Compliance check-up:
Better safe than sorry
Better safe than sorry
Compliance check-up:
Better safe than sorry
Better safe than sorry
Companies in the pharmaceutical industry are validated and meet strict quality specifications. However, there is a considerable compliance risk around the topic of FMD: The suspected cases of counterfeiting that occur again and again in daily operations are not recognised, processed and documented in a GxP-compliant form.
With our free, anonymous and non-binding Compliance Check-up, we analyse and evaluate all critical alerts of your company. To let you know where you stand and how vulnerable you are.
By law (Delegated Regulation § 39), the authorities have the right to see all reports of potential falsification cases. For up to five years. In other words, not a single suspicion of falsification escapes the authorities. Upon request, you must be able to provide information about each individual case: What happened, how was the case handled?
With our cost-free Compliance Check-up, we conduct a comprehensive analysis of GxP compliance based on your existing FMD audit trail:
The analysis takes place entirely within your data system. So you don’t need to disclose any data. Everything remains anonymous.
Yes. We offer our Compliance Check-up to potential clients free of charge. On the one hand, we want to make you aware of potential risks. On the other hand, we would like you to get to know us: medAspis – The FMD Company. We can only do one thing. But that properly. FMD.
We work closely with all NMVOs and know the respective processes in the countries very well. And we are happy to support you in ensuring that FMD functions efficiently and in compliance with GxP.
Cost-free and non-binding FMD Compliance Check-up for GxP compliance.
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.