System Wiki & Architecture Documentation
Enterprise GxP and QMSR Architecture uniting PostgreSQL, Qdrant, Memgraph, and RustFS S3 with 23 Specialized Pydantic AI Agents, Lead CSV Orchestrator, FastMCP Server, and Consolidated Next.js GxPChat Suite.
Documentation Directory
Getting Started
- System Overview: Architectural summary, business context, and regulatory scope.
- Prerequisites & Hardware: System requirements, container specifications, and port allocations.
- Installation & Deployment: Step-by-step instructions for Docker Compose deployment and domain seeding.
- Configuration & Environment: Detailed dictionary of environment variables and operational flags.
GxPChat Consolidated Web Suite
- Suite Architecture: Next.js 16 App Router architecture, reverse proxy, and client navigation.
- Conversational AI Assistant: Smart prompt composer, action commands, and FastMCP integration.
- Enterprise QMS: Document repository, deviations, change control, and ALCOA+ audit trails.
- Physical Asset Management: Master asset register, NIST calibration intervals, and equipment linkages.
- IT Service Desk: Dual-track ticketing, Part 11 account lockouts, and triage routing.
- Computer System Validation: V-Model RTM, CSA risk hub, test execution, and automated VSR generation.
- Disaster Recovery & Backup: SOP-IT-018 and SOP-IT-019 governance, Qualified Person ledger, and restoration drills.
Autonomous AI Agents
- Specialized Agents Directory: Technical reference for all 23 specialized Pydantic AI agents.
- Lead CSV Orchestrator: Virtual Quality Board director and automated VSR compiler.
- Multi-Agent Squad Missions: Autonomous execution flows for cross-functional Missions 1 through 8.
- FastMCP Server & Contracts: FastMCP SSE transport specifications and tool schemas.
Hybrid Retrieval & Data Architecture
- 3-Database Division of Labor: PostgreSQL, Qdrant, and Memgraph functional boundaries.
- Retrieval Pipeline & RRF: Dense and sparse vector search with Reciprocal Rank Fusion.
- EvidenceGate Zero-Trust Filter: Real-time PostgreSQL verification, signature checks, and supersession filtering.
- Document Ingestion Pipelines: Document chunking, taxonomy classification, and database synchronization.
- RustFS S3 Storage & Watcher: S3 object storage, autonomous drop watcher, and workflow dispatch.
Compliance & Observability
- 21 CFR Part 11 & EU Annex 11: Immutable audit trail triggers, electronic signatures, and non-repudiation.
- FDA QMSR & ISO 13485:2016: Medical Device File graph model, cross-process audit readiness, and supplier controls.
- Continuous Evaluation (Pydantic Evals): GxP evaluators, golden benchmark datasets, and CI/CD gates.
- DSPy Prompt Optimization: Declarative optimization, prompt versions, and evaluation metrics.
- Langfuse Observability & Traces: Local Langfuse v4 tracing, OpenTelemetry integration, and score reporting.
Operations & Developer Reference
- Verification & Testing Guide: Running test suites with pytest, evaluation benchmarks, and test coverage.
- REST API & Endpoints Reference: Complete API specifications for all backend services.
- DOCX Generation Microservice: ASP.NET Core service for producing publication-ready regulatory Word deliverables.
- Troubleshooting & Runbook: Incident response procedures, database recovery, and common failure resolutions.