitigated: Ensure users can interpret reasoning behind AI decisions for transparency and contestability.
Operational Implementation
Require models to produce traceable reasoning/citations; measure interpretability scores; use SHAP/LIME for explanations; LangSmith for agent traces
Evidence Required
Explainability evaluation results, feature importance rankings, local explanation samples, agent reasoning traces
Security of Model and Supply Chain
Purpose / Risk Mitigated: Protect models from adversarial manipulation and ensure supply chain integrity.
Operational Implementation
Generate SBOM/ML-BOM for models; verify SLSA level; patch CVEs in ML libraries; track model provenance
Evidence Required
Software Bill of Materials (SBOM), vulnerability scan reports, patch management logs, supply chain verification documents
Prohibited Practices Exclusion
Purpose / Risk Mitigated: Verify system does not use subliminal, manipulative, or social scoring functions prohibited by EU law.
Operational Implementation
Conduct red-team tests for manipulation techniques; document absence of banned features; legal review of use case
Evidence Required
Compliance checklist, red team test logs, legal opinion confirming no prohibited practices
Generative AI Transparency & Copyright Attribution
Purpose / Risk Mitigated: For GPAI: disclose content origin, watermark outputs, list training data sources for copyright compliance.
Operational Implementation
Embed watermark using C2PA standard; publish data summary statement listing training sources; detect AI-generated content
Evidence Required
Watermark verification logs, data summary document, copyright compliance attestation, training data manifest
User Data Rights Management
Purpose / Risk Mitigated: Respect rights of data subjects (access, deletion, correction) per GDPR.
Operational Implementation
Implement data access, deletion, and correction channels; respond to DSAR within 30 days; maintain request logs
Evidence Required
Data subject request logs, response time metrics, deletion verification reports, process documentation
Human Competence & Training
Purpose / Risk Mitigated: Ensure staff understand oversight responsibilities and can effectively monitor AI systems.
Operational Implementation
Provide training and attestation to human reviewers; define competency requirements; annual refresher courses
Evidence Required
Training logs with attendance records, competency assessment results, annual attestation forms