In order to record and measure production processes or correlate them with planned processes, it is essential to be able to manually record data from production at the right time and in the right place using workstations and scanners and, if necessary, machine interfaces.
There is often already a large number of data collection systems in production - whether manual or electronic. However, these are usually isolated solutions and not integrated into a comprehensive production model.
A jumble of responsibilities and systems makes an integrated view of processes difficult and makes customization and expansion according to customer requirements a nightmare.
The customer-specific mapping of production processes and the appropriate data acquisition and integration with the system involved completes the production process in its entirety with a digital image.
ZFabrik builds on tried-and-tested approaches that guarantee a high degree of flexibility in software customization and delivery transparency for the customer on the one hand and ensure high reliability and excellent comprehensibility in error situations on the other.
Essential core elements such as user-friendly data capture, robust and transparent task processing and a high degree of reuse of proven solution designs on a highly integrated software platform that is maintainable in the long term enable us to provide sustainable customer solutions.
Due to regulatory requirements, various industries are required to provide end products or even semi-finished products and blanks with a unique, often randomized, serial number and to implement corresponding infrastructures for administration, itemization and reporting. The serialization of end products also serves as a supporting measure for counterfeit protection.
The European Falsified Medicines Directive (Directive 2011/62/) requires license holders and manufacturers of a large class of medicinal products to affix certain security features, in particular a unique serial number as text and barcode in combination with other data such as product code, batch number and expiration date.
Similar regulations apply to exports to other markets such as the Russian Federation, Turkey, Saudi Arabia and the USA.
The tasks of a software solution for pharmaceutical serialization range from the management of serial numbers to be used as well as serial numbers in use and integration with production equipment to integration with third-party systems of license holders and third-party manufacturers and the creation of reports to authority systems in accordance with specifications.
The secure handling of a variety of supply chain standards (GS1, Tag-Data, EPCIS, CBV) as well as the mastery of communication interfaces is an essential prerequisite.
However, serialization projects can only be successful with a software architecture that is able to work reliably with many millions of serial numbers and map complex workflows in a highly available, reliable and transparent manner.
We have been working in the field of serialization and counterfeit protection since 2010 and in production-critical serialization since 2015. We have significantly developed solutions for pharmaceutical serialization.
The Zf-Work for Pharma product offers a cost-effective level 3 track-and-trace solution for pharmaceutical serialization in production. Zf-Work for Pharma, which was developed in collaboration with tracekey solutions GmbH, perfectly complements the mytracekey PHARMA serialization process.
Our modern Level 3 solution is tailored to the individual needs of our customers and can be efficiently customized. The synchronization of master data and serial number status with mytracekey PHARMA follows a simple and streamlined process.
The Zf-Work for Pharma system implements the decoupling between the remotely operated Level 4 system and the local production environment to ensure secure execution of the serialization workflow on site, independent of the remote network.
The local serialization workflow ensures that all necessary master data and serial numbers are available to label sales units, packaging and logistics units in a compliant manner.
By using the technical interface of the Level 2 infrastructure, the Zf-Work for Pharma system can communicate with the packaging systems and transfer order data as well as (where possible) check the processing progress to ensure that the required quantity of merchentable units has been labeled for a batch.
During local serialization, Zf-Work for Pharma provides serial number tracking and the option for offline post-processing. Once labeling is complete and batch data has been verified, all batch serial number status updates are reported to the Level 4 system and batch production is complete.
The Zf-Work for Pharma system is flexibly adaptable and can be integrated with additional technical infrastructure on site as required. Standardized software logistics, which include both our and customer-specific code, ensure complete, auditable transparency, even with regard to individual adaptations.
ZFabrik is not tied to Level 2 manufacturers and does not favor Level 2 implementations. The Zf-Work for Pharma system is open to all Level 2 systems that support a sufficient technical interface.