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To operate validated applications, a qualified IT infrastructure is needed. The qualification of the infrastructure is becoming increasingly important as a result of the higher levels of training among inspectors and the growing integration of the application landscape (shared services). On the basis of a risk analysis, the GxP-related infrastructure elements are identified and qualified. A balanced strategy and the selection of a suitable technology allow for consistently and effectively qualified IT platforms to be made available. Despite high levels of complexity and networking in current computer systems, redundancy can be prevented as part of the IT infrastructure qualification process.
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Starting point
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The IT infrastructure required to operate validated applications must be qualified
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Central PLS, monitoring and SCADA systems require qualification
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Qualification of central IT components (such as a backup and restore environment)
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Qualification of GxP-related applications on Citrix servers
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Migration of the entire application portfolio from old to new server and client operating systems
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Our contribution
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Classification of individual infrastructure elements and resulting planning of qualification activities
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Technology consultancy on system architectures which are effective in terms of GxP
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Management, coordination and implementation of qualification projects
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Coordination with top level process and software validation activities
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Creating test plans and running tests
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Your benefit
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Reduction in qualification costs as a result of the classification and risk analysis
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Tailored procedure which is compliant with regulations and keeps qualification activities to a minimum
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GAMP SIG IT infrastructure experts
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Broad, practical IT expertise as an intermediary between QA and IT departments
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Customer-specific, pragmatic approach
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Overview of the entire validation effort prevents duplication of activities
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