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This chapter is designed to clarify what the Rotronic Monitoring system is, from the user level to the IT manager level. Based upon the details from this chapter, the IT manager should be able to define if RMS is compliant to the internal IT requirements.
With the details described within the practical answer, the IT manager should be able to gain an understanding of where and why the user requires such an environmental monitoring system.
The technical answer offers the IT manager a deeper insight into all of the various elements of RMS.
Furthermore, a description of the necessary tools to setup RMS via the Cloud solution are listed.
The Rotronic Monitoring System is a modern continuous monitoring system that embraces open architecture and interoperability as well as providing a compliant system for validated applications.
•RMS Software and Device Flow Diagram.
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.
•The Pratical Answer for End Users, Project Managers and Smaller Organisations.
•The Technical Answer for IT Project Managers, System Integrators and Cyber Security Managers.