Integritest Exacta Filter Integrity Test Instrument
Operating and Maintenance Manual Networking 175
NETWORKING THE EXACTA INSTRUMENT
Reasons for Networking the Instrument
The Exacta can be networked for the purpose of data backup or storage. The Exacta can be
accessed from a networked PC and desired files and test records can be accessed and
downloaded.
Validated recipes can be distributed to multiple Exacta units. Recipes generated on one Exacta
can be transferred to other Exacta units* throughout a facility.
Hardware
All Exacta units come standard with a network port. To utilize this option, order one cable/
adapter (catalog number XITXP194) for each system that you wish to network. This item
includes the Networking Guidelines publication (catalog number XITXSP194 G). This
publication can also be ordered separately.
This cable/adapter is utilized by the instrument because it is ingress protected (water tight) on
the instrument side. The other end terminates with a standard RJ45 Ethernet connector for
ease of setup.
The embedded Windows NT platform provides the administrator with standard TCP/IP network
setup features and protocol as supplied by Microsoft.
21 CFR Part 11 Compliance
If the Exacta unit is used in a networked environment, additional precautions must be taken to
ensure 21 CFR Part 11 compliance. The administrator must follow all 21 CFR Part 11
guidelines to establish compliance for networked units. Due to the multitude of network
configurations and their complexity it is not feasible to outline standard guidelines. Therefore,
establishing a network and all connections to a network are outside of Millipore’s scope of
supply. Validation of the network, network connections, and network functionality are also
outside of Millipore’s scope of supply. Please contact your local administrator for all network
questions.
Caution: 21 CFR Part 11 compliance can be affected if the unit is networked. The user
/organization is responsible to ensure and maintain Part 11 compliance for both networked
and non-networked units.
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