---
artifact_class: synthetic_csv_corpus_seed
artifact_status: GENERATED
generator: "Claude (Anthropic) — inline FS authoring, 2026-04-27; expanded 2026-05-12 (FS catch-up to v1.2 URS, T2 uplift)"
seed_corpus_basis:
  - "SLN-URS-COLDCHAIN-001 v1.2"
  - "GAMP 5 Cat 4 SaaS"
  - "21 CFR Part 11; EU GMP Annex 11; EU GDP; WHO TRS 957 Annex 9; USP <1079>"
  - "ICH Q1A(R2); IEC 60068-3-5"
parent_urs:
  document_number: SLN-URS-COLDCHAIN-001
  version: 1.2
  file: ../../URS/_generated/final/Cold_Chain_Logger_Cloud_Platform__Selene_Sciences_URS_v1.3.md
do_not_use_as: [regulated_record, basis_for_real_validation_decisions]
intended_use: [LLM fine-tuning corpus seed]
labelling:
  evidence_level: synthetic_seeded
  signature_status: placeholders
  production_status: simulated_or_example
  source_risk: ai_authored_disclosed
---

# Functional Specification (FS)

## Cold-Chain Logger Cloud Platform — ELPRO Liberty Cloud + ecolog-NET LIB v2.4

**Document Number:** SLN-FS-COLDCHAIN-001 | **Version:** 1.2 | **Effective Date:** 2026-05-12 *(synthetic)*
**Parent URS:** SLN-URS-COLDCHAIN-001 v1.2 | **Site:** Selene Sciences AE (fictional) — Athens HQ + DACH hubs (Konstanz / Basel / Wien)
**System Class:** GAMP Cat 4 — Configured Product (multi-tenant SaaS) + IoT loggers
**Regulatory Scope:** 21 CFR Part 11 §§ .10, .30, .50, .70, .100, .200, .300; EU GMP Annex 11 §§ 4, 6, 9, 11; EU GDP 2013/C 343/01; WHO TRS 957 Annex 9; USP <1079>; ICH Q1A(R2); IEC 60068-3-5; BfArM / Swissmedic / AGES GDP requirements.

## Document Control

| Role | Name | Signature | Date |
|---|---|---|---|
| Author (Solution Architect) | _____________ | _____________ | _____ |
| Reviewer (Validation Lead) | _____________ | _____________ | _____ |
| Reviewer (Cold-Chain Operations Manager) | _____________ | _____________ | _____ |
| Reviewer (Vendor Assurance owner) | _____________ | _____________ | _____ |
| Reviewer (Stability Reviewer) | _____________ | _____________ | _____ |
| Approver (Head of Supply Chain) | _____________ | _____________ | _____ |
| Approver (Head of QA) | _____________ | _____________ | _____ |

## Revision History

| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-04-27 | (synthetic) | Initial issue. |
| 1.2 | 2026-05-12 | (synthetic) | FS catch-up to URS v1.2 (T2 uplift): per-ID expansion for registration / commissioning, lane qualification, CTNS / stability budget, excursion → Halcyon hand-off, reusable-logger reset SOP, multi-tenant; 21 CFR Part 11 sub-section-explicit; DACH GDP context; no range compression. |


| 1.3 | 2026-05-13 *(synthetic)* | v1.3 corpus restructuring: added § N Implementation Risk Register (content transferred from URS § 9, removed per v1.3 reframing — implementation risk lives in FS, not URS); URS-side Project Mode line added to Document Control per METHODOLOGY § 2A.15. | Migration Script |## 1. Purpose

This FS specifies the configuration / integration of ELPRO Liberty cloud + ecolog-NET LIB v2.4 + BLE / NFC loggers to satisfy `SLN-URS-COLDCHAIN-001` v1.2.

## 2. Scope

ELPRO Liberty cloud (multi-tenant SaaS); site-deployed LIB v2.4 box; logger fleet (USB / BLE / NFC); SSO via Okta; integrations with WMS SAP EWM, Halcyon Stability, MasterControl eQMS, carrier GPS feeds. Out: vendor infra; physical-shipping infrastructure.

## 3. System Architecture

```
                Okta SAML 2.0 + MFA
                    │
                    ▼
   ┌────────────────────────────────────────────────────┐
   │  ELPRO Liberty Cloud (Selene tenancy)              │
   │  Logger registration / commissioning                │
   │  Profile lifecycle + evaluation engine              │
   │  CTNS / stability-budget tracker                    │
   │  Lane qualification + temperature-mapping          │
   │  Multi-tenant CMO / CDMO isolation                  │
   └─┬───────────────────┬────────────────┬────────────┘
     │                   │                │
     ▼                   ▼                ▼
   ELPRO LIB v2.4    SAP EWM          MasterControl  +  Halcyon Stability
   (logger download   (Investigation    (deviation)      (excursion-impact)
    appliance,        Hold, Quarantine)
    site-deployed)
```

## 4. Functional Specifications

| FS ID | URS ID | Specification |
|---|---|---|
| FS-VND-01 | URS-VND-01 | ELPRO vendor-assurance pack (SOC 2 Type II, ISO 27001, customer-shared CSV, DPA) tracked in `VA-ELPRO-2026`; annual re-qualification. |
| FS-VND-02 | URS-VND-02 | Release-impact-assessment 14-day SLA; config-affecting changes raise re-validation CR. |
| FS-VND-03 | URS-VND-03 | Annual ELPRO TR-Audit filed in vendor-assurance dossier. |
| FS-LOG-REG-01 | URS-LOG-REG-01 | Logger-registration table: serial, model, firmware, cal-cert-id, cal-due-date, tenant-binding. |
| FS-LOG-REG-02 | URS-LOG-REG-02 | `logger.reusable` boolean drives reset-SOP enforcement before re-deployment. |
| FS-LOG-COMM-01 | URS-LOG-COMM-01 | Commissioning binds logger → shipment-id + profile-version + lane-id; binding signed with site key (Ed25519). |
| FS-LOG-COMM-02 | URS-LOG-COMM-02 | Commissioning UI requires non-expired cal-cert; expired cal blocks commissioning with explicit error. |
| FS-LOG-COMM-03 | URS-LOG-COMM-03 | Chain-of-custody export endpoint `GET /commission/export?shipment_id=...` returns PDF/A-3 + JSON. |
| FS-PROF-01 | URS-PROF-01 | Profile state machine DRAFT → REVIEW → APPROVED → EFFECTIVE → SUPERSEDED with role-restricted transitions. |
| FS-PROF-02 | URS-PROF-02 | Profile schema includes product_code, temp_range_low / high, MKT_limit, excursion_allowances[], stability_budget. |
| FS-PROF-03 | URS-PROF-03 | Commissioning rejects non-EFFECTIVE profile assignment. |
| FS-PROF-04 | URS-PROF-04 | SoD enforced at profile-transition signatures (Author ≠ Approver). |
| FS-PROF-05 | URS-PROF-05 | EFFECTIVE profiles read-only; edits create new version. |
| FS-PROF-06 | URS-PROF-06 | Per-shipment record stores `profile_version_used`; inspectable. |
| FS-EVAL-01 | URS-EVAL-01 | Logger download integrity check via vendor checksum + Ed25519 signature; failure raises `LOGGER_INTEGRITY_EXCEPTION`. |
| FS-EVAL-02 | URS-EVAL-02 | Evaluation engine classifies Pass / Excursion-Investigation / Reject; ruleset versioned. |
| FS-EVAL-03 | URS-EVAL-03 | Manual override UI requires Investigator + Disposition-Approver dual signature + reason capture. |
| FS-EVAL-04 | URS-EVAL-04 | TOR (Time Out of Refrigeration) calculator runs against lane TOR-allowance; reflected in classification. |
| FS-EVAL-05 | URS-EVAL-05 | Each shipment record stamps `eval_algo_version`. |
| FS-LANE-01 | URS-LANE-01 | Lane configuration model holds origin / destination / mode / carrier / season; temperature-mapping evidence linked via document store. |
| FS-LANE-02 | URS-LANE-02 | Lane-qualification evidence linked from configuration to inspection-readiness export. |
| FS-LANE-03 | URS-LANE-03 | Lane state machine Qualified / Provisional / Disqualified; only Qualified lanes used in routine flow. |
| FS-LANE-04 | URS-LANE-04 | Lane re-qualification cadence configurable (annual default); trigger events (carrier change, route change, packaging change) auto-create re-qualification CR. |
| FS-LANE-05 | URS-LANE-05 | Season-profile auto-switch per shipment date using configurable date-window matrix. |
| FS-PART11-01 | URS-PART11-01 | Per § 11.10(a): procedural-control SOPs reviewed annually. |
| FS-PART11-02 | URS-PART11-02 | Per § 11.10(d): Okta SAML 2.0 + MFA. |
| FS-PART11-03 | URS-PART11-03 | Per § 11.10(e): audit trail per FS-AUD-01. |
| FS-PART11-04 | URS-PART11-04 | Per § 11.50: signature events render printed name + date/time + meaning. |
| FS-PART11-05 | URS-PART11-05 | Per § 11.70: HMAC-SHA-256 cryptographic binding. |
| FS-PART11-06 | URS-PART11-06 | Per § 11.100: uniqueness via Okta-DB constraint. |
| FS-PART11-07 | URS-PART11-07 | Per § 11.200: re-authentication at disposition / profile / lane-qualification approvals. |
| FS-PART11-08 | URS-PART11-08 | Per § 11.300: password / credential controls per site InfoSec. |
| FS-GDP-01 | URS-GDP-01 | Distribution-evidence template per EU GDP § 9; receiver country + temperature record + QP assessment included. |
| FS-GDP-02 | URS-GDP-02 | Retention enforced at archive tier: shelf-life of product + 1 y per WHO TRS 957. |
| FS-GDP-03 | URS-GDP-03 | Risk-based stability + transportation strategy captured per USP <1079>; reviewed at periodic review. |
| FS-CTNS-01 | URS-CTNS-01 | Per product / batch CTNS accumulator (`ctns_seconds_above`, `ctns_seconds_below`); incremented at each excursion event. |
| FS-CTNS-02 | URS-CTNS-02 | Stability-budget cap configured per product per ICH Q1A(R2); cap stored on product master. |
| FS-CTNS-03 | URS-CTNS-03 | CTNS-alerts at 50% / 75% / 90% thresholds to Cold-Chain Logistics Lead + Stability Reviewer via email + dashboard. |
| FS-CTNS-04 | URS-CTNS-04 | Daily reconciliation job `ctns-reconcile.py` detects silent breaches (CTNS > budget without alert). |
| FS-CTNS-05 | URS-CTNS-05 | CTNS export endpoint `GET /ctns/export?product_id=...` returns JSON + CSV. |
| FS-HANDOFF-01 | URS-HANDOFF-01 | Excursion auto-creates Halcyon impact-assessment via REST POST with profile-version + lane + temperature-trace + CTNS-consumption fields. |
| FS-HANDOFF-02 | URS-HANDOFF-02 | Auto-deviation in MasterControl eQMS with idempotency key = shipment-id; retry-safe. |
| FS-HANDOFF-03 | URS-HANDOFF-03 | Disposition decision links to Halcyon `assessment_id`; UI surfaces assessment outcome. |
| FS-HANDOFF-04 | URS-HANDOFF-04 | Daily reconciliation detects orphan excursions (no Halcyon assessment); alerts to ops queue. |
| FS-RESET-01 | URS-RESET-01 | Reusable-logger reset SOP workflow: data-wipe verification, battery check, calibration validity, time-sync; reset evidence captured. |
| FS-RESET-02 | URS-RESET-02 | Battery pre-check enforced at commissioning; minimum threshold configurable per logger model. |
| FS-RESET-03 | URS-RESET-03 | Reset-failure blocks re-deployment; routes to Logger Operator triage queue. |
| FS-TENANT-01 | URS-TENANT-01 | Per-tenant data isolation via tenant-id partitioning + row-level security. |
| FS-TENANT-02 | URS-TENANT-02 | Cross-tenant audit-trail access requires Auditor role + documented justification (`access_justification` field). |
| FS-TENANT-03 | URS-TENANT-03 | Tenant onboarding / off-boarding workflow with data-export + retention obligations. |
| FS-AUD-01 | URS-AUD-01 | Audit-trail schema (actor, action, old/new, reason, timestamp_iso8601); covers profile / logger / commissioning / classification / override / signature / lane / CTNS events. |
| FS-AUD-02 | URS-AUD-02 | Append-only DB constraint; tenant admin cannot UPDATE/DELETE. |
| FS-AUD-03 | URS-AUD-03 | Monthly + quarterly review jobs; signed reports filed in QA dossier. |
| FS-AUD-04 | URS-AUD-04 | Retention enforced per § 5.11 of URS at archive tier with object-lock. |
| FS-INT-WMS-01 | URS-INT-WMS-01 | Profile-evaluation result push to SAP EWM via webservice within 5 min of download; Investigation-Hold creation on Excursion-Investigation. |
| FS-INT-EQMS-01 | URS-INT-EQMS-01 | Deviation push to MasterControl idempotent on shipment-id. |
| FS-INT-STAB-01 | URS-INT-STAB-01 | Excursion-impact push to Halcyon Stability per FS-HANDOFF-01. |
| FS-INT-AD-01 | URS-INT-AD-01 | Okta SAML 2.0 + MFA. |
| FS-INT-CARRIER-01 | URS-INT-CARRIER-01 | Carrier GPS feed via vendor-API; per-shipment location series captured. |
| FS-DI-01 | URS-DI-01 | **Attributable:** actor_id + commissioned-logger-id captured. |
| FS-DI-04 | URS-DI-04 | **Original:** logger raw data preserved; corrections recorded as new annotated records. |
| FS-DI-05 | URS-DI-05 | **Accurate:** evaluation + CTNS calculations OQ-validated. |
| FS-DI-06 | URS-DI-06 | **Complete / Consistent / Enduring / Available:** retention + chronological order. |
| FS-PERF-01 | URS-PERF-01 | Evaluation P95 ≤ 30 s per logger. |
| FS-AV-01 | URS-AV-01 | Availability ≥ 99.5% per ELPRO SLA. |
| FS-BAK-01 | URS-BAK-01 | Vendor RPO ≤ 4h / RTO ≤ 24h verified annually. |
| FS-BAK-02 | URS-BAK-02 | Quarterly tenant-data export retained ≥ 5y in site cold storage. |
| FS-SEC-01 | URS-SEC-01 | Okta + MFA; TLS 1.3; AES-256 at rest. |
| FS-SEC-02 | URS-SEC-02 | Annual pen-test; high/critical remediation within 60 days. |
| FS-TRN-01 | URS-TRN-01 | LMS-recorded role-specific training; Cold-Chain Investigator competency mandatory before role-grant. |
| FS-PR-01 | URS-PR-01 | Annual periodic-review run-book auto-collects profile inventory, excursion trends, CTNS consumption metrics, integration health, vendor-assurance status, lane re-qualification status, training currency. |


### 4.1 Cross-System Integration (M-XSYS)

| FS ID | URS ID | Specification |
|---|---|---|
| FS-XSYS-AD-01 | URS-XSYS-AD-01 | Identity integration with `QTZ-URS-AD-001`: SAML 2.0 via Entra ID for tenant admin; logger-device certificates for ingest authentication. Conditional-access binding to policy `Standard SaaS Conditional Access (MFA + named-location)`. SIEM forwarding via syslog (RFC 5424) to Splunk index `gxp-authn` within 5 minutes; SCIM provisioning where the protocol is SAML/OIDC; break-glass accounts gated by CyberArk PAM per AD URS-PAM-* with 24 h password-rotation and dual-witness check-out. |
| FS-XSYS-BAK-01 | URS-XSYS-BAK-01 | Backup integration per `AUR-URS-BACKUP-001`: Veeam Application-Aware processing with PostgreSQL pg_basebackup + WAL for the SaaS-tenant data-warehouse mirror; tier classification = T2; RPO ≤ 24 h; RTO ≤ 24 BH; immutable cloud-tier copy in S3 Object Lock Compliance mode (geo-replicated); air-gap LTO-9 monthly rotation; quarterly QA-witnessed restore test per AUR-FS-BACKUP-001 procedure; restore-certificate quality records retained ≥ 25 y in the eQMS. |


### 4.2 Cross-System Integration — eQMS handover (M-XINT-EQMS)

| FS ID | URS ID | Specification |
|---|---|---|
| FS-XINT-EQMS-01 | URS-XINT-EQMS-01 | CAPA-event publisher posts to eQMS endpoint `POST /capa/tickets` with mTLS + Entra workload-identity; payload schema `eqms.ticket.v1`; OpenAPI artefact `xint-eqms.openapi.yaml`; outbound retry with exponential back-off and DLQ at 5 attempts. |
| FS-XINT-EQMS-02 | URS-XINT-EQMS-02 | eQMS ticket-status webhook subscribed; payload `eqms.status.v1`; consumer rule maps eQMS status `(OPEN, IN-PROGRESS, EFFECTIVENESS, CLOSED)` onto originating-record disposition fields; closed-loop verification gate prevents disposition without `eqms_status=CLOSED`. |

## 5. Configuration Items (CI)

| CI | Item | Value |
|---|---|---|
| CI-01 | Logger calibration cadence | per calibration plan |
| CI-02 | Profile evaluation algorithm version | per release |
| CI-03 | Idempotency keys | shipment-id |
| CI-04 | CTNS alert thresholds | 50% / 75% / 90% |
| CI-05 | Lane re-qualification cadence | annual default |
| CI-06 | Tenant isolation | row-level security on tenant-id |
| CI-07 | Audit retention | shelf-life + 1y / ≥ 25y excursion |

## 6. Risks (FS-level)

Logger calibration drift (FS-LOG-COMM-02); shipment-binding mix-up (FS-LOG-COMM-01 + Ed25519); CTNS silent breach (FS-CTNS-04); duplicate-deviation push (FS-INT-EQMS-01 + idempotency); orphan Halcyon assessment (FS-HANDOFF-04); audit-trail tampering; lane disqualification propagation lag (FS-LANE-03); tenant isolation breach (FS-TENANT-01).

## 7. References

- SLN-URS-COLDCHAIN-001 v1.2
- 21 CFR Part 11 §§ .10, .30, .50, .70, .100, .200, .300
- EU GMP Annex 11 §§ 4, 6, 9, 11; EU GDP 2013/C 343/01
- WHO TRS 957 Annex 9; USP <1079>; ICH Q1A(R2); IEC 60068-3-5; ISO/IEC 17025
- FDA *Computer Software Assurance for Production and Quality Management System Software* (final, February 2026)
- BfArM (DE), Swissmedic (CH), AGES PharmMed (AT) GDP guidance
- ISPE GAMP 5 (2nd ed., 2022); PIC/S PI 041
- ELPRO — *Liberty Cloud Configuration Reference*; *ecolog-NET LIB v2.4 Validation Approach*

## 8. Appendix A — URS → FS Traceability Matrix

| URS ID | FS ID |
|---|---|
| URS-VND-01 | FS-VND-01 |
| URS-VND-02 | FS-VND-02 |
| URS-VND-03 | FS-VND-03 |
| URS-LOG-REG-01 | FS-LOG-REG-01 |
| URS-LOG-REG-02 | FS-LOG-REG-02 |
| URS-LOG-COMM-01 | FS-LOG-COMM-01 |
| URS-LOG-COMM-02 | FS-LOG-COMM-02 |
| URS-LOG-COMM-03 | FS-LOG-COMM-03 |
| URS-PROF-01 | FS-PROF-01 |
| URS-PROF-02 | FS-PROF-02 |
| URS-PROF-03 | FS-PROF-03 |
| URS-PROF-04 | FS-PROF-04 |
| URS-PROF-05 | FS-PROF-05 |
| URS-PROF-06 | FS-PROF-06 |
| URS-EVAL-01 | FS-EVAL-01 |
| URS-EVAL-02 | FS-EVAL-02 |
| URS-EVAL-03 | FS-EVAL-03 |
| URS-EVAL-04 | FS-EVAL-04 |
| URS-EVAL-05 | FS-EVAL-05 |
| URS-LANE-01 | FS-LANE-01 |
| URS-LANE-02 | FS-LANE-02 |
| URS-LANE-03 | FS-LANE-03 |
| URS-LANE-04 | FS-LANE-04 |
| URS-LANE-05 | FS-LANE-05 |
| URS-PART11-01 | FS-PART11-01 |
| URS-PART11-02 | FS-PART11-02 |
| URS-PART11-03 | FS-PART11-03 |
| URS-PART11-04 | FS-PART11-04 |
| URS-PART11-05 | FS-PART11-05 |
| URS-PART11-06 | FS-PART11-06 |
| URS-PART11-07 | FS-PART11-07 |
| URS-PART11-08 | FS-PART11-08 |
| URS-GDP-01 | FS-GDP-01 |
| URS-GDP-02 | FS-GDP-02 |
| URS-GDP-03 | FS-GDP-03 |
| URS-CTNS-01 | FS-CTNS-01 |
| URS-CTNS-02 | FS-CTNS-02 |
| URS-CTNS-03 | FS-CTNS-03 |
| URS-CTNS-04 | FS-CTNS-04 |
| URS-CTNS-05 | FS-CTNS-05 |
| URS-HANDOFF-01 | FS-HANDOFF-01 |
| URS-HANDOFF-02 | FS-HANDOFF-02 |
| URS-HANDOFF-03 | FS-HANDOFF-03 |
| URS-HANDOFF-04 | FS-HANDOFF-04 |
| URS-RESET-01 | FS-RESET-01 |
| URS-RESET-02 | FS-RESET-02 |
| URS-RESET-03 | FS-RESET-03 |
| URS-TENANT-01 | FS-TENANT-01 |
| URS-TENANT-02 | FS-TENANT-02 |
| URS-TENANT-03 | FS-TENANT-03 |
| URS-AUD-01 | FS-AUD-01 |
| URS-AUD-02 | FS-AUD-02 |
| URS-AUD-03 | FS-AUD-03 |
| URS-AUD-04 | FS-AUD-04 |
| URS-INT-WMS-01 | FS-INT-WMS-01 |
| URS-INT-EQMS-01 | FS-INT-EQMS-01 |
| URS-INT-STAB-01 | FS-INT-STAB-01 |
| URS-INT-AD-01 | FS-INT-AD-01 |
| URS-INT-CARRIER-01 | FS-INT-CARRIER-01 |
| URS-DI-01 | FS-DI-01 |
| URS-DI-04 | FS-DI-04 |
| URS-DI-05 | FS-DI-05 |
| URS-DI-06 | FS-DI-06 |
| URS-PERF-01 | FS-PERF-01 |
| URS-AV-01 | FS-AV-01 |
| URS-BAK-01 | FS-BAK-01 |
| URS-BAK-02 | FS-BAK-02 |
| URS-SEC-01 | FS-SEC-01 |
| URS-SEC-02 | FS-SEC-02 |
| URS-TRN-01 | FS-TRN-01 |
| URS-PR-01 | FS-PR-01 |
| URS-XSYS-AD-01 | FS-XSYS-AD-01 |
| URS-XSYS-BAK-01 | FS-XSYS-BAK-01 |
| URS-XINT-EQMS-01 | FS-XINT-EQMS-01 |
| URS-XINT-EQMS-02 | FS-XINT-EQMS-02 |

## 9. Implementation Risk Register

The risks below are properties of the **implementation** (configuration, integration, runtime, operation) of this system, not properties of the user requirements themselves. They are surfaced here for input to the formal Risk Assessment deliverable (FMEA / HAZOP — separate document `<DOC-PREFIX>-RA-NN`). Per-requirement GxP-criticality (R1/R2/R3) remains on each URS requirement and is not duplicated here.

**Origin:** transferred from the URS § 9 Top-level Risks section as part of v1.3 corpus restructuring (LLM Council verdict + user directive 2026-05-13). The transferred content is verbatim from URS; future review may re-frame entries to FS-implementation language or re-distribute to the formal RA artefact.

| ID | Risk | Likelihood | Impact | Mitigation reference |
|---|---|---|---|---|
| R-01 | Logger calibration overdue at commissioning | Medium | Medium | URS-LOG-COMM-02 |
| R-02 | Profile-evaluation rule misconfigured | Medium | High | URS-PROF-01..06 + OQ-EVAL replay |
| R-03 | Manual override without justification | Medium | Medium | URS-EVAL-03 |
| R-04 | Cross-system integration drift (WMS / eQMS / Halcyon) | Medium | Medium | URS-INT-* + integration health |
| R-05 | Audit-trail tampering on vendor side | Low | High | URS-VND-01 + ELPRO TR-Audit |
| R-06 | Logger battery exhaustion mid-shipment | Medium | High | URS-RESET-02 |
| R-07 | CTNS budget silently consumed without alert | Low | Critical | URS-CTNS-03, URS-CTNS-04 |
| R-08 | Lane disqualification not propagated to active shipments | Low | High | URS-LANE-03 |
| R-09 | Stability impact-assessment not generated for excursion (orphan) | Medium | High | URS-HANDOFF-01, URS-HANDOFF-04 |
| R-10 | Reusable logger re-deployed without reset SOP | Low | High | URS-RESET-01, URS-LOG-REG-02 |
| R-11 | Tenant data isolation breach (CMO sees another tenant's data) | Low | Critical | URS-TENANT-01 |

Full evaluation in `SLN-RA-COLDCHAIN-001` (synthetic).

---

**END OF DOCUMENT — synthetic CSV training artifact, not a regulated record.**
