> For the complete documentation index, see [llms.txt](https://docs.sentinel1.tech/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://docs.sentinel1.tech/02-specifications-urs-and-traceability/traceability_matrix.md). # Traceability Matrix Lead Engineer: Andrew C. Rogers (Sui-Generis) Date: 2026-05-10 Classification: Validated Engineering Specification ## Purpose This matrix provides bidirectional traceability between User Requirements Specifications (URS) and the implementation modules intended for Pillar 03 deployment at `docs/03_Logic_Core/app/`. ## Scope * System: SGS-Sentinel Intelligence Base (SG-IB) * Regulatory Frame: GAMP 5, ALCOA+, DSCSA 2026 * Logical Baseline: FastAPI backend, DSCSA parsing, dual-score assessment, quarantine controls, tamper-evident audit chain ## URS to Design Traceability | URS ID | User Requirement Statement | Primary Module(s) (Target Pillar 03 Path) | Compliance/Validation Intent | Verification Reference | | ------- | ----------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------- | --------------------------------------------------------------------------- | | URS-001 | System shall expose a service health and readiness interface for validated operations. | `docs/03_Logic_Core/app/main.py` | Operational visibility and controlled startup/shutdown behavior. | API `/health` execution record; deployment smoke test evidence. | | URS-002 | System shall enforce authenticated access and role-based authorization for protected workflows. | `docs/03_Logic_Core/app/auth.py`, `docs/03_Logic_Core/app/routers/auth.py`, `docs/03_Logic_Core/app/models.py` | Attributable access control consistent with 21 CFR Part 11 principles. | Token issuance/validation test and RBAC negative-path test output. | | URS-003 | System shall normalize database connectivity through environment-controlled configuration. | `docs/03_Logic_Core/app/database.py` | Controlled configuration, deterministic fallback, and deploy portability. | Environment matrix test (valid URL, invalid URL, fallback behavior). | | URS-004 | System shall parse DSCSA payloads and detect missing TI when scan data exists. | `docs/03_Logic_Core/app/parsers/dscsa.py` | Contemporaneous defect detection and quarantine triggering for data integrity failures. | Parser unit test for `QuarantineMissingDataError` and nominal parse path. | | URS-005 | System shall persist quarantine artifacts for manual SOP review without data loss. | `docs/03_Logic_Core/app/services/quarantine.py`, `docs/03_Logic_Core/app/routers/assessments.py` | Original evidence preservation and chain-of-custody continuity (ALCOA+). | Quarantine artifact creation evidence in Pillar 04; quarantine flow test. | | URS-006 | System shall compute deterministic SHA-256 hashes for audit events. | `docs/03_Logic_Core/app/services/audit_hash.py` | Accurate and reproducible event integrity control via canonical serialization. | Hash recomputation parity evidence and tamper detection demonstration. | | URS-007 | System shall maintain prev-hash linkage for tamper-evident audit chaining. | `docs/03_Logic_Core/app/services/audit_hash.py`, `docs/03_Logic_Core/app/routers/assessments.py`, `docs/03_Logic_Core/app/models.py` | Enduring integrity chain supporting forensic reconstruction and mutation detection. | Integrity verification output proving GENESIS-first linkage and continuity. | | URS-008 | System shall evaluate DSCSA technical risk from EPCIS payload characteristics. | `docs/03_Logic_Core/app/services/scoring.py` | Risk-tier derivation for compliance triage and defect escalation workflows. | Score calculation tests with known payload fixtures and expected flags. | | URS-009 | System shall support dual-score output combining technical and attestation dimensions. | `docs/03_Logic_Core/app/services/scoring.py`, `docs/03_Logic_Core/app/routers/assessments.py`, `docs/03_Logic_Core/app/schemas.py` | Transparent compliance posture reporting and actionable verdicting. | `/api/v1/assessment/dual-score` response validation and schema checks. | | URS-010 | System shall store audit records with immutable evidence fields. | `docs/03_Logic_Core/app/models.py`, `docs/03_Logic_Core/app/routers/assessments.py` | Accurate and attributable audit event persistence aligned to ALCOA+. | Database inspection evidence and integrity verification runbook output. | | URS-011 | System shall expose validated API schema contracts for regulated exchanges. | `docs/03_Logic_Core/app/schemas.py` | Legible and consistent contract enforcement for input/output records. | Pydantic model validation tests and OpenAPI review snapshot. | | URS-012 | System shall provide tenant/facility governance endpoints for DSCSA operations. | `docs/03_Logic_Core/app/routers/tenants.py`, `docs/03_Logic_Core/app/routers/facilities.py` | Controlled master-data governance for tenant-bounded compliance workflows. | Endpoint permission and CRUD validation evidence. | ## Traceability Control Notes * This matrix is maintained as a controlled specification artifact. * Any change to URS scope or module responsibility requires matrix revision and evidence update. * Verification outputs are to be archived in `docs/04_Evidence/` with contemporaneous timestamps. --- # Agent Instructions This documentation is published with GitBook. GitBook is the documentation platform designed so that both humans and AI agents can read, navigate, and reason over technical content effectively. Learn more at gitbook.com. ## Querying This Documentation If you need additional information that is not directly available in this page, you can query the documentation dynamically by asking a question. Perform an HTTP GET request on the current page URL with the `ask` query parameter, and the optional `goal` query parameter: ``` GET https://docs.sentinel1.tech/02-specifications-urs-and-traceability/traceability_matrix.md?ask=&goal= ``` `ask` is the immediate question: it should be specific, self-contained, and written in natural language. `goal` is optional and describes the broader end goal you are ultimately trying to accomplish on behalf of the user. GitBook uses it to tailor the answer towards what is most useful for that goal. The response will contain a direct answer to the question and relevant excerpts and sources from the documentation. Use this mechanism when the answer is not explicitly present in the current page, you need clarification or additional context, or you want to retrieve related documentation sections.