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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--nested"> <input class="md-nav__toggle md-toggle " type="checkbox" id="__nav_11" > <div class="md-nav__link md-nav__container"> <a href="../../user-guide/" 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="false"> <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="../../user-guide/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="../../user-guide/administration/" class="md-nav__link"> <span class="md-ellipsis"> Administering an LQMS Installation </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/diagrams/" class="md-nav__link"> <span class="md-ellipsis"> Diagrams </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/documents-lifecycle/" class="md-nav__link"> <span class="md-ellipsis"> Documents & the Lifecycle </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/exports/" class="md-nav__link"> <span class="md-ellipsis"> PDF Exports & the Audit Pack </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/obligations/" class="md-nav__link"> <span class="md-ellipsis"> Recurring Obligations </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/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="../../user-guide/review-comments/" class="md-nav__link"> <span class="md-ellipsis"> Review Comments </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/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="../../user-guide/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="../../user-guide/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="../../user-guide/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="../../user-guide/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="../../user-guide/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 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policy controls, and what an empty grant means </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/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="../../user-guide/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="../../user-guide/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="../../user-guide/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="../../user-guide/trace-links/" class="md-nav__link"> <span class="md-ellipsis"> Trace Links & the Suspect Cycle </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/traceability-workspace/" class="md-nav__link"> <span class="md-ellipsis"> The Traceability Workspace </span> </a> </li> <li class="md-nav__item"> <a href="../../user-guide/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"> </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/architecture/12_glossary.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="12-glossary">12. Glossary<a class="headerlink" href="#12-glossary" title="Permanent link">¶</a></h1> <table> <thead> <tr> <th>Term</th> <th>Definition</th> </tr> </thead> <tbody> <tr> <td>QMS</td> <td>Quality Management System</td> </tr> <tr> <td>LQMS</td> <td>Living Quality Management System — this project. "Living": evidence derives from the running system instead of drifting beside it (ADR-0100); the English carrier of the auditor's "ein gelebtes QMS"</td> </tr> <tr> <td>SOP</td> <td>Standard Operating Procedure</td> </tr> <tr> <td>WI</td> <td>Work Instruction</td> </tr> <tr> <td>Record</td> <td>Evidence document produced by executing a QMS process in a project</td> </tr> <tr> <td>Mandator</td> <td>Customer for whom projects are run, or the operating organization itself; data separation boundary. Classified internal vs. external (ADR-0010)</td> </tr> <tr> <td>Internal mandator</td> <td>The operating organization represented as a mandator; its QMS operations run in project scopes like any product (ADR-0010)</td> </tr> <tr> <td>Scope</td> <td>Workspace holding documents/records: global base scope, mandator scope, or project scope; behavioral differences are declarative capability flags (ADR-0002)</td> </tr> <tr> <td>Copy-on-derive</td> <td>Adopting a document from a higher scope by copying the full content of a released version with a provenance link; later base releases notify, never change, the copy</td> </tr> <tr> <td>RLS</td> <td>PostgreSQL Row-Level Security — database-enforced tenancy policies (ADR-0002)</td> </tr> <tr> <td>Document life cycle</td> <td>Fixed state machine DRAFT → IN_REVIEW → RELEASED → REVOKED, plus terminal CANCELLED (ADR-0003, ADR-0024), with configurable review policies</td> </tr> <tr> <td>Content-freezing transition</td> <td>A life-cycle transition that serializes and hashes a version's content into immutable blob(s) (e.g. submit, release) (ADR-0001/0017)</td> </tr> <tr> <td>Capability flag</td> <td>A declarative attribute on a scope type that varies behaviour (e.g. may-be-derive-source) instead of type-conditional code (ADR-0002)</td> </tr> <tr> <td>Step-up re-authentication</td> <td><strong>Planned — NOT implemented.</strong> <em>Designed as:</em> fresh re-authentication required at a sensitive action (e.g. signing), beyond the active session (ADR-0014, ADR-0011). No code exists today — zero occurrences of <code>acr_values</code>, <code>step-up</code> or <code>stepup</code> outside documentation (verified 2026-08-18). It arrives with electronic signatures</td> </tr> <tr> <td>Review policy</td> <td>Per-scope/document-type configuration: required role approvals, four-eyes rule, transition permissions, release mode (ADR-0003)</td> </tr> <tr> <td>Catalog</td> <td>Globally curated set of definitions (roles, document types) activated per scope as a subset (ADR-0004)</td> </tr> <tr> <td>Role activation</td> <td>A scope opting in to a catalog role; staffed via role assignments, one user may hold several roles (ADR-0004)</td> </tr> <tr> <td>Document ID</td> <td>Human-readable, immutable identifier <code>[<SCOPE-CODE>-]<TYPE-PREFIX>-<DESIGNATOR></code>; designator is an auto-sequence number or a slug (per-type numbering mode); derived documents inherit the source ID unchanged, locally created ones carry the scope code — collision-free by construction (arc42 §8.1)</td> </tr> <tr> <td>Scope code</td> <td>Short, unique, immutable code of a scope (e.g. <code>P42</code>, <code>ACME</code>) used as ID prefix for locally created documents; the global scope is unprefixed</td> </tr> <tr> <td>Four-eyes rule</td> <td>The author of a document version cannot count as one of its approvers; enforced by default</td> </tr> <tr> <td>ADR</td> <td>Architecture Decision Record</td> </tr> <tr> <td>ISO 13485</td> <td>Standard for medical device quality management systems</td> </tr> <tr> <td>IEC 62304</td> <td>Standard for medical device software life cycle processes</td> </tr> <tr> <td>arc42</td> <td>Template for architecture documentation</td> </tr> <tr> <td>RAG</td> <td>Retrieval-Augmented Generation</td> </tr> <tr> <td>CSV <em>(false friend — two senses)</em></td> <td><strong>(1) In the process/ADR layer:</strong> Computerized System Validation — validating that a software tool is fit for its intended use (GAMP 5, ISO 13485 §4.1.6); the generated per-release validation package of ADR-0061 (realization deferred). <strong>(2) In the code and the UI, and this is the only sense a reader meets there:</strong> comma-separated values — the RFC-4180 export renderer <code>Csv</code>/<code>CsvExport</code> behind the trace-chain, validation-matrix and GSPR-conformity downloads. Always say which one is meant</td> </tr> <tr> <td>OIDC</td> <td>OpenID Connect — the identity protocol LQMS delegates authentication to (ADR-0011)</td> </tr> <tr> <td>BFF</td> <td>Backend for Frontend — the server runs the OIDC code flow and holds the tokens in an encrypted token-state cookie (no server-side session store); the browser holds only that opaque cookie (ADR-0011, ADR-0028)</td> </tr> <tr> <td>Permission</td> <td>System-defined, closed-set named capability; roles are configurably mapped to permissions, granted within the scope a role is held and its descendants (ADR-0012)</td> </tr> <tr> <td>Electronic signature</td> <td><strong>Planned — NOT implemented.</strong> <em>Designed as:</em> a signed attestation on a document version (signer + meaning + timestamp + content-hash binding + re-auth proof), manifested with name/date/meaning; Part 11 / Annex 11-capable (ADR-0014). Nothing of it ships today: no signature table or column in any migration, no signing service, no signature task kind (verified 2026-08-18). REQ-SIG-001…009 are tracked as <code>future</code> in the <a href="../../traceability/matrix/">traceability matrix</a>; release approval records state explicitly that they are unsigned pending this capability. <strong>Do not read this row as a present capability</strong></td> </tr> <tr> <td>Part 11 / Annex 11</td> <td>FDA 21 CFR Part 11 and EU GMP Annex 11 — regulations governing electronic records and electronic signatures</td> </tr> <tr> <td>Effective date</td> <td>The date a released version comes into force (<code>effective_from</code>); may differ from the release date. The currently effective version is derived by date (ADR-0015)</td> </tr> <tr> <td>Periodic review</td> <td>A scheduled re-review of a document confirming it is still valid; recorded as evidence and resets the review clock, or initiates a revision (ADR-0015)</td> </tr> <tr> <td>Retention period</td> <td>The defined period a record must be kept (e.g. MDR 10/15 years); during it, retention overrides the right to erasure (ADR-0016)</td> </tr> <tr> <td>Legal hold</td> <td>A suspension of disposal for a scope or record set regardless of retention expiry (ADR-0016)</td> </tr> <tr> <td>Disposal</td> <td>The deliberate, authorized, audited destruction of records at end of retention; recorded in a disposal record (ADR-0016)</td> </tr> <tr> <td>FADP / GDPR</td> <td>Swiss revised Federal Act on Data Protection (nDSG) and EU General Data Protection Regulation (ADR-0016)</td> </tr> <tr> <td>Content part</td> <td>A named file within a document version, stored as an immutable blob; a version may have several (ADR-0017)</td> </tr> <tr> <td>Manifest hash</td> <td>The hash over a version's ordered content parts that binds the whole version for reproducibility and signing (ADR-0017)</td> </tr> <tr> <td>RPO / RTO</td> <td>Recovery Point Objective (max tolerable data loss) and Recovery Time Objective (max tolerable downtime); LQMS targets RPO ≤ 24h, RTO ≤ 1 business day (ADR-0018)</td> </tr> <tr> <td>Task</td> <td>An actionable, tracked work item assigned by role/user, auto-resolving on completion (ADR-0019). The kind vocabulary is closed — the <code>task.type</code> CHECK, currently defined by V063 — and holds twelve values: <code>APPROVAL_REQUIRED</code>, <code>REVIEW_REQUESTED</code>, <code>REJECTED</code>, <code>PERIODIC_REVIEW_DUE</code>, <code>DISPOSAL_DUE</code>, <code>SOURCE_UPDATED</code>, <code>SOURCE_REVOKED</code>, <code>VALIDITY_EXPIRED</code>, <code>ACKNOWLEDGEMENT_REQUIRED</code>, <code>TRAINING_REQUIRED</code>, <code>CERTIFICATION_RENEWAL_DUE</code>, <code>OBLIGATION_DUE</code>. There is <strong>no</strong> signing task kind (see <em>Electronic signature</em>)</td> </tr> <tr> <td>Notification</td> <td>An informational message to a user about a relevant event; distinct from a task (ADR-0019)</td> </tr> <tr> <td>Translation-of</td> <td>A relationship linking a document to its source-language document; each translation is independently controlled (ADR-0020)</td> </tr> <tr> <td>Authoritative-language source</td> <td>The document designated as the governing language version, to which translations link (ADR-0020)</td> </tr> <tr> <td>Relationship</td> <td>A typed, directional link <strong>between documents</strong> (the <code>relationship</code> table, ADR-0021); provenance & translation are instances. The closed vocabulary holds nine values: <code>derived-from</code>, <code>translation-of</code>, <code>supersedes</code>, <code>superseded-by</code>, <code>references</code>, <code>related-to</code>, <code>satisfies</code>, <code>verifies</code>, <code>instantiated-from</code>. Two of them — <code>derived-from</code> and <code>instantiated-from</code> — are <strong>system-managed</strong>: written by copy-on-derive and by template instantiation, never by a user. Distinct from a <em>trace link</em> (next row), which is a different table with a different vocabulary</td> </tr> <tr> <td>Trace link</td> <td>A typed, directional link <strong>between keyed trace items</strong> inside controlled documents (the <code>trace_link</code> table; ADR-0077/-0078, renamed from <code>requirement_link</code> by V057). Its own closed vocabulary holds eight values: <code>verifies</code>, <code>satisfies</code>, <code>derives-from</code>, <code>references</code>, <code>mitigates</code>, <code>implemented-by</code>, <code>validates</code>, <code>complies-with</code>. Note the near-homographs across the two vocabularies — relationships use <code>derived-from</code>, trace links use <code>derives-from</code></td> </tr> <tr> <td>Acknowledgement</td> <td>A controlled record that a user read/acknowledged a document version, optionally gated by a simple questionnaire; required roles per document drive who must acknowledge (ADR-0022)</td> </tr> <tr> <td>MCP</td> <td>Model Context Protocol</td> </tr> <tr> <td>Tree record / PM_DOC</td> <td>The authoritative content of a document version: a ProseMirror document JSON tree (the TipTap schema — Milkdown/Crepe was superseded by ADR-0059; <code>@tiptap/*</code> is the only editor dependency shipped), stored as an immutable blob. <code>PM_DOC</code> is its <code>content_format</code> marker and, since ADR-0058, the only format written. Markdown is derived from it, not stored as the record (ADR-0057/0058)</td> </tr> <tr> <td>Projection</td> <td>The derived, deterministic, canonical Markdown of a version, computed from the tree record by the shared projection function at save time and frozen as the version's text body part. Serves the human-readable record copy, text diffs, the AI/MCP surface, and full-text search (ADR-0057 §2)</td> </tr> <tr> <td><code>content_format</code></td> <td>The per-version format marker: <code>PM_DOC</code> (tree record) or <code>MARKDOWN</code> (v1 markdown-as-record). Only <code>PM_DOC</code> is written since ADR-0058; <code>MARKDOWN</code> is retained as unused schema headroom for a possible future coexistence layer</td> </tr> <tr> <td>Projection fixed point</td> <td>The correctness property pinning the projection: <code>project(import(project(t))) == project(t)</code> — once a document reaches the projection's canonical form, re-importing and re-projecting leaves it unchanged. A standing test over the repurposed fidelity corpus (<code>npm run projection</code>, ADR-0057 §2)</td> </tr> </tbody> </table> <p>TBD: extend as terminology emerges (especially document vs. record vs. file).</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="../11_risks_and_technical_debt/" class="md-footer__link md-footer__link--prev" aria-label="Previous: 11. 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