Independent, expert-led AI qualifications

Evaluate Vendors’ AI design, data use, and compliance with regulator-aligned assessments.

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OUR FOCUS

Gain clear, defensible visibility into a Vendor’s AI maturity, data integrity practices, and compliance posture.

Gain clear, defensible visibility into a Vendor’s AI maturity, data integrity practices, and compliance posture.

Our expertise

Deep technical expertise for GxP environments

  • Leverage deep expertise on AI compliance from industry veteran auditors.

  • Stay compliant with the latest AI capability standards and evolving regulatory landscape.

  • Stay ahead of potential risk and make informed Vendor decisions.

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Our audits

Comprehensive qualification support

Our platform and team of experts enable you to apply rigorous, industry-aligned frameworks to every Vendor evaluation.

Our platform and team of experts enable you to apply rigorous, industry-aligned frameworks to every Vendor evaluation.

Our platform and team of experts enable you to apply rigorous, industry-aligned frameworks to every Vendor evaluation.

Our platform and team of experts enable you to apply rigorous, industry-aligned frameworks to every Vendor evaluation.

  • AI-focused RFI templates mapped to current regulations to ensure you’re asking the right questions of every Vendor.

  • SME-led risk scoring and risk intelligence to flag issues early.
     

  • Custom, regulator-aligned AI audits tailored to your study, Vendor type, and needs.

  • AI-focused RFI templates mapped to current regulations to ensure you’re asking the right questions of every Vendor.

  • SME-led risk scoring and risk intelligence to flag issues early.
     

  • Custom, regulator-aligned AI audits tailored to your study, Vendor type, and needs.

  • AI-focused RFI templates mapped to current regulations to ensure you’re asking the right questions of every Vendor.

  • SME-led risk scoring and risk intelligence to flag issues early.
     

  • Custom, regulator-aligned AI audits tailored to your study, Vendor type, and needs.

A screenshot of the Diligent360 risk tool
A screenshot of the Diligent360 risk tool

Learn more about our audits

Audit Coverage

Audit coverage

Thorough, industry-aligned AI assessments

Diligent evaluates the full lifecycle of a vendor’s AI capabilities, with emphasis on transparency, compliance, and ethical use.

AI Architecture & Model Design

  • Type of AI models used (LLMs, ML models, statistical models, generative tools)

  • Model provenance, training pipeline, and update cadence

  • Use of open-source, commercial, or proprietary models

  • Prompt management, model context windows, and output control mechanisms

Data Use, Training, and Privacy

  • Whether and how customer data is used for model training or fine-tuning

  • Data ingestion flows, preprocessing, and anonymization practices

  • Isolation of customer data from model inference/training layers

  • Controls to prevent unintended data retention, leakage, or memorization

  • Compliance with GDPR, HIPAA, and AI-specific governance frameworks

Third-Party AI & Embedded Tools

  • Identification of external AI services or APIs embedded in the product

  • Risk analysis of dependencies (e.g., model providers, ML infrastructure, vector databases)

  • Contractual and technical safeguards around third-party data use

AI Governance, Auditability & Safety

  • Documented AI policies, acceptable use frameworks, and human-in-the-loop oversight

  • Model monitoring, bias detection, versioning, and performance drift tracking

  • Explainability and transparency practices

  • Security and misuse prevention for model endpoints

  • Guardrails, red-team testing, and hallucination mitigation strategies

Regulatory Alignment & Readiness

  • Preparedness for evolving global AI regulations (EU AI Act, U.S. frameworks, ISO standards)

  • Internal expertise, accountable roles, and governance structures

  • SOPs, validation, and change-management processes for AI-enabled features

rESOURCES

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Find more resources

Qualify innovative Vendors with speed and rigor.

Learn how you can mitigate third-party risk and stay ahead of evolving regulations.

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