AI Governance & Regulatory AI Consulting

• -Life sciences and healthcare organizations introducing AI into regulated processes
• -Health technology companies whose products or services rely on AI and serve regulated customers
• -Quality, compliance and IT leaders asked to approve AI use without an existing policy
• -Investors and acquirers assessing how a target governs its AI

• -A team wants to deploy an AI tool in a GxP, clinical or patient-facing workflow
• -Leadership needs an AI policy and decision rights before scaling pilots
• -Customers, auditors or partners are asking how your AI is controlled
• -New obligations such as the EU AI Act or FDA AI/ML expectations apply to your products

• -AI governance framework development: policy, roles, decision rights and accountability
• -AI use-case inventory and risk classification
• -Algorithmic impact assessments
• -Validation strategy for AI-enabled systems and model risk management
• -Cross-jurisdiction compliance strategy, including EU AI Act readiness
• -Responsible AI implementation and documentation

• -AI governance policy and operating model
• -AI system inventory with risk ratings
• -Impact and risk assessment reports
• -Validation approach for AI-enabled systems, aligned to your quality system
• -Prioritized remediation and readiness roadmap

1. 01Assess. Map where AI is used or planned, who owns it, and which regulated processes it touches.
2. 02Design. Define proportionate controls, policies and validation expectations for each risk level.
3. 03Embed. Work with your quality, IT and business teams to put the controls into daily practice.
4. 04Hand over. Transfer ownership with documentation your team can maintain and defend.

BiggsB provides consulting and governance support. We do not sell AI products as part of this service, and our recommendations do not replace legal advice on specific statutory obligations.

What does an AI governance engagement with BiggsB include?

Typically an inventory of AI use, risk classification, a governance policy with clear decision rights, validation expectations for higher-risk systems, and a roadmap. Scope is set after an initial conversation about your systems and obligations.

Can you validate an AI-enabled system under GxP?

Yes. We apply risk-based computer system validation practices to AI-enabled systems, including documented intended use, model risk management and ongoing performance monitoring appropriate to the risk.

Do we need a full framework before running an AI pilot?

Not always. For early pilots we can define lightweight guardrails that let teams learn safely, then scale the framework as AI use becomes more material.

• Computer System Validation & Computer Software Assurance
• Fractional Executive Leadership
• Quality Systems, GxP Operations & Inspection Readiness

Describe your need on the contact page, email connect@biggsb.com, or book a consultation call.

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