Virtual IT Systems in a GxP Environment

Virtual IT Systems in a GxP Environment

Berlin, Germany

Course No 16786


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Bob McDowall, R.D.McDowall Limited
Yves Samson, Kereon AG
Jürgen Schmitz, GSK


  • Get an overview of technologies discussed currently in the pharmaceutical environment and their potential fields of application,
  • Assess how to use and implement GMP requirements and provisions for virtual IT systems and, where appropriate, for cloud computing,
  • Learn more about the qualification and use of virtual systems in the GMP environment, and
  • Evaluate whether the use of virtual IT systems and cloud computing would be profitable for your company.


Virtual IT systems, cloud computing, and GMP; does this fit together? What are the advantages and disadvantages of these systems in a GMP environment? Are there any limits with their use?

The increasing use of virtual IT systems and cloud computing in a GMP-regulated environment is getting more and more discussed. The virtualisation of computer systems offers a great number of advantages, such as the simultaneous use of multiple operating systems, the simple and low-cost construction of test environments, and the improved utilisation of multi-core processors. 

Can these advantages also be used in a GMP environment and which aspects have to be specifically considered from the “GMP view” for virtual systems and cloud computing?

This event considers virtual systems and cloud computing from the GMP point of view and provides practical support to determine measures regarding the use of
such Systems.

Target Group

The event is aimed at managers in the pharmaceutical industry, suppliers and service providers that operate virtual IT systems and cloud computing in a GMP environment or intend to use them in the future.


Principles of IT qualification and validation
  • Regulatory requirements
  • Definitions
  • Validation and qualification
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

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