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GxPHistorian

Document 08 — Validation Summary Report (VSR) & Release Certificate

Document ID: VSR-GXPHISTORIAN-2026-008 | Release Date (UTC): 2026-10-17T20:21:45Z | System Release Status: QUALIFIED FOR GxP PRODUCTION USE

1. Executive Qualification Summary

The GxPHistorian GxP Industrial Historian (ClickHouse 24.8 Telemetry Archive, PostgreSQL 16 Part 11 Control Plane, Telegraf 1.32 Edge Collector, FastAPI Control Plane, and Grafana 11.2 HMI) has completed all Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities in accordance with VMP-GXPHISTORIAN-2026-001.

MetricTarget Acceptance CriterionActual Executed ResultStatus
User Requirements Coverage (URS-001..015)100% Bidirectional Traceability15 / 15 Requirements Mapped & VerifiedPASS
Automated IQ/OQ Test Suite (pytest)100% Pass Rate (0 Failures)15 / 15 Passed (100.0%)PASS
21 CFR Part 11 Cryptographic Hash Chainchain_valid == true from GENESIS6514 Audit Records Verified (head: 6caa62139f61287283675436...)PASS
Validation Deviations / CAPAs0 Open Critical/Major Deviations0 Deviations EncounteredPASS

2. Deviation & Non-Conformance Log

  • Open Deviations: 0
  • Closed Deviations: 0
  • All 15 IQ/OQ test cases passed on execution without protocol exceptions or data integrity discrepancies.

3. Statement of Fitness for Intended GxP Use

Based on the objective cryptographic evidence captured in oq_execution_results.json and the unbroken SHA-256 WORM audit trail in part11_audit_log, the GxPHistorian GxP Industrial Historian is hereby declared fit for its intended GxP manufacturing use under FDA 21 CFR Part 11, EU GMP Annex 11, and ISPE GAMP 5 (Second Edition).

4. 21 CFR Part 11 §11.50 Electronic Release Signatures

Signer RolePrinted NameUser IDSignature MeaningSigned Timestamp (UTC)Cryptographic Verification
System Owner (IT/OT)Sarah Jenkinsoperator_01System Technical Qualification & Operational Handover Approval2026-10-17T20:21:45ZVerified via pgcrypto & Part 11 Audit Chain
Quality Assurance (QP)Dr. Marcus Vanceqa_approver_01Final QA Validation Release & 21 CFR Part 11 Compliance Approval2026-10-17T20:21:45ZHMAC-SHA256 Bound (6caa62139f61287283675436be696b45...)

Regulatory & Trademark Notice: GxPHistorian GxP Industrial Historian is an independent open-source project engineered for 21 CFR Part 11, EU GMP Annex 11, and ISPE GAMP 5 (2nd Ed.) compliance. PI System, PI Vision, PI DataLink, PI Asset Framework, PI UFL, OSIsoft, and AVEVA are trademarks of AVEVA Group Limited / OSIsoft, LLC and are referenced strictly for comparative interoperability documentation.