Arvato CSDB - Efficient & Secure
Serialization in drug production
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:
The Technology: Arvato CSDB
We offer business solutions & consulting expertise for various target groups
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
We Are Able to Provide the Right Solution for All Countries
Overview
Toolbox
A comprehensive toolbox for a flexible serial number management
Connection
Flexible connection of well-known line providers, external service providers, partners and customers. On-premise and as Software-as-a-Service solution
Security
High safety and security standards for data storage and transfer
Master Data Management
Simple maintenance with small manual effort
Scalability
Problem-free expansion during the project life cycle to meet changing conditions
Integration
Extensive, automated adaptation and connection to all important stakeholders and external supply chain partners as well as seamless integration into existing IT landscapes
Reporting
Reliable and transparent with small manual effort
Shipping Orders
Create shipping orders from the database or by scan. Receiving shipping orders
Production Management
Progress display of production at lines in the CSDB UI, import of operating data for further evaluation of KPIs
EU-Hub Product and Package Registration
Simplified registration in the EU-Hub of batches and status changes
Press release
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.
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