Quickstart & Deployment

Prerequisites

Docker Engine 24+ and Docker Compose v2
Python 3.11+ (optional, for running the local pytest IQ/OQ qualification suite and GMP binder generator)

Step 1: Configure Environment & Launch the Stack

Copy the GxP environment template and start all 5 orchestrated services:

cp .env.example .env
docker compose up -d --build

Verify that all 5 containers (postgres-control, clickhouse-archive, edge-collector, historian-api, grafana-vision) are running and healthy:

docker compose ps
curl -s http://localhost:8020/api/v1/health | jq .

Expected Health Response

{
  "status": "healthy",
  "postgres_control_plane": "connected",
  "clickhouse_archive": "connected",
  "part11_audit_records": 220,
  "sensor_data_rows": 1450
}

Step 2: Inspect Seeded GxP Assets, Tags & Part 11 Users

On initial startup, init-postgres/01_control_plane_part11.sql seeds the ISA-95 asset hierarchy, multi-protocol bioprocess tags, and 21 CFR Part 11 user accounts inside an attributed bootstrap transaction (SET LOCAL app.actor_id = 'system_bootstrap').

Seeded ISA-95 Assets (`assets`)

Asset ID	Asset Name	ISA-95 `ltree` Asset Path	Template
`1`	`Bioreactor_201`	`BioCorp.Fremont.USP.Bioreactor_201`	`Bioreactor_USP_Template`
`2`	`Cleanroom_Suite_104`	`BioCorp.Fremont.Facilities.Cleanroom_Suite_104`	`Cleanroom_EMS_Template`
`3`	`Chrom_Skid_01`	`BioCorp.Fremont.DSP.Chrom_Skid_01`	`Chromatography_DSP_Template`

Seeded Multi-Protocol GxP Tags (`tags`)

Tag ID	Tag Name	ISA-95 `ltree` Asset Path	Attribute	Units	Step Tag (`LOCF`)	Deadband (`exc_dev`)	Limits (`Low` / `High`)	Source Protocol
`101`	`BR201_TEMP_PV`	`BioCorp.Fremont.USP.Bioreactor_201`	`Vessel_Temp_PV`	`degC`	`false` (`LINEAR`)	`0.05`	`35.0` / `38.0`	`OPC_UA`
`102`	`BR201_PH_PV`	`BioCorp.Fremont.USP.Bioreactor_201`	`Vessel_pH_PV`	`pH`	`false` (`LINEAR`)	`0.02`	`6.8` / `7.4`	`OPC_UA`
`103`	`BR201_AGIT_STATE`	`BioCorp.Fremont.USP.Bioreactor_201`	`Agitator_State`	`state`	`true` (`LOCF`)	`0.0`	`0.0` / `2.0`	`SIEMENS_S7`
`301`	`CR104_DIFF_PRESS`	`BioCorp.Fremont.Facilities.Cleanroom_Suite_104`	`Room_Diff_Pressure_PV`	`Pa`	`false` (`LINEAR`)	`0.5`	`12.5` / `50.0`	`BACNET_IP`
`401`	`CHROM01_UV280_PV`	`BioCorp.Fremont.DSP.Chrom_Skid_01`	`UV280_Absorbance_PV`	`mAU`	`false` (`LINEAR`)	`0.1`	`0.0` / `1000.0`	`OPC_DA`

Seeded 21 CFR Part 11 Accounts (`users`)

[!NOTE] init-postgres/01_control_plane_part11.sql seeds bcrypt password hashes via pgcrypto, and app/main.py ensures qualification aliases are synchronized at startup.

User ID	Full Name	Role	Qualification Password
`operator_01`	Sarah Jenkins (Lead USP Operator)	`OPERATOR` / `Process_Operator`	`Operator_Pass_2026!` (or `Operator_2026!`)
`qa_approver_01`	Dr. Marcus Vance (QA Qualified Person)	`QA_APPROVER` / `Quality_Assurance`	`QA_Approve_2026!` (or `QA_Approver_2026!`)

Step 3: Access Interactive Interfaces

Swagger / OpenAPI Interactive REST Docs:
- Open http://localhost:8020/docs in your browser.
Grafana Vision Operator HMI:
- Open http://localhost:3020/d/gxphistorian-gxp-bioreactor-hmi
- Login with admin / GxP_Grafana_2026!

Verify 21 CFR Part 11 Audit Hash Chain:

curl -s http://localhost:8020/api/v1/audit-trail/verify | jq .

Run the 15-Test Automated IQ/OQ Qualification Suite:
Terminal window
```
.venv/bin/pytest -v
```