Digi HygroClip DI digital interface instruction manual Compliance with FDA 21CFR Part II and Gamp

All devices within an RS-485 multi-drop should use the same baud rate. Communication within the RS-485 multi-drop will not work when the devices are configured with different baud rates.

HygroClip DI-4 and DI-4-WL: after changing the baud rate in Device Manager, you should also reflect the change in the configuration of the internal Digi International module used by the device to connect to the LAN. See Baud rate compatibility requirements.

7.3Compliance with FDA 21CFR Part II and GAMP

When used together with the validated ROTRONIC HW4 software – Professional Edition; the HygroClip DI complies with the FDA / GAMP requirements regarding electronic records and electronic signatures. HW4 is designed to keep track of configuration changes and of any probe adjustment. HW4 also keeps track of user events (main operations performed by each user) and self-events (software problems). The records generated by HW4 are protected, have an electronic signature and can be cross referenced one with the other.

7.4Device protection

This function is used to protect the HygroClip DI against malicious users. This is particularly useful when the device is exposed to the Internet. When a device is protected, the following functions are disabled:

•All Device Manager functions

•Log function programming (HygroLog NT)

•Probe adjustment

•Deletion of files from the device memory card (HygroLog NT)

Warning:

The following HW4 automatic functions are also disabled for the protected device:

•Automatic address change when adding new devices to a RS-485 multi-drop network

•Automatic synchronization with the HW4 PC clock

The procedure used to protect or unprotect a device is described, using the HygroClip DI as an example:

Select the device in the device tree and open Device Manager > Device Information: