MODULAR AND FLEXIBLE ONLINE MONITORING SYSTEM
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 Annex 11 and FDA 21 CFR Part 11.

NOTIFICATIONS
RMS allows the user to configure each measuring points with a warning (pre-alarm) and an alarm. Both the warning and the alarm can be configured with a delay (for example for differential pressure) as well as a hysteresis. Notification repetitions can be setup to ensure that critical events are not forgotten, warnings and alarms can be sent via E-Mail, SMS and telephone call.
ISO 14644-2 offers quite an insight into alert and action levels as well as the generation of too many alerts. RMS will allow for specific users to adapt the various levels to ensure that optimal levels are maintained: all changes are documented within the audit trail, stating the user who made the changes, the time stamp and the values before and after the change.

DEVIATION MONITORING
All level excursions are easily and quickly visible within RMS. Each event can be acknowledged and commented so that in case of an audit all relevant information is available. RMS has been built up on a digital level, so any hardware changes will also be visible within the RMS audit trail.

DATA ANALYSIS
The data analysis tool within RMS can help both during the classification phase as well as during the monitoring phase. Critical locations as well as representative locations can be defined and correlations can be made between the various parameters as well as operational state of the cleanroom (at-rest or in operation) and the cleaning phases to review the performance of the installation that might affect the cleanliness levels. 
The data analysis tool can also be used to help determine the alert and action levels based upon the strategies defined within ISO 14644-2.

DALCUALTIONS IN RMS
RMS offers a range of additional calculations to help the users get the most out of their system. ISO 14644-2 states that for example the differential pressure limits can be delayed avoiding too frequent notifications. RMS not only offers a delay function but also a PT1 filter, the PT1 filter is a low pass filter that dams noise and spikes. The PT1 filter function is based on the system step response - an answer of a system (system output) to a heaviside step function on a system input (e. g. a 0 -> 1 step function). The mathematic model describes a System Step Response that follows an e-function. Output level(t) = 1-e^(-t/T). Airflow and air flow velocity can also be calculated within RMS.

CALIBRATION MANAGEMENT
RMS offers a calibration management tool. On one side, all devices can be calibrated within RMS, offering a complete traceability based upon the ISO 21501-4 expectations. Calibration reports can also be generated and documented within RMS.

The ISO 21501-4 requires a minimal yearly calibration, the reminder function within RMS will help define and remind when a device requires a new calibration.

MEASUREMENT PARAMETERS
Rotronic will integrate any particle counter into RMS, via the 4…20mA output or the MODBUS TCP output. Rotronic offer a range or wired and wireless dataloggers for all measurement parameters. Rotronic offer a range of analog and digital sensors. Third party MODBUS TCP devices and analogue devices can also be easily integrated.

Environmental monitoring: relative humidity, temperature, differential pressure, oxygen, carbon dioxide…

Compressed air monitoring: dew point, oxygen…