The PST real-time monitoring solutions (RMS) are designed to help customers ensure compliance within regulated applications. Monitoring anything from temperature, relative humidity and other environmental parameters that PST can offer. The PST RMS offers a range of installation possibilities with both public and exclusive SaaS solutions, On-Premise or directly with a server provided and monitored by PST. Our systems ensure data integrity and help comply to FDA 21 CFR Part 11 and EU Annex 11 requirements.
We provide wireless, real-time monitoring of environmental data. Guardian is a secure, customizable solution for multiple applications across a wide variety of facilities including hospitals, laboratories, blood and tissue banks, biotech and more.
The Guardian hardware provides a single point of control for less-risk, features a fail-safe power source and is highly customizable:
Isensix Guardian technology provides unsurpassed benefits:
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.
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:
Integration of 3rd party devices:
Data Export possibilities:
Turnkey Solution Provider:
The services offered by PST Rotronic are setup following the GAMP©5 life cycle approach to improve GxP compliance efficiency.