Pharmaceutical Serialization
By working with ZFabrik, we have been able to integrate all business partners with whom we work to implement the complex requirements for serialization. We are pleased to have a very competent service provider at our side in ZFabrik, who also makes practicable suggestions for processes and - if necessary - involves us in the design.
A particularly positive aspect is the optimal availability for support requests, which are usually processed immediately and completed on the same day.
Dr. Torsten Brand
Project Manager Serialization at L-A-W Services GmbH
L-A-W Services GmbH, Leipziger Arzneimittelwerk, is a contract manufacturer for pharmaceuticals and other product classes such as medical devices, cosmetics and food supplements. The company produces non-sterile liquid and semi-solid dosage forms. The requirements of the EU Falsified Medicines Directive are implemented for prescription medicines.
Since 2017, L-A-W Services GmbH has been using the Seritrack serialization solution from Giesecke & Devrient GmbH, which was developed in close cooperation with ZFabrik.
Seritrack is used to organize the application of serial numbers during the packaging of prescription medicines and to implement reporting to connected marketing authorization holders via all common interfaces in accordance with the specifications. Seritrack also enables the creation of the reports required for the transmission of serialization data to the EMVO (European Medicines Verification Organisation).
In 2018, ZFabrik took over the support, maintenance and further development of this software solution for L-A-W Services GmbH.
The Seritrack software is based on a modular software architecture and ZFabrik's z2-Environment runtime environment.
Our software architecture and our development approach have contributed massively to the fact that the existing solution is very easy to maintain and can be expanded according to customer requirements.
In the meantime, the software has been expanded in close coordination with L-A-W's quality management team to include numerous features that enable our customer to integrate with other partner companies for pharmaceutical serialisation, in particular label manufacturers and subcontractors.
ZFabrik is very pleased with the successful operation of the serialization system at L-A-W and is looking forward to the continuation of our fruitful cooperation.
Design and implementation of a tracking infrastructure for production
Our requirements for tracking materials along the production along the production chain are specific and must be met with high reliability. This could not be achieved with any standard product on the market.
We therefore decided to develop a special solution with ZFabrik.
Our expectations of ZFabrik were high and have always been met.
We are extremely satisfied with ZFabrik's performance - the implementation and operation of the software is excellent. Our special requirements were and are being met immediately, with very high quality work and a reasonable price-performance ratio.
We are delighted to have chosen ZFabrik and have been working in partnership with them for five years now.
Project manager (anonymised at the client's request)
Due to strict regulatory requirements, it was imperative for our customer to establish seamless, verifiable tracking of all individual items throughout the entire production process.
The overall solution had to guarantee complete data capture. To achieve this, the software had to digitally map complex manual work processes in a secure and comprehensible way and continuously enrich them with machine data.
In close co-operation with the customer's product experts on site, requirements were defined and an implementation plan established that made it possible to put the solution into live operation on time despite very ambitious deadlines.
The solution has been in use on individual units without interruption since 2015 - 100% availability is a mandatory requirement in order to fulfil the regulatory requirements and avoid interrupting production. The system has been fully implemented since 2017.
Since then, the solution has been extensively expanded and supplemented by a large number of complex data analyses and user processes.
However, the data generated is not only required by the government authorities, it is also very valuable for the customer itself, as the seamless mapping of the entire production process makes it possible to analyse production processes in a new and completely accurate way. For example, the available data is used to provide clients with absolutely transparent and reliable reports on production progress.
Over time, the customized solution has evolved into a software platform on which another of our customer's business units was able to quickly implement its solution.
Thanks to our modular and flexible software architecture based on ZFabrik's unique development approach and z2-Environment runtime technology, it is possible to maintain and expand the software cost-effectively.
What we have created together with the customer is trend-setting for this industry - we are very proud of this. The potential of the solution is far from exhausted and we are therefore delighted to be able to continue driving this challenging and successful project forward for our customer.
Platform for the SaaS solution
We are very happy to have been working with ZFabrik for so long. Z-Fabrik's extremely strong understanding of architecture has helped us to develop our mytracekey solution into the technology leader for SME serialisation solutions.
Dr. Stefan Hoffmann
Managing Director of tracekey solutions GmbH
Provision of the runtime environment, architecture and development in teamwork with the customer.
tracekey solutions GmbH implements solutions for the serialisation of pharmaceutical products and has become the No. 1 provider for medium-sized pharmaceutical manufacturers and licence holders in just a few years.
With a young, committed team, tracekey is dedicated to the continuous optimisation and adaptation of the Software-as-a-Service solution as well as the day-to-day support of its customers in the integration of the complex production and reporting network from the manufacturer to the national and international authorities.
Constantly expanding regulations, the multitude of solution providers and the addition of further business processes require great foresight and skilful planning in order to achieve the best result for the customer.
A solution that needs to be constantly adapted and yet must be permanently available in order to maintain the exchange of messages with globally distributed external systems requires a flexible, modularly expandable and scalable architecture.
tracekey uses ZFabrik's runtime environment z2-Environment and its consistent modularization approach in order to continue to meet the complexity requirements of a rapidly growing software platform in the future.
ZFabrik has accompanied tracekey from day one and actively supported it in design and development. We look forward to continuing our collaboration and further successes for tracekey!