Document 07 — Bidirectional Requirements Traceability Matrix (RTM)
Document ID: RTM-GXPHISTORIAN-2026-007 | Generated (UTC): 2026-10-17T20:21:45Z | Coverage: 100.0% (15/15 URS Verified, 0 Gaps)
| URS ID | Requirement Title | FRS / Design Spec | GAMP Cat. | CSA Risk | Automated Pytest Node ID | Executed Timestamp (UTC) | Verdict |
|---|---|---|---|---|---|---|---|
| URS-001 | Multi-Service Container Infrastructure & Non-Default GxP Security Credentials | FRS-INFRA-001 | Category 3 / Category 4 | Medium | gxp-validation-package/tests/test_01_iq_infrastructure.py::test_iq_01_services_and_non_default_credentials | 2026-10-17T16:56:05.724621+00:00 | PASS |
| URS-002 | PostgreSQL 16 Control Plane Extensions & Core GxP Schema Qualification | FRS-PG-002 | Category 4 | Medium | gxp-validation-package/tests/test_01_iq_infrastructure.py::test_iq_02_postgres_extensions_and_schema | 2026-10-17T16:56:05.746410+00:00 | PASS |
| URS-003 | ClickHouse Lossless Time-Series Compression Codecs Verification | FRS-CH-003 | Category 4 | Low | gxp-validation-package/tests/test_01_iq_infrastructure.py::test_iq_03_clickhouse_compression_codecs | 2026-10-17T16:56:05.760770+00:00 | PASS |
| URS-004 | ISA-95 ltree Asset Hierarchy & ClickHouse In-Memory Dictionary Synchronization | FRS-DICT-004 | Category 4 | Medium | gxp-validation-package/tests/test_01_iq_infrastructure.py::test_iq_04_clickhouse_postgres_dictionary_sync | 2026-10-17T16:56:05.775388+00:00 | PASS |
| URS-005 | Stage 1 Edge Exception/Deadband Filtering & Disk WAL Store-and-Forward Buffer | FRS-EDGE-005 | Category 4 / Category 5 | High | gxp-validation-package/tests/test_01_iq_infrastructure.py::test_iq_05_edge_collector_wal_and_deadband | 2026-10-17T16:56:05.778085+00:00 | PASS |
| URS-006 | 21 CFR Part 11 Mandatory Attribution Context Enforcement | FRS-P11-006 | Category 5 | High | gxp-validation-package/tests/test_02_oq_part11_compliance.py::test_oq_01_reject_mutations_without_actor_or_reason | 2026-10-17T16:56:05.806831+00:00 | PASS |
| URS-007 | 21 CFR Part 11 §11.10(e) WORM Audit Trail Immutability | FRS-P11-007 | Category 5 | High | gxp-validation-package/tests/test_02_oq_part11_compliance.py::test_oq_02_worm_audit_log_immutability | 2026-10-17T16:56:05.819484+00:00 | PASS |
| URS-008 | 21 CFR Part 11 §11.200 Electronic Signature Rejection of Unauthorized Credentials | FRS-P11-008 | Category 5 | High | gxp-validation-package/tests/test_02_oq_part11_compliance.py::test_oq_03_electronic_signature_rejects_invalid_credentials | 2026-10-17T16:56:05.921043+00:00 | PASS |
| URS-009 | 21 CFR Part 11 §11.50 & §11.70 Electronic Signature Manifestation & HMAC Binding | FRS-P11-009 | Category 5 | High | gxp-validation-package/tests/test_02_oq_part11_compliance.py::test_oq_04_electronic_signature_approval_and_hmac | 2026-10-17T16:56:06.072722+00:00 | PASS |
| URS-010 | 21 CFR Part 11 Cryptographic SHA-256 Audit Hash-Chain Verification | FRS-P11-010 | Category 5 | High | gxp-validation-package/tests/test_02_oq_part11_compliance.py::test_oq_05_cryptographic_hash_chain_verification | 2026-10-17T16:56:06.128616+00:00 | PASS |
| URS-011 | Multi-Protocol Telemetry Ingestion (OPC UA, BACnet/IP, Siemens S7, Legacy OPC DA) | FRS-HIST-011 | Category 4 | Medium | gxp-validation-package/tests/test_03_oq_historian_core.py::test_oq_06_multi_protocol_telemetry_ingestion | 2026-10-17T16:56:06.143531+00:00 | PASS |
| URS-012 | Bad OPC Signal Quality (quality < 192) Exclusion from GMP Rollups | FRS-HIST-012 | Category 5 | High | gxp-validation-package/tests/test_03_oq_historian_core.py::test_oq_07_bad_quality_exclusion_in_rollup | 2026-10-17T16:56:06.170250+00:00 | PASS |
| URS-013 | PI DataLink Parity: Linear Interpolation vs. Discrete Step (LOCF) Sampling | FRS-DL-013 | Category 5 | High | gxp-validation-package/tests/test_03_oq_historian_core.py::test_oq_08_datalink_linear_and_locf_step_interpolation | 2026-10-17T16:56:06.240340+00:00 | PASS |
| URS-014 | PI Vision PlotValues Parity: LTTB Visual Downsampling Peak Preservation | FRS-LTTB-014 | Category 4 / Category 5 | Medium | gxp-validation-package/tests/test_03_oq_historian_core.py::test_oq_09_lttb_downsampling_preserves_local_peak | 2026-10-17T16:56:06.279220+00:00 | PASS |
| URS-015 | ISA-88 Event Frame Excursion Capture & Zero-ETL Apache Parquet Lakehouse Export | FRS-LAKE-015 | Category 5 | High | gxp-validation-package/tests/test_03_oq_historian_core.py::test_oq_10_event_frame_excursion_and_parquet_lakehouse_export | 2026-10-17T16:56:06.553123+00:00 | PASS |