RC - VLM

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 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