Serialisation has been mandatory for the pharmaceutical industry since 2019. The EU Falsification Directive is a challenge for logistics processes and compliance. This costs time and ties up staff. With Lean FMD, medAspis revolutionises FMD in terms of compliance and speed.
The Falsified Medicines Directive enables comprehensive digital monitoring of logistics processes. What digital footprints does your company leave behind? How do the authorities deal with counterfeit alerts? Find out the most important answers now and how you can protect yourself.
Simply scan 100% GxP compliant, error-free and lightning fast in one go:
» At three different locations, we move 1.2 billion pharmaceutical packages every year. Therefore, Lean FMD and its resulting efficiencies are perfect for us. The medAspis experts also accompanied us during the implementation according to GxP guidelines on every single step. They responded flexibly and competently to our wishes and implemented them together with us. The FMD solution is now perfectly integrated into our own systems.
Our conclusion: medAspis is a strong partner in every respect. «
» medAspis is responsible for the rapid recording of 2D codes in our incoming goods department. Batch control and verification are carried out in the same step, which saves time. The order data comes from Microsoft Dynamics and the data for the finished orders is saved back there. This means that everything in the system is always up to date, fully automatically. medAspis sends the serial numbers to our onboarding partner Tracekey for further processing. «
» For reasons of efficiency, we need a simple and accurate FMD process. The medAspis solution can transfer all data directly to our ERP system. We also appreciate the ability to capture data only. We scan in goods receipt and export later without having to scan again. That really makes our work easier. «
» medAspis has been working for us since the beginning of the Falsified Medicines Directive. We have always been impressed by the speed at which it works. It makes our work even faster and more precise than before. We have gradually integrated more and more functions into our IT. All important data now flows fully automatically into our SAGE system. «
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medAspis Lean FMD covers all requirements for connecting your company to the NMVS responsible for you for the purpose of falsification checks in accordance with the EU Falsification Directive 2011/62/EU and Delegated Regulation (EU) 2016/161.
And much more…
The mobile FMD Speed Scanner is extremely user-friendly with its touchscreen and is full of surprises. Here are some of its features explained:
Scanning continues even without internet. Codes are stored and processed later.
Monitors batches and products in real time and reports deviations immediately.
The scanner stops instantly on error. Scanning continues only after confirmation.
A control number shows missing packs instantly. Just rescan the last row – everything is recorded.
The scanner scans while the server verifies in the background for maximum speed.
Duplicate scans are detected and filtered automatically – no manual checks required.
Das medAspis Lean FMD System ist das Gehirn hinter dem FMD Speed Scanner. Hier werden alle Scan-Ergebnisse gesammelt und weiter verarbeitet.
PIN-protected profiles control access and allowed FMD functions securely.
All scan data is available for further processing and export.
System interface and NMVS messages are displayed in your local language.
Packs, cartons and pallets are logically and transparently linked.
Aggregations can be shared easily or provided to customers.
Groupings with a unique aggregation code for secure processing.
Links packs with delivery note, customer or carton.
Original codes and full NMVS responses are stored completely and permanently.
Web service interface for direct access to all system data in JSON format.
All scan data is archived for at least five years.
Verification is performed directly at scan via NMVS with instant feedback.
Custom reports by product, batch or time period.
Complete overview of all FMD activities as an audit trail.
Central system control with access to all data.
mit medAspis Lean FMD können Sie auf kritische Fälschungsalarme reagieren. Fehlalarme werden verhindert, die übrig gebliebenen kritischen Fälle werden sicher erkannt und können verarbeitet und dokumentiert werden.
Expert support for all questions related to counterfeit alerts.
Structured documentation of all critical alerts.
Clear instructions for operators and supervisors in every alert case.
All critical alerts clearly displayed in the control panel.
All critical situations explained clearly at a glance.
Additional verification before decommissioning returned packs.
Zeitfenster bis zu 2 Stunden – ideal für Pausen und Schichtwechsel.