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Evaluate LQMS
LQMS Known Limits
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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="../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="../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="../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="../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="../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="../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="../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="../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="../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="../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 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"> What a review policy controls, and what an empty grant means </span> <span class="md-nav__icon md-icon"></span> </label> <a href="./" class="md-nav__link md-nav__link--active"> <span class="md-ellipsis"> What a review policy controls, and what an empty grant means </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-section-a--workflow-defaults-for-new-documents" class="md-nav__link"> <span class="md-ellipsis"> 1. Section A — Workflow defaults for new documents </span> </a> </li> <li class="md-nav__item"> <a href="#2-section-b--standing-permissions-on-this-type" class="md-nav__link"> <span class="md-ellipsis"> 2. Section B — Standing permissions on this type </span> </a> </li> <li class="md-nav__item"> <a href="#3-empty-means-nobody--and-it-says-so" class="md-nav__link"> <span class="md-ellipsis"> 3. Empty means nobody — and it says so </span> </a> <nav class="md-nav" aria-label="3. Empty means nobody — and it says so"> <ul class="md-nav__list"> <li class="md-nav__item"> <a href="#when-a-button-is-missing-read-the-box" class="md-nav__link"> <span class="md-ellipsis"> When a button is missing, read the box </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item"> <a href="#4-what-is-refused-and-what-only-warns" class="md-nav__link"> <span class="md-ellipsis"> 4. What is refused, and what only warns </span> </a> </li> <li class="md-nav__item"> <a href="#5-the-toggles-beside-the-grants" class="md-nav__link"> <span class="md-ellipsis"> 5. The toggles beside the grants </span> </a> </li> <li class="md-nav__item"> <a href="#6-saving-is-honest" class="md-nav__link"> <span class="md-ellipsis"> 6. Saving is honest </span> </a> </li> <li class="md-nav__item"> <a href="#7-where-to-start-the-house-four-eyes-set" class="md-nav__link"> <span class="md-ellipsis"> 7. Where to start: the house four-eyes set </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item"> <a href="../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="../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="../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"> <a href="../../traceability-workspace/" class="md-nav__link"> <span class="md-ellipsis"> The Traceability Workspace </span> </a> </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-section-a--workflow-defaults-for-new-documents" class="md-nav__link"> <span class="md-ellipsis"> 1. Section A — Workflow defaults for new documents </span> </a> </li> <li class="md-nav__item"> <a href="#2-section-b--standing-permissions-on-this-type" class="md-nav__link"> <span class="md-ellipsis"> 2. Section B — Standing permissions on this type </span> </a> </li> <li class="md-nav__item"> <a href="#3-empty-means-nobody--and-it-says-so" class="md-nav__link"> <span class="md-ellipsis"> 3. Empty means nobody — and it says so </span> </a> <nav class="md-nav" aria-label="3. Empty means nobody — and it says so"> <ul class="md-nav__list"> <li class="md-nav__item"> <a href="#when-a-button-is-missing-read-the-box" class="md-nav__link"> <span class="md-ellipsis"> When a button is missing, read the box </span> </a> </li> </ul> </nav> </li> <li class="md-nav__item"> <a href="#4-what-is-refused-and-what-only-warns" class="md-nav__link"> <span class="md-ellipsis"> 4. What is refused, and what only warns </span> </a> </li> <li class="md-nav__item"> <a href="#5-the-toggles-beside-the-grants" class="md-nav__link"> <span class="md-ellipsis"> 5. The toggles beside the grants </span> </a> </li> <li class="md-nav__item"> <a href="#6-saving-is-honest" class="md-nav__link"> <span class="md-ellipsis"> 6. Saving is honest </span> </a> </li> <li class="md-nav__item"> <a href="#7-where-to-start-the-house-four-eyes-set" class="md-nav__link"> <span class="md-ellipsis"> 7. Where to start: the house four-eyes set </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/topics/review-policies.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="what-a-review-policy-controls-and-what-an-empty-grant-means">What a review policy controls, and what an empty grant means<a class="headerlink" href="#what-a-review-policy-controls-and-what-an-empty-grant-means" title="Permanent link">¶</a></h1> <p><em>Audience: quality managers configuring a project.</em></p> <p>A <strong>review policy</strong> is set per project, per document type, on <strong>Scope configuration → Review policies</strong> (the gear icon). It answers two different questions, and the box is split into two visually distinct sections because conflating them is what used to confuse people.</p> <p><img alt="The review-policy box" src="scene:scope-config" /></p> <h2 id="1-section-a--workflow-defaults-for-new-documents">1. Section A — Workflow defaults for new documents<a class="headerlink" href="#1-section-a--workflow-defaults-for-new-documents" title="Permanent link">¶</a></h2> <p>Three role groups — <strong>Authors — who may submit</strong>, <strong>Reviewers — who must approve</strong> with the number of approvals required from each, and <strong>Releasers (may release)</strong>.</p> <p>These are a <strong>template</strong>: they are <em>copied onto each new document</em> of this type at creation, where they can still be edited, and they freeze while that document is in review. Changing them affects future documents; documents that already exist keep the bindings they were born with.</p> <h2 id="2-section-b--standing-permissions-on-this-type">2. Section B — Standing permissions on this type<a class="headerlink" href="#2-section-b--standing-permissions-on-this-type" title="Permanent link">¶</a></h2> <p>Three rows in action language — <strong>Revise & periodic review</strong>, <strong>Revoke</strong>, <strong>Cancel</strong> — enforced directly, live, on every document of this type. No copying, no per-document override.</p> <p>Rejecting is not a row here: <strong>whoever may approve may reject</strong>. That is a reviewer's right, not a separate permission.</p> <h2 id="3-empty-means-nobody--and-it-says-so">3. Empty means nobody — and it says so<a class="headerlink" href="#3-empty-means-nobody--and-it-says-so" title="Permanent link">¶</a></h2> <p>Every transition is <strong>always on screen</strong> with its role multi-select. A row with no role is granted to <strong>nobody</strong>, and the box renders that as an explicit <em>"⚠ nobody"</em> chip rather than as an innocuous blank.</p> <p><img alt="A type nobody may act on" src="scene:review-box-nobody" /></p> <p>There is no such thing as "not configured, therefore open". If a permission does not name a role, it is denied to everyone, for every document of that type, until someone grants it. This is the single most important sentence in this topic: an earlier model left ungranted transitions silently open, and the day that changed, a project locked itself out of revising its own documents without any screen ever saying so.</p> <p>A type with <strong>no stored policy at all</strong> is the same state written out: empty workflow groups, so new documents of it cannot be submitted, and no standing permission granted to anyone.</p> <h3 id="when-a-button-is-missing-read-the-box">When a button is missing, read the box<a class="headerlink" href="#when-a-button-is-missing-read-the-box" title="Permanent link">¶</a></h3> <p>This is the flip side of the same property, and it is worth knowing before you meet it: a <strong>half-configured policy locks people out</strong> of every transition nobody was granted, and it does so without complaining. Nothing is broken — the rows were simply never filled in — but the person who wanted to revise, revoke or cancel a document just finds the action absent, with no screen explaining why.</p> <p>So when somebody reports <em>"the button is missing"</em>, the first place to look is this box, on that document's type: the <strong>⚠ nobody</strong> markers are the answer. A row marked <em>nobody</em> is exactly the action that person cannot perform. Grant it to the role they hold, save, and the action appears.</p> <h2 id="4-what-is-refused-and-what-only-warns">4. What is refused, and what only warns<a class="headerlink" href="#4-what-is-refused-and-what-only-warns" title="Permanent link">¶</a></h2> <p>Saving runs one check, and it has tiers.</p> <p><strong>Refused (the save does not happen).</strong> A <strong>prescribing</strong> type whose <strong>Revoke</strong> row is empty. The server says why, in words, naming the type and the standard:</p> <blockquote> <p>'<Type name>' is a prescribing document type, so its 'Revoke' permission must grant at least one role: a released procedure that nobody can revoke cannot be withdrawn when it becomes obsolete (ISO 13485 §4.2.4). Grant it to the role that owns document control in this project — typically the Quality Manager — and save again.</p> </blockquote> <p><img alt="A refused save" src="scene:review-box-blocked" /></p> <p><strong>Warned loudly, but saved.</strong> Each of these is occasionally intended, so the system says what you are choosing rather than deciding for you:</p> <ul> <li><strong>Revoke empty on a record or template type</strong> — such a document can never be withdrawn from force. Intended only for a record series that is by design never revoked.</li> <li><strong>Cancel empty on any type</strong> — nobody may cancel a draft or in-review version; only a version's own author can abandon it, so anyone else's abandoned draft stays in the list forever.</li> <li><strong>Revise & periodic review empty on any type</strong> — no one may record a periodic review or start a revision, so a released document of this type can never be updated through the periodic-review loop.</li> <li><strong>A grant to a role with no active holder</strong> — the permission exists but nobody can exercise it. Flagged inline, with the role named.</li> </ul> <p>The same findings appear on the project's <strong>setup check</strong> chip afterwards, worded identically, so re-reading the configuration can never contradict what the save just told you.</p> <p><img alt="The setup check with gaps" src="scene:scope-config-setup-gaps" /></p> <h2 id="5-the-toggles-beside-the-grants">5. The toggles beside the grants<a class="headerlink" href="#5-the-toggles-beside-the-grants" title="Permanent link">¶</a></h2> <p>Unlike the role lists, these apply <strong>live to every document of the type</strong>:</p> <ul> <li><strong>Four-eyes review</strong> — a round's submitter can never be its approver. Enforced at approval time.</li> <li><strong>Release mode</strong> — <em>Explicit</em> (a releaser releases) or <em>Automatic</em> (the last approval releases; still held back by unresolved comments or a missing questionnaire).</li> <li><strong>Block release while review comments are unresolved</strong> — the comment quality gate.</li> <li><strong>Release flow (records)</strong> — <em>Standard</em> or <em>Direct (single-person release from draft)</em>, available only on record types. The box carries the house doctrine above it: <em>before configuring direct release, ask whether the record — and the process step producing it — is needed at all.</em> See the <a href="../../documents-lifecycle/">lifecycle chapter</a> §4a.</li> </ul> <h2 id="6-saving-is-honest">6. Saving is honest<a class="headerlink" href="#6-saving-is-honest" title="Permanent link">¶</a></h2> <p>The box saves as a whole and tells you when it has unsaved changes. If a save <strong>fails</strong>, the box resets to the stored configuration and says so — <em>"Not saved, and the box was reset to the stored configuration:"</em> followed by the server's reason. A failed save never impersonates a successful one.</p> <h2 id="7-where-to-start-the-house-four-eyes-set">7. Where to start: the house four-eyes set<a class="headerlink" href="#7-where-to-start-the-house-four-eyes-set" title="Permanent link">¶</a></h2> <p>If you are configuring a type for the first time and have no reason to deviate, use the <strong>house four-eyes set</strong>. It is the grant set the <a href="../setup-wizard-lanes/">setup wizard's</a> lane presets write, so a project born through the wizard already has it:</p> <table> <thead> <tr> <th>Row</th> <th>Granted to</th> </tr> </thead> <tbody> <tr> <td><strong>Authors (may submit)</strong></td> <td>Document Author, Quality Reviewer, Quality Manager</td> </tr> <tr> <td><strong>Reviewers (must approve)</strong></td> <td>Quality Reviewer — <strong>alone</strong></td> </tr> <tr> <td><strong>Releasers (may release)</strong></td> <td>Quality Reviewer, Quality Manager</td> </tr> <tr> <td><strong>Revise & periodic review</strong></td> <td>Document Author, Quality Reviewer, Quality Manager</td> </tr> <tr> <td><strong>Revoke</strong></td> <td>Quality Manager</td> </tr> <tr> <td><strong>Cancel</strong></td> <td>Document Author, Quality Manager</td> </tr> </tbody> </table> <p>With <strong>four-eyes review on</strong> and <strong>release mode <em>Explicit</em></strong>.</p> <p>The shape behind it: anyone who may author may also hand their work in; approval is the one narrow gate, held by the quality function alone; document control — revoking a released document, cancelling somebody else's abandoned draft — sits with the Quality Manager; and everyone who works on documents may revise them, because revision is authoring, not authority. The author is in the <em>Cancel</em> row for their own convenience, not for control: a version's own author may always abandon it anyway.</p> <p>Note that the Quality Manager is deliberately <strong>not</strong> in the approval row. Each role in <em>Reviewers</em> carries its own number of required approvals, so adding a second role there does not widen the pool — it <strong>adds a second mandatory signature</strong>. A Quality Manager listed as a reviewer would have to approve every document personally before it could be released. Keep the approval row as narrow as the review you actually want.</p> <p>This is a <strong>starting point, not a rule</strong>. Every row is editable, before and after the wizard writes it; adjust it to the roles your project actually staffs, and re-read §4's warnings as you do.</p> <hr /> <p><em>Governing decisions: ADR-0096 (transition permissions — always visible, deny unless granted; the two sections; the tiered save validation), ADR-0064 (per-document workflow roles — the copy-then-independent template in section A), ADR-0091 (release modes — direct single-person record release), ADR-0054 (unstaffed-role detection — the inline "no active holder" warning), ADR-0073 (the scope-configuration surface). Regulatory frame: ISO 13485 §4.2.4 (control of documents — withdrawal of obsolete documents).</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="../provisioning-birth-path/" class="md-footer__link md-footer__link--prev" aria-label="Previous: How a new organization and project are born"> <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"> How a new organization and project are born </div> </div> </a> <a href="../setup-wizard-lanes/" class="md-footer__link md-footer__link--next" aria-label="Next: The setup wizard: the lanes, and what it writes"> <div class="md-footer__title"> <span class="md-footer__direction"> Next </span> <div class="md-ellipsis"> The setup wizard: the lanes, and what it writes </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>