One of the most critical functions of a GMP monitoring system, aside from recording parameters, is ensuring timely responses to deviations and nonconformities in the production process through audiovisual alerts to personnel.
To alert personnel, various visual elements on the terminal of the control station are used, including local signal lights, traffic lights, and signal panels installed in production areas. Audible devices such as buzzers, speakers, etc., as well as notifications via email, messaging apps, SMS, and similar means, are also employed.
The process of alerting personnel is typically multi-stage and consists of the following steps:
Event Generation
An event in an electronic system can be defined as the identification of certain circumstances or the fulfillment of specific conditions. There are various programmatic mechanisms for implementing events, ranging from system/hardware interrupts at the lowest level to event generation and handling (catching) in high-level object-oriented programming languages. Additionally, there are systems where the event concept is realized through the processing of different status flags.
The lifecycle of an event in an electronic system can be described as follows:
All events in a GMP monitoring system can be classified into two categories: process events and system events.
Process Events
Process events include various circumstances related to changes in system-monitored parameters and the routine operation of the monitoring system, such as:
System Events
System events encompass circumstances related to various failures or deviations in the operation of the monitoring system itself, such as:
It is critical that the GMP monitoring system not only generates but also logs (records) all critical/significant events from a GMP perspective. Since system failures may render event generation and logging functions inaccessible, these capabilities must be duplicated. This ensures that in the event of any module failure, event information is preserved and recorded.
Message Generation
Not every event in the GMP monitoring system requires operator notification. Additionally, an event may lack the necessary accompanying information or instructions for the system to determine how to notify the operator. Therefore, the system requires an additional mechanism to interpret events and generate appropriate messages.
The message generation algorithm analyzes events and creates corresponding messages, adding necessary accompanying information and text comments for the operator, as well as providing the system with instructions on the message category, audiovisual signals to be used, and other relevant details.
Once generated, the message is sent for execution (i.e., the operator alert is triggered).
Typically, messages can be classified into the following three categories:
Alert Output
The Human-Machine Interface (HMI) system reads messages from the relevant queue or system log and displays the corresponding alerts for the operator. These alerts can be presented on the main control station terminal, local terminals, signal lights, beacons, panels, buzzers, loudspeakers, or sent through email, messaging apps, or via SMS to mobile phones.
Quitting (Acknowledgment) of Messages and Event Deactivation
The quitting (acknowledging) function for messages is necessary for several reasons:
When acknowledging a message, the GMP monitoring system should log the following details: the name/account of the user acknowledging the message, the time of acknowledgment, and, if applicable, the user's comment or reason for the acknowledgment.
Additionally, the system should temporarily suppress the repeated generation of the same message if the original conditions that triggered the event and message still persist. This suppression should deactivate once the original conditions cease (i.e., the event is deactivated or reset), allowing the message to be generated again if the conditions reoccur.
Tarqvara GMP Monitoring System
In the Tarqvara GMP monitoring system, the comparison of channel parameter values with established limits and the control of various system functions for errors are performed every second. When certain conditions are met, corresponding messages (alarms/warnings) are generated.
Each message can have the following status:
The lifecycle of a message related to a parameter proceeds as follows:
Messages related to system events do not have a delay timer and are generated immediately.
In the case of emergency shutdowns of software modules or the system, or in the event of communication failures between the server and sensors, an emergency message is generated immediately after operations are restored.
Warning and alarm messages, as well as system failure messages, are also displayed on local signal panels in the affected areas as visual and audible alerts.
Some events generated in the Tarqvara GMP monitoring system do not trigger message generation but are still logged in the Audit Trail.
See also:
GMP Monitoring Systems
Tarqvara GMP Monitoring System
Audit Trail
IT Solutions / GAMP / Data Integrity (RDI)
Computerized Systems Validation (CSV)