Auditability, evaluation, and regulatory readiness for clinical AI
The Quality Management System (QMS) module provides the infrastructure for auditable, evaluable, and regulation-ready AI-assisted healthcare. It encompasses logging, monitoring, evaluation metrics, and compliance documentation across all GacruxAI products.
Rather than retrofitting compliance after deployment, QMS is built into the platform architecture. Every AI inference, user correction, and clinical outcome can be traced, measured, and reported for internal quality improvement and external regulatory requirements.
Audit Logs: Timestamped inference records with user edits
Accuracy Reports: AI vs. final documentation concordance
Error Analysis: Categorized correction patterns by specialty
Compliance Docs: GDPR DPIAs, security assessments, SOC 2 prep
Stakeholders responsible for safe, compliant AI deployment in healthcare
Medical directors, quality leads, and governance officers who need to demonstrate safe AI adoption to trust boards and regulators. Access dashboards showing AI accuracy and user override rates.
Data protection officers, IG leads, and security teams evaluating AI platforms for GDPR, NHS DSPT, and data handling requirements. Pre-built DPIA templates and data flow documentation.
Practice managers and operational leads tracking adoption metrics, usage patterns, and cost-benefit analysis. Reporting tools for procurement justification and efficiency measurement.
Four pillars of quality management for clinical AI
Complete logging of AI outputs, user edits, and final documentation. Traceable from inference to clinical record for incident investigation or quality review.
Standardized accuracy measurement: AI-to-human concordance rates, correction frequency by field, and specialty-specific performance benchmarks.
Pre-prepared documentation for GDPR Article 35 DPIAs, NHS DSPT submissions, and regulatory assessments. Updated as platform evolves.
Defined escalation pathways for AI errors, data breaches, or safety concerns. Root cause analysis templates and corrective action tracking.
Building toward compliance with evolving healthcare AI regulations
Note: GacruxAI products are designed with privacy-first architecture aligned to GDPR and HIPAA requirements. Formal certifications are on the product roadmap as we scale deployment. Current products are documentation tools that assist clinicians-final clinical decisions remain with the healthcare professional.
Building quality infrastructure alongside product development