Infrastructure Qualification
More GxP systems use the facility network as its backbone and data resource. Furthermore, managing the security, the internal and external access, the data management and the overall configuration of a network and its components can be a daunting task. It is not sufficient to qualify the network alone. In most cases the IT infrastructure including procedures, practices and day-to-day operations need to be revisited and updated to ensure that the network and its components are maintained in a qualified state.
At Regulogix, we:
Segment GxP and Non - GxP components of the network
Assist in establishing procedures for: Handover, establishing and managing support services, performance monitoring, incident management, corrective and preventive action, operational change and configuration management, repair activity, periodic review, backup and resort, business continuity management, security management, system administration.
Establish the configuration and specifications of the network and its components
Qualify the network and its components
Qualify the data backup, recovery and disaster recovery mechanisms
Support the ongoing maintenance of the network and its configuration