10 docs tagged with "product-agent"

Asset Management Agent for BIO-QMS. Handles equipment and facility asset changes including calibration status, maintenance records, and production system state transitions under GMP requirements.

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.

Documentation Agent for BIO-QMS. Manages controlled document updates including SOPs, work instructions, batch records, and validation protocols under ISO 13485 document control requirements.

Experience Matching Agent for BIO-QMS. Matches qualified personnel to work orders based on training records, certifications, competency assessments, and separation of duty 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.

Scheduling Agent for BIO-QMS. Manages work order scheduling including resource allocation, time slot optimization, conflict detection, and capacity planning for maintenance and production operations.

Vendor Coordinator Agent for BIO-QMS. Manages external vendor interactions for work orders including task assignment, artifact collection, qualification verification, and communication tracking.

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.