Rotronic Monitoring System alarm protocols were set up to ensure that critical alarms cannot be missed. Notifications can be triggered based upon the risk level
Four levels of alarming are available, activation is based on the defined risk:
1) Reminder for events that are non-urgent:
2) Warning for measured values that are out of limit (measuring point)
3) Alarming for measured values that are out of limit (measuring point)
4)Error for urgent hardware errors:
An overview of the alarms can be seen once the user has logged into the system. The user only sees the alarms relevant to their granted access rights. Each measuring point, if not conforming (green), will be attributed a different colour based upon the alarm status:
Critical alarms can also be set up with a warning before alarms are activated. Hysteresis and a delay can be set up for the warning, with upper and lower limits defined, as well as for the alarming.
All alarms are clearly shown in the audit trail indicating the unique ID for the event, the time and date of the alarm, information about what the alarm is, the target (the measuring point or device) as well as additional details.
Viewing the audit trail, it is easily possible to see if an alarm has been either acknowledged, or if it has ended. If an alarm is acknowledged, the time, date, name of the user who acknowledged the alarm as well as the alarm details are also saved and visible within the audit trail.
Within the audit trail, it is also possible to close or inhibit an alarm.
Alarms can be set up based upon either the measuring point, or via an alarm scheme. For alarms based upon the measuring point the choice of options is limited. Within an alarm scheme the user has the possibility to set a condition such as an active time as well as a warning. An action can be configured in both situations.
The various alarms can be notified in different ways and can be sent to just one or multiple users.
*The user’s telephone number must be added to the system.
1) Stand-alone data logger:
A data logger such as the TL-1D, can help meet the various requirements. However, a stand-alone data logger can potentially generate higher risks than a continuous monitoring system for several reasons including;
2) Building Management System (BMS):
A building management system or building automation system is a computer-based system that controls and monitors the buildings mechanical and electrical equipment such as ventilation, lighting, HVAC, power systems, and fire and security systems. It is possible to use the same hardware used within the BMS for the EMS requirements. Some BMS systems are also FDA CFR 21 Part 11/EU Annex 11 compliant and can be used as an environmental monitoring system for regulated industries.
Using a BMS system may help reduce the costs (only one measurement device, one software), however validating a BMS is more complicated and time consuming than validating an EMS and certain risks still exist:
3) Environmental Monitoring System (EMS):
An Environmental Monitoring System, as its name says, is a tool for monitoring the environmental parameters. The Rotronic Monitoring System is a GAMP©5 category 4 software (configurable software package) combined with category 1 hardware (standard hardware components) designed ground up for GxP applications. RMS helps 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.
In order to carry out the best initial risk management, Rotronic deliver within the GxP documentation package, not only all of the IQ/OQ and PQ documentation, but also the Rotronic Monitoring System Risk Assessment carried out based upon the Rotronic knowledge of the Rotronic Monitoring System.