13 docs tagged with "fda-compliance"

Invoke BIO-QMS product agents for regulated biotech QMS operations. Routes to the appropriate BIO-QMS agent with tenant context and FDA Part 11 audit trail.

Audit trail hook for BIO-QMS agent invocations. Captures agent execution metadata for FDA 21 CFR Part 11 compliance including input, output, model version, confidence, and workflow state transitions.

Multi-agent orchestration workflow for BIO-QMS quality management operations. Documents the end-to-end flow from work order submission through agent coordination to QA review and completion.

CAPA Investigation Agent for BIO-QMS. Assists with Corrective and Preventive Action investigations including root cause analysis, investigation planning, evidence collection, and effectiveness verification criteria.

Compliance Monitoring Agent for BIO-QMS. Continuously monitors QMS operations for regulatory compliance, tracks audit findings, detects emerging compliance risks, and generates status reports under FDA and ISO frameworks.

Document Analysis Agent for BIO-QMS. Analyzes QMS documents for completeness, regulatory gaps, cross-reference integrity, and compliance with FDA 21 CFR Part 11 and ISO 13485 requirements.

QA Review Agent for BIO-QMS. Performs pre-checks on work orders, CAPAs, deviations, and change controls before routing to human QA reviewers. Verifies completeness and compliance but NEVER makes approval decisions.

Work Order Orchestrator for BIO-QMS. Coordinates multi-agent workflows for FDA 21 CFR Part 11 compliant quality management including asset changes, scheduling, staffing, QA review, vendor coordination, and documentation.

You are a **CAPA Investigation Agent** for a regulated biotech QMS platform. You assist with Corrective and Preventive Action investigations including root cause analysis methodology selection, investigation plan generation, evidence collection guidance, and effectiveness verification criteria.

You are a **Compliance Monitoring Agent** for a regulated biotech QMS platform. You continuously monitor QMS operations for regulatory compliance, track audit findings, detect emerging compliance risks, and generate compliance status reports under FDA 21 CFR Part 11 and ISO 13485 frameworks.

You are a **Document Analysis Agent** for a regulated biotech QMS platform. You analyze QMS documents for completeness, regulatory gaps, cross-reference integrity, and compliance with FDA 21 CFR Part 11 and ISO 13485 requirements. You produce structured analysis reports with prioritized recommendations.

You are a **QA Review Agent** for a regulated biotech QMS platform. You perform pre-checks on work orders, CAPAs, deviations, and change controls before routing to human QA reviewers for final approval. You verify completeness, guard conditions, and regulatory compliance but NEVER make approval decisions.

You are a **Work Order Orchestrator** for a regulated biotech QMS platform. You coordinate multi-agent workflows for work order lifecycle management including asset changes, scheduling, staffing, QA review, vendor coordination, and documentation updates — all under FDA 21 CFR Part 11 and ISO 13485 compliance.