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Validation Plan & Summary Report

Document reference: GFTCL-VP-001 ยท Framework: GAMP 5 Category 5 ยท EU Annex 11

FortressAI Research Institute ยท Norwich, Connecticut Patents: USPTO 19/460,960 ยท USPTO 19/096,071 โ€” ยฉ 2026 Richard Gillespie

This document defines how the GaiaFTCL vQbit Quantum VM is validated (the plan) and records the outcome (the summary report). It is the controlling document for the qualification effort.


Part A โ€” Validation Plan

Scope

The complete bespoke (Category 5) system: vQbit VM, Cโด algorithm rail, Franklin orchestrator, substrate store, CLI, and the federation surface. The host macOS is Category 1 infrastructure and out of scope except for stated system requirements.

Approach

Risk-based validation per GAMP 5 Category & Supplier Assessment and Risk Assessment. The V-model is verified on two independent gates:

  1. Build-time gate โ€” 156 swift test GAMP 5 tests under Tests/GAMP5/ (IQ/OQ/PQ/MQ).
  2. Runtime gate โ€” 18โ€“19 in-app checks (SovereignQualificationRunner) against the live shipping stack inside Franklin.app.

Deliverables

URS, FS, SDS, Configuration Spec, RTM, Risk Assessment, IQ/OQ/PQ protocols + reports, Qualification Catalog, and this plan/summary. All are controlled documents in this section.

Acceptance criteria

A release is qualified when: all 156 build-time tests pass; all in-app checks return CALORIE; the RTM shows full bidirectional coverage; and every run seals a re-verifiable MQ receipt.

Roles

Developer-operator (FortressAI Research Institute) authors and executes; the independent build-time and runtime gates provide testing independence; a third-party assessor can re-verify any receipt without developer access.


Part B โ€” Validation Summary Report

Result

CALORIE โ€” qualified. The qualification gates pass on the current baseline.

Gate Count Result
Build-time swift test GAMP 5 suite 156 pass
In-app IQ/OQ/PQ runner 18โ€“19 CALORIE
MQ receipts sealed & retained 120+ append-only

Evidence

Each qualification run writes a federation-cosigned receipt to cells/xcode/qualification_receipts/ (MQ-*.json). Each receipt re-computes its witness hash from its sealed canonical witness, so the result is independently reproducible.

Deviations

Tracked through Operational Procedures โ†’ change control. Any failed check blocks the release until resolved and re-qualified.

Release statement

On a passing baseline the system is released for operational use. Re-qualification is required after any change to a High/Critical configuration item, a substrate schema addition, or a toolchain/OS upgrade.


Cross-references: RTM ยท Qualification Catalog ยท IQ ยท OQ ยท PQ.


Federation-cosigned

This page's source is sealed in the GaiaFTCL federation manifest โ€” page SHA-256 2714a11c0f3e114fโ€ฆ, manifest witness a090592e0609adc8โ€ฆ, signed 2026-06-02T18:58:22Z by cell gaiaftcl-mac-cell. Verify with gaiaftcl wiki sign --all and compare wiki-all-signatures.json.