According to the regulations, medicines that require temperature management are required to be monitored and managed at an item level during transportation. Existing methods cannot meet the regulations and suffice the changing market demands.Have you heard of the strengthened regulation on pharmaceutical distribution?
Existing processes must be evaluated with clear standards in order to devise efficient alternatives.
Is it possible to collect and confirm temperature data
in the product or temperature-controlled container level?
Measuring temperature data on a temperature-controlled container level is mandated in the strengthened regulation. Moreover, the issuance of Proof of Delivery (PoD) with temperature records for each product is necessary during the shipping process. It is thereby necessary to check whether product level temperature management is possible within the current process.
Is there a risk of data loss?
Web-based temperature data loggers using WiFi or LTE network are highly affected by the surrounding networking environment. USB or 1st generation logging devices are at risk of data loss in case of device loss and malfunction. It is necessary to check whether the devices currently in use are suitable for the regulatory response.
Is it convenient to issue and store Proof of Delivery (PoD)?
Issuance and storage of Proof of Delivery (PoD) throughout the entire shipping, transporting, and warehousing process is necessary for the strengthened regulation. Proof of Delivery (PoD) with cumulative temperature records throughout the entire process, must be stored for 2 years. If the records are stored in paper documents, it may significantly increase the chance of records being damaged and require additional personnel and infrastructure to store the documents.
Is it possible to comprehensively manage the cold chain?
Thorough cold chain management starts with item level visibility. When using existing data loggers, the system requires temperature records of data loggers and products in the container to be compared on a one-by-one basis. It is not only a waste of time and human resources, mistakes and errors are likely to happen during the verification process. Checking whether the product level temperature management is possible within the existing process is needed.
Is it possible to instantly respond to the issue and manage the process?
After checking the temperature deviation, it is necessary to examine whether effective response and response process management are possible. In most cases, additional steps such as installing equipment or programs to check the temperature are required. An inefficient response could lead to issues of temperature deviation.
It ensures complete cold chain management by meeting regulatory requirements and pharmaceutical transportation demands.
We have variety of sensor device tailored to your needs. Every device is engineered with innovative technology and small and light, making it easy to be attached to the insulated box.
By integrating with customers database or management systems, our solutions are pre-equipped with product-level information. In this way, you can review and monitor a product's journey without having to do any cumbersome manual work mapping product data with each device.
Temperature records throughout the entire shipping, transporting, warehousing, and return/recall process are thoroughly collected without any blindspots. The patent-based data collection device secures reliable data that is neither dependent on the network connection nor has security concerns.
Our sensor devices are easy-to-operate and do not require additional training or equipment for data verification. Efficient field operation can reduce confusion and additional time at the destination.
Proof of Delivery (PoD) based on the temperature records and product information is automatically issued in a digital format. Data can be safely stored in a digital format, without the risk of data loss or damage.
When the temperature deviates, the return process can be carried out immediately. Moreover, the specific reasons for the return and the temperature records can be found and managed on the Management Console. Repetitive issues can be prevented in advance by identifying the causes of the returns and specific sections.
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