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 EU Annex 11 and FDA CFR 21 Part 11. Rotronic AG design and manufacture RMS hardware and software based upon the GAMP©5 guidelines.
System Overview
The Rotronic continuous Monitoring System allows user to monitor anything from anywhere using an On-Premise or SaaS – Public Cloud software solution. Rotronic offer an SaaS – Exclusive Cloud option for any regulated customer that needs a validated SaaS software solution.
Assured data integrity:
All RMS measurement devices have an internal memory
Wired dataloggers with PoE, 24V and backup battery power
Wireless dataloggers with 24V and/or backup battery power
Encrypted LAN communication
SaaS solutions hosted within an ISO27001 certified datacenter
Secure data access via HTTPS connection and read/write rights only (no delete rights)
Integration of 3rd party devices:
Integration via analog input
Integration via MODBUS TCP protocol
Integration via API
Data Export possibilities:
Export data in .csv or .pdf format
Export data via API
Export data via OPC UA
