Cloud Serialization Solutions to Solve the Data Management Challenge

The life of a serialized product begins with the generation of a unique serial number. A single pharmaceutical company usually handles hundreds of thousands of serialized units or even cases and pallets every year, which means millions of serial numbers plus product master data, events to report and huge amounts of information to be securely stored, indexed and exchanged with authorities and supply chain partners or CMOs. Scalable solutions like Cloud serialization solutions can be the answer to the data management challenge.

This means that, over time, serialization and track & trace processes generate a huge amount of data and pharmaceutical manufacturers therefore need to have sufficient, secure and reliable data storage capacities. Data will need to be indexed and accessible for authorized personnel. Secondly, a highly regulated environment such as the pharmaceutical industry requires data integrity at all times. Data integrity is very important from a business perspective and even more so for regulated GxP companies adhering to GAMP guidelines. This means, you need to secure the storage of this vast amount of data but also ensure strict access controls. Furthermore, this requires a high level of security during data transfer if you think of all the stakeholders you will need to onboard. And there are many entities serialization data will need to be exchanged with: from MAH to CMO or production site and back, with supply chain partners and even, where required, authorities or dispensers like pharmacies and hospitals.