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Hybrid GraphRAG Wiki & Architecture

Collaborative Multi-Agent Squad Missions (Missions 1 to 8)

Overview

The platform packages complex cross-functional Life Sciences workflows into 8 autonomous Multi-Agent Squad Missions (demo_multi_agent_teams.py and /api/demos/team-mission). In each mission, multiple specialist agents collaborate sequentially or in parallel under the Lead CSV Orchestrator to resolve an operational or regulatory challenge.

Mission Directory

Mission 1: Bioreactor Out-of-Tolerance (OOT) Sensor Triage & Return-to-Service

  • Regulatory Triggers: 21 CFR 211.68, ISO 13485 Clause 7.5.1, GAMP 5 Category 4.
  • Participating Agents: AssetManagementAgent, CmmsMaintenanceAgent, DeviationRcaAgent, ValidationTestingAgent.
  • Workflow:
    1. AssetManagementAgent detects pH/DO sensor drift exceeding +/- 0.15 calibration tolerance during a mammalian cell culture run.
    2. DeviationRcaAgent executes forensic 5-Whys deduction and Ishikawa Fishbone categorization, tracing drift to lot-specific diaphragm fouling.
    3. CmmsMaintenanceAgent schedules an emergency work order for sensor replacement with cleanroom clearance.
    4. ValidationTestingAgent drafts a targeted Return-to-Service (RTS) qualification protocol verifying probe slope calibration before batch continuation.

Mission 2: Electronic Batch Record (EBR) Dual-Signature Protocol Failure

  • Regulatory Triggers: 21 CFR Part 11 Subpart C, EU Annex 11 Clause 14, GAMP 5 Category 4.
  • Participating Agents: BatchRecordReviewAgent, DataIntegrityAuditAgent, CapaChangeControlAgent, ValidationTestingAgent.
  • Workflow:
    1. BatchRecordReviewAgent catches an eBR execution lockout where QA secondary verification failed to bind cryptographically.
    2. DataIntegrityAuditAgent inspects audit trail logs, discovering token expiration mid-handshake.
    3. CapaChangeControlAgent drafts an emergency change control (CC-EBR-042) to patch token session persistence without invalidating active sessions.
    4. ValidationTestingAgent runs automated regression verification across dual-signature boundaries.

Mission 3: Chromatography Data System (CDS) 2-Year Periodic Review & Migration

  • Regulatory Triggers: EU Annex 11 Clause 11, GAMP 5 Appendix M5, ALCOA+ Principles.
  • Participating Agents: PeriodicReviewAgent, SystemInterfaceMigrationAgent, DataIntegrityAuditAgent, LeadCsvOrchestrator.
  • Workflow:
    1. PeriodicReviewAgent audits 24 months of Empower CDS operation, scoring system health at 92% and identifying vendor database deprecation.
    2. SystemInterfaceMigrationAgent maps raw chromatographic sequence tables to target cloud database schema.
    3. DataIntegrityAuditAgent executes 100% hash reconciliation on 14,000 chromatograms.
    4. LeadCsvOrchestrator compiles the formal Periodic Review and Migration Clearance Certification.

Mission 4: Cloud LIMS v5.0 Fast-Track FDA CSA Qualification & Go-Live

  • Regulatory Triggers: FDA Computer Software Assurance (CSA), ISO 13485 Clause 7.4.
  • Participating Agents: VendorAssessmentCsaAgent, RiskAssessmentAgent, ValidationTestingAgent, LeadCsvOrchestrator.
  • Workflow:
    1. VendorAssessmentCsaAgent evaluates cloud LIMS vendor audit documentation and ISO/IEC 27001 certifications.
    2. RiskAssessmentAgent applies FDA CSA Critical Thinking matrix: Patient Safety (Indirect), Product Quality (Direct for release testing), Data Integrity (Direct).
    3. Prescribes 80% vendor leveraging with targeted unscripted exploratory testing for custom sample routing workflows.
    4. LeadCsvOrchestrator synthesizes the formal Validation Plan and Qualification Summary.

Mission 5: Analytical OOS to Manufacturing Investigation & Operator Lockout

  • Regulatory Triggers: FDA OOS Guidance (2006/2022), 21 CFR 211.192, 21 CFR 211.25.
  • Participating Agents: OosInvestigationAgent, DeviationRcaAgent, GxpTrainingCompetencyAgent, CapaChangeControlAgent.
  • Workflow:
    1. OosInvestigationAgent executes the 5-point Phase 1 laboratory checklist on an assay potency failure (84.2% vs 95.0-105.0% spec).
    2. Lab error ruled out; escalates to Phase 2 manufacturing investigation.
    3. DeviationRcaAgent discovers incorrect agitation speed entered during granulation step.
    4. GxpTrainingCompetencyAgent flags operator qualification expiration and triggers immediate digital execution lockout in MES until retraining is certified.

Mission 6: Life Sciences SOP & Controlled Document 7-Stage Lifecycle

  • Regulatory Triggers: ISO 13485 Clause 4.2.3, 21 CFR 820.40, GAMP 5.
  • Participating Agents: DocumentAuthoringAgent, DataIntegrityAuditAgent, GxpTrainingCompetencyAgent, LeadCsvOrchestrator.
  • Workflow:
    1. DocumentAuthoringAgent drafts SOP-QA-045 with formal title, purpose, scope, responsibilities RACI matrix, and ALCOA+ controls.
    2. Technical review and pre-flight hash verification.
    3. QA compliance review and 21 CFR Part 11 electronic signature execution.
    4. LMS training curriculum generation and effective date release scheduling.

Mission 7: End-to-End GAMP 5 Validation Plan (VP) 4-Stage Lifecycle

  • Regulatory Triggers: ISPE GAMP 5 Second Edition, EU Annex 11 Clause 4.
  • Participating Agents: RequirementsTraceabilityAgent, RiskAssessmentAgent, ValidationTestingAgent, LeadCsvOrchestrator.
  • Workflow:
    1. Validation planning and GAMP software categorization.
    2. Specification mapping and bi-directional RTM matrix generation.
    3. Qualification protocol design (IQ/OQ/PQ) and execution simulation.
    4. Lead CSV Orchestrator synthesis of the formal Validation Summary Report (VSR).

Mission 8: GxP Backup, Disaster Recovery & SOP Qualification

  • Regulatory Triggers: 21 CFR § 11.10(c), EU Annex 11 Clauses 7 & 16, ISPE GAMP 5, SOP-IT-018, SOP-IT-019.
  • Participating Agents: DisasterRecoveryAgent, AssetManagementAgent, DataIntegrityAuditAgent, LeadCsvOrchestrator.
  • Workflow:
    1. DisasterRecoveryAgent audits automated cloud snapshot logs and continuous WAL replication under SOP-IT-018.
    2. AssetManagementAgent audits physical analytical instruments (e.g. EQ-HPLC-001) under manual dual-custody SOP-IT-019.
    3. DataIntegrityAuditAgent verifies operator LMS certifications, SHA-256 raw sequence hashes, and dual Part 11 signatures.
    4. LeadCsvOrchestrator witnesses periodic sandbox restoration dry-run, asserts RTO (<= 4h) and RPO (<= 1h) SLA compliance, and certifies the disaster recovery posture.

Command Line Execution

Execute missions directly via the terminal:

Terminal window
# Execute single mission (e.g. Mission 8)
docker compose exec api python demo_multi_agent_teams.py --mission 8


# Execute all 8 missions sequentially
docker compose exec api python demo_multi_agent_teams.py --mission all