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Monitoring Software

The Rotronic Monitoring System

The Rotronic Monitoring System (RMS) is a GAMP©5 category 4 software combined with category 1 hardware, helping users monitor their GxP compliant applications, looking into the critical quality attributes and monitoring critical process parameters, helping focus on patient safety, product quality and data integrity and compliant to EudraLex Annex 11 and FDA 21 CFR Part 11.

With RMS, monitoring of any parameter is simple with the core RMS hardware, but 3rd party integration is also possible via analogue and MODBUS TCP signals. Integration and extraction of data is also possible with RMS’s application programming interface (API).

Designed with pharmaceutical companies for pharmaceutical companies, the user-friendly interface makes the monitoring so easy, that the user only has to focus on their main tasks.

Your main benefits:

Compliance, audit and risk management
Time saving with automatic data collection and report generation
24/7 real-time centralised monitoring of all operations
All critical measurements in one system
Real time alarming for critical measuring point

Fast & Easy with the Rotronic SaaS Cloud solution

Forget the hassle of having to maintain your IT infrastructure and focus only on what is crucial to your application. You can setup multiple measurement points in various locations and access the data from any device with a browser and internet connection. Setup alarms and notifications to be sure that you are always informed of what is happening!

Remain compliant to GxP regulations with the Rotronic Exclusive SaaS Cloud solution:

Hosted on a high security and redundant datacentre with your own virtual server, you can run the Rotronic category 4 software in the cloud throughout each and every GxP compliant facility. Equip your worldwide facilities with the RMS hardware and access all of the data, including the audit trail, alarming and data analysis functions from a completely validated system.

Take advantage of your own IT infrastructure with the RMS on-premise solution:

Run the RMS software with an SQL database on your own IT infrastructure and have complete control over your entire system and comply to your own internal regulations, access the interface via most browsers.

THE MAIN SOFTWARE FEATURES:

Alarm overview – see directly how many alarms are active and where it is coming from
Receive alerts via interactive phone, texts and E-Mails
Audit trail to see exactly what happened and when
Monitor multiple locations – one system for all your monitoring locations
Input floor plans – get a real overview of the setup
Scalable – prefect for single points in small installations to thousands of points in worldwide installations
Automatic report generation
Integration of Rotronic and any third party hardware – analogue and digital
Create custom dashboards per user
FDA 21 CFR Part 11 & EU Annex 11 complaint
Automatic validation scripts – for fast and effective OQ validation
Continuously developing based around customer feedback

ADDITIONAL FEATURES:

Add an IP camera and add a snap shot to your alarm report
Calibrate all of your measuring points, possibility to adjust all of the Rotronic devices
Archive all measuring points that are no longer needed, keeping access to the data for as long as necessary
Save all your documents in the system: user manuals, data sheets, calibration certificates, SOP’s…