New York Area
Our Pharmaceutical client is experiencing a rapid growth and as a result they realize that they need to update the IT Infrastructure Qualification process to accommodate the anticipated on-going expansion.
1. IT Infrastructure Qualification Process Design: Define Qualification Requirements, Policies and Procedures – Identify areas that need process improvement and create the IT Policy under which the IT Infrastructure Qualification activities are performed, the Standard Operating Procedures that govern the activities, and the IT forms that will be used to document the installation of equipment; define Risk Categories for all component types according to GAMP 5 Levels.
2. IT Infrastructure Qualification Implementation: Assist with the application of the updated processes and apply a compliant Qualification Process to Infrastructure – Inventory and detail current network components, subsystems, processes and tools in use by IT; Assign GAMP 5 Risk Levels to all components by type in the inventory; complete Installation Qualification Forms for GAMP 5 Level 1 components; Create Qualification documentation for complex components that are determined to be higher than Level 1. Apply the updated IT Infrastructure Qualification process to a High Priority System as a pilot, from which other systems can be modeled against.
3. Integration With Current Configuration Management – Identify touch points in Installation Qualification process where the Configuration Management Database (CMDB) needs to be updated when installation or changes occur; Coordinate Qualification activities with current Change Management procedures; Integrate automatic detection of configuration changes with Qualification and Change Management procedures; Develop procedure for documentation updates when changes are detected.
Azzur proposes to include the services of a senior consultant to provide, direction and quality oversight of deliverables, for the Azzur Group team and to assist the client in developing communication and training materials in support of the IT Infrastructure Qualification.