GAMP 5 System Documentation — Validation Master Plan¶
Document reference: GFTCL-VMP-001 · Framework: ISPE GAMP 5 (2nd ed.) · EU Annex 11 · 21 CFR Part 11 System: GaiaFTCL vQbit Quantum VM · Software category: GAMP 5 Category 5 (bespoke) · Status: Qualified
FortressAI Research Institute · Norwich, Connecticut Patents: USPTO 19/460,960 · USPTO 19/096,071 — © 2026 Richard Gillespie
This is the entry point to the GaiaFTCL vQbit Quantum VM's regulated-system documentation. It maps the full validation lifecycle and indexes every controlled document a professional GAMP 5 assessment expects, from user requirements through qualification, operation, and decommissioning.
The system, in one paragraph¶
The GaiaFTCL vQbit Quantum VM is a bespoke macOS application (Franklin.app) that
runs the M⁸ = S⁴ × C⁴ quantum substrate natively on Apple Silicon. Franklin is the
single sovereign entry point; VQbitVM and FranklinConsciousnessService run as
bundled child subsystems on an internal NATS bus. Every substrate operation is
append-only, federation-cosigned, and sealed with a SHA-256 canonical witness. The
system self-qualifies on every boot (IQ→OQ→PQ→MQ) and writes signed receipts a
regulator can re-verify years later.
The validation lifecycle (V-model)¶
| Specification (left) | Verification (right) | Document |
|---|---|---|
| User Requirements (URS) | Performance Qualification (PQ) | URS ↔ PQ |
| Functional Specification (FS) | Operational Qualification (OQ) | FS ↔ OQ |
| System / Design Specification (SDS) | Installation Qualification (IQ) | SDS ↔ IQ |
| Configuration Specification | Module Qualification (MQ) | Config Spec ↔ Qualification Catalog |
Traceability across both arms is maintained in the Requirements Traceability Matrix.
Controlled document index¶
Specifications - System Architecture Specification — GFTCL-SDS-001 - User Requirements Specification — GFTCL-URS-001 - Functional Specification — GFTCL-FS-001 - Configuration Specification — GFTCL-CFG-001 - GAMP 5 Category & Supplier Assessment — GFTCL-CAT-001
Validation & qualification - Validation Plan & Summary Report — GFTCL-VP-001 - Requirements Traceability Matrix — GFTCL-RTM-001 - Risk Assessment (FMEA) — GFTCL-RA-001 - IQ — Installation Qualification · OQ · PQ - Qualification Catalog · GAMP 5 Test Authority · Sovereign M⁸ Qualification
Operation & compliance - Installation Guide — GFTCL-INST-001 - Data Integrity & 21 CFR Part 11 — GFTCL-DI-001 - Security, Backup & Recovery — GFTCL-SEC-001 - Operational Procedures & Lifecycle — GFTCL-SOP-001
Engineering - Programming & API Guide — GFTCL-API-001 - CLI Reference · Substrate Schema Catalog
Qualification status at a glance¶
| Gate | Scope | Count | Result |
|---|---|---|---|
Build-time swift test GAMP 5 suite |
IQ/OQ/PQ/MQ | 156 tests | CALORIE |
In-app IQ/OQ/PQ runner (SovereignQualificationRunner) |
live stack | 18–19 checks | CALORIE |
Sealed MQ receipts (cells/xcode/qualification_receipts/) |
per-run evidence | 120+ receipts | retained |
Every qualification run seals a federation-cosigned receipt; the evidence chain is append-only and independently re-verifiable.
This document set is maintained as a controlled artifact. Changes route through
Change Control. Each page carries a
federation cosignature once signed via gaiaftcl wiki sign --section GAMP5; until
then it serves with a substrate-honest pending-signature notice.
Federation-cosigned
This page's source is sealed in the GaiaFTCL federation manifest — page SHA-256 fe126aacb2fae922…, manifest witness a090592e0609adc8…, signed 2026-06-02T18:58:22Z by cell gaiaftcl-mac-cell. Verify with gaiaftcl wiki sign --all and compare wiki-all-signatures.json.