Existing SCADA PCs can be fitted a ZignX Medical unit to control access and provide secure system log-off when leaving the system.
Further, custom ZignX logger software can be installed on the SCADA computer which supervises the OS and SCADA applications for GMP critical events. The logger software runs unnoticed in the Windows background. It collates data with user action and system events and secures the information, e.g. on SQL database.
The logger software is highly suitable to secure non-compliant SCADA application and databases.
ZignX Medical can be used to secure access to existing PLC systems by controlling the Operating Panel from witch the PLC is operated.
The ZignX Medical unit are physically installed next to the operating panel and electrically connected to switches, buttons, and keys using a ZignX Auxiliary board.
In this way ZignX Medical controls access and monitor action on each connected switch, button, or key. These are allocated according to user rights configured by the customer. This is all managed from a ZignX browser application running on a connected PC.
The user will not be exposed to changes on the existing equipment other than he or she has to log-in on the ZignX Medical in order to operate the PLC. Actions made by the user are automatically recorded, time-stamped, and saved locally in the ZignX Medical or directly to a desired GXP network location.
The ZignX RFID technology consists of a stationary transceiver and active user RFID tags (token). Besides the wireless token capabilities the ZignX RFID technology can also determine range between tag and the transceiver.
With the ZignX RFID technology it is possible to configure zones that when crossed can trigger an action. ZignX Medical can then automate lock and un-lock of the operating panel when the user leaves/enters a defined working range. A non-activity log-out period can be implemented as well.
The standard 5¼” ZignX Medical enclosure can be replaced with an IP54 or IP65 approved enclosure.
The physical installation depends on the individual equipment and circumstances but several ways of integration or attachment can be offered both as wall-mount or cabinet- mount.
Combining Radio token with the dust and water proof casing will provide an effective solution with no need for open slots.
The ZignX Medical can be custom build, to fit special applications, equipment, or user requirements.
In these cases both hardware and software are utilized to achieve best technical solution. All developments are built as flexible modules that can easily be integrated but also later adjusted and reused in other solutions.
The customized projects (cup) are performed according to GAMP4 guidelines along with validation documentation, e.g. FS, DS, SAT, and Quality Plans.
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