What is Virtualisation?
- Definitions
- Physical platform foundation requirements
- Software for virtualisation
- Virtual platform options
Benefits of Virtualisation
- On demand infrastructure
- Speed of implementation
- Flexibility
Regulations apply to Virtualisation
- Annex 11 key points for consideration
- IT infrastructure shall be qualified
- In-house or hosted system
Qualification of IT Infrastructure
- General Principles of IT Infrastructure Qualification
- How to do qualification in a real environment vs.what to do in a virtual environment
- Qualification Activities
- Roles and responsibilities
- Installation and Testing
Planning of virtualisation projects
- User / Technical Requirements Specification
- Definition of the installation and deployment approach
- Definition of backup cycles and scenarios
- From a virtual server to a virtual farm
- Efficient planning
- Qualification planning
Compliance requirements for virtual systems
- IT Infrastructure Platform
- Server Platform Qualification
- Virtual Platform considerations
- Maintaining the Qualified State during operation
Overview of the virtualisation platform
- Platform components
- Platform operation
- Handling of SANs and VMs
Qualification of the virtualisation platform
- Requirements gathering
- Platform design
- Qualification planning
- Supporting processes
Making of a virtual data centre
- Specification of virtual data centre requirements
- Do I qualify or validate the hypervisor software?
- Building and qualifying a virtual data centre
Risk management
- ASTM E 2500-07
- Good Engineering Practice (GEP)
- Q 9 – Quality risk management
- GAMP 5, M 3
- GEP, Qualification, Validation reconciliation
- NIST-SP 800-30 Risk Management for IT systems
- HA-Op
Virtualisation of laboratory equipment / Desktop virtualisation
- Use cases for virtualisation in a laboratory environment
- Operating a virtual system
Show and tell: Virtualisation documentation
- Technical Requirements Specification
- Configuration Specifications
- Installation Qualification
Change & Configuration Management
- Regulatory requirements
- What is a change?
- Definitions of change management & configuration management
- An outline change management process
Disaster recovery planning
- Regulatory requirements for Disaster Recovery
- Disaster Recovery or Business Continuity Planning?
- Mitigating physical faults
- Triggers for the plan
- Testing the plan
- Keeping the plan up to date
From virtualisation to Cloud Computing
- What is Cloud Computing really?
- Abstraction of services and IT-infrastructure
- Virtualisation vs. Cloud Computing
- Recommendations for a GxP compliant Cloud Computing