Qualification of an IT infrastructure

Our customer had to prepare to have its premises approved by the FDA and needed to qualify its IT infrastructure.

Genipro was mandated to write the computer system life cycle (CSV) documents (URS-SDS-FRA-IOQ) as well as required standard operating procedures (SOPs) to qualify the IT infrastructure (Network, Hosting Servers and Domain Services), then to execute the qualification protocols and write the associated reports.

Since the existing installations had never been qualified, we first had to do a complete inventory of networking equipment and servers and then map the configuration of the installations. The drafting of specification documents (URS, SDS) based on best practices allowed us to identify and implement several improvement opportunities prior to qualification in order to improve the robustness and flexibility of the infrastructure while minimizing qualification efforts. In addition, the implementation of simple and effective SOPs allowed the required level of compliance to be achieved without overly burdening existing practices. Our know-how approach also allowed us to develop the GMP reflexes of IT administrators, who were not accustomed to evolving in a GMP environment where everything must be adequately documented. The client has since obtained FDA approval and we are proud to have contributed to its success.