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.

Pharma-Verpackungen in der Drucklinie

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
Photo of Rainer

Dr. Rainer Gerkens

Head of Pharmaceutical Serialization

Serialization at Biokanol Pharma

The managing directors of Biokanol Pharma report on how SecIdent is used for secure serialization for different MAHs.

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

Convenient, fully integrated connection to the European Hub of the European Medicines Verification System. Onboarding included.

EMVS EU-Hub →

Collaboration with partners

Seamless collaboration with partners possible regardless of their systems or company size.

Collaboration with partners →

Accurate accounting

The accounting program integrated into SecIdent provides a clear overview of the printed serial numbers.

Accurate accounting →

Seamless printer connection

Easy-to-use interfaces allow for full flexibility across a wide range of printing systems.

Seamless printer connection →

Security and compliance

Security and compliance are ensured through rights/roles, logging, and approval processes.

Security and compliance →

Cryptographic serial numbers

Serial numbers generated by SecIdent are not simple random numbers, but cryptographically generated codes. They are unpredictable and can be managed in large quantities.

Cryptographic serial numbers →

Automatic batch documentation

Maximale Flexibilität und 100% Datenhoheit mit der automatischen Chargendokumentation in SecIdent.

Automatic batch documentation →

Support von Mensch zu Mensch

No automated responses, no boilerplate text, and no AI assistants. Every inquiry is handled individually by our experts.

First-class support →

Pharmaceutical Serialization CMO

Serialization with SecIdent Pharma at CMOs

We offer contract manufacturing organizations (CMOs) a powerful and proven solution with SecIdent Pharma for the smooth and legally compliant implementation of the Falsified Medicines Directive 2011/62/EU requirements. Our system covers the entire serialization process. It is based on efficient serial number management and seamless data exchange controlled by configurable workflows.

Challenges for CMOs:

  • Complex data exchange with partners: High costs associated with connecting to the different IT systems of various clients

  • Heterogeneous printing and IT landscape: Difficulties integrating new or different packaging lines into a uniform serialization process.

  • Lack of flexibility: Rigid processes that make it difficult to respond quickly to new customer requirements or short-term project changes.

Key advantages we offer CMOs in serialization:

  • Flexible data exchange with MAHs: SecIdent Pharma enables seamless collaboration with partners, regardless of their systems or company size. Existing interfaces with systems such as TraceLink, Arvato, SAP, and others are easily supported.

  • Easy connection of printing systems: Thanks to numerous interfaces, SecIdent can be seamlessly integrated into existing printing and packaging systems. New printing systems can be connected in minutes via workflows, no programming knowledge necessary.

  • High compliance thanks to integrated accounting program: After printing, SecIdent Pharma automatically deactivates incorrect serial numbers and transmits them to the MAH. This ensures that only valid data is registered in the EU hub.

Übersicht wie SecIdent Pharma bei CMOs genutzt wird

Pharmaceutical serialization MAH

Serialization with SecIdent Pharma at MAHs

SecIdent Pharma helps contract manufacturing organizations (CMOs) make production more efficient and flexible. It also gives marketing authorization holders (MAHs) the central control and legal protection essential for market access. We bridge the gap between contract manufacturers and regulatory requirements, ensuring that your products reach the market safely and in compliance with the law.

Challenges for MAHs:

  • Complex connection: The technical hurdles and susceptibility to errors involved in manually connecting to the EU hub (EMVS) are high.

  • Documentation burden: The concern about presenting incomplete validation documents during inspections ties up enormous resources.

  • Heterogeneous partner landscape: Every CMO uses different systems. Data exchange often consists of different formats.

Here are the key pillars we use to support manufacturers with serialization:

  • Seamless EU Hub Connection: With BrainGate, we provide a fully integrated connection to the EMVS European Hub.

  • Compliance: With every SecIdent Pharma release, you receive complete validation documentation to ensure audit readiness.

  • Centralized control of your partners: Our workflows allow for easy exchange of data with partners, regardless of the systems they use. You can release individual batches on a targeted basis. All serialization data is stored centrally in SecIdent, so you always have 100% sovereignty over your product data.

Übersicht wie SecIdent Pharma bei MAHs genutzt wird

Serialization process

From order to EU-wide registered batch

As a serialization system, SecIdent covers the entire lifecycle of a package. From master data maintenance to registration with the EU hub.

Level 2-5

SecIdent Pharma: Serialization system at level 2-5

Levels 2 & 3: Efficient control at the line and site levels.

SecIdent Pharma receives prepared order data from the ERP system and adds cryptographically generated, tamper-proof serial numbers to it. This data is then transmitted to the printing systems at Level 2. After printing, an automatic data comparison takes place. Successfully generated numbers are reported back, and faulty units are immediately deactivated and fully documented by the system.

Level 4: Central Administration

At this level, SecIdent Pharma communicates with your existing ERP systems or provides all necessary product information as a standalone system. This allows us to fully implement the functions of an ERP system for smaller companies in the context of serialization.

Level 5: Global Networking and EU Hub Connection

The connection to the outside world is fully automated via our BrainGate gateway. All relevant data is transmitted to the European Hub (EMVS) and national repositories without manual intervention. This guarantees secure data exchange with the authorities. Thanks to existing interfaces, we also ensure seamless interoperability with external partners and their third-party systems, such as SAP, TraceLink, and Arvato.

Seamless printer connection

Easy-to-use interfaces allow for full flexibility across a wide range of printing systems.

Seamless printer connection →

Accurate accounting

The accounting program integrated into SecIdent provides a clear overview of the printed serial numbers.

Accurate accounting →

Flexible data exchange with workflows

Write or read data flexibly from third-party systems with freely configurable workflows. This also works locally on the intranet.

Workflows →

EMVS EU-Hub

Convenient, fully integrated connection to the European Hub of the European Medicines Verification System. Onboarding included.

EMVS EU-Hub →

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.

Your company situation

If you tell us a bit about your company and current processes, we can address your situation more specifically.

Your contact details

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