Serialization at Biokanol Pharma
The managing directors of Biokanol Pharma report on how SecIdent is used for secure serialization for different MAHs.
For MAHs, CMOs, and reimporters
Secure serialization for the pharmaceutical industry
SecIdent Pharma is the powerful serialization solution for generating, distributing, and registering cryptographically generated serial numbers throughout the EU.
It offers maximum (process) security, compliance, and interoperability with partners and production lines (level 2 to 5). This allows you to implement Directive 2011/62/EU smoothly and in compliance with the law using a single system.
Overview of pharmaceutical serialization
In safe hands from start to finish.
- Integrated connection to the EMVS European Hub
- Easy connection to any printing equipment and lines
- Smooth collaboration with existing and new partners through automatic data exchange with existing serialization systems
- Targeted sharing of batches and products to partners
- Guaranteed unique cryptographically generated serial numbers
- Compliance and process reliability through rights/roles, logging, and approval processes
- Complete validation documentation for every release of SecIdent Pharma
Dr. Rainer Gerkens
Head of Pharmaceutical Serialization
Pharmaceutical functions
Everything you need for secure serialisation. All from one source.
SecIdent comes with all the features you need to ensure your socialization process runs smoothly from start to finish without any major implementation effort. And all this with maximum security and compliance.
- EMVS EU-Hub
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Convenient, fully integrated connection to the European Hub of the European Medicines Verification System. Onboarding included.
- Zusammenarbeit mit Partnern
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Reibungslose Zusammenarbeit mit Partnern möglich unabhängig von deren Systemen oder Unternehmensgrößen.
- Accurate accounting
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The accounting program integrated into SecIdent provides a clear overview of the printed serial numbers.
- Seamless printer connection
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Easy-to-use interfaces allow for full flexibility across a wide range of printing systems.
- Sicherheit und Compliance
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Sicherheit und Compliance ist gewährleistet durch Rechte/ Rollen, Protokollierung und Freigabeprozesse.
- Cryptographic serial numbers
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Serial numbers generated by SecIdent are not simple random numbers, but cryptographically generated codes. They are unpredictable and can be managed in large quantities.
- Automatische Chargendokumentation
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Maximale Flexibilität und 100% Datenhoheit mit der automatischen Chargendokumentation in SecIdent.
- Human-to-human support
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No automated responses, no boilerplate text, and no AI assistants. Every inquiry is handled individually by our experts.
Integrations
Full flexibility: up and down
Different software systems are often used, particularly in the collaboration between MAHs and CMOs. Thanks to numerous interfaces and configurable workflows, SecIdent offers smooth and secure data exchange with partners, without any implementation effort on either side.
Customers can create workflows in just a few minutes without any programming knowledge. This ensures maximum flexibility and prevents dependencies on suppliers and partners. All serialization data can be stored in SecIdent or accessed via it, allowing the entire serialization process to be controlled centrally in SecIdent.
SecIdent also allows seamless connection to existing printing and packaging systems. SecIdent transfers serial data and batch attributes such as GTIN, expiration date, batch number, and serial number to the printing systems. After successful printing, the accounting program integrated in SecIdent reports back any incorrect or unusable serial numbers. These are then automatically deactivated so that only valid serial numbers are registered in the EU hub.
Serialization process
From order to EU-wide registered batch
SecIdent supports every stage of a package's lifecycle, from master data maintenance to delivery and beyond. For example, it facilitates the process of issuing a recall.
Get in touch with us!
Get in touch & request a personal offer
During a free, no-obligation initial consultation, we will clarify how you can implement your serialization requirements with SecIdent. We would be happy to demonstrate the system to you and answer any questions you may have.
Are you considering switching providers?
Benefit from many years of expertise.
Changing systems sounds complicated and costly, and raises concerns about “friction losses.” We are aware of this and understand the fears associated with such a change.
Our experienced experts have already replaced existing systems on numerous occasions and will provide you with personal support right from the start. Regardless of whether it's a hard transition or a gradual changeover in parallel operation. We ensure that you, your employees, and your partners remain operational at all times and that the benefits of SecIdent are felt as quickly as possible.
Your partners—whether CMOs or MAHs—usually don't even notice the changeover. SecIdent continues to serve existing interfaces without any problems. For example, to TraceLink, Arvato, SAP, and many more.
Communication with partners who already use SecIdent also benefits from the elimination of all interfaces. In addition, this opens up a number of improvements, such as granular permissions, detailed audit trails, and immediate release of batches and serial numbers.
SecIdent® is a service provided by
BRAINORITY Software GmbH
Vor dem Lauch 15
70567 Stuttgart
Phone: +49 711 273603-15
E-Mail: anfrage@secident.com
