Facilitating Partner-Onboarding with Level 4 Serialization Solutions

Implementing functional serialization and track&trace processes requires the alignment of many parties: brand owners, CMOs and the supply chain. Unless serial numbers are generated in-house, pharmaceutical companies have to retrieve them from authorities or manufacturers and, most likely, also will need to perform a certain amount of reporting back to government entities. With 3PLs, warehouses, and other supply chain partners, they will want to exchange logistics data, statistics, or transaction documentation in addition to mandatory tracking & tracing of single units. In the US for example, 3T documents (Transaction Information, Transaction History and Transaction Statement) are required at each transfer of ownership for DSCSA compliance. Therefore, there are many different systems and interfaces that need to be connected.

A sustainable, enterprise-level serialization solution needs to offer unlimited, secure and hassle-free onboarding capacities. However, as diverse as the many trading partners are, as diverse is the data that needs to be shared in terms of format and communication system.  In order to connect players as varied as production sites and contract manufacturing organizations, CPOs and logistics partners (shippers, warehouses), flexible serialization solutions should offer multiple ways of connecting. Only by adapting and being able to take into account the different players’ needs in terms of data exchange will pharmaceutical companies be able to create their own, viable and flexible network to which they can easily and securely add new partners of all sorts. Therefore, Adents Prodigi offers CMOS and pharmaceutical companies multiple ways to connect with partners either through secure webservices (REST API), secure FTPs (SFTP or FTPS) or shared Cloud repositories, based on the latest Microsoft Azure technology.  Secure access is guaranteed through multiple authentication steps so that only authorized parties can access and/or upload information into the system. Further, Prodigi provides automatic audit trails of all actions taken in the system, no  matter how many parties a pharmaceutical company has to hook up to its network.

Different types of information exchanged with a variety of different trading partners come in different data formats – prominent ones include CSV, EPCIS, or other standards – or even proprietary formats. While the use of standard exchange formats is recommended, pharmaceutical manufacturers need to be able to read all kinds of different data formats. Furthermore, they need to ensure that, during transfer, no data is inadvertently altered, lost or otherwise changed. Data integrity is crucial from a business perspective and even more so for regulated GxP companies adhering to GAMP guidelines.

Powerful solutions like Adents Prodigi  can not only read different data formats but “translate” said data before sending relevant information on to another system; all the while ensuring highest levels of data security and integrity at all times. Thus, Prodigi can deliver unlimited and secure data sharing capabilities up, down, and across the supply chain, providing a single platform that can handle data exchange between all entities concerned using their preferred data format and/or exchange protocol standard.