‘Computer system’ is technically the hardware and software of a platform system.  Around that you need to add application software, ancillary equipment, people and procedures to form a ‘Computerized system’. This computerized system then runs within an organizations operating infrastructure (or on in the cloud if run within a cloud-hosted service environment). In a regulated environment, Underlying IT infrastructure must be qualified before making use of any GxP applications.

We are specialists in providing an end-to-end IT Infrastructure qualification services, considering the regulatory requirement fulfillment and industry best practices.

Our framework for IT Infrastructure qualification follows the below approach.