GxPHistorian Documentation Portal

Complete architectural specifications, 21 CFR Part 11 & EU GMP Annex 11 kernel controls, physical connector wiring guides, 35+ biopharma instrument playbooks, and the executed 8-document GAMP 5 Validation Binder.

Quickstart & Deployment 4-Pillar Architecture Print-Ready GMP Validation Binder (HTML)

FDA 21 CFR Part 11 WORM Audit TrailEU GMP Annex 11 & ALCOA+ISPE GAMP 5 (2nd Ed.) & FDA CSAClickHouse 24.8 LTS (DoubleDelta + Gorilla)PostgreSQL 16 ISA-95 ltree & ISA-88 Event Frames15/15 Executable IQ/OQ Qualification Tests

4-Pillar Industrial Historian Architecture

Pillar 1: Multi-Protocol Edge Collector

Telegraf 1.32 + Python Edge Workers normalize OPC UA, BACnet/IP (COV), Siemens S7, Modbus RTU/TCP, Windows COM OPC DA, and RS-232 / PI UFL watchfolders with in-memory Stage 1 Exception/Deadband filtering (ExcDev / ExcMax) and a 1M-metric disk-backed Store-and-Forward WAL.

Pillar 2: Immutable Telemetry Archive

ClickHouse 24.8 LTS (pi_historian.sensor_data) stores raw telemetry with lossless DoubleDelta, Gorilla, and T64 + ZSTD(1) codecs, real-time 1-minute AggregatingMergeTree rollups (WHERE quality >= 192), and native largestTriangleThreeBuckets (LTTB) visual peak preservation.

Pillar 3: 21 CFR Part 11 Control Plane

PostgreSQL 16 + FastAPI (historian-api) manages the ISA-95 ltree Asset Hierarchy, Tag Catalog, and ISA-88 Event Frames, backed by PL/pgSQL WORM triggers, a cryptographic SHA-256 hash-chained audit trail, and §11.200 dual-challenge HMAC-SHA256 electronic signatures.

Pillar 4: Operator HMI, Excel DataLink & Lakehouse

Pre-provisioned Grafana OSS 11.2 Bioreactor & Cleanroom HMI with Event Frame overlays, drop-in Excel DataLink UDFs (xlwings) & zero-macro Power Query CSV respecting LINEAR vs. LOCF step tags, and Zero-ETL Snappy Apache Parquet exports.

GxPHistorian Vision — GxP Bioreactor & Cleanroom HMI Dashboard

Browse Documentation Sections

Overview & OSIsoft PI Parity Matrix Compare every legacy OSIsoft / AVEVA PI System subsystem against its GxPHistorian GxP open-source counterpart.

21 CFR Part 11 & ALCOA+ Technical Controls Inspect the PostgreSQL WORM triggers, SHA-256 cryptographic hash chain, §11.200 electronic signatures, and OPC quality >= 192 rules.

REST API Reference & Excel DataLink Query LTTB downsampled trends, Linear/LOCF sampled DataLink streams, ISA-88 Event Frames, and Apache Parquet exports.

Connectors, Protocols & Wiring Encyclopedia Visual deep-dive into every physical plug (RJ45, M12, DB9, RS-485) and software protocol (OPC UA, OPC DA, BACnet/IP & MS/TP, Modbus TCP/RTU, S7comm, EtherNet/IP, 4–20 mA HART, RS-232 & UFL).

Biopharma Equipment Integration Catalog (Visual Guides) 10 visual step-by-step guides covering 35+ instruments: Cytiva Xcellerex & ÄKTA, Sartorius Biostat & Ambr, BioProfile FLEX2, Vi-CELL BLU, Raman, Lyophilizers, and BACnet EMS.

Cell & Gene Therapy, mRNA-LNP & Controlled-Rate Freezers Visual wiring & setup for Miltenyi CliniMACS Prodigy, Cytiva Sefia S-2000 & Sepax C-Pro, NanoAssemblr GMP mRNA-LNP skids, and Planer Kryo 560 / Thermo CryoMed CRFs.

Stability Chambers, Cold Chain & Steam Autoclaves Binder KBF / Weiss ICH Q1A Stability Chambers (with Mean Kinetic Temperature SQL), Infors / Heracell CO2 Incubators, -80°C ULT Freezers, and Fedegari / Getinge Autoclaves (F0 SQL).

Legacy Fieldbus, Serial RS-232 & PI UFL Zero-DCOM Windows OPC DA bridge, BACnet MS/TP BBMD routing, Modbus word-swapping, Moxa NPort MT-SICS balances, and Sartocheck filter testers.

Hardware Sizing & Capacity Planning Compression math (1.5–2.5 B/sample), 10k–25k tag clinical/pilot GMP reference BOM, 10-year NVMe + 15-year S3 WORM tiering, and Level 2.5 Industrial Edge IPC specs.

GAMP 5 & FDA CSA Validation Binder Browse all 8 executed commercial GMP Validation Binder documents (VMP, URS, FDS, FRA, SOUP Dossier, IQ/OQ Evidence, RTM, and VSR).