Industry context: Medical device manufacturers must demonstrate that user needs trace through system requirements to design requirements, with validation evidence (did we build the right thing?) and verification evidence (did we build it right?) at each level. Regulatory submissions to FDA and Notified Bodies require this traceability chain.
Data Model
Three core entity types forming the requirements V-model, plus use steps for operational context and test case links for V&V evidence.
Sheet Configuration — Whole RTM
The whole-project RTM expands all three levels with V&V branches at each, using color-coded column groups for visual orientation.
Source Configuration
The expand paths define how the RTM query traverses the entity hierarchy, pulling linked items from across multiple documents. V&V branches are nested at each level.
Component-Scoped RTM
The same configuration pattern supports component-level views. Using applyCurrentDocumentTo, a single YAML config serves multiple SRS documents — each showing only the requirements belonging to that subsystem.
Key Patterns
- 3-level V-model hierarchy with V&V test case branches at each level — validation at user needs, verification at system and design requirements.
- YAML anchors (
&orange / *orange) for reusing header styles across V&V columns at multiple levels without repetition.
applyCurrentDocumentTo — a single YAML configuration serves multiple component SRS documents, each automatically scoped to its own requirements.- Cross-document tracing — the expand paths pull System Requirements from SRS documents and Design Requirements from DRS documents via the RTM model relationships.
- Collapsible column groups — each group collapses to its key column for stakeholder-appropriate detail levels.
multiItem: true for V&V plan columns — renders multiple linked test cases as expandable lists within a single cell.
See Also
Last modified on July 10, 2026
