3.6 UNICORN control system
Introduction
ÄKTAprocess is controlled by UNICORN software.
UNICORN can save established processes as methods. Methods include the instructions
necessary for process operation and documentation.
UNICORN includes a comprehensive system of user access levels to be set, limiting the
operations a given user may perform on ÄKTAprocess. To operate the system in a safe
way, you should limit access to the system to those qualified and trained in its operation.
The UNICORN software wizards and the UNICORN manual package provide complete
instructions for programming and for using the software for process control.
System operators are responsible for designing methods which conform to standard
operating procedures and Good Manufacturing Practice procedures.
UNICORN is technically compatible with all relevant sections of FDA 21 CFR Part 11.
A part 11-system assessment checklist is available on request through the local GE
Healthcare representative.
Prerequisite knowledge
At least basic knowledge of UNICORN is required to operate ÄKTAprocess safely.
This manual does not cover how to use UNICORN.
Information on how to use UNICORN can be obtained from the UNICORN manuals.
Contact your local GE Healthcare representative for advice if required.
System networks
UNICORN can be installed on a stand-alone computer to control locally attached systems.
Multiple computers can view the output data from one system.
ÄKTAprocess Operating Instructions 29-0252-49 AA 77
3 System description
3.6 UNICORN control system
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