Healthcare in Wales
AI in Wales pharmaceutical operations — drug discovery, manufacturing quality, clinical trial analysis — operates under FDA AI/ML guidance, GxP validation requirements, and UK GDPR and DPA 2018 compliance frameworks. Clinical AI that cannot demonstrate validation and audit trail compliance will not survive FDA review.
Pharmaceutical technology lives under FDA 21 CFR Part 11. Data integrity isn't optional — it's existential. Clinical trial data, manufacturing execution, regulatory submissions — every system requires validated, compliant infrastructure.
How We Deliver in Wales
United Kingdom and Healthcare Frameworks
Healthcare organizations in Wales operate under both United Kingdom regional frameworks and sector-specific compliance requirements. We embed all applicable frameworks architecturally — not as a parallel compliance workstream running alongside engineering.