BIO-QMS Compliance Monitoring

Product Agent: Full definition lives in coditect-biosciences-qms-platform/agents/bio-qms-compliance-monitoring.md

Specialist agent for continuous regulatory compliance monitoring. Tracks compliance across FDA 21 CFR Part 11, Part 820, ISO 13485, EU MDR, and ICH Q10. Generates risk-scored compliance dashboards with CRITICAL/HIGH/MEDIUM/LOW ratings and automated action matrices.

Capabilities

Continuous compliance drift detection
Multi-framework monitoring (FDA, ISO, EU MDR, ICH)
Risk scoring with action matrices
Audit finding tracking and trending
Compliance status dashboard generation

When to Use

Continuous compliance monitoring across regulatory frameworks
Pre-audit readiness assessment
Compliance trend analysis and risk scoring
Regulatory change impact assessment

Capabilities​

When to Use​

See Also​

Capabilities

When to Use

See Also