More GxP systems use the facility network as its backbone and data resource. Unlike stand-alone systems that are easily definable and “validatable”, a network is a living, breathing, constantly morphing behemoth. 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. Read more..

What can we do for you?

We can help you in:

Revisiting design and segmentation of the network and making necessary
    modifications (e.g. segmenting GxP and non-GxP).

Developing procedures and training IT personnel. This may include procedures
    for:

• Change Control
• Validation
• Operations
• Inventory
• System Standards
• Procurement
• Retirement
• Installation Checklists (desktops, servers, routers, switches)
• Data Management (Backup, Records Retention, Recovery)

Formalizing Interfaces between IT and other facility departments (interfaces with
    HR, QA, management, Facility Security, other departments).

Establishing security procedures and security measures (both for securing internal
    and external access).

Establishing a Configuration Management Program.

Establishing the specifications and configuration of the network and its     components.

Qualification of the network and its components.

Qualification of the data backup, recovery and disaster recovery mechanisms.

Establishing procedures for ongoing maintenance of the network and its
    configuration.