# VRX-PACK-PART11-MAP-001 — URS 36–41 Predicate-Rule / Part 11 Applicability Map (Pack-Level)

| Field | Value |
|---|---|
| Document ID | VRX-PACK-PART11-MAP-001 |
| Purpose | Operationalizes PACK-COR-005. Consolidates the per-module *starter* maps (URS-40 §10.1, URS-41 §10.1) into ONE pack-level predicate-rule applicability map across every record type in URS 36–41, so Part 11 scope is decided once and consistently. |
| Status | **STARTER DRAFT — requires Head of QA + Data Integrity Lead + Legal sign-off AND customer intended-use determination. Not approved. Does not by itself satisfy any module's Part 11 requirement.** |
| Date | 2026-06-07 |
| Owners | Head of QA / Data Integrity Lead (+ Legal where flagged) |
| Rule | Part 11 applies to a record **only** if it is required by a predicate rule, relied upon for a regulated activity, or submitted to FDA. Part 11 is **not** asserted blanket-wide. |

> **Why pack-level:** URS-40 and URS-41 each carry their own *starter* map; URS-36/37/38 also create records. Per-module starters cannot be reconciled at freeze. This is the single map to complete and sign. "Submitted to FDA?" is customer- and use-dependent → `Unknown — customer intended-use determination required` for most rows.

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## 1. Applicability map (starter determinations)

Columns: **Pred?** = required by a predicate rule · **Relied?** = relied upon for a regulated activity · **FDA?** = submitted to FDA. **Det.** = starter Part 11 determination (In-scope / Supporting / Out / TBD). All determinations are STARTER and require sign-off.

| Record type | Module | Pred? | Relied? | FDA? | Audit/e-sig expectation | Starter determination |
|---|---|---|---|---|---|---|
| `customer_accounts` | 36 | No (commercial) | Indirect (gates access) | No | Audit | **Supporting** — not a Part 11 record itself |
| `tenant_environments` | 36 | No | Indirect | No | Audit | **Supporting** |
| `platform.subscriptions` / `module_entitlements` / `seat_allocations` / `license_assignments` | 36 | No | Indirect (entitlement → regulated access, §11.10(d)) | No | Audit; access-control evidence | **Supporting** — access-control relevant (11.10(d)), not a GMP predicate record |
| `platform.license_audit_events` (append-only) | 36 | No | Yes (access-control audit) | No | Append-only audit; **no hash-chain claim until URS-06 proven (DEC-36-26)** | **In-scope (11.10(e) audit)** where relied upon; do not overclaim hash-chain |
| Equipment qualification (`gmp_equipment_qualifications` / URS-37 `equipment_qualifications`) | 37 | **Yes** (21 CFR 211.63/211.68; equipment qualification) | **Yes** | Possibly | Audit + **e-sig** (qualification approval) | **In-scope (likely)** where the system is the record of record |
| Calibration records | 37 | **Yes** (21 CFR 211.68/211.160(b)(4)) | **Yes** | Possibly | Audit + e-sig | **In-scope (likely)** |
| PM work orders | 37 | Yes (211.67 maintenance) | Yes | Possibly | Audit | **In-scope if maintenance is the record of record** |
| Equipment impact assessments / EQ-006 gate evaluations | 37 | Indirect (disposition gating) | **Yes** | Possibly | Audit; gate evidence | **In-scope (likely)** — gates batch/use disposition |
| `gmp_equipment_qualification_exceptions` (e-sig) | 37 | Indirect | Yes | Possibly | **e-sig + authority** (already implemented) | **In-scope (11.50/11.70)** |
| Dashboard snapshots | 38 | No | If relied upon for a decision | No | Reproducible; export audit | **TBD** — Supporting unless relied upon; determination needed |
| Dashboard exports (`dashboard_export_log`) | 38 | No | If shown to inspector / relied upon | Possibly (if exported to FDA) | Export audit; integrity stamp | **TBD** — "true copy" controls if relied upon |
| Inspection-Readiness score | 38 | No | Advisory MI | No | Reproducible from snapshot | **Supporting (advisory)** — not a record of record |
| `dashboard_alerts` | 38 | No | No | No | Ack audit | **Out / Supporting** |
| (URS-39A demo records) | 39A | No | No | No | None (non-GxP) | **Out — non-GxP demo** |
| (URS-39B — records belong to parent modules 02/04/06/16/17/18/…) | 39B | per parent | per parent | per parent | per parent | **Determined by each parent module** (not new record classes) |
| `system_changes` | 40 | No (eng change log) | Indirect (triggers validation) | No | Audit | **Supporting** |
| `validation_plans` | 40 | If the validation protocol of record | Yes if relied upon for release | Possibly | Audit + e-sig (approval) | **In-scope if relied upon** |
| `validation_runs` | 40 | If validation evidence of record | **Yes** (the evidence) | Possibly | Audit; immutable | **In-scope (likely)** |
| `validation_screenshots` | 40 | Attached objective evidence | Yes | Possibly | Integrity hash | **In-scope if part of the evidentiary record** |
| `validation_packages` | 40 | Signed validation report of record | **Yes** (disposition + e-sign) | Possibly | **e-sig**; immutable | **In-scope (likely)** |
| `kb_sources` / `kb_source_reviews` | 41 | No | If corpus feeds a regulated decision | No | Audit + approval e-sig | **In-scope where relied upon** |
| `kb_documents` / `kb_chunks` / `kb_embeddings` | 41 | No | Supporting retrieval substrate | No | Provenance/version | **Supporting** |
| `kb_retrieval_log` | 41 | No | Advisory retrieval evidence | No | Audit; provenance | **In-scope (11.10(e)) where retrieval is relied upon**; advisory content never a record field |

## 2. Cross-cutting determinations to settle (one decision each)

1. **Equipment domain (URS-37):** confirm the system-of-record status vs the existing `gmp_equipment_qualifications` substrate (see VRX-URS37-PATCH-002, FIX-37-010). Part 11 scope follows the canonical SoR decision.
2. **Analytics exports (URS-38):** decide whether dashboard exports/scores are ever relied upon for, or submitted in support of, a regulated decision; if yes → "true copy" + export-integrity controls.
3. **Validation evidence (URS-40):** runs/packages are in-scope where relied upon for release — confirm the customer's reliance model.
4. **KB retrieval (URS-41):** retrieval logs in-scope where the corpus feeds a regulated decision; advisory content remains out of record fields.
5. **"Submitted to FDA?"** column is customer/use-dependent for nearly every row → resolve per customer intended-use before any Part 11 statement.

## 3. Required actions

1. Complete each row's Pred/Relied/FDA determination with evidence; convert STARTER to signed. [Head of QA + DI Lead + Legal]
2. Obtain the customer intended-use determination that drives "Relied?/FDA?". [QA + customer]
3. Reference this single map from URS-40 §10.1, URS-41 §10.1, and URS-37/36/38 (retire the per-module starters). [URS owners under change control]
4. No Part 11 compliance statement for any URS 36–41 record until its row is signed. [QA]

| Boundary Check | Result |
|---|---|
| Primary lens | Data Integrity / Part 11 + Head of QA |
| Owned deliverable | Pack-level predicate-rule applicability map (starter) |
| Out-of-scope (deferred) | Legal predicate-rule interpretation → Legal; customer intended-use → customer + QA; final sign-off → Head of QA + DI Lead |
| Repo | Read-only; no files modified |
| Final status | Starter draft — Head of QA + DI Lead + Legal sign-off required |

*Starter determinations only. Does not satisfy any module's Part 11 requirement by itself. No claim of validation, compliance, or approval.*