Responsibility

The Rotronic Monitoring System is not a stand alone system and as of such, requires other elements to run.

Rotronic AG can fully support the RMS hardware and the RMS software and offers all services, this includes:

• Software Overview.
• Hardware Overview.
• Service Overview.

However, all other elements are not part of the Rotronic AG responsibility and are not supported by Rotronic AG. The list of other elements contains, but is not limited to the following:

• IT Infrastructure:

• Softwares:

• Measurement Devices:

• Maintenance:

IMPORTANT:

Due to the various options of Azure environments, Rotronic AG can only offer limited support when installing RMS within Azure.

In terms of compliance with FDA 21 CFR Part 11 & EU Annex 11, please see the RMS-WP for additional details.