SecIdent - The secure serialization solution for the pharmaceutical industry
Pharmaceutical serialization
Legally compliant implementation of EU Directive 2011/62/EU for manufacturers (MAHs), contract manufacturers (CMOs) and reimporters
Since EU Directive 2011/62/EU came into force in 2019, prescription medicines must be serialized throughout Europe. The aim is to protect medicines from counterfeiting and ensure their traceability along the entire supply chain.
SecIdent is the powerful serialization solution for generating and managing cryptographically generated serial numbers. SecIdent offers maximum compliance, interoperability and (process) security so that the 2011/62/EU Directive can be implemented smoothly and in compliance with the law.
Advantages of serialization with SecIdent Pharma:
- Connection to the EMVS European Hub
- Compliance and process security through rights/roles, logging and approval processes
- Seamless validation documentation for every SecIdent Pharma release
- Simplified collaboration with existing and new partners thanks to the ability to exchange data with existing serialization systems
- Simple connection to any printing systems and lines
- Targeted release of batches and products
Overview of the serialisation process with SecIdent Pharma:
Full flexibility upwards and downwards
Different software systems are often used, especially in the collaboration between MAH and CMO. Thanks to numerous interfaces and configurable workflows, SecIdent offers smooth and secure data exchange with partners. Without major implementation effort on the part of the partner. All serialization data can be stored in SecIdent or retrieved via SecIdent, so that the entire serialization process can be controlled centrally in SecIdent.
SecIdent also enables seamless connection to existing printing and packaging systems. SecIdent transfers serial data and batch attributes such as GTIN, expiry date, batch number and serial number to the printing systems. After successful printing, the balancing program integrated in SecIdent reports back incorrect or unusable serial numbers. These are then automatically deactivated so that only valid serial numbers are registered in the EU hub.
External partners as well as printing and packaging systems are connected via configurable workflows. This ensures a high degree of flexibility, as connections can be implemented quickly and easily.
From the field: How Biokanol Pharma uses SecIdent
Do you already have a serialization provider and want to change?
A system change often sounds complicated and time-consuming. But it doesn't have to be! Our experienced experts have already replaced existing systems several times and will support you personally right from the start. A smooth transition is in everyone's interest.
Contact us now without obligation to outline a possible changeover concept together.
Exchange of data
Would you like to find out more about SecIdent Pharma or do you have questions about the EU directive? Then contact us now and arrange a free, no-obligation consultation.