Controlled Environments

Rotronic

The Rotronic Monitoring System (RMS) is one of the most flexible monitoring systems available on the market today. From small applications with one measurement point to larger systems with several thousand measurement points, RMS offers tailor-made solutions.

We are one of the largest design and build contractors for controlled environments in the Dutch life sciences, we know that monitoring your GxP compliant applications or controlled environment are critical. With RMS you have a GAMP©5 category 4 software solution combined with category 1 hardware. This wil help you monitoring your GxP compliant applications, looking into the critical quality attributes and monitoring the critical process parameters. On top of that, RMS is compliant to EudraLex Annex 11 and FDA 21 CFR Part 11.

Benefits

Rotronic Remote monitoring system offers numerous benefits, including:

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 points

SaaS

– Fast & Easy Rotronic Cloud solutions:

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!

– Exclusive Cloud:

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.

The main software features

FDA 21 CFR Part 11 & EU Annex 11 complaint
Alarm overview – see directly how many alarms are active and where it is coming from
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 – 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
Automatic validation scripts – for fast and effective OQ validation

Interested in a demo?

Please feel free to contact Lars.

Lars Smidt Sales Manager

06 53 80 71 33 lsmidt@kuijpers.nl