Serialized Track and Trace solution for Healthcare Devices

All countries are working at the same end-to eradicate the problem of drug counterfeiting and ensure medical equipment integrity throughout the supply chain. Many countries have their accountability requirements, but a globally harmonized approach is must follow for identification and tracking.

Unfortunately, we are already facing cases of counterfeiting of the COVID-19 related products. The US authorities have warned consumers about fake home-testing kits for the coronavirus. To tackle counterfeiting, the governments worldwide decided that implementing healthcare product serialization can help to significantly reduce the counterfeiting of pharmaceuticals.

Serialization is the process of assigning a unique serial number to each sealable pharmaceutical package, units can be identified and tracked throughout the entire pharmaceutical supply chain. Billions of IOT devices are reshaping the banking, health care, transportation, security and surveillance, retail, manufacturing, home tech, and consumer electronics industries. IoT manufacturing enterprises are often affected by siloed information systems and have lack of data standards, which do not let disparate data combined into a cost-effectively unified view. In a world progressively operated in the cloud, security is important, which makes the unique serialization of contributing elements necessary for the secure distribution of these smart devices. Urgent orders can also be expedited and rerouted, minimizing disruptions to production schedules and customer shipments

Details including the product origin, manufacturing, and expiry date, and the batch number could be associated and identified with the serial number, enabling Track and Trace from the production cycle to the consumer. Serialization and accountability can harmonize and standardize operational processes across manufacturers, distributors, warehouses, shipping carrier services, healthcare bodies, and pharmacies resulting in the synchronized workflow. It also helps in scanning and eliminating expired, damaged, or faulty products, ensuring that only genuine product reaches the consumer.

Deployment of serialization includes many options such as:

Commercial off-the-shelf (COTS) solutions

Several COTS solutions have been developed to comply with serialization and traceability requirements in healthcare sectors. As a result, companies seeking to comply with the new accountability regulations will not be creating internally developed solutions and experiencing the associated risk. Instead, particular parameters may be used to identify and choose commercial solutions that meet the specific requirements of each participant in the supply chain. COTS solutions are available for enterprise serial number management, packaging, and complying with country regulations.

Managed system

Managed systems are installed by the third-party software provider at their managed data center. The provider manages the software on the company's behalf but the data is secured. The software provider is responsible for the hosting of domain, maintenance, and updating of the system.

Cloud-based Systems

Cloud-based services may leverage internet services and IT equipment such as those offered by Amazon (Amazon Web Services ), and establish a community of trading partners and contract service providers. The Cloud-base serialization solution ensures real-time data synchronization among the counterparties within the company network. Cloud-based software does not require investment as it usually resides in a shared environment and the software license costs are low compared to the traditional solutions.

Edge-of-Network

A class of business system known as EDGE is often deployed to extend existing warehouse and distribution centers by capturing information obtained by scanners and sending this information to the existing warehouse systems and enterprise serial number management systems. These systems allow companies to work on their existing systems while adding new workflow and scanning devices for serialization and for handling serialized goods.

Companies need to use the experience and lessons learned from experts to avoid difficulties and expedite the deployment of solutions for serialization. Serialized devices and their components improve healthcare supply chain intelligence and control. Serialization may also be used as a market differentiator to gain consumer confidence in the authenticity of products