The "European Stakeholder Model" (ESM) is supported by the European Federation of Pharmaceutical Associations (EFPIA) and is based on the concept that the serial number of every prescription drug must be verified at the time of dispensing (Point-of Dispensing Verification). The technical implementation is carried out via the "European Medicines Verification System" (EMVS). The national systems and databases are then linked to this model.
The SecIdent® Pharma Coding System enables complex applications for serialization in pharmaceutical companies: During the development of SecIdent, the main focus was on easy integration: the web service can be connected to local systems such as ERP and SPS applications. Via the API interface, the software automatically exchanges counterfeit-proof codes with databases such as SecurPharm and EMVO (European Hub). External service providers, partners and suppliers are connected via a single serial data platform, so that data transfer via potentially unsafe media (physical, e-mail) is completely eliminated. The software has been validated and is in operation at reference customers in the pharmaceutical industry.
Within the framework of the EU Counterfeit Protection Directive, SecIdent® is a powerful L3 system for the creation and management of serial numbers for pharmaceutical serialization. This software for serialization is the ideal solution for medium-sized producers, contract manufacturers and parallel/reimporters. Especially medium-sized companies in the pharmaceutical industry benefit from a SaaS application, as it simplifies the data exchange between contract manufacturer and customer. Great advantages for pharmaceutical companies are the low operating costs and high scalability of the solution. The SecIdent Pharma Coding System is optimized for the diverse requirements of the pharmaceutical supply chain:
Serialization and data exchange with the verification system SecIdent® provides secure transmission of serialization data to national and international verification databases.
The features and versions of SecIdent are based on individual industry requirements. An upgrade is possible at any time without losing any data that has been created up to that point. The Professional and Professional Plus versions extend the range of functions.
|System Properties and Functions||Basic||Professional||Professional Plus||Pharma Coding||Interact||Interact Plus|
|Fail-safe operation through high-availability webservice||●||●||●||●||●||●|
|Multi-language management system||●||●||●||●||●||●|
|High security code generation for individual serialization||●||●||●||●||○||○|
|Code application on the product or packaging (e.g. via laser engraving, RFID, DataMatrix, QR-Code, ff.))||●||●||●||●||●||●|
|Clear authentication process (authentication)||●||●||●||●||●||●|
|Multilevel authorization concept for the administration||●||●||●||●||●||●|
|Performance of contractual and lawful obligations via serialization (compliance)||●||●||●||●||●||●|
|Support via ITS ticket-system||●||●||●||●||●||●|
|Alert Function by sets of rules and incidence control||–||●||●||○||○||○|
|Audit group dependent response page (differentiated authentication)||–||●||●||○||○||○|
|Create additional external attributes for batches||–||●||●||●||○||●|
|Export statistics to relevant production data (market intelligence) by XML/XSD||–||●||●||○||○||○|
|Usage of all functions for customer loyalty with variable response pages (e.g. for product recall, lottery)||–||●||●||○||○||○|
|Grey market detection||–||●||●||–||–||–|
|Schnittstellen und Plus Module||Basic||Professional||Professional Plus||Pharma Coding||Interact||Interact Plus|
|Interface German Hub securPharm||–||–||–||●||○||○|
|Interface to EMVS (European Hub)||–||–||–||●||○||○|
|Interface to your ERP-System||–||–||○||○||○||○|
|Direct supply chain integration via API||–||–||○||○||○||○|
● = Feature / function included in the license