Infrastructure Qualifcation
For each validated application there has to be a list of all qualified components that are used for that application. Audit Authorities and GMP regulations (Annex 11, GAMP) ask for a Qualified Infrastructure nowadays. An IT infrastructure is a complex system of IT components working together to enable the user to “use the applications” that run on it. To qualify an infrastructure the infrastructure has to be split up in parts; the “infrastructure components”. The process of building and changing these components has to follow strict Quality requirements
An IT infrastructure is a complex system of IT components working together to enable the user to ‘use the applications’ that run on it.
The validated status of GxP applications that are dependent upon an underlying IT Infrastructure can be compromised if the IT Infrastructure is not maintained in a demonstrable state of control and regulatory compliance. Data integrity can also be affected by problems related to IT Infrastructure, leading to increased risks which can in turn affect product quality or patient safety.
We QTech Infosolutions have expertise to qualify your Infrastructure. We help companies to qualify all IT Infrastructures , data Centres , Servers , Workstation etc.
