Validation Lifecyle Management

Asset & Configuration management

Functionality:

- Custom overviews of all (automated) systems

- Registration per system of:

• General information
• Roles and user organisation
• Components (hardware, equipment, software and documentation)
• Sub-systems
• Connected systems

- Baseline reporting

- Supplier management

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

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