Components (hardware, equipment, software and documentation)
Sub-systems
Connected systems
- Baseline reporting
- Supplier management
Validation Master Plan (VMP)
Functionality:
- Create and maintain VMP content
- Workflow for document creation, review and approval
- Alerting for periodic update
- Complies with VMP-requirements of Eudralex Annex 15
Validation & Qualification – main functionality
- Configurable workflow for deliverable creation, review and approval
- Generate an appropriate validation process for a given system
- Dashboard with overview on / access to all required deliverables for a given system
- Content creation and management for all validation deliverables
- Integrated forward and backward traceability between all content objects that are part of the given validation process (e.g. business processes, requirements, risk items, test cases etc.)
- Automated document generation, review and approval
- Test management and registration, incl. defect handling and action monitoring
- Design assistance
- Management reporting
Maintain Compliance
Change Control
Functionality:
- Generate an appropriate approach for a change
- Content creation and management
- Automated document generation, review and approval
- Design assistance
Monitor Compliance
- Periodic review
- Standard reports on:
Compliance state
Running processes
Overdue tasks
Not completed tasks
All scheduled events
- Customized reports
Key Performance Indicators (KPI’s) like actual time and effort for the implementation