Many pharmaceutical manufacturers outsource their logistics processes to third party logistics providers (3PL). They are also responsible for the serialisation processes around FMD. The situation is different when manufacturers use internal solutions for logistics. Then they must also comply with all FMD requirements within the framework of manual processes, i.e. above all:
In pharmaceutical production, the vast majority of serialisation processes run automatically. However, manual processes remain when processing individual packs or opened cartons. In cases like these employees will reach for the scanner. These manual processes represent a considerable time and cost factor, especially when tens of thousands of packs are scanned daily at several locations.
medAspis has recognised this specific requirement of pharmaceutical producers for serialisation and has developed a custom-fit solution: fast, integrable into the existing IT and secure.
Lean FMD provides you as a pharmaceutical manufacturer with the right solution to significantly accelerate time-consuming and personnel-intensive serialisation processes around FMD.
Lean FMD is perfectly tailored to your needs as a pharmaceutical manufacturer. This means that our service also meets your high compliance and GDP requirements at the same time, in order to reduce risks and ensure quality. With the zero-alert strategy, there are virtually no more false alarms that are reported to the authorities. Only extremely few real suspected counterfeit cases remain. In these cases, we support you with our unique know-how and provide the right solution: from practical instructions for scanning staff to the professional handling of critical counterfeiting suspicions. Thus, there is no reason for the authorities to examine the issue of FMD more closely during the next audit.
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.