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Arvato CSDB - Efficient & Secure

Serialization in drug production

The Technology
Benefits
Overview
CRPT as a partner
Downloads
References (extract)

IT and Process Consulting That Ensure Your Medicines Are Forgery-Proof

The global healthcare market is undergoing some major changes. Both politicians and the commercial sector are placing an ever-greater focus on drug safety, as more and more countries hammer out the legal framework necessary to ensure that a clear system of labeling for medication packaging is established. Currently several government initiatives are already in place to help combat drug falsification and billing fraud.


What exactly does serialization mean for market participants such as pharmaceutical manufacturers, contract manufacturers, marketing authorization holders and wholesalers?

The serialization experts at Arvato Systems have developed a comprehensive and fully proven serialization solution for the healthcare segment that provides end-to-end cover for the entire process chain. This portfolio includes solutions for commercial entities from small companies to globally active business groups and also covers National Verification Systems.


Find out here how the Arvato CSDB, the solution of the many years of experience gained from our international teams, has been implemented so that you and your company are equipped to deal with future requirements in drug protection.

The Serialization Process: More Than Just a Code on a Package

Whether your activities are restricted solely to a national market or you are engaged in international operations, you must ensure you meet all legal requirements for protecting against drug forgery. In doing this, however, it is important that: Your serialization solution isn't something that just operates in a back corner of your data center. Instead, it is vital that it is directly tied to your ERP software, production and packaging machinery, your external service provider's operating systems and an overarching national verification process.

This means a lot of integration, adaptation of processes and high security precautions. You should deal with the topic early on and put your business processes to the test:

A reliable serialization system must include the integration of product lines, partners, customers and suppliers.

An important component is the data matrix code and serial number that make each package uniquely identifiable.

Data is stored by the manufacturer in the manufacturer database and then verified when dispensed at the pharmacy.

The Technology: Arvato CSDB

ArvatoSystems_Grafik_Technology_CSDB_EN

We offer business solutions & consulting expertise for various target groups

Marketing authorisation holder (MAH)

Contract manufacturing organization (CMO)

Pharmaceutical Wholesalers

EU countries

Pharmaceutical industry active in Russia

Marketing authorisation holder (MAH)

Due to the ever-increasing global regulatory requirements, the topic of serialization is becoming a significant issue for the pharmaceutical marketing authorization holder. Within the production process, they must ensure that the various requirements are implemented before their goods can be released for marketing. Therefore it is recommended that the marketing authorisation holder introduces a system that supports him in orchestrating the relevant serialization processes across all stakeholders.


Arvato Systems offers such a solution with the Arvato CSDB, which not only exchanges master and production data with your business partners very easily via standard interfaces, but also fills the relevant data in the national systems. This enables smooth marketing and prevents additional costs.

Contract manufacturing organization (CMO)

As a contract manufacturer, it is essential for you to design your production processes, which includes the serialization process, efficiently and to network with your customers very easily and flexibly to exchange relevant serialization data. The Arvato CSDB offers you the possibility to orchestrate production orders between the packaging lines and your partner very efficiently. 


On the one hand, the Arvato CSDB offers standard interfaces to all well-known line manufacturers to ensure smooth communication with your machinery. On the other hand, we use the Arvato CSDB gateway technology to request or receive production orders and serial numbers securely from your customers. 

Pharmaceutical Wholesalers

According to the Falsified Medicines Directive, pharmaceutical wholesalers are also required to verify products physically in their possession and, if necessary, to decommission them. Wholesalers must carry out these processes in different cases.


Based on its experience in the digitization of business processes in the logistics sector, Arvato Systems supports and assists licensed pharmaceutical wholesalers with the necessary change processes. The core of this offering is the Arvato Smart Logistics Platform - Healthcare Suite. This in turn is part of the proven platbricks platform (Arvato Smart Logistics Platform), which has been supporting logistics companies in digitizing their business processes since 2016.

EU countries

Arvato Systems currently supplies National Verification Systems for 17 countries in Europe and successfully connects them to the EU hub. The European Medicines Verification Organization has selected the expert for serialization & anti-counterfeiting as its official service provider. Arvato Systems relies on its own team to implement numerous projects in an international environment.

Pharmaceutical industry active in Russia

Similarly to the countries of the European Union and the United States, for example, Russia has also developed a system for serializing medications. With regard to the timeframe, the transition period for the mandatory marking and reporting of pharmaceuticals to the state information system was extended from January 1, 2020 to July 1, 2020. 


We provide you with a detailed white paper on "Serialization of Medications in Russia", in which we explain how companies in the pharmaceutical industry can use our know-how to meet the ambitious requirements in order to continue to operate in Russia.

The Arvato CSDB Combines All the Required Serialization Steps:

Ensuring internal systems & processes are connected, exchange of relevant data
It generates and manages serial numbers
It forms the interface between product lines and the corresponding customers, suppliers & production sites
Data can be reported to the appropriate National Verification Systems
Corresponding reports can be produced - whether the manufacturer is in China, the U.S. or the EU

We Are Able to Provide the Right Solution for All Countries

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Overview

Toolbox

A comprehensive toolbox for a flexible serial number management

Integration

A flexible integration for well-known product manufacturers, external service providers, partners and customers. On-premise and Software-as-a-Service solutions available

Security

High safety and security standards for data storage and transfer

Pricing

Clear and transparent pricing with with customized prizing options & reward systems for long-term customers

Scalability

High scalability of the IT-solution which can be enhanced during the project lifecycle and can be adapted under changing circumstances

Integration

Automated adaption and connection to all important stakeholders and supply chain partners and seamless integration into existing IT landscapes

Reporting

Reliable reporting of all serialization events

Know-how

Regulatory Know-how: Numerous European countries trust Arvato Systems to operate their National Verification Systems

Experience

Experience & expertise: Arvato Systems offers its customers an in-depth understanding of the entire value chain and serialization processes

Press release

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Arvato Systems has been officially named as integration, software and tested solution partner for the Russian Center for Research in Perspective Technologies (CRPT) and was recently added to the CRPT website. We are looking forward to the continued good cooperation!

Arvato Systems: Experts in Serialization

We believe that proximity to our customers is the key to success. With locations around the world, we are always close to them. We understand their needs and have the right solutions.


Whereas industries, such as IT, are well accustomed to the use of serial numbers, for pharmaceutical companies, this is something completely new. Serial numbers have been used for many years on products such as CD-ROM packaging as a proof of authenticity. Because Arvato produces CD-ROMs for software and computer games, so we already know the security regulations required and are thoroughly aware of the demands that comprehensive serial number pools place on technology, administration and organization – valuable experience in serialization projects that we are able to bring to our work in the pharmaceutical industry.

Downloads

Download White Paper: Serialization of Medications in Russia

The MDLP system operated by the Russian company CRPT is the only one of its kind in the world in terms of its scope and complexity. The Russian legislature and the numerous guidelines it stipulates pose a great challenge to manufacturing and selling companies. Download our latest White Paper and learn, among other things, details on how crypto code works, helpful background information, and how you can draw on our many years of expertise and proven IT solutions to implement the serialization of medication for the Russian market by the applicable deadline.

Download Checklist: Serialization readiness in the drug production

As a CMO or a MAH, you need to deal with the already existing as well as the future requirements. We enable you by proving the checklist to gain a valuable overview of the most important topics, with which you should deal and gain clarity.

References (extract)

Serialization

Aenova Group implements the requirements of the Falsified Medicines Directive with the help of the Arvato CSDB IT serialization solution

FMD-compliant

Application of the serialization solution Arvato CSDB at Basic Pharma.

Serialization: Efficient & Secure

Bausch & Lomb uses Arvato CSDB for serialization.

Protection for end users

Serialization for counterfeit protection: Arvato CSDB at Dr. Kade.

Counterfeit proof medicines

Implementation of Arvato CSDB - IT solution for successful drug serialization according to the Falsified Medicines Directive

EU-FMD compliant

Genericon relies on serialization solution Arvato CSDB.

Compliant with the FMD

Arvato CSDB at Grünenthal.

Drug Protection

Pharma Stulln serialized with the Arvato CSDB.

Medication safety

Successful serialization in medicine production with the help of Arvato CSDB

Solution for Pharmaceutical Logistics

Arvato Systems uses logistics solution to fulfill FMD at Yusen Logistics.

Safe Medications

Wörwag Pharma uses the serialization solution Arvato CSDB.

We Rely on Strong Partners

Eqeep Consulting B.V.

Arvato Systems adds Eqeep Consulting B.V. as implementation partner for serialization solution in the Dutch and Belgian healthcare markets. Further joint projects and training by Eqeep for customers in the serialization environment are planned for the future.

TRAXEED - Körber Solutions

We are strengthening our consultancy competencies regarding healthcare division and track & trace projects through the cooperation with TRAXEED. Together we have long-term experiences concerning international implementation projects and stand by our customers side as a strong and reliable partner along the whole supply chain in the pharmaceutical industry.

WIPOTEC-OCS

WIPOTEC-OCS offers state of the art global Track & Trace solutions through its TQS – Traceable Quality System. Over 600 successfully implemented projects reflect the premium quality and reliability valued by our customers. We stand for open interfaces, in-depth expertise in T&T and long term partnerships.

Your Contact for Arvato CSDB

MA_ArvatoSystems_Gurpreet-Singh
Gurpreet Singh
Expert for Serialization and Verification Systems in the Pharmaceutical Industry, US