V5 Ultimate
Compliance

Requirements Traceability

forward traceability · backward traceability · rtm

TL;DR

A bidirectional map linking each user/system requirement to its design, risk control, test case, and validation evidence — proving every requirement was implemented and tested.

Requirements traceability — captured in a Requirements Traceability Matrix (RTM) — shows the bidirectional links between URS items, functional/design specs, risk controls, and test scripts. Forward traceability proves each requirement is tested; backward traceability proves every test exists for a stated requirement. Required by GAMP 5, ISO 13485 design controls, and IEC 62304.

V5 generates the RTM dynamically from tagged records so it never drifts from the underlying specs and test execution.

Regulatory anchors
  • GAMP 5 (2nd Ed.)
  • ISO 13485:2016 §7.3
  • IEC 62304
Industries that live with this
PharmaceuticalMedical DevicesBlood & Tissue
How V5 handles it
21 CFR Part 11 — the operating model, not a checkbox.
Other systems bolt Part 11 on top. V5 enforces it at the database layer so application code can never rewrite history.
Document control with hard kiosk-level training enforcement.
Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.
Related terms
URSFSDSIQ / OQ / PQTraceability MatrixGAMP 5Design controls
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