# Verixa Synthetic Data Set — Index

| Field | Value |
|---|---|
| Manifest | `Verixa_Synthetic_Data_Manifest_v1.0` |
| Owner | CEO, Verixa, A Vertical of Aeonn Health |
| Manifest build (UTC) | 2026-06-08T00:00:00+00:00 |
| Datasets | **43** |
| Total rows | **29,714,298** |
| Real Gold-Standard G2 anchors | **5** (WF-CRC-005, WF-LAB-005, WF-MD-003, WF-QE-007, WF-REG-001) |
| Large datasets (regenerate-from-seed) | 4 (WF-FND-006, WF-GDP-006, WF-LAB-005, WF-QE-007) |
| Doctrine | Verixa Synthetic Data Plan v1.0 (VRX-SDP-001); ARCH-AI-001 AC-2 (advisory-only). |

> **Advisory · ENGINEERING_VERIFICATION · NOT Gold Standard.** Never the system of record
> for any regulatory claim. Head of QA disposition required before any promotion.

## Non-negotiable rules
- Synthetic data is ALWAYS advisory. Never the system of record for any regulatory claim.
- Every generator is deterministic: same seed -> SHA-256-identical output (Gate G6).
- Once a row is assigned to a partition, it stays there forever. Never re-partition.
- A dataset that fails any applicable gate cannot be locked.
- Cite Gold Standard for external claims; synthetic for internal engineering verification only.

## Datasets

`G2` ✓ = real Gold-Standard anchor; N/A = documented engineered prior. `content_sha256` is the canonical determinism anchor. ⟳ = large_dataset (regenerate-from-seed).

| Workflow | Name | URS | Rows | Ver | G1 | G2 | G3 | G4 | G5 | G6 | content_sha256 |
|---|---|---|--:|---|:--:|:--:|:--:|:--:|:--:|:--:|---|
| WF-APQR-001 | Annual Product Quality Review (APQR) | 26, 24, 12 | 2,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `a3c7c631a1c06e38` |
| WF-CRC-001 | Change Control | 13 | 5,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `f5d04aeaf850b71a` |
| WF-CRC-002 | Risk Assessment | 19 | 3,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `c24bcf77cf1ba279` |
| WF-CRC-003 | Root Cause Analysis | 17 | 1,607 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `04b5e5bafd4c013b` |
| WF-CRC-004 | CAPA | 18 | 1,685 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `497e2eb0cec8907a` |
| WF-CRC-005 | Findings | 21 | 2,000 | 1.1.0 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | `a190968e7cd20bec` |
| WF-DOC-001 | Document Control & SOP Lifecycle | 12 | 5,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `b549e94d60b670bd` |
| WF-DOC-002 | Training Management & Qualification | 28 | 100,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `1cf75008f3d2b8b8` |
| WF-DOC-003 | Document Quality Gateway (DQG) Intake | 31, 32 | 20,000 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `22de61df1c99e11e` |
| WF-DOC-004 | Screen Reader / Data Capture (OCR + structured extraction) | 29, 32 | 10,000 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `c86616b2e9c9f68b` |
| WF-FND-001 | Authentication & Session | 01 | 50,000 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `fc678f9c61c1097c` |
| WF-FND-002 | RBAC / Permissions | 02 | 20,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `38c1f69b1ad61ad2` |
| WF-FND-003 | Context Gate / Active Scope Enforcement | 03 | 30,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `b168926ff2783440` |
| WF-FND-004 | Workflow / HITL / E-Signature / Approval Authority | 04 | 25,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `e26b25d7aaf5161a` |
| WF-FND-005 | Authority Profile / Delegation / SoD | 05 | 12,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `c76accdab2494bb7` |
| WF-FND-006 | Audit Trail / Hash Chain / Tamper-Evident ⟳ | 06 | 1,000,000 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `8edf5928a45a4caa` |
| WF-FND-007 | Notifications & Acknowledgments | 30 | 30,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `b59bbcfbad40c91f` |
| WF-FND-008 | Backup / Restore / Operational Resilience | 35 | 3,750 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `ea572bcf11cb1758` |
| WF-FND-009 | Tenant Lifecycle | 08 | 500 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `b49be3adb859f2e4` |
| WF-GDP-001 | Goods Receipt & Inbound Inspection | 34, 09, 10, 11, 23, 33 | 50,000 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `1207086ba1c4e86b` |
| WF-GDP-002 | Cold Chain Data Verification at Receipt | 34, 09, 10, 11, 15, 16, 23 | 30,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `a794d6153bd4c8cb` |
| WF-GDP-003 | Outbound Dispatch & Shipment (FEFO-outbound, pick-pack-release-ship) | 34, 09, 10, 11, 23 | 100,000 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `5d70203ed1d026f2` |
| WF-GDP-005 | Storage Segregation Management (FEFO, status zones) | 34, 09, 10, 23 | 100,000 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `93082cde8a0dba77` |
| WF-GDP-006 | Cold Chain Storage Monitoring ⟳ | 34, 09, 15, 16, 23 | 26,280,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `693003f5f47c8bb8` |
| WF-LAB-003 | Stability Program (ICH Q1A) | 24 | 49,920 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `244d7ba63bf4d49f` |
| WF-LAB-005 | Environmental Monitoring (sterile pilot) ⟳ | 25, 09, 15, 16, 23 | 876,000 | 1.0.0 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | `b8a4e66caa96ae89` |
| WF-MD-001 | Site / Facility Setup | 09 | 100 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `51a804f60fe0e96b` |
| WF-MD-002 | Product / SKU / Drug Master | 10 | 1,000 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `28a0e477a6819ec6` |
| WF-MD-003 | Supplier Master & Qualification Lifecycle | 11 | 500 | 1.1.0 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | `b2f61b47a42d740a` |
| WF-MD-004 | Supplier-Product-Material Approval & Batch Material Gate | 11, 10, 23, 09 | 50,000 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `33d92874621326fc` |
| WF-MD-005 | Study Configuration | 07 | 200 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `2e98981eb7fdfd85` |
| WF-MFG-004 | Batch Manufacturing Record / MBR | 23 | 2,000 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `62d7760745041739` |
| WF-MFG-005 | Batch Release & Disposition | 23, 04, 05 | 2,000 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `ba4a96969f55ee5d` |
| WF-MFG-GATE | GMP Manufacturing Gates (10-point composite) | 33, 23, 11, 10, 09, 28, 12, 16, 15, 18, 04, 05, 06 | 100,000 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `858f7c371728e2a6` |
| WF-MIRA-001 | AI Inference Provenance & Advisory Segregation | 32, 12 | 60,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `27cad3fd3658a9a2` |
| WF-MIRA-002 | HITL Gating, Escalation & Override | 32, 12 | 40,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `2bf6b1316e945ca3` |
| WF-MIRA-003 | Model Registry, Change-Control & Drift | 32, 12 | 24,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `c282212f3e96cbe1` |
| WF-QE-001 | Deviation Management | 16 | 5,000 | 1.1.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `6bdbf98e0a8d78df` |
| WF-QE-002 | OOS/OOT Investigation | 15 | 3,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `ff3354355eb3c4fe` |
| WF-QE-004 | Complaint Handling | 14 | 3,000 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `c390c3c4c50fa0bc` |
| WF-QE-007 | Recall Lifecycle / Distribution Execution ⟳ | 34, 14, 30 | 500,000 | 1.0.0 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | `a16f12dde8a2ba75` |
| WF-QE-LC | Quality-Event Lifecycle Transition Events | 16, 15, 18, 17, 13, 21, 19 | 86,036 | 1.0.0 | ✓ | N/A | ✓ | ✓ | ✓ | ✓ | `3c9495a8181fd223` |
| WF-REG-001 | Regulatory Intelligence | 27, 12 | 30,000 | 1.0.0 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | `9430fa68ae9dce42` |

## Real Gold-Standard G2 anchors

| Workflow | Anchor | Test |
|---|---|---|
| WF-CRC-005 | GS-002 | chi-square goodness-of-fit, p=0.396; detects Cohen's w≥0.111 (small) at 80% power |
| WF-LAB-005 | GS-002 | chi-square goodness-of-fit, p=1.000; detects Cohen's w≥0.047 (small) at 80% power |
| WF-MD-003 | GS-004 | KS 2-sample, p=1.000 |
| WF-QE-007 | GS-004 | chi-square goodness-of-fit, p=0.876; detects Cohen's w≥0.31 (medium) at 80% power |
| WF-REG-001 | — | chi-square goodness-of-fit, p=0.466; detects Cohen's w≥0.032 (small) at 80% power |

## Provenance (11 ALCOA+ columns on 100% of rows)

`synthetic_record_id`, `generator_id`, `generator_version`, `seed_value`, `generation_timestamp_utc`, `schema_hash_sha256`, `is_edge_case`, `edge_case_category`, `partition_assignment`, `partition_assignment_hash`, `advisory_label`

*Generated from `Verixa_Synthetic_Data_Manifest_v1.0` — every figure is manifest-derived.*