Requirement-to-Evidence Trace
Why this control exists, where it applies, who executes it, and what evidence supports the assurance conclusion. Start from either end: an auditor begins at the evidence, an engineer at the asset, a regulatory professional at the requirement.
Every link carries a typed edge and an authority level, and the levels are never flattened into one: a binding requirement, a final guidance, a consensus standard, an industry practice and a SPEQ interpretation stay distinct. The as-of control is a query rather than a display filter — move it and you see the graph that was true on that date, not today’s graph relabelled. Where a link is missing, the break is shown with what it prevents concluding, because an inferred edge would be the most dangerous thing this surface could draw.
This loop remained in its qualified state for 11–18 Aug 2026, because an authored applicability decision, a recorded risk, a preventive control, an effective procedure, a qualified operator, a contemporaneous record and an accepted second-person review all exist and connect.
Forward trace — Suite 2 WFI loop
Authority → instrument → requirement → applicability → risk → control → procedure → role → activity → evidence → review → assurance. Twelve nodes, eleven typed edges, one bounded conclusion.
Accessible equivalent — relationship table
The same trace as semantic HTML: every node, its typed edge to the next, its authority level, source, version and effective interval. No graph, no canvas, no colour dependency.
| # | Object type | Node | Edge to next | Authority level | Source | Version | Effective | Owner |
|---|---|---|---|---|---|---|---|---|
| 1 | Authority | European Commission and national competent authorities | contains | Binding requirement | EudraLex Volume 4 | — | In force | Competent authority |
| 2 | Instrument | EU GMP Annex 1 — Manufacture of Sterile Medicinal Products | contains | Binding requirement | EudraLex Volume 4, Annex 1 | 2022 revision | Effective 25 Aug 2023 | Competent authority |
| 3 | Requirement | Water for injection systems are designed, maintained and monitored to prevent microbial proliferation | applies to | Binding requirement | Annex 1 water-system provisions | 2022 revision | Effective 25 Aug 2023 | Regulatory affairs |
| 4 | Applicability | Suite 2 WFI loop, Building A — confirmed applicable | mitigates | Authored site record | Site applicability decision AD-118 | v3 | From 12 Jan 2026 | Regulatory affairs |
| 5 | Risk | Microbial ingress and biofilm formation in a low-flow section of the distribution loop | implemented by | Authored site record | Site risk assessment RA-204 | v2 | From 03 Mar 2026 | Quality lead |
| 6 | Control | Continuous circulation above minimum velocity, with periodic thermal sanitisation of the full loop | implemented by | Authored site record | Control strategy CS-041 | v4 | From 03 Mar 2026 | Engineering lead |
| 7 | Procedure | SOP-UT-0212 — WFI loop sanitisation and release for use | performed by | Authored site record | Document management system | v7.0 | Effective 14 Jul 2026 | Utilities engineering |
| 8 | Role | Utilities technician, qualified on SOP-UT-0212 v7.0 | produces | Authored site record | Learning management system | — | Current | Training |
| 9 | Activity | Weekly thermal sanitisation cycle, executed 11 Aug 2026 | produces | Authored site record | Building management system | — | 11 Aug 2026 | Utilities engineering |
| 10 | Evidence | Sanitisation cycle record SR-2026-0811, with loop temperature and hold-time trace | reviewed by | Authored site record | Building management system | — | 11 Aug 2026 | Utilities engineering |
| 11 | Review | Second-person review, 12 Aug 2026 — accepted | supports | Authored site record | Quality management system | — | 12 Aug 2026 | Quality assurance |
| 12 | Assurance | Loop remained in its qualified state for the period 11–18 Aug 2026 | — end of trace | SPEQ interpretation | SPEQ derived relationship | — | As of 18 Aug 2026 | SPEQ |
Mobile drill-down uses this table as its primary structure — one node per card, its edge to the next as the card footer, provenance behind a disclosure. The path strip is not shrunk onto a phone.
Change one evidence state and watch readiness move
Ten objects, three evidence fixtures, one calculation. The readiness figure and the four-stage trace below are computed by wfi-slice.ts — the same module the Operational Readiness Command Center reads, so the two surfaces cannot disagree.
A criterion has no resolvable evidence state, so no percentage is shown.
GT-07 cannot be declared ready: 1 criterion has no evidence record to read.
The three fixtures
Change any state. The figure above, the gate, the conditions and the trace all recompute from the shared module.
Four stages, source to proof
The canonical trace geometry. Stage four terminates on whatever actually resolves — the chain stops where it stops being verifiable rather than implying a complete path.
EU GMP Annex 1 · Manufacture of sterile medicinal products (2022 revision)
RC-01 · The system performs to its specification across the qualified operating range · RC-02 · The sanitisation cycle achieves its defined acceptance criteria · RC-03 · Instruments monitoring a critical quality attribute hold a current calibration
EV-01 · WFI system performance qualification report · EV-02 · Sanitisation cycle qualification result
Chain stops at RC-03
EV-01 · WFI system performance qualification report
Chain stops at EV-02, EV-03
RC-03 has no record in CMMS. Conductivity transmitter calibration certificate does not exist to be read, so the criterion cannot be evaluated.
RC-02 is held by EV-02 (Sanitisation cycle qualification result), in review in Commissioning database as of 2026-08-04. It discharges the criterion only once approved.
No percentage is shown. A criterion with no resolvable evidence state cannot be averaged into one, and a figure computed over the remainder would read as a measure of the whole gate.
The gate decision remains a person’s to record. This module computes what the evidence supports and stops there.
Illustrative synthetic trace on a fictional site, for interface design. Instrument titles are cited by name only with no text reproduced, and their applicability to any actual facility is not asserted. Anything marked SPEQ interpretation is a derived reading, not an authority position. SPEQ holds the relationships; every evidence record remains in the system of record named against it.