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Annexes - Quality Document Manager

Reference Documents​

The following documents constitute the fundamental references for configuring and using the quality document management module.

DocumentVersionDateDescription
Functional Analysis Questionnaire1.1-Document management v1.1
Test Plan1.1-Document management v1.1

Glossary​

Definitions of technical and functional terms used in the module.

General Concepts​

TermDefinition
GEDElectronic Document Management
QDMQuality Document Manager
QMDOCQuality Manager Document (former name of the module)
WorkflowDocument validation workflow

Tools and Components​

TermDefinition
Process StudioAvanteam's process-oriented application modeling workshop
SynctoolAvanteam component and configuration injection tool
Graph BuilderGraphical report creation assistant
Team-ConnectCollaborative workspace allowing multiple people to exchange and work on the same document

Technical Fields​

TermDefinition
ValidityNative field indicating a document's validity state (W/V/I)
QVersionDoingTechnical field managing banner display and action buttons
IDPreviousVersionTechnical field containing the ID of the previous version for archiving
Ged_GestionnaireDocument manager - Person responsible for the document

Actions and Functionalities​

TermDefinition
QM_QD_MA"Implementation" workflow action
RevisionHistoricDetail table displaying revision history
Revision modeMicrosoft Office mode for tracking document modifications

Naming Convention​

Follow these conventions to ensure system consistency and maintainability.

Fields​

Use mixed case for field names.

  • Correct example: Ged_Gestionnaire
  • Incorrect example: GED_GESTIONNAIRE

Actors​

Actors use prefixes to indicate their type.

  • Fields: F- prefix (example: F-Verificateur)
  • Roles: R- prefix (example: R-QDMAdmin)
  • Business actors: No prefix (example: Rédacteur, Chef du rédacteur)

Value Lists​

Lists follow these prefixes.

  • Module-specific lists: QDM prefix (example: QDM Document Type)
  • Generic lists: No prefix (example: OuiNon, Processus, Secteur)

Workflow Actions​

Module workflow actions use a standardized prefix.

  • Required prefix: QM_QD_
  • Example: QM_QD_MA (Implementation)

Compatibility and Standards​

Supported Browsers​

The module works on the following browsers.

  • Internet Explorer 9, 10, 11
  • Microsoft Edge (all versions)
  • Google Chrome (recent versions)
  • Mozilla Firefox (recent versions)

ℹ️ Note: Use recent versions to benefit from the latest improvements and security fixes.

Compliance Standards​

Quality Document Manager complies with the following quality and regulatory compliance standards.

  • ISO 13485 (Medical devices)
  • FDA 21 CFR Part 820 (Quality System Regulation)
  • FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures)
  • EU MDR (European regulation on medical devices)

Integration Modes​

Several integration options are available for communicating with other systems.

  • Web Services API
  • XML, XLS, or ETL file exchange
  • ODBC or SQL queries

Existing Data Migration​

Import Tool​

Avanteam provides a specialized import tool for migrating existing documents to Quality Document Manager.

Import Method​

The import follows this process.

  • Via Excel or CSV index files
  • Bulk import of documents and their metadata
  • Respect for existing classification structure
  • History preservation (if available)

Required Effort​

Document migration presents no difficulty. This workload is generally included in the Avanteam service offering.

💡 Tip: Prepare your data in advance to facilitate import.

Recommendations for Successful Import​

Follow these best practices to ensure error-free import.

  • Prepare a complete index file with all metadata
  • Verify data quality before import
  • Perform a test import on a sample
  • Schedule import outside production hours

⚠️ Warning: Validate data in a test environment before importing to production.

Contacts and Support​

Contact Points​

For any questions regarding Quality Document Manager configuration or usage, contact one of the following resources.

  • Avanteam Support: [To be completed]
  • Functional Administrator: [To be completed]
  • Project Team: [To be completed]

Support Resources​

Several resources are available to help you progress.

  • Online documentation
  • Quality Manager FAQ (March 2022)
  • Application-integrated help center
  • Process Studio training for administrators

💡 Tip: Consult the FAQ before contacting support to quickly resolve common questions.

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