MedTracker The future-proof software solution for serialization and track & trace applications

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1 MedTracker The future-proof software solution for serialization and track & trace applications Audit-proof production management for efficient processes Machine-independent software architecture Royalty-free licenses, no "click charge" Modular, extendable system architecture

2 With MEDTRACKER the world to serialization and track & trace is open to you Does legislation throughout the world force you to code pharmaceutical products with unique serial numbers and to assure their traceability in the logistics chain of the consumer? Be it as a drug manufacturer, contract manufacturer or as a contract packer? Before you start dealing with the acquisition of expensive machinery to comply with the regulations, it is wise to think about what the software should look like and how it would be able to securely and reliably control and monitor all necessary processes. With MEDTRACKER from Atlantic Zeiser the world to serialization and track & trace is open to you. Futureproof and for any region of the world. We will show you how MEDTRACKER can make your processes more secure and efficient. MEDTRACKER is able to reliably generate unique serial numbers and store them permanently and securely. For the production of different drugs MEDTRACKER is able to administrate an almost infinite amount of number ranges even when they are produced and packed at the same time on multiple lines or machines for different countries, markets or customers. Many countries have issued different regulations regarding coding principles, workflows and forwarding of data. All requirements have already been implemented in MEDTRACKER and can be adapted and administrated easily.

3 Modular system architecture MEDTRACKER adapts to and grows with your needs If regulations change, it is possible at any time to simply adapt the corresponding coding principles in MEDTRACKER without the need for reprogramming. MEDTRACKER is a one-stop system solution for serialization and track & trace processes, which can also be used as intelligent production management software on machine, line, site or enterprise level. For this purpose, MEDTRACKER provides a multitude of functional modules which can be implemented via generic interfaces for a real-time communication with a wide range of different machines. MEDTRACKER licenses are perpetual and royalty-free. No "click charge" will be applied, no matter how many serial numbers are generated or managed. However a maintenance contract involving yearly fees is available if required. It is possible at anytime to consider an extended workflow by additional functional software modules. Thanks to the modular software architecture of MEDTRACKER, this is possible without the need of costly revalidations or qualifications of the software.

4 These and many other features of MEDTRACKER are available on demand MEDTRACKER sends all serialization data to the printing modules of a packaging line and subsequently registered them with their actual status (provided, printed, verified, rejected) for further use in the MEDTRACKER database. Serialization orders can be imported from ERP system and assigned to the available packaging lines without the danger of repeating serial numbers. Jobs that are already in production can be relocated if lines or machines are needed for another job. MEDTRACKER allows controlling and administrating aggregation processes in automatic packaging lines, as well as manual procedures. The amount of aggregation hierarchies can be adapted freely without the need for programming. It is also possible to manage the repacking in the logistic process or warehouse with MEDTRACKER. For new product configurations it is possible to initiate a release process before starting mass production. This feature guarantees the highest level of process safety. Audit relevant information will be generated and protected against manipulation within MEDTRACKER database, and the authorized user can analyze and print them anytime. In addition, the user management is based on predefined user groups with specific rights according to EudraLex- Volume 4 GMP & CFR 21 Part 11 which enhances process security, minimizes potential sources of errors and renders MEDTRACKER audit-proof.

5 Find out how MEDTRACKER can make your processes more secure and efficient MEDTRACKER can be linked with common ERP systems and renders MEDTRACKER a comprehensive one-stop solution for serialization and track & trace applications on line, site or enterprise level. MEDTRACKER can also be installed on virtual servers which means depending on the actual situation that no additional invest is necessary for IT-Server-hardware or IT-infrastructure. In the field of pharmaceutical packaging MEDTRACKER is the future-proof software solution for serialization and track & trace projects which is able to adapt to your specific requirements and that grows with your needs. Find out how MEDTRACKER can make your processes more secure and efficient.

6 MEDTRACKER is the centerpiece of the system solution from Atlantic Zeiser for the implementation of secure and efficient serialization and track & trace processes in the pharmaceutical industry. In addition, Atlantic Zeiser offers as a one-stop solution provider a wide range of systems and modules which are ideally suited for the use in connection with MEDTRACKER. MedTracker Compatible MEDILINE T&T: modular inline coding module for errected and filled cartons with integrated interface to MEDTRACKER MEDILINE CodeCollect M : manual aggregation unit with ergonomic operation and central serialization solution DIGILINE Versa: complete system for late stage customization an serialization for flat cartons DIGILINE Single: stand-alone high-performance system for the serialization of flat cartons DIGILINE Compact: entry-level personalization and coding solution for short-run printing on flat cartons and cardboard blanks DIGILINE Blister: high-quality, variable digital printing on blister lid foil for small and medium-size batches DIGILINE Label: high-speed label printer for late stage coding and serialization of flat labels in highest quality and durability Atlantic Zeiser leverages its combined competencies to meet your requirements Management software solutions Inkjet printing systems Individualization systems Ink Atlantic Zeiser s excellent service and support Efficient preventive and corrective maintenance Fast emergency and extended service support Installation and start-up support Remote service support and hotline Customized and individual after-sales service concepts Tailor-made service contracts Professional training and workshops Worldwide service network with local service teams incl. part and supply service Consulting ATLANTIC ZEISER Germany Bogenstrasse Emmingen Phone Fax sales@atlanticzeiser.com ATLANTIC ZEISER Americas 15 Patton Drive West Caldwell New Jersey Phone Fax sales@atlanticzeiserusa.com ATLANTIC ZEISER GB 53 Central Way Andover, Hants. SP10 5AN Phone Fax sales@atlanticzeiseruk.com ATLANTIC ZEISER Italy Via Varesina Milano Phone Fax azsrl1983@atlanticzeiser.it ATLANTIC ZEISER France 1 rue du Bulloz PAE des Glaisins Annecy le Vieux Phone Fax info@atlanticzeiser.fr ATLANTIC ZEISER South East Asia No. 7, Jalan Equine 1G Pusat Komersil Equine, Taman Equine Seri Kembangan, Selangor Malaysia Phone sales@atlanticzeiser-asia.com PR310 04/18 Technical specifications and design subject to change without notice. Copyright by Atlantic Zeiser.