The Rotronic Monitoring System (RMS) is a GAMP®5 category 4 software combined with category 1 hardware , designed to support users in monitoring GxP compliant applications. RMS helps track critical quality and monitor critical process parameters, ensuring a focus on patient safety, product quality and data integrity. It helps regulated companies comply with EudraLex Annex 11 and FDA 21 CFR Part 11 regulations. Rotronic AG provides RMS as a validated software, with each version released under a formal change control process.
As of software version 2.7, Rotronic AG assesses all bug fixes using the GAMP®5 risk assessment methodology.
This rating is determined based on Rotronic AG’s best knowledge of applicable regulations, R&D processes, and GxP-relevant applications. However, Rotronic AG cannot guarantee that this assessment fully aligns with each user’s specific expectations. Therefore, Rotronic AG recommends that users independently review all changes in accordance with the regulatory requirements, their application, and their standard operating procedures.
In general, no features are removed between software versions. As such, functional specifications remain unchanged, with only improvements and new features added. All software changes are developed, tested, and validated in alignment with GAMP®5 recommendations.
Based on this information, RMS users should determine whether a system revalidation is required.
Please find below the meaning of the version naming.
Prior to the RMS V2.4.0, the version overview is explained below:
•1: Major version number.
•X.1: Minor version number.
•X.X.1: Bug fix or specific update version number.
•X.X.X.1: Year and day of compilation (for example: 16270 was released on the 270th day of 2016).
As of and including the RMS V2.4.0, the version overview is explained below:
•1: Major version number.
•X.1: Minor version number.
•X.X.1: Bug fix or specific update version number.
•X.X.X.1: Year and build number for the specific version (for example: 23070 was the build 70, released in 2023).
Each change is documented as an RMS-XXX number. As of the software V2.4.0, the RMS-XXXA numbers are also included.
The various versions of the Rotronic Monitoring System are listed below:
•V2.7
Software Support: Rotronic AG will support a specific software version for a period of 3 years until after the MS6 or as of software V2.4.0 as of the phase 3 date of the following software version. The release dates are all visible within each individual software release note.
Update: 17.03.2025.