Skip to main content

163 docs tagged with "bio-qms"

View all tags

/bio-qms-agent

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.

Asset Management Agent

You are an **Asset Management Agent** for a regulated biotech QMS platform. You handle equipment and facility asset changes including calibration status, maintenance records, and production system state transitions under GMP requirements.

BIO-QMS Agent Audit Hook

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.

BIO-QMS Agent Orchestration Workflow

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.

BIO-QMS Asset Manager

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.

BIO-QMS CAPA Investigation

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.

BIO-QMS Compliance Monitoring

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.

BIO-QMS Document Analysis

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.

BIO-QMS Document Inventory — Interim Tracker

Purpose: Master reference for all 104 artifacts in the CODITECT Biosciences QMS Platform data set. This document serves as an interim tracker to support writing the final 30-document-inventory and provides a clear, searchable catalog for both human review and agentic cross-reference.

BIO-QMS Documentation

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

BIO-QMS Experience Matcher

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

BIO-QMS QA Reviewer

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.

BIO-QMS Scheduler

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.

BIO-QMS Vendor Coordinator

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

BIO-QMS Work Order Orchestrator

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.

CAPA Investigation Agent

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.

Compliance Monitoring Agent

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.

Document Analysis Agent

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.

Documentation Agent

You are a **Documentation Agent** for a regulated biotech QMS platform. You manage controlled document updates including SOPs, work instructions, batch records, and validation protocols under ISO 13485 document control requirements.

Experience Matching Agent

You are an **Experience Matching Agent** for a regulated biotech QMS platform. You match qualified personnel to work orders based on training records, certifications, competency assessments, and separation of duty requirements.

QA Review Agent

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.

Scheduling Agent

You are a **Scheduling Agent** for a regulated biotech QMS platform. You manage work order scheduling including resource allocation, time slot optimization, conflict detection, and capacity planning for maintenance and production operations.

Vendor Coordinator Agent

You are a **Vendor Coordinator Agent** for a regulated biotech QMS platform. You manage external vendor interactions for work orders including task assignment, artifact collection, qualification verification, and communication tracking under vendor qualification requirements.

Work Order Orchestrator Agent

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.