QDM (Quality Document Manager) User Guide
Quality Document Manager - Electronic Document Management
Main Sections
Basic Features
Advanced Modules
About
Solution: Quality Manager - EDM Module (Quality Document Manager)
Main Features:
- Complete document lifecycle management
- Configurable validation workflows
- Distribution with acknowledgments
- Understanding assessments (questionnaires)
- Knowledge base (FAQ)
- External document referencing
- Mass distribution campaigns
- Team-Connect for collaborative work
- Automatic codification
- Customizable metadata
- Watermark management
Regulatory Compliance:
- ISO ISO 9001 (ISO 13485 Medical Devices)
- FDA 21 CFR Part 11 (Electronic Records/Signatures)
- FDA 21 CFR Part 820 (Quality System Regulation)
- EU MDR (Medical Device Regulation)
- EU GMP (Good Manufacturing Practices)
Glossary
This glossary defines the key terms and concepts used in Quality Document Manager.
📋 Document Statuses
| Term | Abbreviation | Meaning |
|---|
| Work | W | Document being drafted or revised, not yet applicable |
| Valid | V | Applicable document, official version in effect |
| Invalid | I | Archived document, obsolete, kept for historical purposes only |
| Under modification | - | Applicable document for which a new version is being revised |
🔄 Document Lifecycle
| Term | Description |
|---|
| Drafting | First step in document creation, content and metadata entry |
| Validation | Approval step(s) by designated validators (approver, verifier) |
| Implementation | Final action making the document officially applicable in the organization |
| Revision | Process of modifying an applicable document creating a new version |
| Archiving | Action placing a document in obsolete status while keeping it for historical purposes |
👥 Document Actors
| Role | Responsibility |
|---|
| Author | Person who creates and writes the document content |
| Approver | Person who validates the technical content of the document |
| Verifier | Person who verifies document compliance (optional depending on configuration) |
| Manager | Person responsible for document management over time (revisions, archiving) |
| Reader | User consulting an applicable document |
📤 Document Distribution
| Term | Description |
|---|
| Electronic distribution | Digital document distribution via the application to internal users |
| Paper distribution | Physical printed distribution to people without application access |
| External distribution | Secure sharing with recipients outside the organization (suppliers, customers) |
| Acknowledgment (AR) | Confirmation of document awareness by a recipient |
| Distribution with evaluation | Distribution accompanied by a comprehension questionnaire |
| Distribution campaign | Grouped distribution of multiple documents to a targeted population |
📝 Requests and Revisions
| Term | Description |
|---|
| Revision request | Formal request to modify an applicable document |
| Accept a request | Validation of the request, modification planned in the current version |
| Reject a request | Rejection of the request with rationale |
| Defer a request | Deferral of the request to the next version (N+1) |
| Major version | Significant revision incrementing the main number (1.0 → 2.0) |
| Minor version | Light revision incrementing the secondary number (1.0 → 1.1) |
🖥️ Interface Elements
| Term | Description |
|---|
| Navigator | Left side panel displaying folders and document views |
| Action bar | Toolbar containing available actions (Create, Edit, Distribute, etc.) |
| View | List of documents filtered by criteria (All documents, Applicable, etc.) |
| Portal | Customizable home page with quick access widgets |
| Widget | Configurable display module on the portal (My tasks, Recent documents, etc.) |
| Term | Description |
|---|
| Document sheet | Metadata entry form for the document (header) |
| Metadata | Descriptive information of the document (title, type, process, department, etc.) |
| Office documents | Section to attach source files (Word, Excel, PDF, etc.) |
| Attachments | Complementary files associated with the document (annexes) |
| Document links | Cross-references to other documents in the system |
⚙️ Advanced Features
| Term | Description |
|---|
| Document audit | Periodic review allowing to extend document validity without revision |
| Validity deadline | Date until which a document remains valid (typically 3 years by default) |
| Watermark | Automatic document marking (Controlled copy, Uncontrolled, Archived, etc.) |
| Team-Connect | Collaborative workspace for simultaneous work on a document in revision mode |
| Visual navigation | Graphic access to documents by process or mapping |
| Automatic codification | Automatic generation of document references according to predefined rules |
✅ Compliance and Traceability
| Term | Description |
|---|
| Audit trail | Unalterable history of all actions on a document (who, what, when) |
| Traceability | Ability to retrieve the complete history of a document and its versions |
| Electronic signature | Authenticated validation of a document compliant with regulations (21 CFR Part 11) |
| Workflow | Configurable document validation circuit with steps and participants |
Support
For any questions or assistance, contact:
- Your administrator
- Avanteam support