What is EMS?
Environmental Monitoring System (EMS) is an integrated solution to monitor values and data related to environmental conditions such as temperature, humidity and pressure. The EMS solution generally has two parts, hardware and software, which includes the ability to sample the parameters of environmental conditions, online display, transfer and storage of data, various and practical reports in the form of tables and charts, and many other features. This solution can also create audio, SMS and email alerts with the help of external software modules for comprehensive and continuous monitoring on the EMS system. Another of its capabilities is online analysis of the sampled values, and if a parameter goes out of the defined and desired range, it can be registered and tracked in the system, and it sends the necessary warnings according to the instructions.
The EMS solution is needed by the pharmaceutical, medical equipment, food, livestock and poultry industries, greenhouses and agriculture, aquaculture, pharmaceutical and food distribution network, laboratories, electronic industries, hospitals, transportation, oil and petrochemical industries.
The applications of EMS in the pharmaceutical industry
The EMS is used for monitoring and tracking data in production lines, cleanrooms in the pharmaceutical industry, raw material and product warehouses, chemical and microbiological laboratories and laboratory equipment such as cold rooms, refrigerators, chambers, incubators, and freezers. It can create an online and monolithic structure for sampling, displaying, reporting, and issuing various alerts on the controlled environments mentioned above.
Production Lines
Cleanrooms in the Pharmaceutical industry
Raw Material and Product Warehouses
Chemical and microbiological laboratories
Cold Rooms
Refrigerators, Chambers, Incubators, and Freezers
Gito EMS Solution Parts
Gito EMS has two main parts: electronic hardware and software. The hardware part of this system includes transmitters, sensors, and precision instrument for measuring and sampling environmental parameters such as temperature, humidity, and pressure, and its software part includes web-based monitoring applications and peripheral modules. Gito software has the task of sampling, displaying, reporting, analyzing and storing environmental parameters, and with the help of its peripheral modules, in addition to the mentioned tasks, it can also create voice, SMS and email alerts. All parts of the software have limited access levels, which makes access to settings and all data in a managed and controlled manner available to the system administrator. All requirements mentioned in existing documents such as CFR21 Part 11 are supported in the EMS system. Additional software modules include the following:
EMS Software Modules
The Plan Module
is used to display the data from the environmental monitoring system on a project site plan, along with highly useful and practical features. This module can easily implement complex and large nested plans using the Drill-Down capability, and it presents all data graphically to users.
The SMS Alert Module
can create a 24/7 real-time alerting system for the environment monitoring system. This module notifies users of critical conditions requiring immediate action according to the defined settings and instructions.
The Email Alert Module
establishes a borderless alert system over email for the environment monitoring system. It sends alert signals to users based on defined settings and scenarios, regardless of geographical or national limitations.
The Voice Alert Module
provides a traditional yet highly effective alert system for the environment monitoring system. Utilizing modern technology and powerful logic, it generates practical and effective alerts for users present at the factory during critical conditions.
The Calibration Module
monitors the status of calibration certificates for the equipment related to the environment monitoring system. It provides necessary notifications for appropriate actions, addressing the issue of managing calibration certificates for the EMS system.
The Deviations and CAPA Module
is a comprehensive sub-program for creating, tracking, and managing deviations and preventive and corrective actions in the pharmaceutical and medical equipment industry in a paperless and intelligent manner. This module can operate independently or as an integrated part of the EMS.
How is the Gito EMS implemented?
In the hardware section, Gito EMS transmitters support the Modbus RTU protocol and connect to the server via a CAT6 network cable according to project requirements and standards, forming one or more loops for data sampling and transfer. Using Modbus as the data transfer protocol allows for optimal implementation in cleanrooms, considering the special conditions of these spaces. Some benefits of this implementation method compared to current or voltage methods include:
Very low cost for creating the data transfer infrastructure without limitations on the monitored environment's characteristics.
Fast and easy implementation.
Ability to make changes, add, or remove devices on the transmitter network in the future.
Quick and easy repairs and troubleshooting.
Management and diagnosis of errors on the transmitter network.
No limitations on expanding or relocating transmitters in the future.
No restrictions on the size of the transmitter network or the monitored area.
After cabling and installing the transmitters, the hardware part is connected to the server with the help of a network converter, and by connecting to the software and after making settings, information is collected continuously according to the required schedule and stored in the database. The EMS software is designed on the web, where all the information and settings required by the EMS system can be accessed online in accordance with the defined rules, and the performance of the program users can be managed and tracked. This system intelligently analyzes the data and registers their status in 5 categories and takes appropriate actions in different situations according to the defined instructions. Diverse and analytical reports and quality printed versions are one of the advantages of using Ghetto's environmental condition monitoring system solution.
Gito has over a decade of experience implementing EMS in the pharmaceutical and medical equipment industries. To date, it has covered cleanrooms, laboratories, and warehouses for over 90 companies across various sectors of the pharmaceutical and medical equipment.
What are the supplementary documents for the Gito EMS?
All software and hardware components of the Gito EMS are designed according to GMP (Good Manufacturing Practice) requirements and the highest standards needed for the pharmaceutical industry. The EMS system designed by Gito supports CFR 21 Part 11, and all transmitters have traceable calibration certificates from reference laboratories. The EMS also includes IQ (Installation Qualification) and OQ (Operational Qualification) documentation and is prepared for executing PQ (Performance Qualification) protocols by third-party inspectors. Requirement of the mentioned documents will be announced at the customer's choice when submitting the URS.