BIO-QMS Agent Orchestration Workflow
End-to-end multi-agent workflow for regulated biotech QMS operations.
Overview
The BIO-QMS agent system processes quality management operations through a coordinated multi-agent pipeline. The orchestrator receives requests, dispatches to specialized workers, collects results, and routes through QA review before completion.
Workflow: Work Order Processing
Workflow: CAPA Investigation
Agent Involvement:
- INVESTIGATION phase:
capa-investigationagent performs root cause analysis - ACTION_PLAN phase:
documentationagent drafts action plan documents - EFFECTIVENESS_CHECK phase:
compliance-monitoringagent verifies effectiveness
Workflow: Compliance Monitoring
Circuit Breaker Recovery
Tenant Isolation Flow
Audit Trail Flow
Every agent invocation generates an audit chain:
- AGENT_INVOCATION — Logged when agent job starts
- MODEL_SELECTION — Logged when model tier is resolved
- AGENT_RESPONSE or AGENT_ERROR — Logged on completion
- Workflow linkage — Audit entry linked to state transition (if applicable)
Retention: 7 years for regulated records, 3 years for non-regulated.
Rate Limiting
| Limit | Value | Scope |
|---|---|---|
| Concurrent jobs | 3 | Per tenant |
| Requests/minute | 10 | Per tenant |
| Requests/hour | 100 | Per tenant |
| Job timeout | 2 min (default) | Per job |
| Max timeout | 10 min | Per job |
Key Decision Points
| Decision | Agent | Human Required? |
|---|---|---|
| Route work order to agents | wo-orchestrator | No |
| Pre-check quality record | qa-reviewer | No |
| Approve quality record | - | Yes (always) |
| Root cause methodology | capa-investigation | No |
| CAPA effectiveness decision | - | Yes (always) |
| Compliance risk scoring | compliance-monitoring | No |
| Regulatory submission | - | Yes (always) |
See Also
- Skill:
skills/bio-qms-agent-framework/SKILL.md - Command:
/bio-qms-agent - Hook:
hooks/bio-qms-agent-audit.md - Product SSOT:
submodules/dev/coditect-biosciences-qms-platform/agents/ - TypeScript:
backend/libs/qms-core/src/agents/(7 modules)