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FastMCP Server & Protocol Contracts

Overview

The platform exposes its multi-agent capabilities and regulatory tools via the Model Context Protocol (MCP) using the FastMCP framework (src/mcp/server.py). The MCP server exposes tools over Server-Sent Events (SSE) at endpoint http://localhost:8090/mcp/sse.

Exposed FastMCP Tools Reference (12 Tools)

1. ask_gxp_agent

Dynamic router that delegates inquiries to any of the 23 specialized Pydantic AI agents:

  • Arguments:
    • agent_name: Target agent identifier (e.g. RequirementsTraceabilityAgent, DeviationRcaAgent).
    • query: User instruction or operational scenario.
    • system_code (optional): Filter to specific system (EBR, CDS, LIMS, MES).
  • Return: Structured Pydantic JSON deliverable.

2. compile_validation_summary_report

Synthesizes a multi-agent Validation Summary Report (VSR) for a computerized system:

  • Arguments:
    • system_code: Required system code (EBR, CDS, LIMS, MES, BIOREACTOR).
  • Return: Comprehensive VSR model with IQ/OQ/PQ summaries, RTM matrix, and signatures.

3. execute_team_mission

Executes any of the collaborative multi-agent squad missions:

  • Arguments:
    • mission_number: Integer from 1 to 8.
  • Return: Step-by-step mission audit log, specialist consensus, and disposition.

4. query_hybrid_knowledge_base

Direct interface to the 3-tier Hybrid GraphRAG search engine:

  • Arguments:
    • query: Natural language search phrase.
    • system_code (optional): Scope query to a specific system.
    • limit: Maximum number of chunks to return (default: 5).
  • Return: Dense/sparse vector candidates validated by EvidenceGate.

5. get_regulatory_compliance_status

Calculates real-time compliance health across the 4 key regulatory frameworks:

  • Arguments: None.
  • Return: Framework scorecards for 21 CFR Part 11, EU Annex 11, GAMP 5, and FDA CSA.

6. sign_electronic_record

Executes an immutable 21 CFR Part 11 electronic signature in PostgreSQL:

  • Arguments:
    • record_id: Target entity identifier.
    • signer_name: Full legal name of signer.
    • signer_role: Regulatory role (e.g. System Owner, QA Reviewer).
    • meaning: Regulatory intent (e.g. Approval, Authorship, Verification).
  • Return: SHA-256 signature manifest and audit confirmation.

7. register_asset

Registers a new physical instrument across PostgreSQL and Memgraph:

  • Arguments:
    • asset_tag: Unique hardware code (e.g. EQ-HPLC-005).
    • name: Descriptive equipment title.
    • criticality: DIRECT_GXP_IMPACT, INDIRECT_IMPACT, or NON_GXP.
    • calibration_interval_days: Recalibration cycle duration.
  • Return: Asset registration confirmation and graph edge bindings.

8. filter_assets

Multi-attribute search across 202 enterprise assets:

  • Arguments:
    • criticality: Filter by GxP impact.
    • status: Filter by operational status.
  • Return: List of matching asset records and calibration due dates.

9. submit_helpdesk_ticket

Submits a service request with automatic GxP impact classification:

  • Arguments:
    • title: Problem summary.
    • description: Detailed symptoms.
    • system_code: Affected computerized system.
  • Return: Ticket GUID, assigned tier, and Part 11 audit record.

10. query_helpdesk_tickets

Queries service desk tickets by status and criticality:

  • Arguments:
    • status: Filter by status (OPEN, ESCALATED_TO_QA, RESOLVED).
  • Return: Array of active ticket records.

11. update_helpdesk_ticket

Updates ticket lifecycle state, triage notes, or resolution:

  • Arguments:
    • ticket_id: Target ticket GUID.
    • status: New lifecycle state.
    • resolution_notes: Engineering and QA notes.
  • Return: Updated ticket confirmation.

12. audit_gxp_backup_and_restoration

Autonomous audit of backup and disaster recovery compliance:

  • Arguments:
    • target_system (optional): System code to evaluate.
  • Return: SOP-IT-018 and SOP-IT-019 compliance audit scores, RTO/RPO verification, and gap warnings.