|
<< Click to Display Table of Contents >> Navigation: Service Overview > RMS Validation Guide |
The Rotronic Validation Guide is the overview of the GxP validation document templates created by Rotronic for the Rotronic Monitoring System (RMS) based upon Rotronic’s knowledge of the system. RMS, a GxP regulated computerised continuous monitoring system for critical control parameters, is a GAMP©5 category 4 software and category 1 hardware designed and manufactured in the Rotronic headquarters in Switzerland.
These document templates are not limited and can be adapted based upon end users finished product and application knowledge, based around a life cycle approach within a quality management system, scaleable life cycle activities and science-based quality risk management.
As described within the GAMP©5: A risk-based approach to compliant GxP computerised systems, the primary responsible for the validation of the continuous monitoring system is the regulated company and as of such is responsible for the review and approval of the finalised validation templates.