{"id":5975,"date":"2024-02-13T14:00:19","date_gmt":"2024-02-13T13:00:19","guid":{"rendered":"https:\/\/staging.thescon.de\/?page_id=5975"},"modified":"2024-02-14T12:02:21","modified_gmt":"2024-02-14T11:02:21","slug":"infrastructure-qualification","status":"publish","type":"page","link":"https:\/\/www.thescon.de\/en\/infrastructure-qualification\/","title":{"rendered":"Infrastructure Qualification"},"content":{"rendered":"\t\t
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Infrastructure Qualification<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Applications that control or support business processes are an essential part of a business’s success. You have to ensure patient safety, product quality, and data integrity through the validation of these applications.<\/p>

Like any software, however, these applications depend directly on the underlying IT infrastructure. If the infrastructure is not or only insufficiently maintained, there exists a risk that the systems can or will be compromised or that data will be manipulated. For this reason, infrastructure qualification is part of GxP compliance and is explicitly required from a regulatory perspective (Annex 11).<\/p>

Increasing complexity, virtualization, outsourcing in the form of infrastructure, platform or software as a service (XaaS), present major challenges to the qualification of the infrastructure. The initial stages of infrastructure qualification can be difficult and raise many questions:<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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