SecIdent Pharma is a proven, affordable pharmaceutical serialisation software for generating, distributing and reporting unique identifiers across the EU. It creates cryptographically secured serial numbers, passes them to your packaging lines or contract manufacturers and reports them to the EMVS EU Hub.
Whether you are implementing the requirements for the first time or replacing an existing system, both routes end at the same result. The difference lies in how the project is scoped, not in the system.
Head of Pharmaceutical Serialization
April 10, 2026
A server in Europe isn't enough. Real sovereignty means knowing who operates your data — and being able to leave at any time.
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On 7 May at interpack 2026 in Düsseldorf: SecIdent and Wipotec demonstrate live how DPP-compliant 2D codes are generated and transmitted directly to the packaging line — no rebuilding, fully …
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Change providers in pharmaceutical serialization without risk: Learn how SecIdent Pharma secures your production through parallel migration and expert support.
September 4, 2025
Biokanol Pharma setzt seit vielen Jahren erfolgreich auf SecIdent Pharma! Sehen Sie hier, wie SecIdent Pharma bei unserem Kunden Biokanol Pharma eingesetzt wird.
The effort rarely sits in the software. It sits in the chain around it: master data from the ERP, number ranges, handover to the packaging line, feedback on verified and rejected units, EMVS onboarding. We build that chain together with you and supply the validation documentation you will need to produce in an audit.
A migration rarely fails on technical grounds. It fails on the worry about live batches and established partner connections. Both can be protected: SecIdent continues to serve existing interfaces to systems such as SAP, TraceLink or Arvato, and the switch can run in parallel operation. Your clients and contract partners usually notice nothing.
Serialisation requirements do not sit in a single legal text. Directive 2011/62/EU, the Falsified Medicines Directive, makes safety features mandatory. The operational detail comes from Delegated Regulation (EU) 2016/161, which supplements Directive 2001/83/EC with detailed rules on the safety features appearing on the packaging of medicinal products for human use. It has applied since 9 February 2019.
Safety features come in two parts. The unique identifier holds the product code, serial number, batch number and expiry date, with a national reimbursement number added in some member states. The serial number is randomly generated, so it cannot be derived. Alongside it sits an anti-tampering device that makes opening evident.
The code is a GS1 Data Matrix. Data elements are flagged by application identifiers, so every scanner in Europe recognises the same fields. The ECC200 error correction standard keeps the code readable even where printing is damaged or imperfect. Serial numbers are handed over to the printing lines under full logging.
Before shipping, the marketing authorisation holder reports every serial number to the EU Hub of the European Medicines Verification System, or EMVS, which distributes the data to the national repositories. At the point of dispensing, the pharmacy checks the number and decommissions it. Unknown or duplicate numbers raise an alert.
Repackaging or relabelling a medicine destroys the existing safety features, which must then be replaced with equivalent ones. Parallel importers therefore need the same functions as manufacturers, plus a documented mapping between the original and the replacement identifier. The original is decommissioned in the EMVS and the new one reported.
| Funktion von SecIdent | Bedeutung für Sie |
|---|---|
| Cryptographic serial numbers | Non-derivable, globally unique, manageable at high volumes |
| EMVS EU Hub connection | Fully automated transmission via the BrainGate gateway |
| Packaging line integration | Handover to Level 2, automatic reconciliation, immediate decommissioning of faulty units |
| Reconciliation | Auditable view of numbers generated, printed, rejected and reported |
| Partner data exchange | EPCIS events and other common exchange formats, whichever system the partner runs |
| Third-party system integration | Existing interfaces to SAP, TraceLink, Arvato and other serialisation systems, with no custom development |
| Rights, roles, logging | Separation of duties, audit trail, defined release workflows |
| Validation documentation | Complete validation documentation for every release |
SecIdent Pharma takes order data from the ERP system, adds the serial numbers and transfers them to the packaging lines. After printing, successfully generated numbers are reported back, while faulty units are decommissioned in the system and documented.
Communication with existing ERP systems. Where no ERP covers serialisation, SecIdent Pharma can run as the leading system.
Transmission to the EU Hub and the national repositories via BrainGate, with no manual steps. External partners and their third-party systems connect through the existing interfaces.
Biokanol Pharma has used SecIdent for several years across multiple MAHs, heterogeneous production lines and growing serial number volumes. The company's managing directors describe how the system works in their day-to-day production environment.
The managing directors of Biokanol Pharma report on how SecIdent is used for secure serialization for different MAHs.
SecIdent Pharma takes into account the specific requirements of the various stakeholders in the pharmaceutical supply chain.
Manufacturers and MAHs benefit from centralized control of all serialization processes, clear release workflows, and transparent partner integration.
CMOs use flexible workflows and standardized interfaces to work efficiently with different clients and system environments.
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.
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
A complete list of questions and answers is available on our FAQ page.
Only if you submit packs to the EMVS yourself, which is the MAH. Most MAHs use it for automated master data, pack upload, updates and alerting. CMOs usually do not need it, since they do not submit to the EMVS, and a very small MAH can use SecIdent to export PackData files and upload them manually through the EMVO Gateway. SecIdent runs with or without BrainGate.
Yes, you must have successfully completed both the formal and technical onboarding processes at EMVS in order to use BrainGate. We are happy to assist you with the latter, from applying for certificates to commissioning BrainGate.
BrainGate simplifies the complicated authentication, encryption, and transmission mechanisms of the EU Hub and maps them to an easy-to-use, uniform RESTful API.
Furthermore, responses and alerts from the EU Hub can be received via numerous channels (HTTP, queue, email, etc.).
An intuitive user interface is also available for registering and updating product master data.
Absolutely yes. The purpose of BrainGate is to enable easy connection to existing software without in-depth knowledge of the EU hub's interface mechanisms.
You must have successfully completed the formal and technical onboarding process of the EMVS. We will assist you with the latter or take care of it entirely.
We use RESTful JSON for the BrainGate interfaces. Your software must support this.
Once you have completed the formal onboarding process at EMVS, we will assist you with technical onboarding and technical qualification for the EU hub. Once the connection has been successfully tested, we will support you with integration into your existing software and provide detailed interface documentation.
BrainGate is billed monthly. The price consists of a flat rate and a variable component based on the number of serial numbers. The price per serial number is also determined by the flat rate. The flat rate starts at EUR 300 plus VAT.
Yes. Your master data, batches and serials are yours. You can export them and move on with no lock-in.
SecIdent is billed monthly. The price calculation is based on the number of active serial codes. In addition, there is a fixed monthly flat rate, which is influenced by factors such as the number of products/users and the price per serial code.
Accordingly, the price varies depending on the package booked and the number of codes. All details can be found on our pricing page.
No. A serial is billed for being active in SecIdent, which is independent of whether and how the pack is submitted to the EMVS. Hub submission, whether automated through BrainGate or by manual PackData upload, has no bearing on the active count.
Only if you submit packs to the EMVS yourself, which is the MAH. Most MAHs use it for automated master data, pack upload, updates and alerting. CMOs usually do not need it, since they do not submit to the EMVS, and a very small MAH can use SecIdent to export PackData files and upload them manually through the EMVO Gateway. SecIdent runs with or without BrainGate.
It applies for as long as the serial stays active, which means as long as its batch is open in SecIdent. When you archive a batch, its serials go inactive, stop counting and are credited back.
Your plan. The higher the plan, the lower the fee per active serial. Plans also raise the number of products (GTINs), workflows and partners the platform handles for you.
A serial is active from the moment it exists in SecIdent and can be worked with, which is to say once it is in the system. That is the only billed metric. One active serial corresponds to one serialized package.
A quota is a fixed volume of active serials, prepaid at a discount. While you stay within it your invoice is flat every month, which makes cost predictable and easy to budget against your production plan.
Owned serials are the ones SecIdent generates for the packs you serialize. Foreign serials are generated elsewhere, for example by a MAH or a CMO you work with, and imported into SecIdent. Each foreign serial is stored on your behalf.
With GS1 Digital Link, every physical product gets a digital twin. This happens by integrating product-specific data into a web-enabled link in accordance with the GS1 standard. This link leads to a website that can be viewed by anyone. On this page, it is possible to contact the manufacturer and customer directly.
SecIdent can generate valid GS1 Digital Links with integrated serial numbers and transmit them to printing systems. Furthermore, online verification via sec.id is a compatible Digital Link resolver.
SecIdent can embed serial codes in any format for transmission and delivery. These include, for example:
SecIdent specializes in adapting to existing system environments as much as possible and actively connecting with them. This usually saves time-consuming integration projects and costs that are difficult to calculate.
There are four basic levels for integration:
No. Partners can retrieve serial numbers and metadata via API or transfer them via a configurable workflow (e.g., as an XML file). Furthermore, existing serial numbers can be imported from partners.
If your partner also uses SecIdent, additional functions for approval, process reliability, and logging can be used. However, this is not required.
SecIdent's basic licenses already cover a high level of availability and service quality. If you would like a separate SLA (e.g., for shorter response times or designated contact persons), we offer this at an additional cost.
SecIdent includes online help that explains how to use the software. In addition, there is detailed technical documentation for developers and external partners.
If you are unable to find the information you need in the manual, you can contact us via our ticket system and we will assist you with your request.
Optionally, our support team can also set up workflows for connecting to partners and printing systems.
SecIdent significantly reduces the validation effort by providing complete validation documentation for each software release, guaranteeing your audit security. The system architecture supports compliance through a detailed rights and roles concept, complete logging, and structured approval processes.
SecIdent thus offers a legally compliant solution in accordance with the Falsified Medicines Directive 2011/62/EU, which relieves pharmaceutical companies of the high documentation burden and maximizes process reliability.
SecIdent comes with all the features you need to ensure your serialization process runs smoothly from start to finish without any major implementation effort. And all this with maximum security and compliance.
Convenient, fully integrated connection to the European Hub of the European Medicines Verification System. Onboarding included.
Seamless collaboration with partners possible regardless of their systems or company size.
The accounting program integrated into SecIdent provides a clear overview of the printed serial numbers.
Easy-to-use interfaces allow for full flexibility across a wide range of printing systems.
Security and compliance are ensured through rights/roles, logging, and approval processes.
Serial numbers generated by SecIdent are not simple random numbers, but cryptographically generated codes. They are unpredictable and can be managed in large quantities.
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