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Architecture
Architecture
1. Introduction and Goals
2. Architecture Constraints
3. Context and Scope
4. Solution Strategy
5. Building Block View
6. Runtime View
7. Deployment View
8. Crosscutting Concepts
9. Architecture Decisions
10. Quality Requirements
11. Risks and Technical Debt
12. Glossary
The arrival bundle format
Decisions (ADRs)
Decisions (ADRs)
ADR-0001: Content-Addressed Document Storage with PostgreSQL as Source of Truth
ADR-0002: Single Instance with Scope Hierarchy and Copy-on-Derive
ADR-0003: Fixed Life Cycle States with Configurable Review Processes
ADR-0004: Global Catalogs for Roles and Document Types with Per-Scope Activation
ADR-0005: Modular Monolith
ADR-0006: Three-Layer Search with In-Database Index and Pluggable LLM
ADR-0007: Angular Frontend with Server-Side-Only Enforcement
ADR-0008: Flyway Migrations and jOOQ Codegen from the Migrated Schema
ADR-0009: RLS Enforcement via a Session-Scoped Authorized Scope Set
ADR-0010: Self-Managed QMS via an Internal Mandator
ADR-0011: Authentication via OIDC SSO with Server-Side (BFF) Sessions
ADR-0012: Permission-Based Authorization and System Bootstrap
ADR-0013: User Identity Lifecycle
ADR-0014: Electronic Signatures (Part 11 / Annex 11-Capable)
ADR-0015: Document Effectivity, Periodic Review & Validity
ADR-0016: Data Retention, Disposal & Privacy (FADP / GDPR)
ADR-0017: Multi-Part Version Content
ADR-0018: Non-Functional Targets (Capacity, Availability, Security)
ADR-0019: Notifications & Tasks
ADR-0020: Internationalization (Content Language, Time Zones, Formatting)
ADR-0021: General Typed Document Relationships
ADR-0022: Read-Acknowledgement & Questionnaires
ADR-0023: Migration / Import — Current Released State
ADR-0024: Draft / In-Review Cancellation
ADR-0025: Disposal & Erasure Mechanics (Storage, Index, Backups)
ADR-0026: RLS Runtime Safety — Connection-Pool Scope Isolation
ADR-0027: RLS Boundary — Content-Plane vs Control-Plane
ADR-0028: Stateless Encrypted Token-State Cookie (no server-side session store)
ADR-0029: Document Content Model — Draft-Freeze, Content-Table RLS, Append-Only Audit
ADR-0030: Review & Life-Cycle Realization Model
ADR-0031: Released-base readability enforcement & copy-on-derive mechanics
ADR-0032: Frontend realization — Quinoa, Angular Material, i18n & E2E
ADR-0033: CSRF control for the BFF session — SameSite + JSON content-type
ADR-0034: Notification realization — in-process domain events + system-context fan-out
ADR-0035: Fan-out contract as shipped — gate semantics, count disclosure, audit protocol
ADR-0036: Repository layer — services carry rules, repositories carry jOOQ
ADR-0037: Task scheduler — in-process tick, advisory-lock election, SQL sweep
ADR-0038: Periodic-review realization — derived due date, policy-gated confirmation
ADR-0039: Sweep & periodic-review contract as shipped — grants, guards, addressing
ADR-0040: Disposal-due surfacing — closure-anchored retention, scope-level legal hold
ADR-0041: Email channel & notification i18n — notification-as-outbox, structured messages
ADR-0042: Disposal execution — document tombstoning, single-actor hard-gated destruction
ADR-0043: Disposal blob deletion is post-commit, GC-backstopped
ADR-0044: Search FTS baseline — event-indexed, RLS-scoped search_index
ADR-0045: Image Attachments as Content Parts (Rich-Content Slice R2)
ADR-0046: Four-Eyes — Submitter Excluded from Approval
ADR-0047: Four-Eyes — Submitter-Only Exclusion
ADR-0048: Document Organization — Folder Tree per Scope
ADR-0049: Content Model Round 2 — Type Categories, Template Instantiation, Trace Relations, Completeness Rules
ADR-0050: Live Frontend — SSE State Push, CodeMirror 6, Draft Presence
ADR-0051: In-Text Document Links (doc: Scheme)
ADR-0052: Addressees & Read-Acknowledgement (REQ-TRN Realization)
ADR-0053: Addressees Per Document + Process Owner (amends ADR-0052 K-1)
ADR-0054: Process Owner Is a Role (amends ADR-0053 P-3)
ADR-0055: WYSIWYG Editing Mode over Markdown (editor step R4)
ADR-0056: Visual-Editor Chrome via Milkdown Crepe (gated adoption)
ADR-0057: Content Record Is the ProseMirror Document Tree; Markdown Becomes a Derived Projection
ADR-0058: PM_DOC Is the Only Content Format (pre-production cut; amends ADR-0057 §5)
ADR-0059: Editor Engine Switches to TipTap (spike-gated; supersedes the Milkdown/Crepe choice)
ADR-0060: Backup & Restore — Scripted Ordered Backup with Automated Restore Rehearsal
ADR-0061: CSV — Generated Validation Package per Release
ADR-0062: SBOM — CycloneDX over the Production Layers, Validated Against the Artifact
ADR-0063: User Identity Binds on Subject Only (Issuer Becomes Provenance)
ADR-0064: Per-Document Workflow Role Bindings (Author / Reviewer / Releaser), Enforced
ADR-0065: Diagrams — Excalidraw as the Manual Layer, Mermaid Stays for Text-First/UML
ADR-0066: WITHDRAW — the Author Side May Reclaim a Version from Review
ADR-0067: Review Comments — Anchored, Immutable, Resolvable
ADR-0068: Confluence/Jira QMS Import — Staged, Read-Only, Repeatable
ADR-0069: Arbitrary File Attachments — Download-Only Confinement
ADR-0070: Training Questionnaires — Versioned, Auto-Scored, Release-Gated
ADR-0071: Training Plans — Document Obligations + External Trainings & Certifications
ADR-0072: Diagrams — Self-Hosted draw.io Replaces Excalidraw
ADR-0073: Per-Scope QMS Configuration Surface
ADR-0074: PDF Export of Released Documents — Server-Side via Apache FOP over the Canonical Projection
ADR-0075: Source History Import — Continuity Without Forged Audit
ADR-0076: Periodic-review status visibility (completing MVP gap #2)
ADR-0077: Requirement Items — Keyed Blocks Inside Controlled Documents
ADR-0078: Generalized Trace Items (Traceability Model — Stage A)
ADR-0079: Risk & Risk-Control Items (Traceability Model — Stage B)
ADR-0080: Traceability Workspace — Hub, Sub-Pages, and Role-Gated Views
ADR-0081: Draft-Only Trace-Structure Changes, Server-Enforced
ADR-0082: Table-Shaped Risk Authoring over Risk Blocks
ADR-0083: The TD Dossier — a Versioned, Cross-Scope, Regulatory-Structured Deliverable
ADR-0084: Validation & Regulatory Axes (Traceability Model — Stage C)
ADR-0085: Relation-Layer Consolidation — One Trace Vocabulary, One Surface
ADR-0086: Requirement Traceability Chains — End-to-End Path View + Flat Path Export
ADR-0087: The Scope Traceability Report — One Derived Overview Artifact, Never a Controlled Document
ADR-0088: Verification Evidence Classes — Planned vs. Verified, Derived at the Read Layer
ADR-0089: Recurring Obligations — Periodic Tasks With Record Evidence, Not Calendar Series
ADR-0090: Release & Versioning Policy — Deliberate Releases, One Auditor-Facing Number
ADR-0091: Release Modes — Single-Person Record Release With a Structural Four-Eyes Floor
ADR-0092: Orphan-Blob Garbage Collection With a Quarantine Bin
ADR-0093: One Scope Context — the Toolbar Switcher Is the Only Scope Selector
ADR-0094: Calendar-Anchored Obligation Schedules (Clamped, Never Too Late)
ADR-0095: Key-Rule Governance — Free Until First Use, Then Frozen
ADR-0096: Transition Permissions — Always Visible, Deny Unless Granted
ADR-0097: A Governed Provisioning Surface — MANAGE_SCOPES
ADR-0098: Org Chart × Role System — Marriage at the Evidence Level, Never in Authorization
ADR-0099: The User Manual is an In-App Topic Reference, Not a Document
ADR-0100: LQMS Is the Living Quality Management System
ADR-0101: The Executable Validation Journey (PQ Evidence That Cannot Drift)
ADR-0102: Typed Template Variables (text | date | number — and Deliberately No Enum)
ADR-0103: npm audit Joins the Verification Gate as a Second Standing Input
ADR-0104: The Issued Dossier Is a Persisted Artifact of Record — and Clones to a New Draft
ADR-0105: Navigation Information Architecture — Group by Moment-of-Use
ADR-0106: The Client Reflection Follows Assignments, Not Only Content Reach
ADR-0107: The Audit Append Gate Follows Assignment Reach, Not Content Reach
ADR-0108: Mandator Membership — Invite-Accept, with Pre-Assigned Responsibilities
ADR-0109: Organization Founding Is Its Own Process
ADR-0110: The Audit Trail Is Not a Read Model
ADR-0111: The Imported-Person Model, and Project Portability's First Doctrines
ADR-0112: The Element-Kind Catalog — Semantics in the Model, Not Only in the Code
ADR-0113: Project Arrival Import — Records Arrive as They Are, People Arrive as They Were
ADR-0114: The Operating Model Arrives — Roles as Functions, Names as Words, People as This Instance's Decision
ADR-0115: Collaborative Draft Editing — Two Carets, One Truth, Honest Credit
ADR-0116: The System Maintenance Surface — the App Backs Itself Up, the Host Keeps One Dumb Job
ADR-0117: Role Documentation — a Link, a Finding, Per-Source Recognizers; Substitution Rejected
ADR-0118: The Offline QMS Copy — the Repo Carries the Audit Pack, Not a Second Renderer
ADR-0119: Module-Internal Package Structure — Capabilities First, Layers Second, the Root Is the Surface
ADR-0120: The Shared Kernel — the Domain-Exception Vocabulary Leaves the Authorization Module
ADR-0121: The Project Administrator Role — Per-Scope Administration With Read Access, Seeded in the Base Catalog
ADR-0122: Organization-Level Administration — the Cascade Stays, Becomes Visible, and Founds Projects
ADR-0123: Draft Save-Points — Every Save Restorable, Kept for the Life of the Version
ADR-0124: The Birth Path Completes Without Borrowing Content Clothes
ADR-0125: The Export Twin — Export Emits an Arrival Bundle
ADR-0126: Project Dissolution — the Un-Birth of an Unused Scope
ADR-0127: The Base-QMS Layers — One Library, Derived Adaptations, Local Records
ADR-0128: The GLOBAL Cascade Carries Administration, Never Content
ADR-0129: Role Identity from a GLOBAL Assignment Acts in GLOBAL Alone
ADR-0130: Break-Glass — the Project Administrator's Escalation Is a First-Class, Witnessed, Self-Expiring Act
ADR-0131: Role Substitution as Declared Adoption Edges — Emergency Cover Is Governed, Own-Name, Timed Staffing
ADR-0132: Dual-Hat Reviewer Satisfaction Is a Declared Policy Choice — the Strict Floor Stays the Default
ADR-NNNN:
</span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_5" > <div class="md-nav__link md-nav__container"> <a href="../../requirements/" class="md-nav__link "> <span class="md-ellipsis"> Requirements </span> </a> <label class="md-nav__link " for="__nav_5" id="__nav_5_label" tabindex="0"> <span class="md-nav__icon md-icon"></span> </label> </div> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_5_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_5"> <span class="md-nav__icon md-icon"></span> Requirements </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../requirements/stakeholder_requirements/" class="md-nav__link"> <span class="md-ellipsis"> Stakeholder Requirements </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/gap-analysis/" class="md-nav__link"> <span class="md-ellipsis"> Requirements Gap Analysis </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_admin/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Administration, Permissions & Onboarding </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_api_ui/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: API & User Interface </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_audit_reporting/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Audit Trail & Regulatory Reporting </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_auth/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Authentication & Session </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_backup/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Backup & Restore </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_catalogs/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Catalogs, Roles & Users </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_data_protection/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Data Protection, Retention & Disposal </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_documents/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Documents, Versions & Storage </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_dossiers/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Technical Documentation Dossiers </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_effectivity/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Effectivity, Periodic Review & Validity </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_gspr/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Regulatory Conformity (GSPR / Essential Principles) </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_i18n/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Internationalization </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_lifecycle/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Life Cycle & Reviews </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_memberships/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Mandator Membership & Invitations </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_migration/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Migration & Import </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_nfr/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Non-Functional </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_notifications/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Notifications & Tasks </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_obligations/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Recurring Obligations </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_relationships/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Document Relationships </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_risk/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Risk Management (ISO 14971 Hazards & Controls) </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_sbom/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Software Bill of Materials & Supply-Chain Assurance </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_search/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Search </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_separation/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Scopes, Mandators & Separation </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_signatures/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Electronic Signatures </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_training/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Read-Acknowledgement & Questionnaires </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_users/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: User Identity & Lifecycle </span> </a> </li> <li class="md-nav__item"> <a href="../../requirements/req_validation/" class="md-nav__link"> <span class="md-ellipsis"> Software Requirements: Design Validation & the Validation Traceability Axis </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_6" > <div class="md-nav__link md-nav__container"> <a href="../../process/" class="md-nav__link "> <span class="md-ellipsis"> Process (IEC 62304) </span> </a> <label class="md-nav__link " for="__nav_6" id="__nav_6_label" tabindex="0"> <span class="md-nav__icon md-icon"></span> </label> </div> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_6_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_6"> <span class="md-nav__icon md-icon"></span> Process (IEC 62304) </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../process/configuration_management_plan/" class="md-nav__link"> <span class="md-ellipsis"> Configuration Management Plan </span> </a> </li> <li class="md-nav__item"> <a href="../../process/problem_resolution/" class="md-nav__link"> <span class="md-ellipsis"> Problem Resolution Process </span> </a> </li> <li class="md-nav__item"> <a href="../../process/risk_management/" class="md-nav__link"> <span class="md-ellipsis"> Risk Management </span> </a> </li> <li class="md-nav__item"> <a href="../../process/software_development_plan/" class="md-nav__link"> <span class="md-ellipsis"> Software Development Plan </span> </a> </li> <li class="md-nav__item"> <a href="../../process/verification_plan/" class="md-nav__link"> <span class="md-ellipsis"> Verification Plan </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_7" > <label class="md-nav__link" for="__nav_7" id="__nav_7_label" tabindex="0"> <span class="md-ellipsis"> Operations </span> <span class="md-nav__icon md-icon"></span> </label> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_7_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_7"> <span class="md-nav__icon md-icon"></span> Operations </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../operations/genesis-installation/" class="md-nav__link"> <span class="md-ellipsis"> Genesis: Birthing an LQMS Installation with a Base Library </span> </a> </li> <li class="md-nav__item"> <a href="../../operations/deployment/" class="md-nav__link"> <span class="md-ellipsis"> LQMS Deployment Guide </span> </a> </li> <li class="md-nav__item"> <a href="../../operations/server-deployment/" class="md-nav__link"> <span class="md-ellipsis"> LQMS Server Deployment (single Linux host, public HTTPS) </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_8" > <div class="md-nav__link md-nav__container"> <a href="../../traceability/" class="md-nav__link "> <span class="md-ellipsis"> Traceability </span> </a> <label class="md-nav__link " for="__nav_8" id="__nav_8_label" tabindex="0"> <span class="md-nav__icon md-icon"></span> </label> </div> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_8_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_8"> <span class="md-nav__icon md-icon"></span> Traceability </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../traceability/matrix/" class="md-nav__link"> <span class="md-ellipsis"> Requirements Traceability Matrix </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_9" > <div class="md-nav__link md-nav__container"> <a href="../../validation/" class="md-nav__link "> <span class="md-ellipsis"> Validation (tool lane) </span> </a> <label class="md-nav__link " for="__nav_9" id="__nav_9_label" tabindex="0"> <span class="md-nav__icon md-icon"></span> </label> </div> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_9_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_9"> <span class="md-nav__icon md-icon"></span> Validation (tool lane) </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../validation/templates/ai-authorship-posture/" class="md-nav__link"> <span class="md-ellipsis"> AI-Authorship Posture — How LQMS Is Built, and Why the Validation Evidence Does Not Rest on It (TEMPLATE) </span> </a> </li> <li class="md-nav__item"> <a href="../../validation/templates/intended-use/" class="md-nav__link"> <span class="md-ellipsis"> Intended-Use Specification — LQMS as a QMS / Document-Control Tool (TEMPLATE) </span> </a> </li> <li class="md-nav__item"> <a href="../../validation/templates/tool-risk-assessment/" class="md-nav__link"> <span class="md-ellipsis"> Tool-Risk Assessment — LQMS as a QMS Tool (TEMPLATE) </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_10" > <label class="md-nav__link" for="__nav_10" id="__nav_10_label" tabindex="0"> <span class="md-ellipsis"> Regulatory </span> <span class="md-nav__icon md-icon"></span> </label> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_10_label" aria-expanded="false"> <label class="md-nav__title" for="__nav_10"> <span class="md-nav__icon md-icon"></span> Regulatory </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../../regulatory/mdr-annex-i-skeleton/" class="md-nav__link"> <span class="md-ellipsis"> MDR Annex I — GSPR authoring skeleton (paraphrased) </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item md-nav__item--active md-nav__item--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_11" checked> <div class="md-nav__link md-nav__container"> <a href="../" class="md-nav__link "> <span class="md-ellipsis"> User guide </span> </a> <label class="md-nav__link " for="__nav_11" id="__nav_11_label" tabindex="0"> <span class="md-nav__icon md-icon"></span> </label> </div> <nav class="md-nav" data-md-level="1" aria-labelledby="__nav_11_label" aria-expanded="true"> <label class="md-nav__title" for="__nav_11"> <span class="md-nav__icon md-icon"></span> User guide </label> <ul class="md-nav__list" data-md-scrollfix> <li class="md-nav__item"> <a href="../tutorial/" class="md-nav__link"> <span class="md-ellipsis"> Tutorial — from zero to a released document </span> </a> </li> <li class="md-nav__item"> <a href="../administration/" class="md-nav__link"> <span class="md-ellipsis"> Administering an LQMS Installation </span> </a> </li> <li class="md-nav__item"> <a href="../diagrams/" class="md-nav__link"> <span class="md-ellipsis"> Diagrams </span> </a> </li> <li class="md-nav__item"> <a href="../documents-lifecycle/" class="md-nav__link"> <span class="md-ellipsis"> Documents & the Lifecycle </span> </a> </li> <li class="md-nav__item"> <a href="../exports/" class="md-nav__link"> <span class="md-ellipsis"> PDF Exports & the Audit Pack </span> </a> </li> <li class="md-nav__item"> <a href="../obligations/" class="md-nav__link"> <span class="md-ellipsis"> Recurring Obligations </span> </a> </li> <li class="md-nav__item"> <a href="../project-context/" class="md-nav__link"> <span class="md-ellipsis"> The Project Context & App Version </span> </a> </li> <li class="md-nav__item"> <a href="../review-comments/" class="md-nav__link"> <span class="md-ellipsis"> Review Comments </span> </a> </li> <li class="md-nav__item"> <a href="../topics/activity-trail/" class="md-nav__link"> <span class="md-ellipsis"> Who did what, when — reading a project's activity </span> </a> </li> <li class="md-nav__item"> <a href="../topics/admin-scopes/" class="md-nav__link"> <span class="md-ellipsis"> Renaming a project, and what can never change </span> </a> </li> <li class="md-nav__item"> <a href="../topics/authority-view/" class="md-nav__link"> <span class="md-ellipsis"> Who holds each function here, and what may it do </span> </a> </li> <li class="md-nav__item"> <a href="../topics/break-glass/" class="md-nav__link"> <span class="md-ellipsis"> The permission I need is held by a role I do not hold — what now? </span> </a> </li> <li class="md-nav__item"> <a href="../topics/coverage-and-chains/" class="md-nav__link"> <span class="md-ellipsis"> Coverage or chains? — which requirement view answers your question </span> </a> </li> <li class="md-nav__item"> <a href="../topics/credentials/" class="md-nav__link"> <span class="md-ellipsis"> Your password: changing it, resetting it — and why LQMS never sees it </span> </a> </li> <li class="md-nav__item"> <a href="../topics/emergency-cover/" class="md-nav__link"> <span class="md-ellipsis"> Who may cover for whom here — declaring emergency cover, and reading where the glass was broken </span> </a> </li> <li class="md-nav__item"> <a href="../topics/key-rules/" class="md-nav__link"> <span class="md-ellipsis"> Special elements: what a project declares, and when its names freeze </span> </a> </li> <li class="md-nav__item"> <a href="../topics/memberships/" class="md-nav__link"> <span class="md-ellipsis"> Belonging to an organization: invitations, acceptance, and what they change </span> </a> </li> <li class="md-nav__item"> <a href="../topics/provisioning-birth-path/" class="md-nav__link"> <span class="md-ellipsis"> How a new organization and project are born </span> </a> </li> <li class="md-nav__item"> <a href="../topics/review-policies/" class="md-nav__link"> <span class="md-ellipsis"> What a review policy controls, and what an empty grant means </span> </a> </li> <li class="md-nav__item"> <a href="../topics/setup-wizard-lanes/" class="md-nav__link"> <span class="md-ellipsis"> The setup wizard: the lanes, and what it writes </span> </a> </li> <li class="md-nav__item"> <a href="../topics/staffing-and-assignments/" class="md-nav__link"> <span class="md-ellipsis"> Staffing people into roles, and the accountable holder </span> </a> </li> <li class="md-nav__item"> <a href="../topics/technical-dossier/" class="md-nav__link"> <span class="md-ellipsis"> How do I assemble a technical dossier? </span> </a> </li> <li class="md-nav__item"> <a href="../trace-items/" class="md-nav__link"> <span class="md-ellipsis"> Trace Items — Requirements, Risks & Risk Controls </span> </a> </li> <li class="md-nav__item"> <a href="../trace-links/" class="md-nav__link"> <span class="md-ellipsis"> Trace Links & the Suspect Cycle </span> </a> </li> <li class="md-nav__item md-nav__item--active"> <input class="md-nav__toggle md-toggle" type="checkbox" id="__toc"> <label class="md-nav__link md-nav__link--active" for="__toc"> <span class="md-ellipsis"> The Traceability Workspace </span> <span class="md-nav__icon md-icon"></span> </label> <a href="./" class="md-nav__link md-nav__link--active"> <span class="md-ellipsis"> The Traceability Workspace </span> </a> <nav class="md-nav md-nav--secondary" aria-label="Table of contents"> <label class="md-nav__title" for="__toc"> <span class="md-nav__icon md-icon"></span> Table of contents </label> <ul class="md-nav__list" data-md-component="toc" data-md-scrollfix> <li class="md-nav__item"> <a href="#1-the-hub-and-per-view-permissions" class="md-nav__link"> <span class="md-ellipsis"> 1. The hub and per-view permissions </span> </a> </li> <li class="md-nav__item"> <a href="#2-requirement-coverage" class="md-nav__link"> <span class="md-ellipsis"> 2. Requirement coverage </span> </a> </li> <li class="md-nav__item"> <a href="#3-requirement-chains" class="md-nav__link"> <span class="md-ellipsis"> 3. Requirement chains </span> </a> </li> <li class="md-nav__item"> <a href="#4-risk-traceability" class="md-nav__link"> <span class="md-ellipsis"> 4. Risk traceability </span> </a> </li> <li class="md-nav__item"> <a href="#5-training-compliance-quality-managers" class="md-nav__link"> <span class="md-ellipsis"> 5. Training compliance (quality managers) </span> </a> </li> <li class="md-nav__item"> <a href="#6-reference-coverage-the-references-web" class="md-nav__link"> <span class="md-ellipsis"> 6. Reference coverage (the references web) </span> </a> </li> <li class="md-nav__item"> <a href="#7-validation-matrix" class="md-nav__link"> <span class="md-ellipsis"> 7. Validation matrix </span> </a> </li> <li class="md-nav__item"> <a href="#8-gspr-conformity" class="md-nav__link"> <span class="md-ellipsis"> 8. GSPR conformity </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item"> <a href="../training/" class="md-nav__link"> <span class="md-ellipsis"> Training & Acknowledgements </span> </a> </li> </ul> </nav> </li> </ul> </nav> </div> </div> </div> <div class="md-sidebar md-sidebar--secondary" data-md-component="sidebar" data-md-type="toc" > <div class="md-sidebar__scrollwrap"> <div class="md-sidebar__inner"> <nav class="md-nav md-nav--secondary" aria-label="Table of contents"> <label class="md-nav__title" for="__toc"> <span class="md-nav__icon md-icon"></span> Table of contents </label> <ul class="md-nav__list" data-md-component="toc" data-md-scrollfix> <li class="md-nav__item"> <a href="#1-the-hub-and-per-view-permissions" class="md-nav__link"> <span class="md-ellipsis"> 1. The hub and per-view permissions </span> </a> </li> <li class="md-nav__item"> <a href="#2-requirement-coverage" class="md-nav__link"> <span class="md-ellipsis"> 2. Requirement coverage </span> </a> </li> <li class="md-nav__item"> <a href="#3-requirement-chains" class="md-nav__link"> <span class="md-ellipsis"> 3. Requirement chains </span> </a> </li> <li class="md-nav__item"> <a href="#4-risk-traceability" class="md-nav__link"> <span class="md-ellipsis"> 4. Risk traceability </span> </a> </li> <li class="md-nav__item"> <a href="#5-training-compliance-quality-managers" class="md-nav__link"> <span class="md-ellipsis"> 5. Training compliance (quality managers) </span> </a> </li> <li class="md-nav__item"> <a href="#6-reference-coverage-the-references-web" class="md-nav__link"> <span class="md-ellipsis"> 6. Reference coverage (the references web) </span> </a> </li> <li class="md-nav__item"> <a href="#7-validation-matrix" class="md-nav__link"> <span class="md-ellipsis"> 7. Validation matrix </span> </a> </li> <li class="md-nav__item"> <a href="#8-gspr-conformity" class="md-nav__link"> <span class="md-ellipsis"> 8. GSPR conformity </span> </a> </li> </ul> </nav> </div> </div> </div> <div class="md-content" data-md-component="content"> <article class="md-content__inner md-typeset"> <a href="https://github.com/nburri/lqms/edit/main/docs/user-guide/traceability-workspace.md" title="Edit this page" class="md-content__button md-icon"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 24 24"><path d="M10 20H6V4h7v5h5v3.1l2-2V8l-6-6H6c-1.1 0-2 .9-2 2v16c0 1.1.9 2 2 2h4zm10.2-7c.1 0 .3.1.4.2l1.3 1.3c.2.2.2.6 0 .8l-1 1-2.1-2.1 1-1c.1-.1.2-.2.4-.2m0 3.9L14.1 23H12v-2.1l6.1-6.1z"/></svg> </a> <h1 id="the-traceability-workspace">The Traceability Workspace<a class="headerlink" href="#the-traceability-workspace" title="Permanent link">¶</a></h1> <p><em>Audience: everyone doing design control; §5 additionally for quality managers.</em></p> <p>The <strong>Traceability workspace</strong> is the home for reading traceability across a scope — requirement coverage, risks, chains, reference coverage, and training oversight. It is an <strong>overview hub</strong> with a tile per view; each tile shows a headline metric and a status, and links to a focused sub-page. The nav entry appears only if you hold a traceability permission in some scope (like <em>Admin</em> and <em>Scope configuration</em>), and the hub aggregates across all the scopes where you do.</p> <h2 id="1-the-hub-and-per-view-permissions">1. The hub and per-view permissions<a class="headerlink" href="#1-the-hub-and-per-view-permissions" title="Permanent link">¶</a></h2> <p><code>Traceability</code> opens the hub — <em>"QMS health at a glance — pick a view."</em> Its tiles:</p> <table> <thead> <tr> <th>Tile</th> <th>What it shows</th> </tr> </thead> <tbody> <tr> <td><strong>Requirement coverage</strong></td> <td>covered / total, and a gap count (§2)</td> </tr> <tr> <td><strong>Risk traceability</strong></td> <td>risk count and a gap count (§4)</td> </tr> <tr> <td><strong>Reference coverage</strong></td> <td>the scope's document-citation completeness rules and any gaps (§6) — <em>shown only where a scope has configured at least one rule</em></td> </tr> <tr> <td><strong>Requirement chains</strong></td> <td>stakeholder requirements satisfied / total, gaps (§3)</td> </tr> <tr> <td><strong>Obligations</strong></td> <td>recurring-duty freshness — <em>"{{ok}}/{{total}} OK"</em> (see <a href="../obligations/">Recurring obligations</a> §4)</td> </tr> <tr> <td><strong>Training compliance</strong></td> <td>overdue count / on track (§5)</td> </tr> <tr> <td><strong>Validation</strong></td> <td>user needs validated / total, and a gap count (§7)</td> </tr> <tr> <td><strong>GSPR conformity</strong></td> <td>applicable clauses complied with / total, and a gap count (§8)</td> </tr> </tbody> </table> <p>Access is <strong>two-tier</strong>, enforced server-side and reflected in the UI (a hidden tile is never the only protection — the sub-page's data endpoint enforces the same rule, and the routes are guarded):</p> <ul> <li><strong><code>VIEW_TRACEABILITY</code></strong> — the engineering-trace views (requirement coverage, risk, document coverage, requirement chains, the validation matrix, and GSPR conformity). Granted to scope members by default, so today's reach is preserved; row-level security still bounds the <em>data</em> to what you may see.</li> <li><strong><code>VIEW_TRAINING_COMPLIANCE</code></strong> — the training-oversight view only. This is deliberately more restricted (it is personal-data-sensitive: who is overdue), held by the quality-manager role.</li> </ul> <p>Everything is <strong>scope-aware</strong>: you see a view for the scopes where you hold its permission, and the data is RLS-bounded to those scopes.</p> <p><strong>Some tiles follow your project's vocabulary.</strong> <em>Validation</em>, <em>GSPR conformity</em> and <em>Requirement chains</em> appear only where the project actually declares those axes — where it uses user needs and validation cases, regulatory references, or stakeholder requirements (see <a href="../topics/key-rules/">key rules</a> §0 for how a project declares its element kinds). A 62304 supplier project that verifies against requirements it is handed simply has no validation lane, so a permanent empty <em>0 of 0</em> there would be a reproach for something it was never asked to do. The rule is declaration-or-content: a project that declares the axis keeps the tile even while it is still empty, and a project that holds such items keeps it even if nobody declared anything — content is never hidden. The verification and coverage views are <em>not</em> conditioned this way: a project that writes requirements and never verifies them has a real gap, and that stays loud.</p> <p><strong>One project at a time.</strong> The tiles roll up across every project you can see, but each focused sub-page shows a single project — the one chosen in the toolbar's <strong>Project context</strong> switcher. With <em>All projects</em> selected, a sub-page that needs one project shows a <strong>Select a project</strong> prompt instead of data; pick one there and the toolbar follows (see <a href="../project-context/">The project context</a>).</p> <p><strong>The whole picture in one PDF.</strong> The hub header also carries a <strong>Traceability report (PDF)</strong> action, gated by <code>VIEW_TRACEABILITY</code> exactly like the trace tiles. It downloads one derived PDF compiling the scope's whole traceability picture: a front-page <strong>gap digest</strong> (the unhealthy items across the scope — unsatisfied/unverified requirements, the risk gap counts, coverage-rule gaps, user needs not validated, applicable GSPR clauses not complied with, unjustified N/A exclusions, suspect links), then sectioned tables for the requirement chains, the <strong>requirement-verification</strong> status of each software requirement (its evidence class — unverified / planned only / verified, ADR-0088), the risk chains, the document-relation coverage, the <strong>validation matrix</strong> (§7), and the <strong>GSPR conformity</strong> clauses (§8). Like every export it is <strong>derived at export</strong> — a point-in-time compilation, labelled <em>"as at export"</em> and <strong>not</strong> a controlled document (two exports on different days may legitimately differ, by design). It is per-scope: with a single traceability scope the button downloads that scope's report directly; across several, it opens a short menu to pick which scope. The same report also rides in the scope audit pack — see <a href="../exports/">exports</a> §6.</p> <h2 id="2-requirement-coverage">2. Requirement coverage<a class="headerlink" href="#2-requirement-coverage" title="Permanent link">¶</a></h2> <p><em>"How many of this scope's requirements are covered — each requirement covered by at least one inbound 'verifies' or 'satisfies' link."</em> A requirement counts as <strong>covered</strong> when it has <strong>at least one inbound <code>Verifies</code> OR <code>Satisfies</code></strong> link. The evidence is counted separately per requirement and shown as chips — and the verifies evidence is <strong>split by class</strong> (ADR-0088): <strong>planned ×N</strong> (a verification <em>designated</em> — a plan, or a report not yet released) and <strong>verified ×N</strong> (an executed, released report) — beside <strong>satisfied ×N</strong>. They mean different things (a software requirement is verified by evidence; a stakeholder requirement is satisfied by software requirements; a plan is not yet an executed report). The <em>covered</em> verdict itself is unchanged. See <a href="../trace-links/">trace-links</a> §1 and §5.</p> <p>The page gives you:</p> <ul> <li>The headline — <em>"{{count}} of {{total}} requirements covered"</em> (or <em>"Every requirement is covered."</em>).</li> <li>A <strong>Filter by kind</strong> control (Functional / Non-functional / Stakeholder / Safety / …) so you can ask coverage of a single kind.</li> <li>The enumerable <strong>gap list</strong> — the requirements <em>not yet covered</em> — and the covered list with each requirement's evidence chips.</li> <li>The <strong>requirements registry</strong> — every defined key with its <strong>Kind</strong>, <strong>Priority</strong>, <strong>Document</strong>, <strong>Last changed</strong> version, <strong>Links</strong>, and a <strong>Text</strong> excerpt. A key with any suspect link touching it is flagged, with the hint to review it on its document.</li> </ul> <h2 id="3-requirement-chains">3. Requirement chains<a class="headerlink" href="#3-requirement-chains" title="Permanent link">¶</a></h2> <p>Coverage answers each hop in isolation; the <strong>Requirement chains</strong> view walks the whole path an auditor walks: <em>"Stakeholder requirement → satisfying software requirements → verification evidence, walked end to end."</em> Rows are the scope's <strong>stakeholder</strong> requirements (requirement items of kind <em>Stakeholder</em> — the specification lane, distinct from <em>user needs</em> / the Validation matrix §7; see <a href="../trace-items/#72-stakeholder-requirements-vs-user-needs-verification-vs-validation">trace-items §7.2</a>); each expands to the software requirements that <strong>satisfy</strong> it, and each of those to its <strong>verification</strong> evidence. Because chains branch and have unequal depth (one stakeholder requirement may feed several software requirements, some ending without a verification hop), the screen is expandable rows, not a rectangular grid.</p> <p>Each chain carries honest, non-suppressible roll-up flags:</p> <ul> <li><strong>Not satisfied</strong> — <em>"No software requirement satisfies this stakeholder requirement."</em></li> <li><strong>Satisfied, unverified</strong> — <em>"A satisfying software requirement carries no verification evidence — satisfied is not verified."</em> (reported per software requirement, not averaged away).</li> <li><strong>Planned only</strong> (ADR-0088) — the chain is satisfied and every verification is <em>designated</em>, but the evidence is all <strong>planned</strong> (a plan, not an executed report). A quiet amber flag — the honest intermediate between <em>Satisfied, unverified</em> and clean. Each evidence chip shows its class and, for a verified one, its release date (<code>QMS-DEV-VER-011 · v4 · verified 2026-07-19</code> vs <code>… · planned</code>).</li> <li><strong>Suspect on path</strong> — a link somewhere on the chain is suspect; re-attest it on its source document (see <a href="../trace-links/">trace-links</a> §4).</li> </ul> <p>The headline aggregates — <em>"{{satisfied}} of {{total}} stakeholder requirements satisfied"</em>, <em>"{{count}} fully verified"</em>, <em>"{{count}} planned only"</em> (shown when > 0), <em>"{{count}} suspect on the path"</em>.</p> <blockquote> <p><strong>The auditor's matrix is an export.</strong> The flat traceability matrix — one row per complete path, stakeholder key → software key → evidence document/version, with per-hop suspect state and the roll-up flag — is a <strong>Download matrix (CSV)</strong> on this page, not the screen. That CSV is the artifact auditors mean by "traceability matrix", and it feeds the validation-report generator.</p> </blockquote> <h2 id="4-risk-traceability">4. Risk traceability<a class="headerlink" href="#4-risk-traceability" title="Permanent link">¶</a></h2> <p><em>"Hazard → control → requirement / verification → residual risk, with completeness gaps."</em> Rows are the scope's risks; each expands to the controls that <strong>mitigate</strong> it, each control's <strong>Implemented by</strong> target(s) (a requirement item or an SOP/WI document) and its <strong>Verified by</strong> document, and the risk's initial and residual scores. The completeness gaps are surfaced as counts and per-row hints, each naming where and how to close it:</p> <ul> <li><strong>Risk without control</strong>, and its variant <strong>residual recorded without a control</strong>.</li> <li><strong>Control not implemented</strong> / <strong>Control not verified</strong> — with <em>Add mitigation…</em> / <em>Add verification…</em> remedies (see <a href="../trace-links/">trace-links</a> §2). A control's verification renders its evidence <strong>class</strong> (ADR-0088): a planned-only verification reads as <strong>planned</strong>, never as a green verified; the <em>not verified</em> gap still fires only when there is <strong>no</strong> <code>Verifies</code> link at all.</li> <li><strong>Residual not acceptable</strong>.</li> </ul> <p>An <strong>accepted-without-reduction</strong> risk — an initial risk you judged acceptable, with no control and no residual — is shown as complete (<em>"Accepted without reduction — the initial risk is acceptable, so no control is required."</em>), <strong>not</strong> as a gap. Scores render as recorded tokens; nothing is computed (see <a href="../trace-items/">trace-items</a> §4).</p> <p>The same derivations back the in-document <strong>Risk table</strong> grid (columns <strong>Controls</strong>, <strong>Impl. by</strong>, <strong>Verified by</strong>, <strong>Gaps</strong> under <em>Derived (from links)</em>), scoped to a single document — so an author sees a risk's coverage while authoring it, and this scope-wide view rolls all documents together.</p> <h2 id="5-training-compliance-quality-managers">5. Training compliance (quality managers)<a class="headerlink" href="#5-training-compliance-quality-managers" title="Permanent link">¶</a></h2> <p>The QMB training-compliance oversight — scope compliance numbers, overdue and aging, expiring certifications — lives here, at the <strong>Training compliance</strong> view, gated by <code>VIEW_TRAINING_COMPLIANCE</code>. It moved out of <em>My training</em> on purpose: <em>My training</em> is your personal view (your obligations, your certifications), while oversight ("who is overdue") is a different audience and a more sensitive surface. The content and the numbers are unchanged — see <a href="../training/">training.md</a> §3 for what each figure means and how "overdue" is defined.</p> <h2 id="6-reference-coverage-the-references-web">6. Reference coverage (the references web)<a class="headerlink" href="#6-reference-coverage-the-references-web" title="Permanent link">¶</a></h2> <p>The <strong>Reference coverage</strong> view is the home for whole-document <code>references</code> — the navigational web of which document points at which — and the <strong>completeness rules</strong> over it (ADR-0049 §4). Pick a scope; each rule is an entry point that opens a coverage-first result (<em>"N of M covered"</em> + progress, the uncovered documents first with in-place gap closing, the covered ones collapsed, and a list↔grid toggle). An <em>"Explore ad hoc…"</em> expander runs the same query as a plain-language sentence.</p> <p>This view is a <strong>pure references web</strong> (ADR-0085): every trace <em>claim</em> — verifies / satisfies / derives-from — lives on the trace-link layer, so the relation layer keeps only <code>references</code> (plus system-managed lifecycle provenance). The rule builder and the ad-hoc explorer offer only the two <code>references</code> reading directions, closing a gap in place adds a <code>references</code> edge, and a completeness rule can name <strong>no other relation type</strong>: one that tried would be refused, with a message pointing at where claim completeness is answered — <em>Requirement coverage</em> (§2) and <em>Requirement chains</em> (§3). Rule management is gated by <code>CONFIGURE_REVIEW_POLICY</code>; the in-place gap fix follows the same <strong>draft-only</strong> rule as any structure change (see <a href="../trace-links/">trace-links</a> §3).</p> <p><strong>The rules are the opt-in.</strong> Citation completeness — <em>"every quality record cites its governing SOP"</em> — is a house rule a scope adopts, not a duty every scope owes. A scope that has configured no coverage rule therefore shows <strong>no Reference coverage tile</strong> on the hub, and its Traceability report carries <strong>no document-coverage section</strong>: nothing is hidden, there is simply nothing this scope has asked to be measured on. Configure the first rule (from the view itself, reachable by its route) and both appear. The same grammar governs the <em>Requirement chains</em>, <em>Validation</em> and <em>GSPR</em> tiles, each on its own declaration.</p> <h2 id="7-validation-matrix">7. Validation matrix<a class="headerlink" href="#7-validation-matrix" title="Permanent link">¶</a></h2> <p><em>"User need → validating validation-cases / records, with the design-elements that realize the requirements."</em> The <strong>Validation matrix</strong> answers the validation axis of the V-model — did you build the <em>right</em> thing? — which is distinct from verification (did you build the thing <em>right</em>?). Rows are the scope's <strong>user needs</strong>; each expands to the validation evidence that <strong>Validates</strong> it — a validation case, or a whole Validation Plan / Report document linked at document level.</p> <p>Each row carries an honest, non-suppressible flag:</p> <ul> <li><strong>Not validated</strong> — <em>"No validation-case or validation record validates this user need."</em> The hard gap: a need with nothing confirming it.</li> <li><strong>Planned only</strong> — <em>"Validation is designated but the evidence is still only planned — a plan, not an executed, released validation record. Release the validation record to make it validated."</em> The amber middle state — the validation is appointed but not yet run.</li> <li><strong>Suspect on path</strong> — a <code>Validates</code> link on the row is suspect (the need's content changed since it was attested); re-attest it on the source document.</li> </ul> <p>The three states are the same ADR-0088 evidence classing the requirement views use, read for the <code>Validates</code> link (see <a href="../trace-links/">trace-links</a> §6):</p> <ul> <li><strong>validated</strong> — an <em>executed, released</em> validation record (a document of a verification-evidence type) validates the need. Its chip reads <em>"validated {{date}}"</em>.</li> <li><strong>planned</strong> — the <code>Validates</code> link exists but its source is a plan or an unreleased draft. Its chip reads <em>"planned"</em>. "Planned" is never dressed up as done — releasing the executed record is what turns it into <em>validated</em>.</li> <li><strong>not validated</strong> — there is no <code>Validates</code> link at all (the chip reads <em>"no validation"</em>).</li> </ul> <p>The headline aggregates — <em>"{{validated}} of {{total}} user needs validated"</em>, <em>"{{count}} genuinely validated"</em>, <em>"{{count}} planned only"</em> (when > 0), and <em>"{{count}} suspect on the path"</em> (when > 0). Below the needs, a <strong>Design realization</strong> panel (<em>"Design-elements that satisfy requirements — the V-model's "how"."</em>) lists the design elements that <strong>Satisfies</strong> the scope's requirements — the design leg of the same axis.</p> <p><strong>CSV and report.</strong> A <strong>Download matrix (CSV)</strong> action exports the flat auditor's matrix (one row per need → validation evidence, with class and gap). The same content is a validation-matrix section of the scope traceability report (§1) and rides in the audit pack (permission-conditionally, like every trace section).</p> <h2 id="8-gspr-conformity">8. GSPR conformity<a class="headerlink" href="#8-gspr-conformity" title="Permanent link">¶</a></h2> <p><em>"Regulatory-ref clause → complying requirements / design-elements, with the verification state of each complier."</em> The <strong>GSPR conformity</strong> view is the conformity table an auditor reads against MDR Annex I (or any regulation/standard you authored as regulatory references — see <a href="../trace-items/">trace-items</a> §7.5). Rows are the scope's <strong>regulatory-reference</strong> clauses in clause order; each expands to the requirements / design elements that <strong>Complies with</strong> it, and each complier's verification state.</p> <p>Each clause shows its <strong>applicability</strong> — <em>applicable</em>, <em>not applicable</em>, or <em>not assessed</em> — and carries honest flags:</p> <ul> <li><strong>Not covered</strong> — <em>"This applicable clause has no requirement or design-element that complies with it. Author a complies-with link from a requirement."</em> An applicable principle with nothing claiming conformity.</li> <li><strong>Coverage unverified</strong> — <em>"The clause is complied with, but no complying requirement carries released verification evidence — the compliance is designated, not yet demonstrated."</em> The compliance is claimed, but the evidence is planned-only (the same ADR-0088 class as everywhere else).</li> <li><strong>N/A — no justification</strong> — the <strong>hard gap</strong> (see below).</li> <li><strong>Suspect on path</strong> — a <code>Complies with</code> or <code>Verifies</code> link on the row is suspect; re-attest it on the source document.</li> </ul> <blockquote> <p><strong>Why an unjustified N/A is a hard gap — not a soft warning.</strong> When a clause is marked <em>Not applicable</em> but carries <strong>no justification</strong>, the view raises a red flag: <em>"This clause is marked not-applicable but carries no justification — an unjustified exclusion is an audit finding. Record the justification on the clause."</em> This is deliberate, and it is counted as a <em>hard</em> gap, not a gentle reminder, because an auditor reads an unexplained "not applicable" as <strong>evasion</strong> — a principle quietly excluded to avoid demonstrating conformity. The honest posture is to state <em>why</em> each excluded clause does not apply (e.g. "the device has no patient-contacting materials"). The authoring grid warns you of the same thing as you type (see <a href="../trace-items/">trace-items</a> §8); the conformity view is where it becomes a counted gap and lands in the report's gap digest.</p> </blockquote> <p>The headline aggregates — <em>"{{covered}} of {{applicable}} applicable clauses complied with"</em> and <em>"{{count}} conformant"</em> (a distinct, stronger claim: covered <strong>and</strong> verified), then the gap counts, led by <em>"{{count}} N/A without justification"</em> as the hard gap, followed by <em>"{{count}} not covered"</em>, <em>"{{count}} coverage unverified"</em>, and <em>"{{count}} suspect on the path"</em> (each shown only when > 0). A complying requirement's evidence renders its class — <em>"verified {{date}}"</em> / <em>"planned"</em> / <em>"unverified"</em> — and a properly justified exclusion reads <em>"Not applicable — justification recorded."</em></p> <p><strong>CSV and report.</strong> A <strong>Download matrix (CSV)</strong> action exports the flat conformity matrix. The same content is a GSPR-conformity section of the scope traceability report (§1) and rides in the audit pack — so the unjustified-N/A hard gaps surface in the report's front-page gap digest too.</p> <hr /> <p><em>Governing decisions: ADR-0080 (the workspace — hub + focused sub-pages, two-tier per-view permissions VIEW_TRACEABILITY / VIEW_TRAINING_COMPLIANCE, server-enforced & route-guarded, training oversight moved out of My training), ADR-0084 (Stage C — the validation matrix & GSPR conformity views, derived read models, VIEW_TRACEABILITY-gated, joined to the one project context, tiled on the hub, sectioned in the report & audit pack; the unjustified-N/A hard gap), ADR-0085 (relation-layer consolidation — one trace vocabulary on the trace-link layer, the references card & Document-coverage view become the pure references web), ADR-0088 (verification evidence classes — planned vs. verified, derived at the read layer, reused for the validates link & conformity coverage), ADR-0077 §6 + Clarification §4 (requirement coverage — verifies OR satisfies, separate counts), ADR-0086 (requirement chains + the CSV matrix export), ADR-0087 (the scope traceability report — one derived PDF over the read models, downloaded from the hub and carried in the audit pack), ADR-0079/0082 (risk traceability view + the document-scoped grid), ADR-0049 (document relations & completeness rules), ADR-0071 (training compliance content), ADR-0089 (the obligations tile + oversight sub-page), ADR-0093 (the one project context — sub-pages read the toolbar switcher, the neutral "Select a project" state).</em></p> </article> </div> <script>var target=document.getElementById(location.hash.slice(1));target&&target.name&&(target.checked=target.name.startsWith("__tabbed_"))</script> </div> <button type="button" class="md-top md-icon" data-md-component="top" hidden> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 24 24"><path d="M13 20h-2V8l-5.5 5.5-1.42-1.42L12 4.16l7.92 7.92-1.42 1.42L13 8z"/></svg> Back to top </button> </main> <footer class="md-footer"> <nav class="md-footer__inner md-grid" aria-label="Footer" > <a href="../trace-links/" class="md-footer__link md-footer__link--prev" aria-label="Previous: Trace Links & the Suspect Cycle"> <div class="md-footer__button md-icon"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 24 24"><path d="M20 11v2H8l5.5 5.5-1.42 1.42L4.16 12l7.92-7.92L13.5 5.5 8 11z"/></svg> </div> <div class="md-footer__title"> <span class="md-footer__direction"> Previous </span> <div class="md-ellipsis"> Trace Links & the Suspect Cycle </div> </div> </a> <a href="../training/" class="md-footer__link md-footer__link--next" aria-label="Next: Training & Acknowledgements"> <div class="md-footer__title"> <span class="md-footer__direction"> Next </span> <div class="md-ellipsis"> Training & Acknowledgements </div> </div> <div class="md-footer__button md-icon"> <svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 24 24"><path d="M4 11v2h12l-5.5 5.5 1.42 1.42L19.84 12l-7.92-7.92L10.5 5.5 16 11z"/></svg> </div> </a> </nav> <div class="md-footer-meta md-typeset"> <div class="md-footer-meta__inner md-grid"> <div class="md-copyright"> <div class="md-copyright__highlight"> Built from <code>v0.9.56-4-g06c7f811</code> (commit <code>06c7f811</code>, 2026-09-09) — the same Markdown the repository ships. </div> </div> </div> </div> </footer> </div> <div class="md-dialog" data-md-component="dialog"> <div class="md-dialog__inner md-typeset"></div> </div> <script id="__config" type="application/json">{"base": "../..", "features": ["navigation.instant", "navigation.tracking", "navigation.top", "navigation.footer", "navigation.indexes", "toc.follow", "search.suggest", "search.highlight", "content.code.copy", "content.action.edit"], "search": "../../assets/javascripts/workers/search.6ce7567c.min.js", "translations": {"clipboard.copied": "Copied to clipboard", "clipboard.copy": "Copy to clipboard", "search.result.more.one": "1 more on this page", "search.result.more.other": "# more on this page", "search.result.none": "No matching documents", "search.result.one": "1 matching document", "search.result.other": "# matching documents", "search.result.placeholder": "Type to start searching", "search.result.term.missing": "Missing", "select.version": "Select version"}}</script> <script src="../../assets/javascripts/bundle.83f73b43.min.js"></script> </body> </html>