Custom AI for the CRO: how we ship AI inside the model risk framework you already operate.
Model risk management is the discipline of identifying, measuring, monitoring, and controlling the risk of model failure across the lifecycle, from data ingestion through validation, deployment, change-control, and retirement. AI does not replace this framework. AI sits inside it. We design every system to fit your existing three-lines-of-defence governance, with documentation that maps to SR 11-7, the EU AI Act risk tiers, and DORA outsourcing obligations before the model goes near a production decision.
Independent validation pack, model inventory entries, change-control logs, and breach-reporting workflow. Delivered as artefacts your second line can sign off without rewrites.
The five concerns we hear on every CRO discovery call.
Model risk inventory
EU AI Act risk classification
DORA outsourcing
Independent validation
Change control
Breach and incident reporting
For CROs, the spine is Readiness.
For a CRO, the spine is Readiness. A two-week data and workflow audit before any code, with the output mapped to your model risk framework, your three-lines-of-defence governance, and your regulator's posture. We document risk classification under the EU AI Act, lifecycle stage under SR 11-7 logic, and outsourcing posture under DORA where applicable. The Readiness deliverable is a written diagnosis your second line can validate without rewrites.
AI does not replace your model risk framework. AI sits inside it, or it does not ship.
Where CROs typically engage us first.
Decision support
Document processing
Internal knowledge AI
Process orchestration
What the engagement looks like from your seat.
What CROs need from a partner, and what we ship.
Risk classification memo
Independent validation pack
Model inventory entry
Change-control workflow
Breach-reporting hooks
DORA outsourcing pack
CRO questions, answered.
Does TRACE map to SR 11-7?
Yes. SR 11-7 organises model risk around development, implementation, use, validation, and governance. TRACE-Readiness covers development and implementation through the workflow audit and architecture spec. TRACE-Architecture covers use through the production-grade build with versioning, observability, and rollback. TRACE-Citations covers validation through the evidence chain on every output, which is what an independent validator uses to replay and assess the model. TRACE-Trust covers governance through the residency, sub-processor, and audit-log posture. The mapping is documented per engagement and signed off before Build phase.
How do you handle model change-control?
Every change to the production system is a controlled event. Foundation-model upgrades, prompt changes, retrieval-pipeline changes, and tool-schema changes go through an impact assessment, an evaluation-suite rerun, and a sign-off chain that matches your three-lines-of-defence framework. The change is logged with the trigger, the diff, the test result, and the approver. Promotion to production is gated by a passing regression suite. The full chain is reviewable in the audit log.
What about DORA outsourcing requirements?
If we are processing data on your behalf under DORA, the contract includes the elements DORA Article 28 expects: written agreement, sub-contracting register, exit strategy, security and audit rights, incident-notification SLAs, and the regulator's right to access. We disclose every sub-processor that touches inference, retrieval, or storage, and we keep the list current. If your environment requires a critical-third-party-provider posture under DORA, we structure the engagement to support it.
How is AI risk-classified under the EU AI Act?
We classify every system against the four-tier risk taxonomy in the EU AI Act before Build phase. Most enterprise systems land in limited-risk (transparency obligations) or high-risk under one of the eight Annex III categories (employment, education, essential private and public services, law enforcement, justice, migration, biometric identification, critical infrastructure). For high-risk systems, we ship the conformity-assessment scaffolding the regulation requires: risk management, data governance, technical documentation, record-keeping, transparency, human oversight, accuracy, robustness, and cybersecurity. The classification memo is delivered in Discovery and refreshed if the use case changes.
Who does the independent validation?
Independent validation is, by definition, performed by people independent of the build team. We support your second line by delivering the validation pack as a structured artefact, but the sign-off is theirs. Where you do not have an internal validation function, we work with a partner network of independent model validators we can introduce, with the engagement scoped and contracted directly between you and them.
Where to go next.
Prohibited, high-risk, limited-risk, minimal-risk explained article by article.
How we apply TRACE to KYC, AML, and credit-decisioning AI inside EBA-regulated environments.
Where the two regimes overlap, where they diverge, and the single combined compliance programme.
Bring us the CRO mandate. We bring the audit-ready system.
Discovery starts with a scoped audit. The deliverable is yours either way. We respond within two business days at info@ainora.lt.