AI Validation
Turn Belief Into
Documented Proof
Validation is the process of demonstrating — through documented evidence — that a system performs reliably, consistently, and as intended in real-world use. We transform "we think it works" into "we can prove it."
We execute hands-on IQ/OQ/PQ validation — the same methodology the FDA has required for medical device software for 30 years — applied to AI.
Our Approach
Validated, Not Just Documented
Most AI governance tools answer one question: "Are we documented?" They map policies and track frameworks. We answer a different question: "Are we validated?" We run the actual test cases, record the evidence, track findings, and produce audit-ready reports. Documentation describes intent. Validation proves performance.
Why Validation Matters
✓ Defensible Decisions
Regulators and auditors require documentation proving your AI system behaves as expected under defined conditions.
✓ Trustworthy Outputs
Validated models produce outputs you can rely on for clinical, operational, or safety-critical decisions.
✓ Understood Risk
Risk classification and controls mean you know exactly where your system could fail and what prevents it.
✓ Controlled Change
Change management protocols ensure that updates to your AI systems don't silently introduce new failure modes.
Methodology
A Proven Validation Framework, Applied to AI
Borrowed from 30 years of FDA-regulated software validation and adapted for modern AI systems.
Installation Qualification (IQ)
Confirm the AI system is correctly configured, deployed, and integrated in its intended environment, with documented evidence of setup and data lineage.
Operational Qualification (OQ)
Test the system against defined specifications across expected operating conditions — accuracy, fairness, robustness, and boundary behavior.
Performance Qualification (PQ)
Prove the system performs reliably in real-world use over time, with drift monitoring, escalation thresholds, and ongoing re-validation.
Compliance Frameworks We Support
NIST AI RMF compliance is the recognized safe harbor across most US state AI laws — one validation program maps to multiple jurisdictions.
Why Now
The Compliance Deadlines Are Already Here
| Regulation | Status | What It Requires | Penalty |
|---|---|---|---|
| Texas TRAIGA | In effect Jan 1, 2026 | Disclosure of AI use in clinical settings; intent-based liability; 60-day cure period. | Up to $200K / violation |
| Colorado AI Act (ADMT) | Effective Jan 1, 2027 | Impact assessments, bias audits, transparency notices, 30-day adverse-outcome notification, 3-year records. | $20K / violation |
| FDA QMSR / SaMD | Effective Feb 2026 | Documented validation of AI performance, data integrity, and ongoing monitoring for AI-enabled devices. | Device action |
| HIPAA Security Rule | Final rule late 2026 | Access controls, audit logging, transmission security for any AI touching PHI. | OCR enforcement |
Organizations that establish formal AI validation in 2026 are positioned as compliance leaders when audits begin. Those that wait will be responding to enforcement notices.
What We Do
Three Steps. One Standard of Proof.
Every engagement follows the same sequence — assess first, validate next, then monitor for the long run.
01
Assess
Know where you stand before you move.
We audit your AI systems against applicable regulatory frameworks, classify risk tiers, and deliver a prioritized gap analysis — so you know exactly what needs to be fixed before an auditor finds it.
Schedule a ConsultationWhat's Included
- AI readiness audit against FDA, NIST AI RMF, ISO 42001, and state laws
- Risk tier classification per applicable frameworks
- Regulatory gap analysis with prioritized remediation roadmap
- Third-party and vendor AI system evaluation
Deliverable
Gap analysis report + risk classification document
02
Validate
Run the tests. Build the evidence. Produce the proof.
We execute hands-on IQ/OQ/PQ validation — running actual test cases, recording evidence, tracking findings, and producing a signed, audit-ready documentation package your team can defend.
Schedule a ConsultationWhat's Included
- Installation Qualification (IQ): deployment, configuration, data lineage
- Operational Qualification (OQ): accuracy, robustness, fairness testing
- Performance Qualification (PQ): real-world reliability and edge-case behavior
- Complete audit trail construction for every decision and output
Deliverable
Signed IQ/OQ/PQ evidence package + audit-ready report
03
Monitor & Govern
Stay compliant as your systems and regulations evolve.
Validation is not a one-time event. We build the monitoring infrastructure and governance structures that keep your AI compliant as models drift, regulations change, and new systems are deployed.
Schedule a ConsultationWhat's Included
- Drift monitoring thresholds and escalation protocols
- Governance charter: ownership, review cadences, change control
- Regulatory tracking across active and emerging frameworks
- Quarterly health checks and re-validation planning
Deliverable
Monitoring framework + governance charter
The Platform
Powered by FulcrumIQ
Our validation work is accelerated by FulcrumIQ — our AI validation platform, live in beta at fulcrumiq.ai. It automates the IQ/OQ/PQ lifecycle, generates compliance evidence automatically, and monitors your AI systems for drift after validation.
Explore FulcrumIQEngagement Tiers
Ways to Work With Us
Every engagement is scoped to your systems, risk profile, and regulatory exposure. We provide a tailored proposal after a short discovery call.
Assessment
1–2 weeks
Risk classification, abbreviated testing, gap analysis, framework mapping.
Full Validation
3–6 weeks
Complete IQ/OQ/PQ for 1–3 systems, audit-ready evidence package, signed report.
Enterprise
8–13 weeks
Full program for all high-risk systems, board reporting, governance charter, monitoring.
Retainer
Ongoing
Drift monitoring, regulatory tracking, advisory, quarterly health checks.
Who We Serve
Built for Regulated Environments
Our validation services are designed for organizations where AI system failures carry regulatory, clinical, or safety consequences — not just operational inconvenience.
- Medical Device Manufacturers
- Life Sciences Organizations
- Healthcare Technology Companies
- FDA-Regulated Manufacturers
- Enterprises Deploying AI in Regulated Contexts
EAM + Validation
Already working with us on an EAM implementation or strategy engagement? Validation services integrate seamlessly — ensuring your maintenance and asset data systems meet the same rigorous documentation standards as your AI deployments.
Schedule a ConsultationReady to Validate Your AI Systems?
Start with an AI Readiness Assessment — a clear picture of where you stand and what it takes to get compliant.
Schedule a Consultation