Virtual IT-Systems in a GxP Environment
Speakers
Bob McDowall, McDowall Consulting
Yves Samson, Kereon AG
Jürgen Schmitz, GSK
Objectives
- 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 if your company
Background
Virtual 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.
Programme
IT Infrastructure in a GxP Environment
- Regulatory requirements
- Definitions
- Validation and qualification
- Definitions
- Physical platform foundation requirements
- Software for virtualisation
- Virtual platform options
- On demand infrastructure
- Speed of implementation
- Flexibility
- Annex 11 key points for consideration
- IT infrastructure shall be qualified
- In-house or hosted system
- IT infrastructure platform
- Server platform qualification
- Virtual Platform considerations
- Maintaining the qualified state during operation
- 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
- 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
- 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
- Specification of virtual data centre requirements
- Do I qualify or validate the hypervisor software?
- Building and qualifying a virtual data centre
- Use cases for virtualisation in a laboratory environment
- Operating a virtual system
- 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
- What is cloud computing really?
- Abstraction of services and IT infrastructure
- Virtualisation vs. cloud computing
- Recommendations for a GxP-compliant cloud computing
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more
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