Pharma:
Intelligent Control of GxP Facilities
In the pharmaceutical industry, quality must be guaranteed. Digitalize your operations to avoid risks and increase productivity.
A system of systems
Intelligent control of GxP facilities refers to the automation and monitoring of facilities that comply with good practice regulations (GxP) to ensure the quality and safety of pharmaceutical, biotechnological, and medical device products.
This approach combines advanced technology, automation systems, and specialized software to ensure that manufacturing and production processes comply with the regulatory standards established by agencies such as the FDA and the EMA.
Do you know how an intelligent GxP facility system can help you?
Integration of all relevant GxP Variables.
- Integrate relevant GxP probes from the hygiene and environmental control system of clean rooms.
- Integrate particle counters.
- Integrate variables related to water plants and rings.
- Cleaning status of equipment or rooms.
HMI platform deployed throughout the plant, enabling other functions
- HMI on fixed or mobile equipment to deploy guided manufacturing and EBR functions.
- Manage the manufacturing context of each room or equipment.
- Deploy digital logbooks.
- Deploy a representation and tracking of mobile containers.
- Allows the creation of an operations control center.
Integration of production and measurement equipment.
- Integrate equipment in weighing booths, barcode guns, or label printers.
- Integration of IPC equipment, such as scales, durometers, calipers, or other measuring equipment.
- Integration with PLC or other machine controllers such as reactors, lyophilizers, autoclaves.
Capture your data in real time. To any equipment, machine, or instrument integrated into your system.
Comply in the best possible way with ALCOA+. Do you need to increase security, accuracy, and productivity by collecting sampling values from IPC equipment automatically?
Integrate your scales, barcode or QR guns, RFID readers or printers to ensure that your systems are equipped with mechanisms to automate marking, traceability, plant stock management, preparation of minor components, notification of events to the digital Logbook, etc.
The different machines or equipment you have in your facilities can be available in your system. Integrate Reactors, lyophilizers, autoclaves, plants, or water rings. You set the limit.
All relevant GxP variables in a single system. Maintain your systems, connect the signals you need.
Many companies in the sector have multiple information systems that allow recording values of variables that can be considered relevant GxP. However, these systems often have a number of shortcomings such as:
- They are not deployed in all areas of the plant.
- They are more designed to manage the facilities and not the GxP needs.
- The type of registration and data exploitation in these systems is not used, and the values of the probes are manually noted in the paper manufacturing guides.
The deployment of a GxP Facility Control system allows integrating the variables of those systems and managing them with the approach you need.
Record:
- All the signals that your users need in the same interface. Automatic alarms based on the specifications of the product or process in progress.
- Automatic recording of GMP variable values during the process (Data Integrity compliant).
- Automatic recording and association to the Batch of any alarm that may affect production. Calibration data of each probe or equipment.
- Digitize and quickly access the necessary information.
- Audit Trail and all the necessary features to be validated according to the latest versions of the GAMP.
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