How I Work
Britt Biocomputing architects operational AI validation and governance frameworks for agentic and generative AI in pharma R&D. I make frontier AI systems inspectable, defensible, and audit-ready for GxP-regulated environments.
Every engagement follows the same lifecycle — the depth scales with your risk.
Find out where you stand
Before a regulator or auditor does.
The House of AI Governance
Free DownloadFlagship guide + 25-point organizational readiness checklist. A five-layer model for building trustworthy AI in regulated science — from data governance through business ROI.
- Five-layer governance architecture with layer-by-layer breakdown
- 25-point readiness checklist with scoring rubric
- FDA / EMA / EU AI Act regulatory timeline (2024–2026)
- Control layer deep dive — where governance becomes defensible
20-Minute Fit Check
FreeI'll walk through your current setup, tell you where you are on the validation lifecycle, and recommend the smallest next step that creates the most clarity. No pitch. Just a map.
Book a fit check →AI Validation Readiness Briefing
For teams that know they have gaps — and need a concrete starting point.
90-Minute Briefing + Written Assessment
$2,500Your team. Your use cases. Your readiness score — mapped to the House of AI Governance. You leave with a written one-page readiness assessment, a prioritized gap list, and a clear recommendation for next steps — whether that's working with me or not.
- 90-minute live session with your cross-functional team
- House of AI Governance mapped to your specific use cases
- Written one-page readiness assessment with scoring
- Prioritized gap list and recommended next step
Turn your AI from "we use it" into "we can defend it."
Full engagements for organizations ready to build the evidence layer.
R&D Fit-for-Purpose Sprint
For a single AI tool or LLM deployment. I define Context of Use, build a risk-tiered testing protocol, develop an error taxonomy, and deliver an acceptance-criteria package your QA team can run with. You get a validation strategy scoped to the risk — not a 200-page template.
- Context of Use specification
- Risk-tiered validation protocol
- Error taxonomy (hallucination types, confidence miscalibration, domain-specific failure modes)
- Acceptance criteria and test case design
Agentic & Multi-Agent Evidence Package
For organizations deploying agentic AI architectures — multi-step workflows, autonomous tool-calling, cross-system orchestration. I design the oversight model, build frozen-architecture validation, define escalation paths, and create the evidence package that covers both FDA and EMA expectations.
- HITL/HOTL oversight architecture per context of use
- Frozen-architecture validation (version-locked models, prompts, APIs, temperature)
- Agent transparency and escalation architecture
- Hallucination compounding analysis for multi-agent pipelines
- Dual-jurisdiction evidence package (FDA + EMA + EU AI Act alignment)
GxP Validate-Launch
Full validation lifecycle for AI systems entering GxP-regulated workflows — R&D, CMC, Clinical, Quality, or Pharmacovigilance. Includes everything in the Sprint plus validation master plan, monitoring architecture, drift detection thresholds, and audit-ready documentation.
- Validation master plan
- Full IQ/OQ/PQ-equivalent protocol suite for AI
- Production monitoring and drift detection architecture
- Audit-ready documentation package
Fractional AI Validation Leadership
For organizations scaling from one use case to many.
Embedded Fractional Leader
I embed with your team as a fractional Head of AI Quality — owning the validation lifecycle across your AI portfolio, building governance frameworks, training your workforce, and translating between data science, quality, and regulatory teams. For organizations that need the role before they're ready to hire it full-time.
- Ongoing validation oversight across your AI portfolio
- AI governance framework development and maintenance
- Cross-functional translation (data science ↔ QA ↔ regulatory)
- Workforce training on AI oversight models and responsible use
- Inspection readiness and regulatory horizon scanning
Bolt on to any engagement
CSA for Analytics Pipelines
URS → risk assessment → test scripts → traceability for NGS, PV, and HEOR data/compute lineage.
Human Oversight Design
Decision thresholds, escalation rules, reviewer checklists, and cognitive forcing functions to prevent rubber-stamping.
Vendor & Model Assessment
Rubric-based evaluations of hosted LLMs, embeddings, retrieval stacks, and agentic platforms — scored against your risk tier.
Regulatory Translation
I speak both Python and Part 11. Bridging data science, quality, and regulatory teams across FDA, EMA, and EU AI Act.
SOP Modernization
CSV/CSA alignment, monitoring-light SOPs, log-retention and access controls — updated for agentic and generative AI workflows.
Training & Enablement
Workshops for QA, IT, and R&D teams. "How to read the evidence" briefings for leadership and board stakeholders.
Tool Qualification
Risk-based Part 11/CSA checks for your validation platform — e-sig, audit trail, URS traceability, roles, and identity preservation.